Archive for the ‘Hypogonadism’ Category

TheGlobal Steroids Market isexpected to grow at a CAGR of XX% during the forecast period, 2017-2025.Increase in geriatric population drives the androgens and anabolic steroids market, as older men are more prone to hypogonadism. Additionally, rise in obesity in men propels the global androgens and anabolic steroids market.

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The increasing poor health status especially in the developing countries is projected to fuel the growth of the market during the forecast period. Moreover, rise in government initiatives for better health care is attributed to the growth of the global androgens and anabolic steroids market.This report analyses the future prospects of Global Steroids Market.

Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

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Top Key Companies Analyzed in Global Steroids Market are PFIZER Novartis Merck Sanofi Johnson And Johnson GSK Astrazeneca Cipla Sumitomo

Key benefit of this report: This report provides current market trends and future growth expectations. This report examines the market size and changing competitive dynamics It covers information regarding key drivers, challenges or restraining market growth It provides a five-year forecast assessed on the basis market value chain, porters five forces, and supply chain management. Market factor analysis delivers treasured information regarding the possible purchasers and suppliers and understanding the stakeholders involved. This report incorporates data regarding companies and business decision by having complete insights on the markets and by creating in depth analysis of market segments.

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Major Points Covered in Table of Contents:1. Executive Summary2. Demographic Overview3. Research Methodology4. Premium Insights5. Market Overview6. Market Factor Analysis7. Market Segment by Types8. Market Segment by Application9. Market Segment by Routes of Administration10. Market Segment by End User11 Market Segment by Regions12 Market Trends & Competitive Analysis

13 Company ProfilesAuthor ListDisclosure SectionResearch MethodologyData Source

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COVID-19 Impact on Global Steroids Market 2020: Industry Trends, Size, Share, Applications, SWOT Analysis by Top Key Players and Forecast Report to...

RALEIGH, N.C., May 21, 2020 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals announced today that the United States Patent and Trademark Office (USPTO) has issued two key patents related to its lead asset, Kyzatrex*. Kyzatrex is an oral Testosterone Replacement Therapy (TRT) that uses an innovative formulation to improve effectiveness and safety.

These allowed claims will provide strong IP protection to December 2030, over 8 years of potential commercial runway. They supplement Marius Pharmaceuticals already robust global patent portfolio for Kyzatrex, which includes granted patents in the European Union, Canada, China, Taiwan, Japan, New Zealand and other key markets, and pending applications in India, and US. Marius Pharmaceuticals patent portfolio includes filings that extend protection to 2033, with the potential to extend protection out to 2040.

The allowed claims protect Kyzatrex, an innovative formulation designed to increase bioavailability and provide a favorable pharmacokinetic (PK) profile compared to other therapeutic alternatives. Om Dhingra, Chief Executive Officer of Marius commented This innovation is truly exceptional as we have created a formulation with a unique PK profile which we believe drives important clinical significance.

Marius Pharmaceuticals Chief Financial Officer Shalin Shah said We are very pleased to strengthen the intellectual property portfolio for Kyzatrex and excited that it has tremendous potential to be differentiated and unique option in the TRT space. We are also drawing a line in the sand between a new treatment paradigm and old testosterone therapies.

Marius Pharmaceuticals has recently completed its pivotal Phase 3 study for Kyzatrex and intends to submit its New Drug Application (NDA) to the Food & Drug Administration (FDA).

About Kyzatrex

Kyzatrex is an experimental therapy for the treatment of primary and secondary hypogonadism (congenital or acquired). Testosterone is a crucial hormone that plays key roles in human growth and development and a wide range of other functions including metabolic and cardiovascular. Sources estimate that 15 million men in the United States suffer from hypogonadism, but only approximately 10% are currently treated. The co-morbidities of men suffering from hypogonadism are also a significant burden on patients and the healthcare system, these include Type 2 Diabetes and other serious chronic conditions.

Current marketed treatments are dominated by painful injections and messy topical applications with transference risk. Kyzatrex is an orally administered therapy, which avoids those drawbacks. Market research points to 93% of patients indicating they would ask their physician about Kyzatrex and more than half would consider a switch from their current regimen.

About Marius Pharmaceuticals

Marius pharmaceuticals is a cutting-edge biopharma company focusing on treating widespread conditions that have been triggered primarily through Androgen deficiency. Our pipeline consists of assets focused on inflammation while our commercial arm is at the forefront of data science technologies core to our commercialization of our lead asset Kyzatrex.

*Kyzatrex is a tentative Tradename currently under review with the FDA

For more information, contact:Shalin Shahshalin@mariuspharma.comwww.mariuspharma.com

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Marius Pharmaceuticals Announces Issuance of Two Key Patents Protecting its Proprietary Oral Testosterone Therapy - Yahoo Finance

Analysis Report on Male Hypogonadism Market

A report on global Male Hypogonadism market has hit stands. This study is based on different aspects like segments, growth rate, revenue, leading players, regions, and forecast. The overall market is getting bigger at an increased pace due to the invention of the new dynamism, which is making rapid progress.

The given report is an excellent research study specially compiled to provide latest insights into critical aspects of the Global Male Hypogonadism Market.

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Some key points of Male Hypogonadism Market research report:

Strategic Developments: The custom analysis gives the key strategic developments of the market, comprising R&D, new product launch, growth rate, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale.

Market Features: The report comprises market features, capacity, capacity utilization rate, revenue, price, gross, production, production rate, consumption, import, export, supply, demand, cost, market share, CAGR, and gross margin. In addition, the report offers a comprehensive study of the market dynamics and their latest trends, along with market segments and sub-segments.

Analytical Tools: The Global Male Hypogonadism Market report includes the accurately studied and assessed data of the key industry players and their scope in the market by means of a number of analytical tools. The analytical tools such as Porters five forces analysis, feasibility study, and many other market research tools have been used to analyze the growth of the key players operating in the market.

COVID-19 Impact on Male Hypogonadism Market

Adapting to the recent novel COVID-19 pandemic, the impact of the COVID-19 pandemic on the global Male Hypogonadism market is included in the present report. The influence of the novel coronavirus pandemic on the growth of the Male Hypogonadism market is analyzed and depicted in the report.

The global Male Hypogonadism market segment by manufacturers include

Competition Landscape

This analytical research report on the global male hypogonadism market is a complete package, which includes intelligence on key participants underpinning the market expansion. In the last chapter of the report, which elucidates the competitive scenario of the market, strategies implemented by the market players, along with their product overview, company overview, key financials, key developments and SWOT analysis has been rendered exhaustively. In addition, region-wide spread of these market players, their future expansion plans, market shares, revenues, and mergers & acquisition activities between them have been described in detail in this concluding chapter of the report. An intensity map has been employed in the report to profile the market players situated across geographies.

