Anika Starts New Year With Fidia Acquisition, Direct Sales Plan
This article was originally published in The Gray Sheet
Anika Therapeutics' acquisition of Fidia Advanced Biopolymers provides a "critical mass" of hyaluronic acid-based products to market in the U.S. alongside its PMA-pending Monovisc single-injection knee osteoarthritis therapy, the firm said
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Single-injection viscosupplement is approved to treat osteoarthritis of the knee in patients who have failed to respond to more conservative therapy, the firm announces Feb. 26. On Dec. 9, FDA's Orthopedic and Rehabilitation Devices advisory panel recommended approval of Genzyme's PMA supplement for the single-dose version of Synvisc (approved in 1997). Unlike Synvisc-One, Synvisc requires three intra-articular injections at one-week intervals (1"The Gray Sheet" Dec. 15, 2008, p. 13). Genzyme says it will launch Synvisc-One "immediately.
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.
In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.