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FDA O-Fer October Drug Approvals

Updated with stock prices.

BOSTON ( TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?

The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals (ALXA - Get Report) and Jazz Pharmaceuticals (JAZZ - Get Report) received the bad news. Last week, it was FDA rejections for Human Genome Sciences (HGSI) and Hospira (HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes (ALKS - Get Report) is expecting FDA to rule on its drug for opioid addiction.

Alexza's market value was sliced in half Monday, with the stock at $1.37, after the FDA raised questions about the safety and manufacturing of AZ-004, a drug/device combination for the treatment of schizophrenia and bipolar disorder.

After listening to Alexza's conference call, it sounds like the FDA's list of issues with ZA-004 are long and not necessarily easy to resolve, at least without time and money.

AZ-004 is a small, handheld device that delivers a rapid, single, inhaled dose of the antipsychotic drug loxapine into the lungs of patients. The FDA, however, raised concerns about the potential for AZ-004 to interfere with lung function, while the agency's medical device division is concerned about how the drug inhalation device -- dubbed "Staccato" -- is manufactured.

Perhaps most troubling was the revelation that some of the lung safety concerns cropped up in patients who used the Staccato device to deliver a placebo.

Given this safety concern, analysts on Alexza's conference call Monday asked whether FDA was questioning the approvability of the company's entire drug delivery technology platform. Alexza is developing the Staccato handheld inhaler for use with a variety of drugs to treat diseases like migraine headaches, anxiety and breakthrough cancer pain.

Alexza management had little comfort for uneasy investors Monday because the company has yet to speak with the FDA about AZ-004 rejection. The company did say that FDA concerns about the lung safety of AZ-004 were surprising because the issue did not come up during the drug-device's review cycle.

Alexza is partnered with Valeant Pharmaceuticals (VRX - Get Report), but Valeant is not on the hook financially until AZ-004 is approved. That leaves the responsibility for paying for any additional AZ-004 pre-approval work entirely in Alexza's lap. If the AZ-004 delay drags on, Valeant can walk away from the partnership without having to pay another dime.

If investors are giving Alexza the cold shoulder, they seem quite pleased -- or at least nonplussed -- with FDA's decision to deny Jazz Pharmaceuticals the opportunity to expand the marketing of Xyrem/JZP-6 into fibromyalgia.
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ALXA $0.32 0.69%
ALKS $29.45 -8.46%
AVNR $16.96 0.00%
BIOD $0.26 -1.89%
JAZZ $114.16 -6.25%


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