Research Methodology

Credibility of the researched statistics and data is backed by the unique research methodology employed by the analysts at PMR, which ensures higher accuracy. PMRs research report on the global male hypogonadism market can assist its readers in gaining detailed insights on many different aspects governing the market around key regional segments included in the report. The report readers can further slate key strategies for tapping into vital revenue pockets and gaining benefits over the intensifying competition in the market. Information presented in the report has been scrutinized and monitored thoroughly by PMRs industry experts. Figures and numbers offered in the report have also been validated by the analysts in order to facilitate strategic decision making for the report readers.

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Important queries addressed in the report:

Moreover, the report highlighted revenue, sales, manufacturing cost, and product and the States that are most competitive in the lucrative market share idea. There is a discussion on the background and financial trouble in the global Male Hypogonadism economic market. This included the CAGR value during the outlook period leading to 2025.

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The Economic Impact of Coronavirus on Male Hypogonadism Market Analysis and Value Forecast Snapshot by End-use Industry 2019-2021 - 3rd Watch News

Scientists have found in a new study that men who have lower levels of testosterone have a higher risk of dying from coronavirus if they ever catch the disease. In the study, researchers have discovered that in 45 COVID-19 patients admitted in the intensive care unit in a German hospital, testosterone plays a crucial role in their survival against the deadly virus.

Researchers found that the broad majority of men admitted had significantly low testosterone levels. Without an ample supply of the sex hormone, the body won't be able to regulate its immune response, which could lead to a deadly 'cytokine storm.' They have found that testosterone may be capable of keeping the body's immune system from going out of control.

In the study, the researchers evaluated the first 45 COVID-19-positive patients admitted to the ICU at the University Medical Center Hamburg-Eppendorf. Thirty-five of the patients were men, while ten were women. Seven of the patients required oxygen, and 33 of them required the use of ventilation.

Before the patients received any invasive procedures, their hormone levels were assessed on their first day of admission to the ICU. Samples from the patients were tested for 12 hormones, along with testosterone and dihydrotestosterone.

Of the male COVID-19 patients sent to ICU at the German hospital, more than 68% recorded low levels of testosterone. On the contrary, the majority of female patients had elevated testosterone levels. Of all the participants in the study, nine men and three women died.

Although low levels of testosterone can not curb the immune response in men, the study found that in female COVID-19 patients, higher testosterone levels were linked to a more compelling inflammatory response.

The sex hormone is known to aid in controlling the body's immune response. However, when a man has low levels of testosterone, the immune system is not at its best and can lead to further damage when contracting an infection.

This could possibly lead to a so-called cytokine storm, which occurs when the immune system goes berserk as it tries to kill the pathogen. A cytokine storm eventually begins injuring the body itself and, if left alone, can cause death.

Read Also: Testicles Are Serving as 'Reservoirs' For Coronavirus Making Men More At Risk of Longer and Severe Case of COVID-19: Study

Hypogonadism in men is a condition where the body doesn't produce enough of the sex hormone, testosterone. The hormone plays a crucial role in masculine growth and development during puberty.

Some men are born with hypogonadism, while others develop them later on in life, usually from infection or injury. Some types of the condition can be treated with testosterone replacement therapy.

The condition can undoubtedly reduce the quality of life and, in some cases, has resulted in the loss of livelihood and separation of couples. Testosterone has many vital actions involved in metabolism, vasculature, and brain function. Furthermore, the hormone also has well-known effects on bone and body composition.

Statistics prove that coronavirus seems to hit men harder than women. Experts say that some of it may be due to the behavior of men when it comes to tobacco smoke and drinking alcohol. Such lifestyle and behavior could predispose them to have more underlying diseases than women.

Another behavioral factor to consider is that men tend to seek medical care later in the course of disease than women do. Most women tend to act fast and consult their physicians right away, while men display the 'macho' attitude and avoid going to see their doctor as much as possible.

Biological factors could play a part in this too. Professionals say that men have weaker immune systems and that sex hormones involved in the process of how the immune system starts an inflammatory response to pathogens may also be involved.

Also Read: COVID-19 Male Patients to Receive Female Sex Hormones Estrogen and Progesterone To See if They Could Help Reduce Severity

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Men With Hypogonadism Leading to Low Testosterone Levels are More Likely to Die From the Coronavirus, Study Fi - Science Times

Therapeuticsmd

Moreover, the Male Hypogonadism Therapy report offers a detailed analysis of the competitive landscape in terms of regions and the major service providers are also highlighted along with attributes of the market overview, business strategies, financials, developments pertaining as well as the product portfolio of the Male Hypogonadism Therapy market. Likewise, this report comprises significant data about market segmentation on the basis of type, application, and regional landscape. The Male Hypogonadism Therapy market report also provides a brief analysis of the market opportunities and challenges faced by the leading service provides. This report is specially designed to know accurate market insights and market status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Table of Content

1 Introduction of Male Hypogonadism Therapy Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Male Hypogonadism Therapy Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Male Hypogonadism Therapy Market, By Deployment Model

5.1 Overview

6 Male Hypogonadism Therapy Market, By Solution

6.1 Overview

7 Male Hypogonadism Therapy Market, By Vertical

7.1 Overview

8 Male Hypogonadism Therapy Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Male Hypogonadism Therapy Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Male Hypogonadism Therapy Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 - Cole of Duty

Since the COVID-19 infection flare-up in December 2019, the malady has spread to right around 100 nations around the world with the World Health Organization proclaiming it a general wellbeing crisis. The worldwide effects of the coronavirus sickness 2019 (COVID-19) are now beginning to be felt, and will essentially influence the Healthcare Industry in 2020.

According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Company Profiles

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Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

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North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

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Male Hypogonadism Market to Witness over CAGR Growth in Revenue During the COVID-19 Pandemic - Germany English News

The global Androgen Replacement Therapy Market research report thoroughly explains each and every aspect related to the Androgen Replacement Therapy Market, which facilitates the reports reader to study and evaluate the upcoming market trend and execute the analytical data to promote the business. The growth trend forecasted on account of thorough examination offers in-depth information regarding the global Androgen Replacement Therapy Market. A pathway of development is offered by the market to the several connected networks of businesses under it, which include different firms, industries, organizations, vendors, distributors, and local manufacturers too. All the key Androgen Replacement Therapy Market players compete with each other by offering better products and services at a reasonable price in order to grab significant share at the regional and global level market.

