Posted: Wed, Jun 6 2012. 10:34 PM IST Hyderabad : Indian drug
maker Dr. Reddy’s Laboratories Ltd and European biotechnology firm Merck Serono
will jointly develop and manufacture biosimilar compounds—subsequent versions
of innovator biopharmaceutical products that go off patent—to treat cancer, the
two companies said on Wednesday. The focus of the venture will be on so-called
monoclonal antibodies. Merck Serono, a division of Merck KGaA , based in
Darmstadt, Germany, and Hyderabad-headquartered Dr. Reddy’s will co-develop
biosimilar molecules, with the Indian partner leading early product and
complete phase I development. Merck Serono will take over manufacturing of the
compounds and will lead Phase III development. The partners will share the cost
of research and development. Photo: Bloomberg “The partnership covers
co-development, manufacturing and commercialization of the compounds around the
globe, with some specific country exceptions,” Dr. Reddy’s said in a statement.
Dr. Reddy’s has to date launched four biosimilar molecules. The partnership
with Merck Serono expands on Dr. Reddy’s presence in the biosimilar space in
select emerging markets and enables participation globally. Up to now, complex
biotechnology medicines, which are given by injection, have been largely immune
from generic competition, unlike conventional chemical pills and capsules. But
the landscape is starting to change as patents end and regulators establish
guidelines for developing so-called biosimilar versions of drugs, posing a
threat to leading biotech groups like Roche and Amgen. In contrast to
conventional chemical medicines, biotech products are impossible to copy
precisely, forcing generic companies to develop biosimilars, which are close to
the original but need to be sold as separate medicines. Merck Serono will
undertake commercialization globally, outside the US and with the exception of select
emerging markets which will be co-exclusive or where Dr. Reddy’s maintains
exclusive rights. Dr. Reddy’s will receive royalty payments from Merck Serono
upon commercialization. In the US ,
the parties will co-commercialize the products on a profit-sharing basis. “We strongly believe that biosimilars is an important area of future growth
and these products give us the opportunity to provide affordable and innovative
medicines to patients across the globe,” said G. V. Prasad, vice-chairman and
chief executive officer of Dr. Reddy’s. He said recent guidance from the
European Medicines Agency and the US Food and Drug Administration on
biosimilars made it clear that “any significant player in the field will need
strong biologics development, manufacturing and commercialization
capabilities,” adding that Merck Serono’s and Dr. Reddy’s expertise in these
fields would make for a powerful partnership. Europe
has already approved some biosimilars, including copycat versions of human
growth hormone and the anaemia treatment EPO. However, antibodies for diseases
such as cancer and rheumatoid arthritis are a much bigger commercial prize. Stefan
Oschmann, chief executive officer of Merck Serono, said sharing know-how, risks
and rewards was the right approach towards entering the biosimilar market,
citing Dr. Reddy’s expertise in generic drugs and emerging markets as well his
company’s expertise in developing, manufacturing and commercializing
biopharmaceuticals. “It’s a positive and equivalent
tie-up for Dr. Reddy’s,” said Hemant Bakhru, an analyst at Mumbai-based foreign
brokerage CLSA Asia-Pacific Markets. “The tie helps Dr. Reddy’s to take their
biosimilars through late stage clinical trials, where it requires huge
investment.” There will be time lag before the tie-up starts reflecting on Dr.
Reddy’s earnings. “It takes at least two-three years to see any impact of this
tie-up on earnings of Dr. Reddy’s,” Bakhru said. Shares of Dr. Reddy’s declined
by 0.25% to Rs.1,614.75 at the close of trading on BSE Ltd while the benchmark
Sensex index rose by 2.71% to close at 16,454.30 points. viswanath.p@livemint.com
Reuters also contributed to this story.
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