-a purified hyaluronate sodium I.V./I.A. product for
horses-
BELLEVILLE, ON,
Dec. 1, 2013 /CNW/ - 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.
Urocidin™ U.S. Regulatory Pathway
A meeting with the U.S. Food and Drug
Administration to discuss the potential for accelerated approval of
Urocidin™ that had been scheduled for December 18, 2013 has now been postponed to allow
the Company additional time to gather information required by the
regulator. A new meeting date will be set once this information has
been put together.
ASX Delisting
Given the very low level of trading on the
Australian Securities Exchange (ASX), the small number of CDIs
remaining, and the significant liquidity for Bioniche shares on the
Toronto Stock Exchange (TSX), it intends to delist from the
official list of the ASX, subject to ASX approval. As a result of
the delisting, the Company expects to realize a savings in
administrative and compliance obligations. Following the delisting,
Bioniche Common Shares will continue to trade on the TSX.
All holders of CDIs will be offered several
alternatives, including selling or transferring their holdings to
the TSX, where there is a more liquid market. CDI holders will be
sent an information package in due course which explains in detail
the options available to them. It is important that CDI holders
take time to consider this information package carefully.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based,
technology-driven Canadian biopharmaceutical company focused on the
discovery, development, manufacturing, and marketing of proprietary
and innovative products for human and animal health markets
worldwide. The fully-integrated company employs more than 200
skilled personnel and has three operating divisions: Human Health,
Animal Health, and One Health. The Company's primary goal is to
develop and commercialize products that advance human or animal
health and increase shareholder value.
Bioniche Animal Health develops, manufactures
and markets veterinary biopharmaceutical products worldwide. In
North America, it has development,
manufacturing and marketing facilities in Belleville, Ontario, Canada, Athens, Georgia, U.S.A. and Pullman, Washington, U.S.A. In Australia, business is conducted from
Armidale, New South Wales, where
research, development and manufacturing facilities are located. The
Company engaged Evercore in May, 2013 to lead the divestment of its
Animal Health business unit. At such time as a definitive agreement
is reached, the proposed sale transaction will be presented to
Company shareholders for a vote.
For more information, please visit
www.Bioniche.com.
Except for historical information, this news
release may contain forward-looking statements that reflect the
Company's current expectation regarding future events. These
forward-looking statements involve risk and uncertainties, which
may cause, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties
related to the regulatory approval process, and other risks
detailed from time to time in the Company's ongoing quarterly and
annual reporting.
SOURCE Bioniche Life Sciences Inc.