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level. Furthermore, benefits related to application of testosterone replacement therapy include an increase in muscle tissue, overall surge in energy, and significant decrease in depression symptoms.

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This report sample includesBrief Introduction to the research report.Table of Contents (Scope covered as a part of the study)Top players in the marketResearch framework (presentation)Research methodology adopted by Coherent Market Insights

The report incorporates an estimated impact of strict standards and regulations set by the government over the market in the upcoming years. The market report also comprises exhaustive research done using several analytical tools such as SWOT analysis to identify the market growth pattern.

Top Manufacturers in GlobalAndrogen Replacement TherapyMarket Includes:AbbVie, Inc., Allergan Plc, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International Plc, Mylan N.V., Novartis International AG, Pfizer, Inc., Clarus Therapeutics, Ferring Holding SA, Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Upsher-Smith Laboratories, LLC, Dr. Reddys Laboratories, Bausch Health Companies Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical.

Regions & Countries Mentioned In The Androgen Replacement Therapy Market Report:

Key Highlights of the Table of Contents:

Androgen Replacement Therapy Market Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global market, years considered, and study objectives. Furthermore, it tuches the segmentation study provided in the report on the basis of the type of product and applications.

Androgen Replacement Therapy Market Executive Summary: This section emphasizes on the key studies, market growth rate,Competitive landscape, market drivers, trends, and issues.

Androgen Replacement Therapy Market Production by Region: The report provides information related to import and export, production, revenue, and key players of all regional markets studied are covered in this section.

Androgen Replacement Therapy Market Profile of Manufacturers: Analysis of each market player profiled is detailed in this section. This also provides SWOT analysis, products, production, value, capacity, and other vital factors of the individual player.

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Table of Contents

Report Overview:It includes the Androgen Replacement Therapy market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.

Executive Summary:This section of the report gives information about Androgen Replacement Therapy market trends and shares, market size analysis by region and analysis of global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.

Profiles of International Players:Here, key players of the Androgen Replacement Therapy market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.

Regional Study:All of the regions and countries analyzed in the Androgen Replacement Therapy market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.

An Overview of the Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus. As authorities encourage social distancing and consumers stay indoors, several businesses are hit. However, coherent, coordinated, and credible policy responses are expected to offer the best chance at limiting the economic fallout.

National governments and international bodies are focused on adopting collaborative efforts to encourage financial institutions to meet the financial needs of customers and members affected by the coronavirus. However, there are some sectors that have remained unscathed from the impact of the pandemic and there are some that are hit the hardest.

We, at Coherent Market Insights, understand the economic impact on various sectors and markets. Using our holistic market research methodology, we are focused on aiding your business sustain and grow during COVID-19 pandemics. With deep expertise across various industries-no matter how large or small- and with a team of highly experienced and dedicated analysts, Coherent Market Insights will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

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Androgen Replacement Therapy Market 2020 Coronavirus (Covid-19) Business Impact Future Forecast Assessed On The Basis Of How The Market Is Predicted...

Healthcare Business

Chris Lange

Aytu BioScience Inc. (NASDAQ: AYTU) has been a stock market darling since it broke onto the COVID-19 testing scene. As a result, the stock has absolutely exploded this year. Although many were concerned at the onset of the year about Nasdaq compliance, the stock price quickly quieted these concerns when COVID-19 hit the scene.

Aytu BioScience stock traded as low as $0.34 a share in February before it came out with a test to help fight the pandemic. Since then, the shares have reached as high as $2.99, but they have normalized and found a trading range between $1.25 and $1.65.

Testing for the coronavirus has become a lucrative field. Other companies specifically dealing with this include Quest Diagnostics Inc. (NYSE: DGX), Co-Diagnostics Inc. (NASDAQ: CODX) and Becton, Dickinson and Co. (NYSE: BDX). Their stocks have seen solid gains since they entered the coronavirus test business as well.

Aytu BioScience is a specialty pharmaceutical company. It focuses on the development and commercialization of novel products in the fields of hypogonadism (low testosterone), cough and upper respiratory symptoms, insomnia, and male infertility.

What has set this company apart from the rest is that it has secured an exclusive distribution agreement for the right to commercialize a rapid COVID-19 test. The company said that the test has been licensed from L.B. Resources in Hong Kong. It licensed North American rights from a product developer named Zhejiang Orient Gene Biotech.

The test is intended for professional use, at point of care. What stands out here is that the test is said to deliver clinical results in two to 10 minutes, wherever it is administered.

Late in April, the company announced that it has partnered with Sterling Medical Devices to finalize the development of the Healight platform technology. Basically, this tech is a novel endotracheal catheter that acts as a potential treatment for the coronavirus.

Management believes the Healight platform technology has the potential to affect outcomes positively for critically ill patients infected with coronavirus and other infections. Aytu, with support of the team at Cedars-Sinai, is working with the U.S. Food and Drug Administration (FDA). The aim is to determine an expedited regulatory process with the potential to enable near-term use of the technology initially as a coronavirus intervention for critically ill intubated patients.

Aytu BioScience held its 2020 annual meeting in late April. A few key developments there will have an impact on the direction of the company. To start, a few new directors will get their turn on the board.

In the meeting, stockholders elected Joshua Disbrow, Steven Boyd, Gary Cantrell, Carl Dockery, John Donofrio Jr., Michael Macaluso and Ketan Mehta to the companys board of directors for one-year terms.

Separately, stockholders approved an advisory vote on executive compensation and ratified the appointment of Plante & Moran as the independent auditor for the company for the 2020 year. Stockholders also approved the board of directors to authorize a reverse split of the companys common stock.

However, the board did not elect to proceed with a reverse stock split at that time. This decision is the result of Aytu regaining compliance with Nasdaq listing requirements, including having a $1.00 closing bid price for the companys common stock. Additionally, the board noted that effecting a reverse split would not be in the best interest of shareholders at the time.

Check out the companys 8-K from this meeting on the U.S. Securities and Exchange Commission website.

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COVID-19 Testing Continues to Lift Aytu BioScience Stock - 24/7 Wall St.

