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Gilead, Regeneron, Sanofi, Pfizer, Abbott Face Big Dates in August


Drug approval decisions include Gilead's Quad HIV pill, Pfizer's rheumatoid arthritis medicine, and Regeneron and Sanofi's cancer drug.

MINYANVILLE ORIGINAL August is the month in which much of the business world grinds to a halt. The days leading up to Labor Day are excruciatingly slow for those of us not on vacation and looking for news to write about.

However, for a handful of drug and biotech companies, there are some significant dates ahead in the next few weeks. Here's a quick rundown of the highlights. Some dates are subject to change.

August 4

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) expect word from the Food and Drug Administration on possible US approval for Zaltrap to treat advanced colon cancer. If approved, the medicine would be an important product for Sanofi, which is trying to build its cancer drug business. Zaltrap approval potentially would be a meaningful revenue driver for Regeneron. (Note that the date is a Saturday so a decision may come earlier.)

August 12

Traded over the counter, Talon Therapeutics (TLON) stock is up more than 300% this year on hope for the drug Marqibo to treat a rare type of blood cancer. The drug won the backing of a panel of FDA advisers and the agency initially delayed a decision on the drug until August 12. Asked why the FDA deferred the decision to a later date, Talon CEO Steven Deitcher told Minyanville there were no concerns expressed by the agency. Given the company's small market cap, Talon shares could swing wildly on a decision. The stock closed at $1.77 per share Monday.

August 27

Gilead Sciences (GILD) expects to hear about US approval of a new HIV medicine. Gilead may be known for its promising hepatitis C drugs in development, but it still makes most of its money from HIV therapies. And, for now, Gilead is still the company to beat for new medicines for the AIDS virus. As its name implies, Quad is four medicines in one pill. Simplifying the regimen for patients is important and this can be a significant product for Gilead. The company's shares are up by more than a third this year, largely on hope for new hepatitis C treatments. FDA advisers backed the drug in May. (See HIV Drug Maker Gilead Sciences Scores Two Wins.)

August 28

Abbott Laboratories (ABT) faces a panel of expert advisers to the FDA reviewing yet another use for the drug Humira. Abbott's Humira is predicted to become the world's biggest-selling drug this year. One of the reasons for Humira's success is Abbott found multiple uses for the medicine, which was initially approved to treat rheumatoid arthritis. Abbott will go before the panel to argue why Humira should be approved to treat ulcerative colitis, an inflammatory bowel disease. The company, which also makes medical devices, diagnostic tests, and baby formula, plans to spin off its drug business into a new publicly traded pharmaceutical maker to be known as AbbVie by the end of the year.

Pfizer (PFE) may get word in August from the FDA on market approval for an oral rheumatoid arthritis medicine that would compete with Abbott's Humira, Amgen's (AMGN) Enbrel, and Johnson & Johnson's (JNJ) Remicade. The Pfizer drug, tofacitinib, would be a breakthrough treatment as it would be the first pill to compete with the standard injected therapies. A panel of FDA advisers backed the treatment by an 8-2 vote in May. (See Pfizer's Rheumatoid Arthritis Pill Endorsed by FDA Panel.) In a release Tuesday, Pfizer said it had expected a decision by August 21, but that timing may be delayed as the FDA is asking for more study data to support an approval of the drug.

Twitter: @brettchase

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