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Key FDA Events to Watch Out for in Jun 2017

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The FDA, which approved 22 treatments last year, has given its approval to 21 drugs so far in 2017 including 3 in May. Key approvals so far in 2017 include Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Some of these drugs have blockbuster potential.

With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance. Here is a look at a few important regulatory events scheduled for the month of June.

Alkermes plc (ALKS - Free Report) , which is known for its focus on treatments for central nervous system (CNS) diseases, is looking to expand the label of its schizophrenia treatment, Aristada. The long-acting injectable atypical antipsychotic, which is currently available in once-monthly and once-every six week dosing options, is under review for 2-month dosing. The 1064 mg dose, if approved, would be the only 2 month antipsychotic on the market. A response from the FDA for this dosing option is expected on Jun 5, 2017. Alkermes’ shares are up 6.8% year-to-date (YTD), better than the Zacks-categorized Medical-Biomedical/Genetics industry which is up 2.7% in 2017.

Ligand Pharmaceuticals Incorporated (LGND - Free Report) , which develops and acquires technologies that help pharma companies discover and develop medicines, is awaiting an FDA action date for one of its partnered assets -- Baxdela (delafloxacin). Partner Melinta is looking to get an oral as well as IV formulation of Baxdela approved for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). A decision from the FDA is expected on Jun 19, 2017. Approval would trigger a $1.5 million approval milestone payment for Ligand as well as a 2.5% royalty on net sales of the IV formulation.

YTD, Ligand has performed better than the Zacks-categorized Medical-Biomedical/Genetics industry with the company gaining 9.8% while the industry is up 2.7%.

The FDA will also respond on the approvability of Shire plc’s SHP465 this month. The resubmitted NDA was accepted for review earlier this year with a decision for the once-daily treatment for attention deficit hyperactivity disorder (ADHD) expected on Jun 20, 2017. SHP465 has had a long journey with the FDA initially giving an approvable letter way back in May 2007. At that time, the agency had asked for additional studies. Shire, a key player in the ADHD market, expects to launch the treatment in the second half of the year provided it gains approval. The ADHD market is huge though highly genericized. About 10.5 million adults in the U.S. are estimated to have ADHD.

Shire’s shares are up 3.3% so far in 2017, lagging the Zacks-categorized Medical-Drugs industry which is up 5.7% YTD.

Another company that expects a decision for an ADHD drug is Neos Therapeutics, Inc. . The company intends to launch the drug in Fall 2017 assuming a positive response from the FDA on Jun 19.

Portola Pharmaceuticals, Inc. expects to hear from the FDA about its experimental oral, once-daily Factor Xa inhibitor anticoagulant, betrixaban, on Jun 24, 2017. Betrixaban is under priority review for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Timely approval would make betrixaban the first anticoagulant to be approved for this patient population. More than 24 million acute medically ill patients admitted to the hospital annually in G7 countries are at risk for VTE, either while in the hospital or after discharge.

YTD, Portola has outperformed the Zacks-categorized Medical-Drugs industry with shares soaring 66.4% compared to the industry gain of 5.7%.

The FDA will also be deciding on the approval status of a subcutaneous formulation of Roche’s (RHHBY - Free Report) multi-billion dollar drug, Rituxan, this month. With an FDA advisory panel voting unanimously in favor of approving the formulation for certain types of blood cancer, chances of gaining FDA approval on Jun 26 look pretty good. Formulated using rHuPH20, a technology licensed from Halozyme, the subcutaneous formulation can be administered in five to seven minutes compared to an hour and a half or more for the intravenous formulation.

Roche has outperformed the Zacks categorized Large Cap Pharmaceuticals industry YTD with shares up 20.5% while the industry is up 11.4%. Roche is a Zacks Rank #3 (Hold) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some other FDA decisions scheduled for this month include a response regarding Coherus’ biosimilar version of Neulasta (PFUDA date: Jun 9, 2017) while an FDA advisory panel (Endocrinologic and Metabolic Drugs Advisory Committee) will be meeting on Jun 20 to discuss a supplemental new drug application for Novo Nordisk’s (NVO - Free Report) Victoza (liraglutide) -- Novo Nordisk is looking to get Victoza’s label expanded for use as an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events in adults with type II diabetes and high cardiovascular risk.

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