May 1, 2008
Attn: Health and News Editors
For Immediate Release
Biosimilar G-CSF: Cooperation on Three
Continents.
Toronto, ON (May 1, 2008) — 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®, 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 $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 $2 Billion in R&D 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”.
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For further information:
Mr. Elie Betito
Director Public & Government Affairs
Tel: 416-749-9300 Ext. 7366
Cell: 416-558-5491
ebetito@apotex.com
Kwizda Pharma GmbH
Helmut Brunar, Ph.D., M.Sc.
VP Research & Business Development
Tel: +43 / 664 / 822 57 60
h.brunar@kwizda.at
www.kwizda.at
Intas Biopharmaceuticals Limited
Siddharth J. Baad
Corporate Communications
Tel: +91–2717–660208
siddharth.baad@intasbiopharma.co.in
www.intasbiopharma.co.in
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