August 20, 2009 / 2:06 PM / 11 years ago

UPDATE 3-Anika soars on FDA filing expectations, rival's stumble

* Expects to submit final trial data to FDA by year end

* Knee osteoarthritis injection gets Health Canada OK

* Expects to launch Monovisc this month in Canada

* Shares up as much as 74 pct; among biggest gainers

* Analyst: FDA panel rejection of rival to benefit Anika (Recasts, adds analyst comment, updates stock movement)

By Anand Basu

BANGALORE, Aug 20 (Reuters) - Anika Therapeutics’ (ANIK.O) shares rose as much as 74 percent as its knee drug moved a step closer to a complete filing for U.S. approval Thursday, a day after rival Q-Med’s QMED.ST drug was rejected by a regulatory panel.

Anika also said its Monovisc injection for the treatment of osteoarthritis of the knee was approved by Canadian health regulators.

On Wednesday, a U.S. advisory panel had urged regulators to reject a proposed injection to treat knee pain from Q-Med AB and Smith & Nephew (SN.L) (SNN.N). [ID:nN19483022]

The panel, in a 6-1 vote, recommended against approval of the Durolane injection for arthritis patients. The vote makes it unlikely the product will win approval as the U.S. Food and Drug Administration usually follows panel advice.

Susquehanna Financial analyst David Turkaly said the FDA panel decision on Durolane could benefit Anika in the longer run as Monovisc could be the second single injection product in the United States along with Genzyme Corp’s GENZ.O Synvisc-One.

Anika said it was successfully moving forward on its goal of achieving the FDA’s approval for Monovisc in the United States.

The company said it expects to launch the drug in Canada this month through its distribution partner Rivex Pharma Inc, an arm of Helix BioPharma Corp (HBP.TO).

Anika expects to submit final modules of the clinical data to U.S. regulators before the end of 2009 under its modular premarket approval application (PMA) that allows submission of clinical data on a rolling basis.

The company has already submitted its initial module to the FDA.

Monovisc is currently being reviewed by the FDA under modular PMA. In a traditional PMA, the company submits all clinical data at the same time, regardless of when testing is completed, whereas in a modular PMA, it can submit clinical data in discrete sections soon after completing testing and analysis.

Anika had already completed a U.S. late-stage trial for the drug and is now completing the retreatment study, which is designed to demonstrate the safety and benefit of repeat injections.

Monovisc is already available in the European Union since the second quarter of 2008, the company said.

Shares of the company were up $1.68 at $6.74 in afternoon trade Thursday. They touched a high of $8.80 earlier in the session.

For the alerts double-click [ID:nWNBB7823] . (Editing by Anil D’Silva, Vinu Pilakkott)

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