Upcoming Catalysts for Biotech Stocks
By Lisa LaMotta May 03, 2010 2:10 pm
Watch InterMune, Vivus, and other companies in the sector as important events approach in May.
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InterMune (ITMN)
Vivus (VVUS)
Amylin Pharmaceuticals (AMLN)
Eli Lilly (LLY)
Alkermes (ALKS)
Questcor Pharmaceuticals (QCOR)
NicOx’s (COX)
Cell Therapeutics (CTIC)
Shire Pharmaceuticals (SHPGY)
Alkermes (ALKS)
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Now that earnings season is winding down, investors have other biotech catalysts that they should be marking on their calendars. These catalysts include FDA responses, medical conferences, advisory committee meetings, and more. Here’s what to watch:
May 4
InterMune (ITMN) expects to hear from the FDA concerning its idiopathic pulmonary fibrosis therapy pirfenidone, also known as Esbriet. The drug is a treatment for a fatal lung disease that affects about 200,000 people in the US and Europe who are between the ages of 50 and 75. In March, an advisory committee voted for approval of pirfenidone despite a number of questions about safety and efficacy. (For more on the prospects of pirfenidone, see The Next Biotech Drug to Watch: InterMune’s Pirfenidone)
Vivus (VVUS) is expected to make a presentation in the morning at the American Society of Hypertension meeting in New York. The biotech company will present further phase III data on its promising obesity drug Qnexa and how it affects blood pressure in obese patients. The drug is currently one of three obesity treatments being scrutinized by the FDA. An advisory committee is expected to convene in July to discuss the safety and efficacy of Qnexa. The FDA will likely make its final approval decision in late October.
May 3 -7
Keep an eye on Amylin Pharmaceuticals (AMLN), Eli Lilly (LLY), and Alkermes (ALKS) as the three companies await a response form the FDA concerning their once-weekly injectible diabetes treatment Bydureon. The government oversight agency will give the companies a new approvable date for the drug -- either June or October. (For more commentary on Bydureon, see Bydureon Application Resubmitted, But Sales Potential Is Bleak)
May 6
The Peripheral and Central Nervous System Drugs Advisory Committee will meet on this date to discuss Questcor Pharmaceuticals (QCOR) Supplemental New Drug Application for HP Acthar Gel. The drug is already approved to treat flare-ups of multiple sclerosis as well as a few other indications, but the market for these uses is small -- sales of the drug totaled $87.6 million for all of 2009.
Questcor is now seeking the approval of the drug for infantile spasms, a seizure disorder seen in children. The drug is already widely prescribed for the off-label use in the treatment of infantile spasms, but Questcor currently doesn't have the right to promote the drug for that indication. The FDA already denied approval of Acthar for the treatment of IS in May 2007. Expect a more positive outcome this time around, but don’t expect the company to make that much more money off of this indication. Final word on approval of the drug will likely be given by the FDA by June 11.
May 12
The Arthritis Advisory Committee and the Drug Safety and Risk Management Committee will meet at 8 a.m. EST on this date to access the viability of NicOx’s (COX) osteoarthritis drug naproxcinod. The company expects to hear a final decision from the FDA by July 24.
A few short weeks after the company announced that the FDA required an advisory committee meeting, NicOx released the results of a phase III study showing that naproxcinod performed better than a placebo. The study also showed that naproxcinod didn't adversely affect the blood pressure of patients like naproxen has been known to do. Naproxen is a widely prescribed nonsteroidal anti-inflammatory.
May 14
Cell Therapeutics (CTIC) has rescheduled its shareholders meeting to this date after the company failed to have enough investors at its last meeting in April to hold a vote on issuing more shares. The biotech is virtually out of money and its only promising drug was recently rejected by the FDA. Now Cell Therapeutics is gasping for air as it tries to raise further capital in hopes of conducting further studies of pixantrone, so that the drug can be resubmitted to the FDA for approval. Yet, investors and analysts have already considered this company dead in the water. (For further insight into Cell Therapeutics problems see Cell Therapeutics' Last 80 Days?)
May 20-22
Expect to hear data from Shire Pharmaceuticals (SHPGY) at the Society of Biological Psychiatry conference in New Orleans. The company will be presenting data from a study that combined two of its ADHD medications -- Intuniv and Vyvanse. Analysts consider a label change that would allow these drugs to be taken together as a major positive for the company.
May 22-27
Alkermes will be presenting at the American Psychiatric Association meeting. The biotech will talk about data from a study that shows the effectiveness of its alcohol dependence treatment Vivitrol in opioid-dependent patients. Vivitrol has never really taken off as an alcohol dependence treatment, the company crediting society's aversion to see this condition as a disease. Yet, Alkermes is hopeful that the other indication will be more fruitful; analysts are skeptical at best. (For more details about the company see Alkermes Aims to Play With the Big Biotechs)
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