Report Draws On Strategic Intelligence and Competitive Analysis
Information From Newport Horizon Global(TM)
PHILADELPHIA and LONDON, Jan. 9 /CNW/ - Thomson Scientific, part of The
Thomson Corporation (NYSE: TOC; TSX: TOC) and leading provider of information
solutions to the worldwide research and business communities, has released the
first issue of Movers and Shakers. This newest report in the Pharma Matters
series analyzes the U.S. generics market from July to September 2007, profiles
some of the companies breaking into the market, and highlights molecule
patents currently being challenged.
Movers and Shakers reviews the U.S. generics market using strategic
intelligence and competitive analysis information drawn from Thomson
Scientific's Newport Horizon Global, the critical product targeting and global
business development system from the industry authority on the global generics
market, in order to assess one of the world's most important pharmaceutical
"Because of the dynamic nature of the generics market in the U.S., the
common perception is that the market is relatively easy to break into," said
Kate Kuhrt, director, Generics and API Intelligence, Thomson Scientific.
"However, our research has shown that there is huge competition between the
incumbents and new companies vying for a slice of the market, and clearly
there will be winners and losers. Ours is the first quarterly report to
identify the real 'movers and shakers' within the generics market."
The first quarterly report covers the period of July to September 2007,
and highlights the key indicators of the state of play of the industry. These
Abbreviated New Drug Applications (ANDA): An ANDA is the first step in
the process a company needs to follow in order to release a generic drug in
the U.S. and is submitted to the FDA to prove that the generic version is
equivalent to the brand name drug (reference listed drug).
Paragraph IV challenges: A generic company may obtain FDA approval before
patent expiry if it certifies its product does not infringe the listed patents
or the patents are invalid (paragraph IV certification). In addition, the
first company to file an ANDA with paragraph IV certification is awarded a
180-day period of exclusivity for the ensuing generic product, giving the
filer an important competitive advantage. Bioequivalent generic versions of
drugs that are not protected by patents can be produced and marketed in the
U.S. by any company, subject to FDA approval.
Who Are the Movers and Shakers This Quarter?
Molecules recently exposed to paragraph IV challenges: Big Pharma
companies such as sanofi-aventis, Eli Lilly, Hoffmann-La Roche and AstraZeneca
all saw challenges in the period from July to September on molecules they have
Companies taking their first steps into the US generics industry: The
report highlights companies that were felt to be of significant interest. This
quarter, the report focuses on Dabur India Ltd, who launched a Paragraph IV
challenge on the drug oxaliplatin, Zhejiang Huahai Pharmaceutical Group Co
Ltd, a Chinese company that has received tentative approval for nevirapine
200mg tablets under the President's Emergency Plan for Aids Relief (PEPAR)
program, and GeneraMedix Pharmaceuticals Inc., an American company based in
New Jersey that has received FDA approval for a selection of new products.
"The global stakes involved in the US generics market become evident when
you see that the top country filing ANDAs in the US is India, and the company
recorded as having the most Paragraph IV patent challenges is Teva, an Israeli
Pharma company," added Kuhrt. "Clearly, the message is that American companies
cannot presume that they will have a home advantage in this market."
About This Quarterly Report:
Data for this report was compiled and analyzed using Newport Horizon
Global(R) a critical product targeting and global business development system
from Thomson Scientific. Created specifically for generic pharmaceutical
companies and strategic API manufacturers, it allows them to identify and
evaluate product opportunities worldwide, ensuring they will be the first to
find the generic product and niche opportunity, first to make the deal, and
first to get to market.
For a copy of the full report with analysis, visit:
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About The Thomson Corporation
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customers. With operational headquarters in Stamford, Conn., Thomson provides
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and Toronto stock exchanges (NYSE: TOC; TSX: TOC).
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