April Catalysts For Biotech And Drug Stocks

By Brett Chase April is shaping up to be an important month for a number of biotech and drug companies, including some important dates for potentially breakthrough hepatitis C treatments. Here are the key events for some companies. Dates are subject to change. April 5 Optimer Pharmaceuticals (OPTR) faces an FDA advisory panel that will review fidaxomicin, a powerful antibiotic. Specifically, the drug treats Clostridium difficile infection, a diarrhea prevalent in hospital patients. There has been no new antibiotic for this infection in decades. Investors should get a sense of the FDA's thinking on this drug Friday when documents are released before Tuesday's panel. The FDA staff should give a hint of the agency's views on the drug's safety and effectiveness. Astellas Pharma licensed sales rights in Europe and parts of the Middle East and Africa. (To read Andrea Woroch's five tips to avoid getting stuck with useless gift cards, click here.) April 6 The FDA is expected to decide whether to approve Xenoport's (XNPT) drug Horizant for the neurological disorder known as restless legs syndrome. As the name suggests, people with this condition have an overwhelming urge to move their legs due to discomfort. The condition can be painful. Xenoport and partner GlaxoSmithKline (GSK) await a decision after the FDA initially rejected the drug in February of last year due to concerns about cancer found in rats during early company studies. The agency asked the companies to provide additional data. April 14 Human Genome Sciences (HGSI) plans an investor meeting in New York. The most significant topic probably will be an update on launching the lupus drug Benlysta after that product was approved by the FDA earlier this month. (See Drug Approval Boosts Human Genome Sciences.) (To check out Justin Rohrlich's article on Verizon's CEO government shutdown warnings, click here.) April 21 Amgen (AMGN) will hold an investor meeting in New York. Deutsche Bank analyst Robyn Karnauskas predicts the company will announce plans for its first dividend. (See Is Amgen Closer to Paying a Dividend.) April 27 Merck (MRK) will try to win over a panel of government advisers for endorsement of its hepatitis C drug boceprevir. Hepatitis C is a huge market opportunity as more than 4 million people in the US alone are believed to have the liver-eroding virus. Many infected people have been carrying the virus for years and may not know until liver damage is detected. Merck is in a race with Vertex Pharmaceuticals (VRTX) to get its drug to market. The FDA panel will make recommendations related to approval of the treatment. April 28 A day after Merck's panel, Vertex faces the same advisers who will consider its hepatitis C treatment telaprevir. Some medical experts and Wall Street analysts consider Vertex to have the superior treatment. Vertex is collaborating with Johnson & Johnson (JNJ) and Mitsubishi and those companies would sell the drug outside North America. “With approval these products can become new standards of care against this global disease,” says a recent Leerink Swann analysis. Meeting materials for the two panel hearings can be found here. (To read Lee Adler's piece on rising housing prices, click here.) April 29 Spectrum Pharmaceuticals (SPPI) is expected to hear from the FDA on whether the drug Fusilev can be used with chemotherapy to treat patients with advanced stages of colon cancer. Fusilev was approved in 2008 to counter the effects of chemotherapy in bone cancer patients. Spectrum is attempting to get the drug approved for colon cancer patients after being rejected in October 2009 because the FDA didn't think the treatment was effective. April 30 Glaxo is expected to hear from the FDA on whether its drug Lamictal can be marketed to treat patients 13 and older who have seizures while on a single epilepsy medicine. A panel of advisers recommended approval on March 10. To read the rest, head over to Minyanville.
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