Healthcare Business

5 Critical Biotech Drug Dates and Events for December

BioCryst Pharmaceuticals

BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) is expecting an FDA decision by December 23, 2014, on the intravenous peramivir NDA as a treatment for influenza. This company has most recently been known for its news around Ebola. In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst had previously said that it had reached agreement with FDA regarding all requirements for a complete NDA submission, which included results in over 2,700 subjects treated with peramivir in 27 clinical trials. BioCryst had also previously said that peramivir has been approved in Japan and Korea.

BioCryst shares were down over 4% at $10.35 with less than three hours left in regular trading. The stock has a consensus analyst price target of $17.73 and a 52-week trading range of $5.63 to $14.62. The market cap is $743 million. The projected annual sales for the full year 2014 are $11.1 million and for the full year 2015 are $43.3 million.

Vertex Pharmaceuticals

In October, Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 13 to two to recommend approval of KALYDECO in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA. The FDA is expected to make a decision on the approval of ivacaftor by December 30, 2014. Vertex gave the same disclosure that most biotech companies give when they receive panel backing: Advisory committees provide the FDA with independent scientific and medical advice on safety, effectiveness and appropriate use of potential new medicines, but the FDA is not bound by the committee’s recommendation.

Vertex shares were recently trading around at $117.25, with a consensus analyst price target of $122.05 and a 52-week trading range of $59.79 to $120.91. Vertex was recently named as a top pick for 2015 by RBC Capital Markets. Vertex has a market cap of $28 billion. The projected annual sales for the full year 2014 are $566 million and for the full year 2015 are $1.3 billion.

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POZEN

POZEN Inc. (NASDAQ: POZN) has its NDA resubmission ongoing, and an FDA decision on PA8140/PA32540 as a secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers is due by December 30, 2014. The company has just freshly announced that it and Sanofi (NYSE: SNY), via Sanofi US, have mutually agreed to terminate their agreement for commercialization of the investigational products, PA8140 and PA32540 effective November 29, 2014. All licenses granted to Sanofi US will be terminated and all rights to the products will revert to POZEN. POZEN stuck with its December 30 PDUFA date in the press release, confirming that the Sanofi pact was off. It said:

Our goal at POZEN continues to be to maximize shareholder return. Management and the Board of Directors are taking this opportunity to evaluate all strategic options for YOSPRALA and POZEN. As we continue to work with the FDA during these final weeks leading up to our December 30th PDUFA date, we are very happy with the current FDA-proposed package insert. With respect to how well YOSPRALA may perform in the marketplace, we believe that the clinical profile of the drug, as described in the current FDA-proposed package insert, will meet or exceed the assumptions we made when we started our development and evaluated the commercial potential for this product. Given that the target population for YOSPRALA could exceed 20 million patients in the US, we will be fully engaged in the near term evaluating strategic options available to the company.

Shares of POZEN were down about 16% at $7.47 with less than three hours left in regular trading on Monday. The stock has a consensus analyst price target of $11.00 and a 52-week trading range of $5.96 to $9.90. The market cap is $239 million. The projected annual sales for the full year 2014 are $40.10 million and for the full year 2015 are $38.60 million.

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