Alkermes Gains FDA Approval For Vivitrol, Anticipating Oct 22 Approval with Amylin Pharmaceuticals

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Again another winning prediction from my FDA calendar for October.  Expect large gains for Alkermes tomorrow.  I wouldn't sell the stock as they have another approval up on Oct. 22nd in conjunction with Amylin and Eli Lilly for Bydureon, a weekly injectible diabetes medication.  I expect a FDA approval for that one too.  But you never know with the FDA.  Amylin already has approvals for daily injections but has modified the technology for weekly injections, so again I anticipate its approval as well.  Good news for Alkermes.

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 Alkermes addiction drug wins wider U.S. approval

Tue Oct 12, 2010 7:26pm EDT

* Vivitrol already used in U.S. for alcoholics
* Approval may help turn around money-losing drug
* Shares up nearly 69 percent in 2010
* Shares up another 4.2 percent after hours

LOS ANGELES, Oct 12 (Reuters) - U.S. health regulators have approved Alkermes Inc's (ALKS.O) bid to market its Vivitrol addiction drug as a monthly injection to treat those hooked on powerful opioid painkillers, the company said on Tuesday.

Wider approval of the drug, which is already approved to help treat alcoholics, is expected to help the biotech firm, which says its costs of making the drug exceed what earns in sales. Alkermes earns revenues from just one other approved product.

Shares of Alkermes rose 4.2 percent at $16.34 in after-hours trade on Tuesday, after having risen 68.8 percent so far this year ahead of the anticipated expansion. The company is also awaiting a decision from the U.S. Food and Drug Administration on its diabetes drug Bydureon.

Leerink Swann Research Analyst Steve Yoo has said Vivitrol's sales could reach $125 million by 2015 with wider approval.

Cambridge, Massachusetts-based Alkermes reported net sales of $20.2 million for fiscal 2010, compared with $16.9 million in 2009 for Alkermes and its then-partner Cephalon Inc (CEPH.O).

Analysts have cited price and access as barriers in the alcohol dependency market that have kept Vivitrol from generating much use.

But for drug addicts, some say the monthly treatment could have dramatic results.

Jerry Rhodes, who heads the recovery division at substance abuse treatment provider CRC Health Group, said his company would use Vivitrol. It "could be a game changer" and help 1prevent patients from relapsing in the months after they are discharged from treatment centers, he said. (Reporting by Susan Heavey and Deena Beasley; Editing by Leslie Adler)

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