ENGLEWOOD, CO / ACCESSWIRE / May 7, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that the Company will present its operational results for the quarter ended March 31, 2020 on May 14, 2020, at 4:30 p.m. ET. The Company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information

1- 877-407-9124 (toll-free)1- 201-689-8584 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 34718.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/588844/Aytu-BioScience-to-Report-Fiscal-Q3-FY-2020-Results-and-Business-Update

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Aytu BioScience to Report Fiscal Q3 FY 2020 Results and Business Update - Yahoo Finance

Therapeuticsmd

The scope of the Report:

The report analyzes the key opportunities, CAGR, and Y-o-Y growth rates to allow readers to understand all the qualitative and quantitative aspects of the Male Hypogonadism Therapy market. A competition analysis is imperative in the Male Hypogonadism Therapy market and the competition landscape serves this objective. A wide company overview, financials, recent developments, and long and short-term strategies adopted are par for the course. Various parameters have been taken into account while estimating market size. The revenue generated by the leading industry participants in the sales of Male Hypogonadism Therapy across the world has been calculated through primary and secondary research. The Male Hypogonadism Therapy Market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Highlights of the Male Hypogonadism Therapy market study:

Speculations for sales:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Male Hypogonadism Therapy market. Additionally, it includes a share of every segment of the Male Hypogonadism Therapy market, giving methodical information about types and applications of the market.

Key point summary of the Male Hypogonadism Therapy market report:

This report gives a forward-looking prospect of various factors driving or restraining market growth.

It presents an in-depth analysis of changing competition dynamics and puts you ahead of competitors.

It gives a six-year forecast evaluated on the basis of how the market is predicted to grow.

It assists in making informed business decisions by creating a pin-point analysis of market segments and by having complete insights of the Male Hypogonadism Therapy market.

This report helps users in comprehending the key product segments and their future.

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Male Hypogonadism Therapy market

Chapter 2: Evaluating the leading manufacturers of the global Male Hypogonadism Therapy market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Male Hypogonadism Therapy market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Finally, the report global Male Hypogonadism Therapy market describes Male Hypogonadism Therapy industry expansion game plan, the Male Hypogonadism Therapy industry knowledge supply, appendix, analysis findings and the conclusion. It includes a through explanation of the cutting-edging technologies and investments being made to upgrade the existing ones.

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Market Research Intellect also provides customization options to tailor the reports as per client requirements. This report can be personalized to cater to your research needs. Feel free to get in touch with our sales team, who will ensure that you get a report as per your needs.

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Male Hypogonadism Therapy Market 2020 | Growth Drivers, Challenges, Trends, Market Dynamics and Forecast to 2026 - Cole of Duty

Given the debilitating impact of COVID-19 (Coronavirus) on the Male Hypogonadism market, companies are vying opportunities to stay afloat in the market landscape. Gain access to our latest research analysis on COVID-19 associated with the Male Hypogonadism market and understand how market players are adopting new strategies to mitigate the impact of the pandemic.

Analysis of the Global Male Hypogonadism Market

Persistence Market Research (PMR) recently published a market study which provides a detailed understanding of the various factors that are likely to influence the Male Hypogonadism market in the forecast period (20XX-20XX). The study demonstrates the historical and current market trends to predict the roadmap of the Male Hypogonadism market in the coming years. Further, the growth opportunities, capacity additions, and major limitations faced by market players in the Male Hypogonadism market are discussed.

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Regional Overview

Our team of analysts at PMR, trace the major developments within the Male Hypogonadism landscape in various geographies. The market share and value of each region are discussed in the report along with graphs, tables, and figures.

Competitive Outlook

This chapter of the report discusses the ongoing developments, mergers and acquisitions of leading companies operating in the Male Hypogonadism market. The product portfolio, pricing strategy, the regional and global presence of each company is thoroughly discussed in the report.

Product Adoption Analysis

The report offers crucial insights related to the adoption pattern, supply-demand ratio, and pricing structure of each product.

Company Profiles

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Key Takeways Enclosed in the Report:

Queries Related to the Male Hypogonadism Market Explained:

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The impact of the coronavirus on the Male Hypogonadism Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 20582019-2019 - Jewish Life News

Testosterone Cypionate Market report provides an in-depth analysis of the overall market over a period from 2020-2026. The Testosterone Cypionate Market report also provides the market impact and new opportunities created due to the COVID19 catastrophe.

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Testosterone Cypionate Market 2020-2025: Segmentation

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Breakup Product Type:200 mg/mL, 100 mg/mL

Breakup by Application:Primary hypogonadism, Hypogonadotropic hypogonadism, Late-onset hypogonadism

Geographic segmentation

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Testosterone Cypionate Market 2020: Potential growth, attractive valuation make it is a long-term investment | Know the COVID19 Impact | Top Players:...

Male hypogonadism is a failure of the testes that produce the male test hormone testosterone, sperm, or both. It can be due to a testicular disorder or the result of a disease process involving the hypothalamus and pituitary gland. The male hypogonadism market is anticipated to grow owing to increasing case of testosterone deficiency among men. However, high side effects is one of the major restraints for the market growth. Moreover, rising geriatric population all across the world coupled with rising cases of obesity and rheumatoid arthritis are expected to benefit the growth of the market in the forecast period.

Some of the key players of Male Hypogonadism Market:AbbVie Inc., Allergan plc, Astrazeneca plc, Bayer AG, Eli Lilly and Company Ltd., Endo International plc., Finox Biotech,, Laboratoires Genevrier, Merck & Co., Inc., Teva Pharmaceutical Industries Ltd.

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The Global Male Hypogonadism Market research report offers an in-depth analysis of the global market, providing relevant information for the new market entrants or well-established players. Some of the key strategies employed by leading key players operating in the market and their impact analysis have been included in this research report.

Segmentation by product type:Klinefelters Syndrome

Kallmann Syndrome

Pituitary Disorders

Others

Segmentation by Drug Delivery:Topical Gels

Injectable

Transdermal Patches

Others

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The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global Male Hypogonadism market based on product and application. It also provides market size and forecast till 2027 for overall Male Hypogonadism market with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America (SAM), which is later sub-segmented by respective countries and segments.

Fundamentals of Table of Content:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.5 Market by Application1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Male Hypogonadism Market Size2.2 Male Hypogonadism Growth Trends by Regions2.3 Industry Trends

3 Market Share by Key Players3.1 Male Hypogonadism Market Size by Manufacturers3.2 Male Hypogonadism Key Players Head office and Area Served3.3 Key Players Male Hypogonadism Product/Solution/Service3.4 Date of Enter into Male Hypogonadism Market3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Product4.1 Global Male Hypogonadism Sales by Product4.2 Global Male Hypogonadism Revenue by Product4.3 Male Hypogonadism Price by Product

5 Breakdown Data by End User5.1 Overview5.2 Global Male Hypogonadism Breakdown Data by End User

Continue for TOC

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Recent Facts that led Male Hypogonadism Market on top by 2027 with Top Key Players like AbbVie Inc., Allergan plc, Astrazeneca plc, Bayer AG, Eli...

