Anika Therapeutics (NASDAQ:ANIK) Health Canada Approval of Arthritis Drug Sends Trading Volume Sky High as FDA Approval is Up Next.
Gaining over 48% ($2.47) in early trading this morning, Anika Therapeutics Inc., (ANIK) http://www.anikatherapeutics.com/ set a new market cap of $82 million. ANIK is currently trading in the $7.20 range. ANIK has a 3-Month average daily trading volume of a mere 33,432 shares and today, trading volume surged past 1,315,522 shares at the time of this writing.
ANIK announced today that it had received approval from Health Canada (the National Canadian Drug Administration) to commercialize and distribute ANIK's single injection supplement called Monovisc for the treatment of osteoarthritis of the knee throughout Canada and the Canadian healthcare system.
ANIK management said it expects to launch the drug this month through Rivex Pharma Inc., its distribution partner in Canada. Monovisc has been widely available in Europe since Q2 2008.
ANIK President and CEO Charles H. Sherwood, Ph.D., said, "We are successfully moving forward on our goal of achieving FDA approval for Monovisc in the U.S. The initial PMA modules have been submitted to the FDA and are currently under review.
"We expect to submit the final module containing the clinical study data prior to year-end 2009. We are confident that Monovisc will be as well received in North America as it has been in Europe."
On July 22, ANIK released its Q2 2009 report and posted a Q2 revenue increase of 5% to $8,771,000 compared with $8,379,000 in the same period last year. Product revenue for the first six months of 2009 grew 6% to $17,290,000 from $16,246,000 in the first six months of 2008.
ANIK total revenue for Q2 09 increased 5% to $9,524,000 from $9,060,000 in Q2 08. Total revenue for the first six months of 2009 increased 6% to $18,724,000 compared with $17,609,000 for the same period in 2008.
ANIK makes and sells therapeutic products for tissue protection, healing, and repair. ANIK products are based on hyaluronic acid, a naturally occurring biocompatible polymer found in the body. In addition to Monovisc, ANIK sells Orthovisc, a product used in the treatment of specific forms of osteoarthritis in humans.
At $7.20, ANIK is below its 52-week high of $8.96 set on 08-22-08 and is above its 52-week low of $2.96 set on 01-02-09. At $7.20, ANIK is above both its 50-day and 200-day moving averages. ANIK has trailing twelve month revenues of $36 million and a trailing twelve month diluted EPS of $0.32. Its shares out versus float ratio is near-parity.