-a purified hyaluronate sodium I.V./I.A. product for horses-
BELLEVILLE, ON, Dec. 1, 2013 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that its purified hyaluronate sodium product for horses - NexHA™ - has been approved by the U.S. Food and Drug Administration (FDA) for sale in the U.S. The product was launched in Canada in December of last year and will be launched in the U.S. next week at the American Association of Equine Practitioners' Annual Convention in Nashville, Tennessee.
NexHA™ is a formulation of purified hyaluronate sodium that can be administered to horses by intravenous or intra-articular injection. It is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis. Hyaluronate sodium acts as a replacement for synovial fluid, the naturally occurring lubricant in articular joints. Joint degeneration is associated with the loss of synovial fluid, and the lack of its lubricant effects results in considerable pain and inflammation for the horse.
The Company has been developing different formulations of sodium hyaluronate for the equine markets in Canada, Australia, Turkey, Hong Kong, and New Zealand - sold as Enhance ® - since 2001/02. Both Enhance ® and NexHA™ are produced with a sodium hyaluronate solution that is obtained from a selective fermentation source using a manufacturing process that is free from thermal degrading effects and delivering high specificity."We are pleased to be able to offer equine veterinarians and, in turn, horse owners and trainers another option to address joint issues in their performance horses," said Mr. Andrew Grant, President, Bioniche Animal Health (global). "The U.S. market for joint-related therapies is estimated to be $40 million per year." Corporate Updates Divestment of Animal Health Business The divestment of the Animal Health business being managed by Evercore continues to progress, and the Company is currently in the negotiation phase. If negotiations are successfully concluded, the preferred offer will be brought to shareholders for approval at a special meeting within 30-60 days of signing a definitive agreement.