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10 biotechs await FDA decisions in June

May 26, 2017

June has the potential to be a make-or-break month for a number of biotech companies. At least 10 are facing critical decisions by the U.S. Food and Drug Administration (FDA). Let’s take a look.

1. Alkermes

Based in Dublin, Ireland, Alkermes (ALKS) is awaiting a decision on June 5 for its supplemental New Drug Application (sNDA) for a two-month dosing regimen of Aristada to treat schizophrenia. In October 2015, the FDA approved once-monthly and once-every-six-weeks dosing options for adults with schizophrenia. Annual net sales of the drug were $47.2 million last year, up from $4.59 million the year before. A thumbs-up from the FDA would expand the drug’s market opportunities.

Alkermes stock is currently trading for $58.25.

2. Coherus Biosciences

Headquartered in Redwood City, Calif., Coherus (CHRS) has a June 9 date for its CHS-1701, a proposed biosimilar to Amgen (AMGN)’s Neulasta. Neulasta treats neutropenia, a deficiency of white blood cells caused by chemotherapy. In 2016, Neulasta brought in $4.65 billion in sales. On May 10, Amgen sued Coherus for copyright infringement, which followed a 2016 lawsuits over trade secrets.

Coherus Biosciences stock is currently trading for $20.40.

3. Merck & Co.

Merck (MRK)’s cancer drug, Keytruda, continues to rack up new treatment options. On May 23, the FDA approved it as a first cancer regimen for any solid tumor that was microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). On June 14, the FDA will determine if it can be used as a first- and second-line treatment in bladder cancer. In 2016, Keytruda raked in $1.4 billion, up 148 percent from the previous year.

Merck stock is currently trading for $64.93.

4. Adamis Pharmaceuticals

Based in San Diego, Adamis (ADMP) is going for its third resubmission of an NDA for its Epinephrine Pre-filled Syringe for emergency treatment of allergic reactions (anaphylaxis). The FDA shot it down in March 2015 and June 2016. The PDUFA date hasn’t been disclosed, but RTT News estimates it is June 15.

Adamis stock is currently trading for $4.

5. Genmab

Headquartered in Copenhagen, Denmark, Genmab (GEN.CO) focuses on differentiated antibodies for cancer. On June 17, the FDA will make a decision on its Daratumumab in combination with pomalidomide and dexamethasone to treat relapsed or refractory multiple myeloma (MM). Daratumumab was approved in November 2015 as a monotherapy for multiple myeloma in patients who have received prior therapy at least three times. And in November 2016, the FDA approved it in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone in MM patients who’ve received at least one therapy regimen previously. Genmab licensed the drug from Johnson & Johnson (JNJ), which markets it under the name Darzalex.

Genmab stock is currently trading for 1,387 Danish Krone ($208.91 US).

6. Neos Therapeutics

Based in Grand Prairie, Texas, Neos is taking another shot on Cotempla XR-ODT for attention deficit/hyperactivity disorder (ADHD). It was rejected by the FDA in November 2015. The agency asked Neos to perform a bridging study to show bioequivalence between the clinical trial results and to-be-marketed drug product, including assessing how food effects the drug. A PDUFA date is June 19.

Neos stock is currently trading for $7.95.

7. Ligand

It is actually Melinta Therapeutics, a privately held partner of Ligand (LGND), that is waiting on a NDA for IV and oral Baxdela to treat hospital-treated acute bacterial skin and skin structure infections. The PDUFA date is June 19. Ligand is slated to receive a royalty of 2.5 percent on net sales if approved, as well as a $1.5 million approval milestone.

Ligand Pharma stock is currently trading for $113.38.

8. Shire

Headquartered in Dublin, Ireland, Shire (SHPGY)’s SHP-465 for ADHD has a PDUFA date of June 20. Its active ingredient is the same as Adderall XR’s, also from Shire. Adderall XR lost patent protection in 2009. SHP-465 is longer-acting (16 hours compared to 12). A submission for the drug was rejected in May 2007 by the FDA, asking for more clinical studies. The resubmission was approved in January 2017.

Shire stock is currently trading for $185.35.

9. Portola Pharmaceuticals

Based in South San Francisco, Calif., Portola (PTLAN) has a June 24 PDUFA date for its Betrixaban, an oral, once-daily Factor Xa inhibitor blood thinner. It is looking for approval for extended-duration treatment of venous thromboembolism or VTE in acute medically ill patients.

Portola stock is currently trading for $38.65.

10. Roche

The pharmaceutical giant is waiting for a June 26 decision on its subcutaneous Rituximab co-formulated with Halozyme Therapeutics (HALO) Enhanze Technology. Rituximab, as an IV formulation, was approved in 2006 to treat patients with diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma (NHL). It’s also been approved for other indications, including follicular B-cell, CD20-posistive NHL and chronic lymphocytic leukemia (CLL). RTT News writes, “The new co-formulation includes the same monoclonal antibody as intravenous Rituxan and hyaluronidase, a technology licensed from Halozyme, to deliver medicine under the skin. It has been unanimously recommended for approval by an FDA panel in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.”

Roche stock is currently trading for $267.20.


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