Calgary, Alberta
November 22, 2006
Canadian biotechnology company
secures manufacturing partner to supply insulin in preparation
for preclinical and clinical development
SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a broad pipeline
of protein-based
pharmaceuticals and non-pharmaceutical products, today announced
the completion of a Technology Transfer and Manufacturing
Agreement with Cangene Corporation, a biopharmaceutical company
and contract manufacturing organization, for the processing and
purification of SemBioSys' plant-produced insulin. The contract
is part of the Company's preparations for its Investigational
New Drug Application (IND) and the initiation of clinical
trials. Cangene will manufacture insulin for SemBioSys'
preclinical and early stage clinical development.
"Obtaining the services of a
credible and reliable manufacturing organization like Cangene is
a critical component of our clinical plan for insulin," said
Andrew Baum, President and CEO of SemBioSys Genetics Inc. "The
execution of this contract is the second significant development
milestone for our insulin program, following on our announcement
this past July of successfully achieving commercially viable
levels of insulin accumulation in
safflower. We continue to advance our insulin development plan.
In the near term, we expect to announce the regulatory strategy
we will pursue in the U.S. for our insulin product and to
receive in vivo and in vitro bioequivalence results comparing
insulin produced from safflower to commercially available
insulin products."
With the signing of the contract,
SemBioSys intends to immediately begin work with Cangene to
implement technology transfer of the manufacturing process,
which enables cGMP production of insulin from transgenic
safflower. By solidifying the manufacturing capacity for
insulin, SemBioSys remains on track to complete its preclinical
work and file its IND in the fourth quarter of 2007. Cangene
will be responsible for purification of clinical grade material
isolated from safflower seed produced by SemBioSys' proprietary
production technology. The contract with Cangene allows
SemBioSys to avoid the costs associated with building and
maintaining a stand-alone manufacturing facility during the
early stages of clinical development.
Demand for insulin for the
treatment of diabetes reached an estimated 5,500 kilograms in
2005 and is projected to increase to 16,000 kilograms by 2012.
SemBioSys believes its safflower-produced insulin can reduce
capital costs compared to existing insulin manufacturing by 70%
and product costs by 40%. In addition, because of the ease in
scaling-up crop acreage, plant-produced insulin offers
significant improvements in the flexibility and
speed of scale-up.
Calgary, Alberta-based SemBioSys Genetics Inc. is a
biotechnology company focused on the development,
commercialization and production of biopharmaceuticals and
non-pharmaceutical products based on its plant genetic
engineering skills and proprietary oilbody-oleosin technology
platform - the Stratosome(TM) Biologics System. Its two lead
pharmaceutical product candidates are insulin and a
developmental cardiovascular drug called Apo AI. It also has a
series of non-pharmaceutical products addressing animal and
aquaculture health, nutritional oils and human topical markets.
SemBioSys currently has funded partnership agreements with
Martek Biosciences Corporation, Lonza Inc. and Arcadia
Biosciences, Inc.
Cangene is one of Canada's largest biopharmaceutical companies.
It was founded in 1984 and is headquartered in Winnipeg,
Manitoba. Cangene uses patented manufacturing processes to
produce plasma-derived and recombinant therapeutic proteins.
Cangene also provides contract research and manufacturing
services using its drug-manufacturing expertise and the
resources of Chesapeake Biological Laboratories, Inc. (a wholly
owned subsidiary). The Company has manufacturing facilities in
Winnipeg, Manitoba and Baltimore, Maryland. Cangene's website,
www.cangene.com, includes product and investor information,
including past news releases. Chesapeake's website is
www.cblinc.com. Cangene is
listed on the Toronto Stock Exchange under the symbol CNJ. |