BIO/PHARMA WEEKLY NEWS (10/12/2019 – 10/18/2019)

What headlines caught your attention this week?

❖❖❖ Innovations ❖❖❖

Pfizer Posts Detailed Phase 3 Data on Its Dupixent Rival (Fierce Biotech)

Pfizer’s JAK1 inhibitor—acrocitinib is a potential challenge to Sanofi and Regeneron’s atopic dermatitis drug Dupixent. In their previous Phase 3 trial, 43.8% of subjects treated with acrocitinib showed clear or almost clear skin, compared with 7.9% in the placebo group. Patients with acrocitinib treatment experienced better improvement on a pruritus (itchiness) scale compared to the group treated with Dupixent. Pfizer will complete a third Phase 3 trial using Dupixent as a comparator. Results will be released in the first half of next year.


New Approval! J&J vision Nets FDA Approval for Wavefront-Guided PRK Laser Eye Surgery (Fierce Biotech)

J&J Vision got green light from FDA for its wavefront-guided photorefractive keratectomy, or PRK eye surgery, as an alternative to LASIK for treating nearsightedness. PRK’s clinical data showed 99% of patients achieved 20/16 vision or better six months following surgery.


Cell Therapy Startup Raises $16 Million to Fund Its Quest for the Holy Grail in Regenerative Medicine (Endpoints)

The startup Mogrify raised $16 million in Series A. Their core technology is to use induced pluripotent stem cells (iPSC) from one part of the human body and regenerate it into cells of other body parts of any developmental stage. Mogrify’s iPSC approach is more scalable and less risky than Yamanaka’s method.


Sanofi Opens Its First Digital Manufacturing Facility in Massachusetts (BioSpace)

Sanofi opened its first new digital manufacturing facility in Massachusetts, aiming to transform industry’s biologic manufacturing process. The company is also planning the next-generation manufacturing facilities in Canada, Brazil, Ireland, France, and Belgium.


Ancestry Launches Consumer Genetics Tests for Health, Intensifying Rivalry with 23andMe (STAT)

Ancestry will offer consumers health information based one their genetic test results, through orders by physicians. The lowest price option is $49. So far 17 disease-associated genes are included in the tests. Ancestry will use next-generation DNA sequencing technology to analyze consumers’ genetic data.


Reata Surprises with Positive Data in Challenging Rare Disease (Biopharma Dive)

Reata Pharmaceuticals beat Wall Street’s dismal expectation by announcing the positive clinical data on a rare, genetic neurodegenerative movement disorder called Friedreich’s Ataxia. Its proprietary drug is omaveloxolone (omav). Omav-treated group showed improved clinical assessment scores in speech, swallowing, limb coordination, standing, and walking compared with the placebo group. Serious adverse events include upper respiratory tract infection, laryngitis, non-cardiac check pain, and high liver enzymes like ALT and AST. Company’s stock value spiked by more than 60%.


After Snapping Up Ra Pharma, UCB Hits the Mark in Psoriasis Trial (BioSpace)

Last week, UCB announced to acquire Ra Pharma for $2.1 billion. This week, UCB has good news of its psoriasis drug bimekizumab in the first Phase 3 trials (out of three). After a course of 16-week, bimekizumab-treated patients demonstrated at least a 90% improvement in selected psoriasis assessment scales. The drug inhibits IL-17A and IL-17F which are the two key cytokines causing inflammatory issues in psoriasis and several others diseases.


Fitbit Partners with BMS, Pfizer on Early Atrial Fibrillation Detection Project (MedCity News)

Bristol-Myers Squibb and Pfizer would collaborate with Fitbit to improve early diagnosis of artrial fibrillation in people who have higher risk of stroke. The collaborative team will seek FDA approval after detection software is developed for the wearable devices.


Gilead, Spring Bank’s Hep B Combo Shows ‘Incremental Benefit,’ But All Eyes on Higher Doses: Analysts (Fierce Biotech)

Gilead and Spring Bank Pharmaceuticals each developed drugs against hepatitis: Vemlidy and inarigivir. A Phase 2 study of the joint effort revealed an “incremental positive benefit” in primary endpoint of HBsAg levels when patients were co-administered with inarigivir-Vemlidy versus either drug alone. Also, more patients responded to the combination therapy than monotherapy, 18% vs. 10%. CATALYST Phase 2b study is underway.

❖❖❖ Policies & Regulations ❖❖❖

Pelosi Drug Pricing Bill Promises Savings, but Could Gag R&D – CBD Analysis (Endpoints)

Nancy Pelosi proposed Lower Drug Costs Now Act. The new act could cut Medicare spending by $345 billion over the period of 2023-2029, but may also hurt manufacturers’ incentive of making drugs.


FDA Is Smashing the Status Quo for Regulatory Science (STAT)

To enhance FDA’s review efficiency, Office of New Drugs will undergo a revolutionary reorganization. With the new plan, the number of specific clinical review divisions will increase from 19 to 27, which will recruit more well-trained review staff to review emerging cases like real-world evidence, adaptive clinical trials, etc.


RWE to Supplement RCTs: FDA Projects Continue (RAPS)

COTA, Inc. is one of the companies FDA has been collaborating on understanding benefits of real-world data and real-world evidence (RWE). COTA pointed out that RWE can complement randomized clinical trials but never to replace them.


Updated Guide Changing Science of Flu Shots (STAT)

Due to the “intra-season waning” theory, experts at the CDC recommend people getting annual flu vaccination before the end of October. Statin doesn’t undermine the effectiveness of flu vaccine, according to the FDA and the CDC analysis on medical records.

❖❖❖ Setback ❖❖❖

Eli Lilly to Shutter Neuroscience R&D Center Next Year (Fierce Pharma)

Eli Lilly is shutting down its UK-based neuroscience center by the end of 2020. Totally 270 employees will be affected. Two-thirds of staff (non-laboratory) will relocate to a new location. Neuroscience research will be consolidated into the US site.


Lilly Cancer Drug Pipeline Hit by Trial Setback (BioPharma Dive)

Eli Lilly acquired Armo Biosciences for $1.6B to develop pegilodecakin (a pegylated version of interleukin-10) for patients with metastatic pancreatic, lung, and renal cell cancers. However the Phase 3 SEQUOLA trial targeting metastatic pancreatic disease flopped on the overall survival. The forthcoming lung cancer Phase 2 clinical results early next year will guide future plans of clinical development.
Another Hit for AbbVie: Unexpected $673M Irish Tax Bill Adds to Allergan Merger Woes (Fierce Pharma)

The new twist of the $63 billion AbbVie and Allergan merger is that Irish will collect $632 million of tax (1% stamp duty). In response to a “second request” from the Federal Trade Commission, Allergan will sell off brazikumab and Zenpep that have overlapping indications with Skyrizi and Creon (AbbVie’s) to clear antitrust hurdles.


Roche Limits Biosim Damage to Cancer Blockbusters, but It’s Still Early, Execs Warn (Fierce Pharma)

Amgen launched Avastin biosimilar Mvasi and Herceptin biosimilar Kanjinti. Roche has seen 9% of growth decline in the first half of this year. The negative impact caused by biosimilar competition in US is less severe as opposed to Europe. Sales of the two legendary cancer drugs have shrunk by 30% to 40%. However, the damage is limited in the Chinese market due to limited number of biosimilars there.

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