India Generics Companies Lead Pharmaceutical Innovation in Asia Pacific, According to Thomson Reuters
(Thomson Reuters ONE) -
Thomson Reuters Asia Pacific R&D Factbook details significant increases in
innovation investment and development of novel drug pipelines.
Singapore, September 27, 2011 - Multi-national pharmaceutical companies are
likely to face increased competition for new molecular entities from India-based
generics companies, according to the 2011 CMR International Asia Pacific R&D
Pharmaceutical Factbook, released today by CMR International, a Thomson Reuters
business.
According to the research contained in the Factbook, India's generic drug
companies are making significant investments in innovative R&D and have
generated the largest new drug pipelines among generics companies worldwide in
the years between 2006 and 2010.
India-based generics companies are now leading the rest of the world's generics
companies in discovering and developing new biopharmaceutical entities that have
not been previously available for therapeutic use in man. Although India is
reported to have nearly 90 innovative products in the pipeline, almost half of
them are already in the preclinical phase.
Phil Miller, product director at Thomson Reuters, said: "Between 2006 and 2010,
the majority of the innovative drug pipeline developed by India-based generic
companies was in the pre-clinical stage but over time, we expect these
candidates to transition to latter stages of the R&D pipeline as a normal
evolution of pipeline development. We believe this developing pipeline will be
both a source of new competition for the established multi-national
pharmaceutical companies, as well as an opportunity for them to invest in, or
collaborate with, emerging players."
The Asia Pacific Factbook also reports that by continuing to shift their
operating model towards participating in high risk, high-reward drug patent
challenges (known as Paragraph IV challenges), India-based generic companies are
adopting an increasingly aggressive approach to securing market share. The
change in approach is highlighted by the 72 percent increase in the number of
Paragraph IV patent challenges raised by Indian companies between 2009 and 2010.
"If a generic company is the first to file its Abbreviated New Drug
Application(1) (ANDA) with a Paragraph IV certification and prevails in the
subsequent lawsuit, it would be granted a period of market exclusivity of 180
days," said Miller. "This exclusivity can be a significant advantage for a
generic company as it would have the only generic version available in the
market."
According to the Factbook, Asia Pacific continues to be a key area of focus for
the global pharmaceutical industry. The region's large prospective patient
population offers an attractive market for approved drugs and makes it highly
suitable for patient recruitment and clinical development. In 2009, the Asia
Pacific region contributed 10 percent of the total patients recruited globally -
twice as much as in 2003. This is a considerable shift away from US-focused
clinical development strategies.
Despite the increasing trend of Asia's involvement in global clinical trials,
countries in the region still face significant challenges, including:
· By stage of regulatory filing, in 2008, Japan was more than two years
behind the first ever submission. This means that new medicines are not being
filed in Japan until more than two years after they were filed in the first
market (typically the regulated markets such as the U.S.
or EU).
· Between 60 percent and 90 percent of companies perceive Chinese
regulatory requirements to be higher than "normal".
· Singapore has the highest occurrence of low performing clinical trial
sites in the region.
The information published in the Factbook is based on primary sources covering
major pharmaceutical companies which account for approximately 80 percent of the
industry's global R&D expenditure.
CMR International, a Thomson Reuters business, is the world leader in global
pharmaceutical R&D performance measurement. For almost 15 years, CMR
International has worked with the leading global pharmaceutical companies to
assess R&D productivity and provide insights into industry trends in order to
strengthen planning and effectiveness of R&D. Since 2003, CMR International has
published the pharmaceutical R&D Factbook, an annual report for the
pharmaceutical R&D sector providing a reliable source of key reference metrics.
For further information, please go to:
http://cmr.thomsonreuters.com/services/factbook. ()
(1)An ANDA is an application for a U.S. generic drug approval for an existing
licensed medication or approved drug
Thomson Reuters
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York and major operations in London and Eagan, Minnesota, Thomson Reuters
employs more than 55,000 people and operates in over 100 countries. For more
information, go towww.thomsonreuters.com.
CONTACT
Pamela Lim
Thomson Reuters
Asia Pacific
+65 6870 3212
pamela.lim(at)thomsonreuters.com
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Thomson Reuters Corporation via Thomson Reuters ONE
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Datum: 27.09.2011 - 03:01 Uhr
Sprache: Deutsch
News-ID 69545
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