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BELLEVILLE, ON, November 29, 2004 – Bioniche Life Sciences
Inc. (TSX: BNC), a research-based, technology-driven Canadian
biopharmaceutical company, today announced that it has received
approval from the U.S. Department of Agriculture (USDA) to market its
proprietary product, SETTLE, for the treatment of equine endometritis
caused by Streptococcus zooepidemicus. It is the Company’s
intent to register this product in other jurisdictions as well.
“We are pleased to introduce this new therapy into the U.S. market
in time for the 2005 equine breeding season,” said Martin Warmelink,
President of Bioniche Animal Health, a Division of Bioniche Life
Sciences Inc. “SETTLE has been clinically proven as a fast-acting,
specific endometritis therapy for broodmares. It is the end result of
clinical research conducted over a period of five breeding seasons.”
Endometritis is a non-life threatening disease that affects 25% to
40% of broodmares worldwide. The disease results in low conception
rates or loss of pregnancies if conception occurs. It is a serious
concern for breeders, often resulting in economic losses from low
foaling rates, therapies, and repeated inseminations. If not
successfully treated during the acute phase (conventional treatment
involves intrauterine or intravenous antibiotics for three to four
consecutive days), the original infection can result in a chronic,
degenerative inflammatory condition compromising future fertility and
requiring a laborious and costly battery of treatments. SETTLE offers
breeders an additional therapy that can be easily assimilated into
reproductive treatment protocols.
“SETTLE is an important product for Bioniche,” said Graeme McRae,
President & CEO of Bioniche Life Sciences Inc. “It has been developed
from one of our core proprietary technologies that has been shown in
both humans and animals to induce a profound response in the immune
system. Enhancing the body’s natural immune system to fight disease is
preferable to introducing antibiotics and other pharmaceuticals.
Excessive or inappropriate use of antibiotics can result in the
proliferation of antibiotic-resistant bacteria.”
In August of this year, Bioniche released the first results of a
fully controlled and monitored (GCP) study using a proprietary
formulation of mycobacterial cell walls (SETTLE) to treat
bacterial-induced endometritis in susceptible mares. The study results
were presented at the Modern Vaccine/Adjuvant Formulation Conference in
Prague, Czech Republic.
The study demonstrated that immunomodulation with a single dose of
SETTLE resolved the bacterial infection and normalized the uterine
inflammatory responses, resulting in successful treatment of the
endometritis.
SETTLE will be officially unveiled at the upcoming Conference of the
American Association of Equine Practitioners in Denver, Colorado,
December 4th – 7th.
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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 products
for human and animal health markets worldwide. The Company employs
more than 300 skilled personnel and has three principal operating
divisions: Animal Health, Food Safety, and Human Health, which
includes Bioniche Therapeutics and Bioniche Pharma Group. The
Company’s primary goal is to develop proprietary cancer therapies
supported by revenues from marketed products in human and animal
health. For more information, please visit
www.bioniche.com.
About Bioniche Animal Health
The Animal Health Division of Bioniche Life Sciences Inc. has
marketing subsidiaries in Australia, Canada, Europe, and the United
States. It is responsible for research, development, manufacturing,
and marketing of veterinary biologics, pharmaceuticals, and
nutritionals. This Division has a global portfolio of 60 products,
which fall into the categories of: reproduction and embryo
transfer; immunostimulant; and vaccines. Many of the innovative
technologies discovered and developed by Bioniche Animal Health
have been further developed by Bioniche Therapeutics (in the Human
Health Division of Bioniche Life Sciences Inc.) into effective
treatments for human health conditions.
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.
For further information, please contact:
Jennifer Shea
Corporate Communications Manager
Bioniche Life Sciences Inc.
Telephone: (613) 966-8058 ext. 1250
Cell: (613) 331-6432
Jennifer.Shea@Bioniche.com
For SETTLE product information, please contact: Bioniche Animal
Health USA, Inc.
Telephone: (888) 549-4503
vet.usa@bioniche.com
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