The global Male Hypogonadism Therapy market study presents an all in all compilation of the historical, current and future outlook of the market as well as the factors responsible for such a growth. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities and threats of each Male Hypogonadism Therapy market player in a comprehensive way. Further, the Male Hypogonadism Therapy market report emphasizes the adoption pattern of the Male Hypogonadism Therapy across various industries.

The Male Hypogonadism Therapy market report examines the operating pattern of each player new product launches, partnerships, and acquisitions has been examined in detail.

The report on the Male Hypogonadism Therapy market provides a birds eye view of the current proceeding within the Male Hypogonadism Therapy market. Further, the report also takes into account the impact of the novel COVID-19 pandemic on the Male Hypogonadism Therapy market and offers a clear assessment of the projected market fluctuations during the forecast period.

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The key players covered in this studyEli LillyPfizerAbbVieNovo NordiskMerck KGaAMylanBayerTevaNovartisAbbottRocheEndo InternationalIpsenANI PharmaceuticalsTherapeuticsMD

Market segment by Type, the product can be split intoParenteralTransdermalOralOthersMarket segment by Application, split intoHospitalsDrugstoresOthers

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Male Hypogonadism Therapy status, future forecast, growth opportunity, key market and key players.To present the Male Hypogonadism Therapy development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Male Hypogonadism Therapy are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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The Male Hypogonadism Therapy market report offers a plethora of insights which include:

The Male Hypogonadism Therapy market report answers important questions which include:

The Male Hypogonadism Therapy market report considers the following years to predict the market growth:

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Why Choose Male Hypogonadism Therapy Market Report?

Male Hypogonadism Therapy Market Reportfollows a multi- disciplinary approach to extract information about various industries. Our analysts perform thorough primary and secondary research to gather data associated with the market. With modern industrial and digitalization tools, we provide avant-garde business ideas to our clients. We address clients living in across parts of the world with our 24/7 service availability.

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Addressing the potential impact of coronavirus disease (COVID-19) on Male Hypogonadism Therapy Market : Future Growth and Challenges Analyzed Aminet...

The report on Male Hypogonadism Market delivers a succinct analysis on industry size, regional growth and revenue forecasts for the upcoming years. The report further sheds light on significant challenges and latest growth strategies adopted by manufacturers who are a part of the competitive spectrum of this business domain

The report commences with a concise introduction to the Male Hypogonadism market, as well as the present market scenario, market size, a summary of similar industries, and accurate market share estimates.

The driving factors influencing the profitability scale of this business space and the annual growth rate of this industry over the forecast duration have been enumerated in the report. Substantial data with reference to the consumption patterns and rates and patterns of Male Hypogonadism market in conjunction with a conclusive overview of the price analysis is also provided.

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A synopsis of the geographical gist of the geographical landscape unveiled:

Report Objectives:

What are the pivotal highlights of Male Hypogonadism market?

The Male Hypogonadism market report basically is a detailed study of business sphere with respect to the driving forces influencing the dynamics of this industry, consumption value across various geographies, import and export patterns and volumes, and the contribution of major participants toward the Male Hypogonadism market expansion.

The Report Answers the key Questions

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Male Hypogonadism Market Key Players, Product and Production Information analys - News by aeresearch

Company has Partnered with Sterling Medical to Finalize the Development of Cedars-Sinai-Developed 'Healight' Medical Device for Use in Patients with Coronavirus

ENGLEWOOD, CO / ACCESSWIRE / April 27, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

"Sterling has been working with the Cedars-Sinai team for the past several weeks on a very accelerated schedule to develop this much needed device," said Dan Sterling, President of Sterling Medical Devices. "We are happy to now be partnering with Aytu to further advance this critical project as fast as we possibly can for the many patients in need."

"The Aytu team is very pleased to be working with Sterling Medical on this important development program and in the fight against coronavirus," stated Josh Disbrow, Chairman and CEO of Aytu BioScience. Disbrow further commented, "Sterling has a stellar reputation as a best-in-class medical device product firm with more than 21 years of experience, over 1,100 projects engineered, with none failing to receive FDA regulatory approval upon submission. Our team is actively engaged with our colleagues at Sterling in an effort to finalize the device development, with hope of enabling human use in the very near future."

The company believes the Healight platform technology has the potential to positively impact outcomes for critically ill patients infected with coronavirus and other infections. Aytu, with support of the team at Cedars-Sinai, is working with the FDA to determine an expedited regulatory process to potentially enable near-term use of the technology initially as a coronavirus intervention for critically ill intubated patients.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial in China and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, and compliance. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory approval of Class I, II and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21, CFR 820, and 21 CFR Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, our ability to enforce the exclusivity provisions of the distribution agreement, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, the manufacturer of the COVID-19 Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, our ability to obtain additional COVID-19 Rapid Tests to meet demand, our ability to secure additional tests if the manufacture of the COVID-19 Rapid Tests is unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/587152/Aytu-BioScience-Signs-Development-Agreement-with-Sterling-Medical-Devices-to-Advance-the-Development-of-Healight-as-a-Potential-Coronavirus-Treatment

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Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment...

SEATTLE, April 23, 2020 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, the global human immunoglobulin (pH4) for intravenous injection (COVID-19) market is estimated to be valued at US$ 43,205.8 million in 2020, and is expected to exhibit a CAGR of 12.7% during the forecast period (2020-2027).

Key Trends:

Key trends in the market include viral disease outbreaks, the increasing prevalence of chronic lymphocytic leukemia, and demand for immune globulin products in the market.

According to the American Cancer Society around 60,530 new cases of leukemia will be diagnosed in the U.S in 2020 out of which 21,040 new cases will be of chronic lymphocytic leukemia (CLL).

Similarly, according to the Cancer Research UK, around 3,500 new cases of chronic lymphocytic leukemia (CLL) were diagnosed in the U.K in 2017.

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Moreover, the growing demand for immune globulin (IG) products is expected to drive the human immunoglobulin (ph4) for intravenous injection (COVID-19) market growth. For instance, on August 12, 2019, the U.S. Food and Drug Administration (FDA) confirmed that demand for immune globulin products has increased in recent years and there is a shortage of Immune Globulin (Subcutaneous) (IGSC) and Immune Globulin (Intravenous) (IGIV) products in the U.S. The U.S. Food and Drug Administration is working closely with manufacturers such as Asceniv, Bivigam, Octagam, Panzyga, Privigen and others of various immune globulin (intravenous) (IGIV) products to help mitigate the supply situation for IG products.

