Anika's Monovisc Paralyzed As FDA Gives Thumbs Down Yet Again

Shares of Anika Therapeutics Inc. (ANIK: Quote) dropped 14% to $10.26 in after-hours trading Tuesday, after the company's premarket approval filing for osteoarthritis product Monovisc in the U.S. failed to pass regulatory muster this time too.

Monovisc is a single injection viscosupplement developed for osteoarthritis pain relief.

Anika submitted its premarket approval filing for Monovisc in December 2009 but was issued a deficiency/non-approvable letter. The following year - in 2010, the company submitted additional data and analyses, but was informed by the FDA that deficiencies still existed.

During the first quarter of 2011, Anika even requested a review of Monovisc by the Advisory Panel to assist in the resolution of any remaining issues, and had been in discussions with the U.S. regulatory agency since then.

Though the request for an Orthopedic Advisory Panel review of Monovisc was denied by the FDA, the company was given an audience with the Chief Scientific Officer of the Center for Devices and Radiological Health, a branch of the FDA, on June 12, 2012, to address concerns related to the non-approvable letter issued for Monovisc PMA.

The company, which had remained optimistic regarding the approval of Monovisc, was expecting the FDA decision this month. But much against Anika's expectations, yesterday, the Chief Scientific Officer of the Center for Devices and Radiological Health of the FDA announced that the non-approvable decision for the Monovisc PMA that was previously disclosed is being upheld.

Anika said that it intends to meet with the FDA at the earliest to determine the next steps concerning the Monovisc product.

Monovisc is approved for use in the European Economic Area and Turkey.

ANIK has thus far hit a 52-week low of $8.07 and a 52-week high of $17.70.The stock closed Tuesday's trading at $11.95.

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by RTT Staff Writer

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