Cangene drug approved in U.K
newswire.ca
TORONTO AND WINNIPEG, July 27 /CNW/ - Cangene is pleased to announce the
achievement of yet another clinical milestone today - it has received
regulatory approval to sell its hyperimmune product, WinRho SDF(R), in the
United Kingdom. ''This is a significant approval and will also allow us to
request registration in other EU countries through the mutual recognition
procedure within the next few months.'' said John Langstaff, Cangene's
president and CEO. The U.K approval for WinRho SDF(R) is for preventing
hemolytic disease of the newborn, which is an immune incompatibility between a
mother and unborn baby. Cangene received this approval eight months after
submitting the file to the Medicines Control Agency (MCA) in the U.K. After
originally submitting WinRho in Germany as the first entry into the European
Union, Cangene focussed on the U.K., at the request of the MCA, where the
product received expedited review due to an urgent need. Under the mutual
recognition procedure, once a drug is approved in the country of first
licensure, the company files for a mutual recognition review, and the other EU
member countries respond within 90 days; either approving the product, or
requesting additional information from the company.
WinRho SDF(R), Cangene's first commercial hyperimmune product, is a
purified antibody that reacts with a certain type of red blood cell (Rh+
cells). In addition to its use for preventing hemolytic disease of the
newborn, the drug is licensed to treat ITP (immune thrombocytopenic purpura;
an immune-mediated clotting deficiency) in the U.S., Canada and Israel. WinRho
is purified from specially collected human plasma and manufactured using an
industry-leading combination of solvent-detergent and nanofiltration for virus
inactivation. Cangene currently sells the drug in more than twenty countries
worldwide.
Cangene is one of Canada's largest biotechnology companies. Founded in
1984 in Mississauga, Cangene's main locations now include Mississauga and
Winnipeg. It uses patented manufacturing processes to produce plasma-derived
and recombinant therapeutic proteins. It is also using its drug-manufacturing
expertise in a developing contract manufacturing business. Its FDA-licensed,
ISO 9001-registered manufacturing facilities are located in Winnipeg.
GLOSSARY
--------
antibody - a specialized protein produced by blood cells that
binds specifically to a foreign substance and
inactivates it.
hyperimmune - highly purified preparation of a specialized antibody
made from human plasma
ITP - immune thrombocytopenic purpura; an autoimmune
disorder causing abnormal destruction of blood
platelets, potentially leading to severe bleeding
MCA - Medicines Control Agency: a regulatory body
nanofiltration - a highly effective filtration process
platelet - small disk-shaped body in the blood,
plasma - the fluid (non-cellular) portion of blood
WinRho SDF(R) - an antibody to Rh+ red blood cells (e.g. O+ blood
type), used to prevent hemolytic disease of the
newborn, an immune incompatability between a mother
and baby, and to treat a clotting disorder known as
immune thrombocytopenic purpura or ITP. WinRho SDF(R)
has received Orphan Drug Status in the U.S. granting
it market exclusivity until 2002.
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For further information: Mr. John McMillan, General Manager at
(204) 275-4310 or at jmcmilla@cangene.com.; Cangene's web address is
www.cangene.com |