Key Market Takeaways:

Key players operating in market are

Takeda Pharmaceutical Company Limited, Baxter International Inc., CSL Behring, Bayer AG, Grifols, S.A., Octapharma AG, Shanghai RAAS Blood Products Co., Ltd., Hualan Biological Engineering Inc., China Biologic Products, Inc., Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., Boya Bio-Pharmaceutical Group Co., Ltd., ADMA Biologics, Inc., and Sinopharm Group Co., Ltd.

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Market Segmentation:

Related Topics:

HEALTHCARE CONTRACT RESEARCH OUTSOURCING MARKET

Healthcare Contract Research Outsourcing is conducted by pharmaceutical and medical device sectors for development of new drugs and medical devices. Clinical trials form the key part of pharmaceutical drug and medical device development and in the current scenario clinical trials are conducted across multiple locations in various geographies. Increasing cost and time required for drug development is expected to propel growth of the global healthcare contract research outsourcing market over the forecast period.

Read more @ https://www.coherentmarketinsights.com/market-insight/healthcare-contract-research-outsourcing-market-3788

ANDROGEN REPLACEMENT THERAPY MARKET

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level.

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Global Human Immunoglobulin (pH4) for Intravenous Injection (COVID-19) Market to Surpass US$ 99,772.2 Million by 2027 - CMI - GlobeNewswire

Global Male Hypogonadism Market: Snapshot

Hypogonadism in males refers to a condition in the male body where the testes show a significantly reduced level of functioning than normal. The overall result of male hypogonadism is a reduction in the rate of biosynthesis of male sex hormones. This state is more commonly known as interrupted stage 1 puberty. Hypoandrogenism, or the low androgen or testosterone level in a male can vary in severity from person to person. It is often the cause of partial or complete infertility. There are multiple forms of male hypogonadism and even more ways to classify them. Most endocrinologists commonly classify male hypogonadism on the basis of the level of defectiveness of the male reproductive system.

In many cases, doctors also measure the level of gonadotropins to classify a patient between primary and secondary male hypogonadism. Primary male hypogonadism refers to the cause of the condition being due to defective gonads. There are different types of primary male hypogonadism, including Turner syndrome and Klinefelter syndrome. Secondary male hypogonadism is caused by defects in pituitary or hypothalamic glands. They include Kallmann syndrome and hypopituitarism.

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Global Male Hypogonadism Market: Overview

Male Hypogonadism refers to a clinical condition, wherein the testes fail to produce enough testosterone leading to delayed puberty or incomplete development. The condition is related to impaired development of muscle mass, development of breast tissues, impaired body hair growth, and lack of deepening of the voice.

The male Hypogonadism market can be segmented by therapy, type, drug delivery, and geography.

The report presents an in-depth analysis of the global male hypogonadism market with current trends and future estimates to explain the imminent investment pockets. The quantitative analysis of the market for the forecast period from 2017 to 2025 will enable stakeholders to capitalize on the prevailing growth opportunities.

Global Male Hypogonadism Market: Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

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Male Hypogonadism Market Analysis On Trends and Need 2025 - Latest Herald

The Male Hypogonadism Market globally is a standout amongst the most emergent and astoundingly approved sectors. This worldwide market has been developing at a higher pace with the development of imaginative frameworks and a developing end-client tendency.

Given the debilitating impact of COVID-19 (Coronavirus) on the Male Hypogonadism market, companies are vying opportunities to stay afloat in the market landscape. Gain access to our latest research analysis on COVID-19 associated with the Male Hypogonadism market and understand how market players are adopting new strategies to mitigate the impact of the pandemic.

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The worldwide Male Hypogonadism market is an enlarging field for top market players,

Company Profiles

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This Male Hypogonadism report begins with a basic overview of the market. The analysis highlights the opportunity and Male Hypogonadism industry trends that are impacted the market that is global. Players around various regions and analysis of each industry dimensions are covered under this report. The analysis also contains a crucial Male Hypogonadism insight regarding the things which are driving and affecting the earnings of the market. The Male Hypogonadism report comprises sections together side landscape which clarifies actions such as venture and acquisitions and mergers.

The Report offers SWOT examination and venture return investigation, and other aspects such as the principle locale, economic situations with benefit, generation, request, limit, supply, and market development rate and figure.

Quantifiable data:-

Geographically, this report studies the top producers and consumers, focuses on product capacity, production, value, consumption, market share and growth opportunity in these key regions, covering North America, Europe, China, Japan, Southeast Asia, India

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Research objectives and Reason to procure this report:-

Finally, the global Male Hypogonadism market provides a total research decision and also sector feasibility of investment in new projects will be assessed. Male Hypogonadism industry is a source of means and guidance for organizations and individuals interested in their market earnings.

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The impact of the coronavirus on the Male Hypogonadism Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 20682019-2019 - Jewish Life News

Therapeuticsmd

Global Male Hypogonadism Therapy Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Global Male Hypogonadism Therapy Market Regions and Countries Level Analysis

The regional analysis is a very complete part of this report. This segmentation highlights Male Hypogonadism Therapy sales at regional and national levels. This data provides a detailed and accurate analysis of volume by country and an analysis of market size by region of the world market.

The report provides an in-depth assessment of growth and other aspects of the market in key countries such as the United States, Canada, Mexico, Germany, France, the United Kingdom, Russia and the United States Italy, China, Japan, South Korea, India, Australia, Brazil and Saudi Arabia. The chapter on the competitive landscape of the global market report contains important information on market participants such as business overview, total sales (financial data), market potential, global presence, Male Hypogonadism Therapy sales and earnings, market share, prices, production locations and facilities, products offered and applied strategies. This study provides Male Hypogonadism Therapy sales, revenue, and market share for each player covered in this report for a period between 2016 and 2020.

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We offer state of the art critical reports with accurate information about the future of the market.

Our reports have been evaluated by some industry experts in the market, which makes them beneficial for the company to maximize their return on investment.

We provide a full graphical representation of information, strategic recommendations and analysis tool results to provide a sophisticated landscape and highlight key market players. This detailed market assessment will help the company increase its efficiency.

The dynamics of supply and demand shown in the report offer a 360-degree view of the market.

Our report helps readers decipher the current and future constraints of the Male Hypogonadism Therapy market and formulate optimal business strategies to maximize market growth.

