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Del.icio.usShares of Anika Therapeutics, Inc. (NASDAQ: ANIK) rose nearly 74 percent on Thursday after the drug maker received approval from Health Canada for its osteoarthritis of the knee treatment, MONOVISC™. The product will be distributed in Canada by Anika’s distribution partner, Helix BioPharma Corp.
“Health Canada approval marks an important next step as we continue to expand the geographic reach of our novel osteoarthritis treatment therapy and establish MONOVISC as the premier single-injection product on the market worldwide,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer in a statement.
The single injection viscosupplement drug has been available in the European Union since early 2008 and is currently being evaluated by the U.S. Food and Drug Administration.
The company has steadily made progress toward U.S. approval of the knee drug, and is expected to submit additional clinical data to the FDA before the end of the year. The company filed a modular premarket approval (PMA) application with the FDA for MONOVISC, which allows for submission of clinical data on an ongoing basis rather than all at once. Anika had previously presented an initial module of trial data for MONOVISC™.
MONOVISC™ is currently undergoing a retreatment study, which focuses on the safety of the drug and the benefits of repeat injections.
Anika also received a boost on Thursday as news broke that a U.S. advisory panel recommended that regulators reject a similar injection treatment for knee pain submitted by rival companies Q-Med AB and Smith & Nephew.
The panel decision could have long-term advantages for Anika if MONOVISC™ gets FDA approval. The drug would be the second single injection product on the market with the other being Genzyme Corporation’s drug, Synvisc-One™.
Tags: ANIK, buzz stocks, pharmaceutical stocks, therapeutics