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Coming Catalysts for Biotech Stocks During October

September was a busy month for the FDA and especially for its advisory committees who met to discuss more than one obesity drug as well as an addiction treatment and an antibiotic. The upcoming month will bring cooler weather and the final decisions on the approvability of some of the drugs discussed by the panels. Biotech investors should keep a close watch on which way the FDA goes with each of these drugs.

October 3
Hospira's (HSP) Dyloject for the treatment of moderate to severe pain, mostly used after operations, will face approval by the FDA. It will be the first non-steroidal anti-inflammatory approved for this purpose in 20 years.

October 4
Human Genome Sciences (HGS) and Novartis (NVS) are expecting a decision on their chronic hepatitis C treatment Zalbin. Don't expect a positive decision on this drug after the FDA expressed concerns about the risk/benefit ratio for the drug at the current dose.

October 11
Alexza Pharmaceuticals (ALXA) is awaiting approval of it schizophrenia drug AZ-004. The drug is an inhaled formulation of the drug loxapine. The Canadian biotech Biovail (BVF) acquired the right to the drug in February and will market it in North America if it gets approved. Analysts believe the drug could have a market of $500 million.

Jazz Pharmaceuticals (JAZZ) will also face an FDA decision on this day for its fibromyalgia drug JZP-6. The drug, with the proposed brand name Rekinla, was scrutinized by the Arthritis and Drug Safety and Risk Management Advisory Committees on August 20 which decided that it was safe and effective. The drug is already approved for the treatment of narcolepsy under the brand name Xyrem. Concerns were raised about the abuse potential for Rekinla because of its close chemical relationship to the date rape drug GHB. (See Jazzing Up a Date Rape Drug)

October 12
Alkermes (ALKS) expects an approval decision for its opioid addiction treatment Vivitrol on this date. The drug is already approved as an injectable treatment for alcohol dependence. In November, the biotech announced positive results of a phase 3 study that showed Vivitrol helped patients stay off opioids. A recent panel of experts recommended approval of the drug for the new indication in mid-September.

October 18
The Cardiovascular and Renal Drugs Advisory Committee will meet to discuss the risks and benefits of erythropoeisis-stimulating agents, which are drugs that stimulate production of red blood cells. The drugs that will be scrutinized include Amgen's (AMGN) Aranesp and Epogen, and Johnson & Johnson's (JNJ) Procrit.

October 21 and October 22
The Anesthetic and Life Support Drugs Advisory and the Drug Safety and Risk Management Advisory Committees will meet to discuss Purdue Pharma's OxyContin pain tablets and King Pharmaceuticals (KG) Embeda, an extended release pain medication.

October 22
Later in the month, Alkermes will face the FDA again, along with Eli Lilly (LLY) and Amylin Pharmaceuticals (AMLN). The companies will be looking for the approval of Bydureon -- the long-acting formulation of their diabetes drug Byetta. The once-weekly injectible was passed over once by the regulatory agency, which wanted more information on the risks of the drug. It will face stiff competition from Novo Nordisk's (NVO) Victoza if it finally gets to market. Victoza has gained 27% of the GLP-1 market since it was approved in January.

Arena's obesity drug will face approval on this day as well. Lorqess, also known as lorcaserin, was panned by an advisory committee in mid-September. The panel was concerned with the moderate efficacy of the drug and had worries over tumors that appeared in rats. Shareholders have brought suit against the company for not properly disclosing this information. The stock has lost 80% of its value since hitting its 52-week high in July.

October 28
The FDA will make its decision on Vivus' Qnexa. An advisory panel to the FDA voted against approval in July. The panel thought that risks surrounding pregnancy and cardiovascular issues were too great to allow the drug to reach the market without more testing. Newer data from a two-year study may help the company gain approval at a later date. Expect the FDA to issue a Complete Response Letter or extend the date of approval.

October 29
Forest Laboratories (FRX) is hoping to gain approval of its antibiotic for the treatment of skin infections (cSSSI) and community-acquired pneumonia (CABP). A panel voted 21 to 0 in favor of approval in early September. The panel decided that the drug looked efficacious without presenting any further safety risks than products already on the market.

The FDA will make an approvable call on Avanir Pharmaceuticals' (AVNR) Zenvia, meant for the treatment of involuntary emotional outbursts related to brain disease. Four years ago, the FDA asked for more information on the drug. The company has since conducted another late-stage trial with a lower dose of the drug. Analysts expect an 80% chance of approval.

October 30
Biodel's (BIOD) injectable diabetes drug Linjeta, formerly known as VIAject, has many investors believing that it can't make it past the FDA this time around, but will likely get approval at a later date. The company can't afford more clinical trials or to commercialize the drug on its own. Eli Lilly and Sanofi-Aventis (SNY) are likely to go after a partnership on the drug. (See Sanofi and Lilly Likely Suitors for Biodel).

http://www.minyanville.com/businessmarkets/articles/lorcaserin-qnexa-linjeta-embeda-oxycontin-diabetes/9/30/2010/id/30332?camp=syndication&medium=portals&from=yahoo