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Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Male Hypogonadism Therapy market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Male Hypogonadism Therapy market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Male Hypogonadism Therapy Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

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Male Hypogonadism Therapy Market Analysis by Size, Share, Top Key Manufacturers, Demand Overview, Regional Outlook And Growth Forecast to 2026 Cole...

SEATTLE, April 23, 2020 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, the global human immunoglobulin (pH4) for intravenous injection (COVID-19) market is estimated to be valued at US$ 43,205.8 million in 2020, and is expected to exhibit a CAGR of 12.7% during the forecast period (2020-2027).

Key Trends:

Key trends in the market include viral disease outbreaks, the increasing prevalence of chronic lymphocytic leukemia, and demand for immune globulin products in the market.

According to the American Cancer Society around 60,530 new cases of leukemia will be diagnosed in the U.S in 2020 out of which 21,040 new cases will be of chronic lymphocytic leukemia (CLL).

Similarly, according to the Cancer Research UK, around 3,500 new cases of chronic lymphocytic leukemia (CLL) were diagnosed in the U.K in 2017.

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Moreover, the growing demand for immune globulin (IG) products is expected to drive the human immunoglobulin (ph4) for intravenous injection (COVID-19) market growth. For instance, on August 12, 2019, the U.S. Food and Drug Administration (FDA) confirmed that demand for immune globulin products has increased in recent years and there is a shortage of Immune Globulin (Subcutaneous) (IGSC) and Immune Globulin (Intravenous) (IGIV) products in the U.S. The U.S. Food and Drug Administration is working closely with manufacturers such as Asceniv, Bivigam, Octagam, Panzyga, Privigen and others of various immune globulin (intravenous) (IGIV) products to help mitigate the supply situation for IG products.

Key Market Takeaways:

Key players operating in market are

Takeda Pharmaceutical Company Limited, Baxter International Inc., CSL Behring, Bayer AG, Grifols, S.A., Octapharma AG, Shanghai RAAS Blood Products Co., Ltd., Hualan Biological Engineering Inc., China Biologic Products, Inc., Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., Boya Bio-Pharmaceutical Group Co., Ltd., ADMA Biologics, Inc., and Sinopharm Group Co., Ltd.

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Market Segmentation:

Related Topics:

HEALTHCARE CONTRACT RESEARCH OUTSOURCING MARKET

Healthcare Contract Research Outsourcing is conducted by pharmaceutical and medical device sectors for development of new drugs and medical devices. Clinical trials form the key part of pharmaceutical drug and medical device development and in the current scenario clinical trials are conducted across multiple locations in various geographies. Increasing cost and time required for drug development is expected to propel growth of the global healthcare contract research outsourcing market over the forecast period.

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ANDROGEN REPLACEMENT THERAPY MARKET

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level.

Read more @ https://www.coherentmarketinsights.com/market-insight/androgen-replacement-therapy-market-3787

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Global Human Immunoglobulin (pH4) for Intravenous Injection (COVID-19) Market to Surpass US$ 99,772.2 Million by 2027 - CMI - Yahoo Finance

ENGLEWOOD, CO / ACCESSWIRE / April 23, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced the signing of a definitive agreement (the "Agreement") with Singapore-based Biolidics, Limited (SGX: 8YY; "Biolidics") to exclusively distribute Biolidics' COVID-19 IgG/IgM Rapid Test in the United States.

Under the terms of the Agreement, Aytu will exclusively distribute Biolidics' COVID-19 IgG/IgM rapid antibody test in the United States. Aytu has committed to purchase 500,000 tests within one business day from the date of signing of the Agreement. As an additional component of Aytu's exclusivity, the Company has committed to purchase a minimum of 1,250,000 tests within the first three months of the Agreement.

Biolidics' COVID-19 IgG/IgM Rapid Test has been issued Provisional Authorization for distribution by Singapore's Health Science's Authority (HSA), and the product has been authorized for export from Singapore. Biolidics' COVID-19 IgG/IgM Rapid Test will be supplied from Biolidics' facility in Singapore.

Aytu will collaborate with Biolidics and lead the U.S. clinical trials processes and plans to complete and obtain U.S. Food and Drug Administration ("FDA") 510k regulatory filing clearance of the COVID-19 IgG/IgM rapid test kits.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are pleased to be partnering with Biolidics in distributing this COVID-19 rapid test in the U.S. With the continued call in the United States for increased COVID-19 testing, we are entering this distribution Agreement at an excellent time. We have experienced significant demand for our current COVID-19 rapid test, so adding this test to our product offering will enable us to better meet the high demand in the U.S. We look forward to a productive working relationship with Biolidics and thank them for their confidence in allowing Aytu to take this product to market in the United States."

Incorporated in 2009 and listed on the Singapore Stock Exchange, Biolidics Limited is a Singapore-based precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, risks associated with the our COVID-19 rapid tests including our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufactures of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the Company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test and Healight-Related Inquiries:

COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/586556/Aytu-BioScience-Announces-Exclusive-Distribution-Agreement-for-COVID-19-IgGIgM-Rapid-Test-with-Singapore-Based-Biolidics-Limited

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Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited - Yahoo Finance

Chinese Officials Confirm China Won't Restrict Exports of Medical Products Needed to Fight Coronavirus

Company in Late-Stage Negotiations to Secure Distribution Agreement for Additional COVID-19 IgG/IgM Rapid Test Which is Approved by China's National Medical Products Administration (NMPA)

ENGLEWOOD, CO / ACCESSWIRE / April 17, 2020 / Aytu BioScience, Inc. (AYTU), (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that export and delivery of the Company's incoming COVID-19 rapid tests remains on track as previously announced.

Additionally, the Company is in late-stage negotiations to secure rights to distribute a second COVID-19 IgG/IgM rapid test, which is approved by China's National Medical Products Administration (NMPA).

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "Since the Company began taking the fight to COVID-19, we have continued to aggressively search for and evaluate diagnostic tests and other novel technologies that may complement our current product offering and benefit COVID-19 patients. Also, given the nationwide shortage of tests, we believe we are obligated to secure as many additional tests as we can to help with this shortage. To that end, I am excited to say we're in the final stages of securing yet another IgG/IgM antibody rapid test for U.S. distribution. This test is already approved by China's NMPA, is being regularly exported from China, and has strong clinical performance. By securing this additional antibody test, we expect to have an even greater supply to fulfill the substantial demand we're experiencing. We all need to continue to do the very best we can to help COVID-19 patients and those medical professionals for whom they care."

