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5 FDA Decisions to Watch Out for in October 2016

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The drug development process is often lengthy and time-consuming and involves a lot of funds and resources. It could take a drug anything between 10-12 years to be successfully developed and reach the market. In such a scenario, key pipeline events including data readouts and regulatory updates are highly awaited - companies which hit the bull’s eye become overnight success stories with shares even doubling or tripling on positive news while negative outcomes have an equally strong effect on the shares and failure may very well spell doom for these companies. So far in 2016, the FDA has approved 17 new drugs including Zepatier (hepatitis C virus - HCV), Taltz (moderate-to-severe plaque psoriasis), Epclusa (HCV) and Exondys 51 (Duchenne muscular dystrophy).

Here is a look at important regulatory events scheduled for this month.

Tecentriq (non-small cell lung cancer indication): Roche Holding AG’s (RHHBY - Free Report) cancer immunotherapy, Tecentriq, is currently under FDA review for a specific type of non-small cell lung cancer (NSCLC) in patients whose disease progressed on or after platinum-containing chemotherapy. Tecentriq was granted priority review by the FDA and a response is expected on Oct 19. Approval for this indication would expand the patient population for the drug, which is the first cancer immunotherapy medicine in Roche’s portfolio. Every year, about 1.59 million people across the globe die from lung cancer, the leading cause of cancer death globally. NSCLC accounts for about 85% of all cases. Tecentriq, which is already approved for a specific type of advanced bladder cancer, is one of the most promising new products in Roche’s portfolio and has blockbuster potential.

ROCHE HLDG LTD Price and Consensus

Sarilumab (active, moderate-to-severe rheumatoid arthritis): Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi’s (SNY - Free Report) sarilumab is currently under FDA review with a response expected on Oct 30. The companies are looking to get sarilumab approved for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). What makes sarilumab all the more interesting is the positive head-to-head data compared to AbbVie’s multi-billion dollar drug, Humira, reported earlier this year.

REGENERON PHARM Price and Consensus

Regeneron and Sanofi have collaborated for quite a few other drugs including PCSK9 inhibitor, Praluent (marketed) and Dupixent (dupilumab; under regulatory review for inadequately controlled moderate-to-severe atopic dermatitis in adults).

SANOFI-AVENTIS Price and Consensus

Zinplava (prevention of C. difficile infection recurrence): Merck & Co., Inc. (MRK - Free Report) is scheduled to get a response from the FDA regarding the approval status of its Biologics Licensing Application (BLA) for Zinplava (bezlotoxumab) on Oct 23. Earlier this year, an FDA advisory panel had voted (10 to 5 with one abstention) that the company has provided substantial evidence of the safety and effectiveness of Zinplava for the prevention of C. difficile infection recurrence in patients aged 18 years and older.

The FDA was initially expected to respond on Jul 23, 2016; however, the PDUFA date was extended by three months as the company was asked to submit new data and analyses from a couple of studies that were a part of the BLA. Merck is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

MERCK & CO INC Price and Consensus

Xtandi (label update to include head-to-head data versus Casodex): Pfizer, Inc. (PFE - Free Report) , which recently added prostate cancer treatment Xtandi to its portfolio through the Medivation acquisition, has an FDA action date coming up this month -- a supplemental New Drug Application (sNDA) was filed by Medivation and partner Astellas with data from head-to-head studies of Xtandi versus Casodex (bicalutamide). A label change incorporating head-to-head data against Casodex would help change the prescribing pattern of urologists leading to a boost in sales. The FDA is expected to give a decision regarding the sNDA on Oct 22. With Pfizer just closing its $14 billion acquisition of Medivation, this will be a closely watched event.

PFIZER INC Price and Consensus

Arymo ER (pain management): Specialty pharma company Egalet Corporation’s Arymo ER (morphine sulfate), is under FDA review for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. A response from the agency is expected on Oct 14.

Earlier this year, the FDA’s advisory panels had recommended the approval of Arymo ER as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse. While the agency is not required to do so, it usually follows the advisory committee's recommendation.

EGALET CORP Price and Consensus

Apart from the above regulatory events, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee will be meeting on Oct 19 to review the efficacy and safety of Allergan plc (AGN - Free Report) and Serenity Pharmaceutical’s  SER120 (desmopressin nasal spray) for the treatment of adult onset nocturia. Advisory panels provide the FDA with independent opinions and recommendations from outside experts on new drugs as well as FDA policies.

Meanwhile, several companies will be presenting data at the annual European Society for Medical Oncology congress (Oct 7 – 11).

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