Amgen exiting neuroscience R&D

Amgen Inc. (AMGN) announced during the 3Q-2019 earnings call conference on 10/29/2019, its exit from the neurosciences research and early development programs. The company's head of research and development, David Reese stated:

Upon careful evaluation of our pipeline and the challenges inherent in developing drugs for major neurologic diseases, we've made the decision to end our neuroscience research and early development programs with the exception of programs centered on neuro inflammation that will be pursued by our inflammation TA."

The company saw success with aimovig for migraine patients, but its study of a late-stage candidate in Alzheimer's disease in partnership with Novartis (NVS) was halted a few months back. In response to a caller's question about the neuroscience decision, David said that the company was looking at alternative models to maintain a hand in the neuroscience segment. It could potentially be with venture capital or maybe academic institutions. The company's CEO, Bob Bradway added that Amgen would capitalize on the insights from its work with deCODE in human genome sequencing. Amgen's R&D cost-cutting could be an indirect effect of its product price restructuring strategy following the results of such exercise with repatha, and aimovig, which are now available at "relatively affordable co-pay levels." According to unconfirmed reports, there will be 180 layoffs across the company, with the highest impact being at Cambridge, MA location.

In a major setback to Novartis, the U.S. FDA has suspended enrollment of new study participants in the company's phase 1 STRONG trial of zolgensma (anasemnogene abeparvovec-xioi) (AVX-101) in patients with Type 2 spinal muscular atrophy (SMA). The company has clarified that this was a partial clinical hold on the intrathecal (injection into the spinal canal) administration of the gene therapy. The hold was the result of the FDA receiving information from Novartis' subsidiary AveXis, about a preclinical animal study that showed "dorsal root ganglia (DRG) mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss." AveXis is already under investigation for data manipulation related to the company's submission for approval of zolgensma. Novartis blamed two "senior," "founder" executives at AveXis for the scandal, who have since been terminated.

Novartis further clarified that the partial clinical hold does not affect the approved use of zolgensma and IV administration.

Zolgensma competitors: risdiplam from the collaboration of Roche (OTCQX:RHHBY) and PTC Therapeutics, Inc. (PTCT), and spinraza from the collaboration of Biogen (BIIB) and Ionis Pharmaceuticals, Inc. (IONS) stand to benefit. All the four companies' stocks gained, while Regenxbio Inc. (RGNX) shares lost over 10% as the company receives milestones and royalties from zolgensma licensor AveXis.

This company's stock price touched the 52 weeks low and high: $0.9 and $3.6 respectively, in the past one week (10/25/2019 to 10/30/2019), and a gain of over 57% year-to-date. IVERIC bio, Inc. (ISEE) is a clinical-stage company developing treatments for patients with orphan, inherited retinal diseases with significant unmet medical needs. Iveric announced on 10/28/2019, initial top-line data from the randomized, controlled, phase 2b clinical trial of Zimura (avacincaptad pegol) in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The pre-specified primary endpoint of reduction in the mean rate of GA growth over 12 months was met. Data showed statistical significance, with the reduction in the mean rate of GA growth being 27.38% (p-value = 0.0072) for the zimura 2 mg group, and 27.81% (p-value = 0.0051) for the zimura 4 mg group, as compared to the respective corresponding sham control groups. Zimura was generally well tolerated, with no zimura treatment-related inflammation or discontinuations from the trial. There also were no ocular serious adverse events (SAEs) or cases of endophthalmitis reported in the study eye. The most frequently reported ocular adverse events (AEs) were related to the injection procedure.

Zimura is a complement factor C5 inhibitor. It binds to C5, inhibiting its cleavage into terminal C5a and C5b, thereby decreasing the activation of inflammasomes and the formation of membrane attack complex (MAC). The potential of this mechanism to prevent or reduce the degeneration of retinal pigment epithelial (RPE) cells provides the basis for the zimura monotherapy in GA secondary to dry AMD, and in stargardt disease (STGD1). The company's therapeutics pipeline includes a HtrA1 inhibitor candidate in preclinical stage for GA secondary to dry AMD.

The company also has a gene therapy focused pipeline of product candidates in the preclinical stage.

(Pipeline images source: company website)

The company seems to be looking for partnerships in zimura monotherapy for both GA secondary to dry AMD and STGD1.

AbbVie (ABBV) announced positive top-line data from the SELECT-PsA 2 phase 3 study of RINVOQ (upadacitinib) in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease-modifying anti-rheumatic drugs (bDMARDs). The study results showed that both doses of RINVOQ: 15 mg and 30 mg, once daily, met the primary endpoint at week 12 versus placebo, with 57% on the 15 mg arm and 64% on the 30 mg arm of RINVOQ compared to 24% in the placebo arm achieving ACR20. At week 12, patients on RINVOQ treatment arms also had greater improvements in physical function, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). At week 16, 52% of patients on 15 mg and 57% of patients on 30 mg of RINVOQ achieved a Psoriasis Area Severity Index (PASI) 75 response compared to 16% on placebo. At week 24, 25% of patients on 15 mg and 29% of patients on 30 mg RINVOQ achieved minimal disease activity (MDA) compared to 3% of the placebo group.

SELECT-PsA 2 Efficacy Results

RINVOQ 15 mg

(n=211)

RINVOQ 30 mg

(n=218)

Placebo

(n=212)

p-value

ACR20a at week 12

57%

64%

24%

p<0.0001

ACR50a at week 12

32%

38%

5%

p<0.0001

ACR70a at week 12

9%

17%

0.5%

p<0.0001

HAQ-DIb at week 12

-0.30

-0.41

-0.10

PASI 75c at week 16

52%

57%

16%

p<0.0001

MDAd at week 24

25%

29%

3%

p<0.0001

(Table source: company PR linked above)

There were no new safety signals, putting the safety profile of RINVOQ consistent with that of previous studies across indications. Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated diseases. Psoriatic arthritis is a heterogeneous systemic inflammatory disease affecting more than 50 million people worldwide.

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Link:
Amgen Exits Neuroscience Research: The Good, Bad, And Ugly Of Biopharma - Seeking Alpha

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