Mr. Disbrow continued, "On March 31, an announcement was made by China's Ministry of Commerce restricting the export of medical materials that have not obtained approval from the NMPA. It is important to note that just yesterday the Associated Press released an article titled, China says no plans to limit export of anti-virus supplies.' The article states: Commerce Ministry spokesman Gao Feng said Beijing has taken steps to speed up customs clearance while ensuring the quality of exported epidemic-prevention goods. Gao said Thursday, China has not and will not restrict the export of epidemic prevention materials.' These statements provide us with confidence and are consistent with the information we continue to receive from our test kit licensor. We remain confident about the timely delivery of the Company's incoming order of COVID-19 IgG/IgM tests," commented Mr. Disbrow.

Mr. Disbrow concluded, "We have received further confirmation that the COVID-19 IgG/IgM Rapid Test manufactured by Zhejiang Orient Gene is in the approval process with NMPA. We remain highly confident in the test's clinical performance as recently demonstrated in a published, third-party peer-reviewed study and believe that the Zhejiang Orient Gene COVID-19 IgG/IgM Rapid Test is a reliable test in detecting COVID-19 antibodies. The independent study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives, which we believe establishes strong clinical utility of the test."

The Company will continue to inform our stakeholders about our continuing developments relating to our COVID-19 fight and the progress of the Aytu BioScience business.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Story continues

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing Zhejiang Orient Gene's COVID-19 Rapid Test (the "COVID-19 Rapid Test"), shipping delays or regulatory processes and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, Zhejiang Orient Gene's ability to manufacture the COVID-19 Rapid Test on a high volume scale, manufacturing problems, customs problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, Zhejiang Orient Gene's ability to obtain approval from China's National Medical Product Administration ("NMPA") to continue to manufacture and export the COVID-19 Rapid Test, the impact the ongoing disputes surrounding COVID-19 between the People's Republic of China and the United States of America may have on our ability to import additional COVID-19 Rapid Tests from Zhejiang Orient Gene, our ability to successfully identify and enter into an agreement with an alternative manufacture of a COVID-19 rapid test that is approved by the NMPA, the timing of any agreement with an alternative manufacture of a COVID-19 rapid test, any reputational or business harm that we may incur in the event the COVID-19 Rapid Test is not reliable or accurate in testing for COVID-19, any reputational or business harm that we may incur for selling the COVID-19 Rapid Test from a manufacture that is not currently approved by the NMPA, whether the testing standards of the NMPA are comparable to the FDA's standards and any market inference whether positive or negative that may be derived from selling rapid tests that are or are not manufactured by companies approved by the NMPA, scientific and market acceptance of antibody tests as acceptable tests for the detection of COVID-19, the reliability of independent third-party study as it relates to the measure of effectiveness of the COVID-19 Rapid Test, our ability to obtain COVID-19 rapid tests from NMPA approved manufactures on acceptable terms, our ability to meet the demand for COVID-19 rapid tests, unfavorable media coverage related to the COVID-19 Rapid Test, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/585517/Aytu-BioScience-Confirms-Export-and-Incoming-Delivery-of-COVID-19-IgGIgM-Rapid-Tests

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Aytu BioScience Confirms Export and Incoming Delivery of COVID-19 IgG/IgM Rapid Tests - Yahoo Finance

Independent clinical study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives

ENGLEWOOD, CO / ACCESSWIRE / April 16, 2020 / Aytu BioScience, Inc. (AYTU), (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that results from an independent clinical study using the Company's licensed Coronavirus Disease 2019 ("COVID-19") IgG/IgM Rapid Test were published in the journal Infection Ecology & Epidemiology, further validating the accuracy, specificity and performance of the antibody rapid test.

In this recently published clinical study which included 29 COVID-19 positive cases confirmed by PCR and 124 healthy donors, the rapid test showed an overall specificity of 100% and 99.2% for IgM and IgG, respectively. The authors note, "The high negative predictive value indicates that the rapid test will be useful for detecting past infections and possible immunity, which may be crucial for restoring social functions after lockdown."

Capillary blood samples or serum from PCR-confirmed COVID-19 patients were analyzed with results from the COVID-19 IgG/IgM Rapid Test. Sixty-nine percent of samples from PCR-confirmed COVID-19 patients tested IgM positive, and 93.1% tested IgG positive. These results are well in line with the previously reported specificity of 91.9% for IgG and IgM. The authors note that variability in samples obtained during COVID-19 disease or convalescence period means that in the PCR-confirmed cases, antibodies may not yet have had time to develop. If this were the case, sensitivities of the test could actually be higher.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented "This independently conducted study, which was peer-reviewed and published earlier this week, demonstrates the clinical performance of this COVID-19 IgG/IgM rapid test and establishes the test's utility in understanding a patient's past exposure to COVID-19 and its potential to assess patient immunity as we move past this pandemic and get our society back to work. We are happy to see a leading clinical institution further establish the clinical utility of this important serological test."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has now been validated in multiple independent trials and is CE marked.

https://www.tandfonline.com/doi/full/10.1080/20008686.2020.1754538

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

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Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/585321/Aytu-BioScience-Announces-Positive-Results-from-an-Independently-Conducted-Clinical-Study-of-the-Companys-Licensed-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Announces Positive Results from an Independently Conducted Clinical Study of the Company's Licensed COVID-19 IgG/IgM Point-of-Care...

Company Places Third Purchase Order for One Million Tests

ENGLEWOOD, CO / ACCESSWIRE / April 15, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs today provided an update on the supply and distribution of the company's licensed COVID-19 IgG/IgM Rapid Test. The company has sold or allocated the initial 100,000 tests to U.S. customers and is awaiting delivery of the next 500,000 tests.

Additionally, the company has increased the size of its third purchase order to one million tests. The company has been informed the order has been accepted by the manufacturer.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "The company has been working on multiple fronts to distribute the initial shipment of COVID-19 IgG/IgM Rapid Tests while coordinating the incoming supply of our next shipment of 500,000 tests. We are pleased that the manufacturer has completed this second order, which is now awaiting customs clearance. Further, we have been informed the manufacturer has accepted another purchase order, which was increased to one million tests. We are proud to be helping the medical community in delivering our initial shipment of tests to those professionals in need. We look forward to having additional supply to further fulfill the significant demand we have for COVID-19 tests. With the 500,000 tests now awaiting clearance, we'll be in a position to fulfill the pending orders very soon."

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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Aytu BioScience Provides Update on its Licensed COVID-19 IgG/IgM Rapid Test Supply and Ongoing U.S. Distribution - Yahoo Finance