Biosimilar G-CSF: Cooperation on Three Continents.
02/05/2008 00:27
PR Newswire
TORONTO, Canada, May 1 /PRNewswire/ -- A biosimilar protein that can be used to treat neutropenia (a side effect
of cancer chemotherapy) is to be developed by Apotex Inc. of Canada in
collaboration with Intas Biopharmaceuticals Limited (IBPL) of India.
Neukine(R), a recombinant granulocyte colony stimulating factor (G-CSF) is
already manufactured and marketed in India and other countries by IBPL.
Kwizda Pharma of Austria had been working with IBPL to develop G-CSF for the
European market for some time. Effective immediately, Kwizda Pharma has
transferred all of its rights in IBPL's G-CSF to Apotex. Apotex and IBPL have
concurrently agreed to extend the collaboration to development of G-CSF for
North America (US and Canada)
Dr. Helmut Brunar, VP Research and Business Development of Kwizda Pharma
explains the mutual benefits of the agreement: "It is part of Kwizda Pharma's
current business strategy to work together with non-European pharmaceutical
companies to break into the European market. That is why we worked with IBPL
to successfully complete a phase I clinical trial and have transferred our
rights in IBPL's G-CSF to Apotex including initiation of a phase III trial
for the approval of G-CSF in Europe."
Dr. Jeremy B Desai, Apotex Executive Vice President, Research &
Development adds, "This agreement represents an important milestone for
Apotex, as it strengthens the organization's development in Europe and will
offer support for entering this important market with future biosimilar
products currently in the Apotex development pipeline."
Speaking on the development, Shri Mani Iyer, Executive Director, IBPL,
said, "This business deal brings together two companies having respective
expertise in niche areas of operations. IBPL and Apotex are eying a
significant share of total G-CSF market in North America and Europe, which is
currently estimated to be around CDN$1.4 billion annually. Although
guidelines for biosimilar product registration in North America are not yet
finalized, the companies anticipate that there would be a clear pathway for
biotech companies, once the legislation is in place. IBPL and Apotex are keen
to explore prospective business opportunities for more biosimilar products in
the coming years."
About Kwizda GmbH
Kwizda GmbH is a privately owned group of companies and has been
operating since 1853 (pharmaceutical division). Kwizda Pharma is a leading
Austrian manufacturer and wholesaler of proprietary, in-licensed and
third-party pharmaceuticals, OTC drugs and hospital infusions. In 2007, the
company recorded sales of approximately EUR 50 million.
About Apotex Inc.
Apotex Inc. is the largest Canadian-owned pharmaceutical company,
employing over 6,800 people in research, development, manufacturing and
distribution facilities world-wide. Apotex produces more than 300 generic
molecules in a variety of different presentations which, in Canada, are used
to fill over 75 million prescriptions a year - the largest amount of any
pharmaceutical company in this country. In the next 10 years, Apotex will
spend CDN$2 Billion in R? and has presently over 600 products under
development.
About Intas Biopharmaceuticals Limited
Since launch of biotechnology operations in May 2000, Research &
Development, Manufacturing and Marketing of biopharmaceutical products, with
a special focus on Oncology (Cancer), are major thrust areas for IBPL. The
company is India's first and only biopharmaceuticals manufacturing company to
receive European Union - Good Manufacturing Practice (EU-GMP) certification.
Today, Intas Biopharmaceuticals Limited is the sole manufacturer of Pegylated
GCSF in India and markets under the brand name "NEUPEG".
For further information:
Kwizda Pharma GmbH,
Helmut Brunar, Ph.D., M.Sc., VP Research & Business Development,
T +43-664-822-57-60,
E h.brunar@kwizda.at,
W http://www.kwizda.at;
Apotex Inc.,
Elie Betito, Director, Public & Government Affairs,
T +1-416-749-9300, ext. 7366,
M +1-416-558-5491,
E ebetito@apotex.com,
W http://www.apotex.com;
Intas Biopharmaceuticals Limited,
Siddharth J. Baad, Corporate Communications,
T +91-2717-660208,
E siddharth.baad@intasbiopharma.co.in,
W http://www.intasbiopharma.co.in
For further information: Kwizda Pharma GmbH, Helmut Brunar, Ph.D., M.Sc., VP Research & Business Development, T +43-664-822-57-60, E h.brunar@kwizda.at; Apotex Inc., Elie Betito, Director, Public & Government Affairs, T +1-416-749-9300, ext. 7366, M +1-416-558-5491, E ebetito@apotex.com; Intas Biopharmaceuticals Limited, Siddharth J. Baad, Corporate Communications, T +91-2717-660208, E siddharth.baad@intasbiopharma.co.in