Flamel has launched U.S. distribution of its recently FDA-approved hypotension drug Akovaz, adding that its shareholders approved reincorporation in Ireland, the company said in separate announcements.
The launch of Akovaz was expected in the third quarter after the U.S. regulatory agency in April approved use of the drug for the treatment of hypotension in the event of a crisis during a surgical procedure. The drug is typically indicated for treatment of allergic disorders such as bronchial asthma.
The injectable drug is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent indicated for the treatment of a significant reduction in blood pressure that might occur while a patient is under anesthesia. Flamel estimates the market volume to be about seven million vials per year when factoring in sales to repackaging companies.
Revenue expectations for Akovaz issued in Flavel’s fiscal guidance for the year are pegged to fall in the range of $110 million to $120 million.
Separately, Flamel said shareholders voted to approve the company’s reincorporation to Ireland from France under a crossborder merger. Under the arrangement, the company will merge with its wholly owned subsidiary, Avadel Pharmaceuticals Limited, effective Jan. 1, 2017. At that time, the company will operate under the name Avadel Pharmaceuticals.
"Flamel's vision has transformed over the last few years from a pure play drug delivery company, to that of a diversified specialty pharmaceutical company capable of independently developing and marketing its own proprietary products,” Mike Anderson, CEO, said in a statement. “Ireland is an ideal location to execute this vision as it is quickly becoming a global pharma hub, and offers corporate governance policies more akin to those in the U.S.”
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