-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,
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."
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.
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
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
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
SOURCE: Bioniche Life Sciences Inc.
For further information:
Jennifer Shea, Vice-President, Communications, Investor & Government Relations
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058; from Australia: 0011 1 613-966-8058
Cell: (613) 391-2097; from Australia: 0011 1 613-391-2097