(Adds details, background, analyst comment; adds share
By Vrinda Manocha
Feb 25 Anika Therapeutics Inc said the
U.S. Food and Drug Administration approved its drug to treat
pain and improve joint mobility in patients with osteoarthritis
of the knee, more than four years after it first filed for
The company's shares rose about 33 percent to $45.98 in
extended trading after the approval for Monovisc, which is
already sold in Canada, the United Kingdom and countries in the
Middle East, Europe and Asia.
"Management did a tremendous job in pushing forward through
multiple rejections at the FDA," Summer Street Research analyst
Mark Landy said.
"We believe this product will be competitive in a market
that is becoming more focused on single-shot injections."
Sanofi SA and Zimmer Holdings Inc also
market single-injection treatments for osteoarthritis of the
The single-injection Monovisc could be an advantage over
Anika's other knee osteoarthritis pain drug, Orthovisc, which is
administered via three injections.
Osteoarthritis is a chronic condition caused by cartilage
breakdown in joints, resulting in bones rubbing together, which
leads to stiffness and pain. About 27 million people in the
United States have osteoarthritis, according to the Arthritis
The company said on Tuesday the drug will be marketed in the
United States by Depuy Synthes, a unit of Johnson & Johnson
, as part of an agreement signed in 2011.
Anika said it would receive a $5 million milestone payment
from DePuy Synthes when the drug was first sold and that it
would also get milestone payments as well as product transfer
and royalty fees.
The company's first filing for approval in December 2009 was
rejected by the FDA on grounds that there were deficiencies in
Anika appealed the decision, but failed to win approval in
December 2012, when the FDA upheld its decision.
The company submitted an amended application in January
2013, which was approved on Tuesday.
Anika's shares closed at $34.48 on the Nasdaq on Tuesday.
(Reporting By Vrinda Manocha in Bangalore; Editing by Savio