Securities Law News

Alkermes Hid FDA Drug Application Details From Investors: Suit

Dec. 28, 2018, 4:42 PM

A biopharmaceutical firm hid the true nature of its dealings with the FDA as it prepared to bring a new depression drug to market, investors said Dec. 27.

Alkermes PLC told investors that it had met with the Food and Drug Administration and was “on track” to get its new drug approved, according to a complaint filed in the U.S. District Court for the Eastern District of New York.

But it didn’t reveal that it had disregarded the agency’s instructions when putting together its application, the complaint said.

The FDA refused to review the Ireland-based firm’s application in April, according to the complaint. The agency said it couldn’t complete a review because Alkermes didn’t provide enough evidence that the drug would effectively treat depression and needed to conduct more clinical trials.

Alkermes stock price fell $12.73 per share—nearly 22 percent—after the rejection became public, according to the complaint.

The company “disregarded the FDA’s advice” about what measurements to use in its drug trials, according a briefing the agency released in October. Alkermes stock then fell an additional 1.4 percent, the complaint said.

Alkermes in November revealed that the FDA had voted 21-2 against approving its new drug, according to the complaint. At the hearing, FDA representatives said Alkermes had disregarded specific agency advice on data analysis, according to an article from business news site Xconomy partially reproduced in the complaint. The company’s share price then fell another $3.09, or around 7.5 percent, the complaint said.

An Alkermes representative declined to comment on ongoing litigation.

The case is Karimian v. Alkermes PLC, E.D.N.Y., No. 1:18-cv-07410, complaint filed 12/27/18.

To contact the reporter on this story: Jennifer Bennett in Washington at jbennett@bloomberglaw.com

To contact the editors responsible for this story: Jo-el J. Meyer at jmeyer@bloomberglaw.com; C. Reilly Larson at rlarson@bloomberglaw.com

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