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Pfizer, Gilead Sciences, Arena Pharmaceuticals Face Big Dates in May [UPDATE]

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There are a number of FDA drug marketing decisions and panel reviews. Investors also await the May 16 ASCO abstracts release.

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MINYANVILLE ORIGINAL

UPDATE May 2, 2012: Protalix BioTherapeutics (PLX) and Pfizer (PFE) were approved in the US to sell a new drug to treat the rare genetic condition known as Gaucher disease. Protalix licensed the US sales rights to Pfizer, which also will sell the drug in most other markets. Protalix plans to sell the treatment, Elelyso, in the company's home market of Israel. Protalix rose 21% in early US trading Wednesday. Shares of Pfizer rose less than 1% to $22.88. Pfizer plans to compete with rivals in the US by pricing the drug lower than Sanofi's Cerezyme, which was for years the only treatment for Gaucher. Cerezyme costs patients about $200,000 a year on average. Shire (SHPGY) also has a drug on the market, Vpriv, which sells at about a 15% discount to Cerezyme.

Pfizer faces three important dates in May related to possible Food and Drug Administration approvals. Elsewhere, Arena Pharmaceuticals (ARNA) takes its next step as it tries to become the first company in more than a decade to win US approval for a new diet pill in the US. And investors in cancer-drug developers will pore over scientific study data to be released mid-month ahead of a major medical conference.

Here is a rundown of some important dates for drug and biotech companies in May. Some dates are subject to change.

May 1
Protalix Biotherapetuics and Pfizer expect to hear word from the FDA on possible market approval for a new treatment for the rare condition, Gaucher disease. If approved, Pfizer will help sell the drug. The FDA rejected Protalix's drug last year, saying the company needed to show the treatment works and is safe. (See: Protalix Plunges on FDA Rejection.) Shares of Protalix are up more than 40% this year, trading at $6.98 midday Monday.

Pfizer announces first-quarter earnings. Investors will be interested to hear an update on how the company plans to spend proceeds from the almost $12 billion sale of its baby food business to Nestle. Other topics: drugs in development and other divestitures. A conference call will be held at 10 a.m. EDT.

May 4
Alexza Pharmaceuticals (ALXA) awaits a decision from the FDA on Adasuve, an inhaled drug to treat agitation in schizophrenic and bipolar patients. The FDA delayed an approval decision on this treatment after a split vote by a panel of expert government advisers in December. The FDA advisers voted 9-8 to clear the drug for sale as long as Alexza developed a plan to mitigate safety issues. The drug was previously rejected by the agency because of fear of respiratory side effects, a problem that may be difficult to detect in psychiatric patients.

May 8
Regeneron (REGN) appears before a panel of FDA expert advisers as it tries to win approval to sell the drug Arcalyst for the additional use of preventing gout flares. In 2008, the drug was approved for sale in the US to treat a rare, genetic autoinflammatory disease, but gout represents a much bigger market opportunity. Arcalyst sales were just under $20 million last year, a figure already eclipsed by Regeneron's newly approved eye drug Eylea.

May 9
An FDA advisory panel will review Pfizer's experimental pill, tofacitinib, to treat rheumatoid arthritis. The pill would compete with injected drugs, including Abbott Laboratories' (ABT) Humira, Amgen's (AMGN) Enbrel, and Johnson & Johnnson's (JNJ) Remicade. Pfizer helps sell Enbrel in the US but that agreement is expected to end in July.

May 10
Arena Pharmaceuticals will appear before a committee of FDA advisers who will review the company's diet pill lorcaserin and make recommendations to the agency on market approval. This is the second go-around for Arena, which was rejected in 2010 on safety concerns. Arena is racing Vivus to sell the first new diet drug in the US in more than a decade. (See: Arena Shares Sink as Big Dates for Diet Pill Makers Near.)

Another FDA panel will debate a new use for Gilead Sciences' (GILD) HIV treatment Truvada. Gilead wants to market the drug as a preventative treatment against the AIDS virus. Gilead is heavily focused on developing a new treatment for hepatitis C but HIV treatments are still the most important market for the big biotech company. Truvada is a top-selling treatment for people already infected with HIV.

May 11
Gilead faces an FDA advisory committee to review its four-in-one drug Quad for treatment of HIV. As patents for Gilead's big HIV drugs begin to expire in the next several years, Gilead still wants to continue to be the market's dominant player. (See: Gilead Scores Win With Quad Drug Study.)

May 13
Bulletin Board company Talon Therapeutics (OTCBB: TLON) is expected to hear from the FDA on possible approval of its drug Marqibo for a rare disease known as Philadelphia chromosome-negative acute lymphoblastic leukemia. In March, FDA advisers voted 7-4 for approval with two panel members abstaining.

May 16
Scientific abstracts for the big cancer conference known as ASCO will be released on www.asco.org at 6 p.m. (EDT). Investors will pore over the studies by a number of clinical-stage drug companies specializing in cancer research. The meeting of the American Society of Clinical Oncology will be held in Chicago June 1-5.

May 23
J&J will appear before an FDA advisory committee as the company seeks broader use of the anti-clotting drug Xarelto. The company wants to sell the drug to prevent heart attack or stroke in patients with a history of chest pains or heart attacks.

May 24
Pfizer will face FDA advisers who will consider the drug Vyndaqel for treatment of a rare, neurological disease. Pfizer won European approval for the drug in November.

Twitter: @brettchase

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