In The Field - Pharmaceutical Technology

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In The Field

Pharmaceutical Technology

"We predicted profitability in the US industry before the end of the decade," said Mike Hildreth, Americas biotechnology leader for Ernst and Young in a company release. "Only a strong deal year with high charges for in-process research and development kept the industry from reaching that goal."
-Patricia VanArnum


Bristol-Myers Squibb and Pfizer Sign Development and Commercialization Pact

New York (Apr. 26)—Bristol-Myers Squibb Company (BMS, and Pfizer, Inc. ( entered into a collaborative agreement for the development and commercialization of apixaban, an anticoagulant that BMS discovered. The companies are studying apixaban's ability to prevent and treat various venous and arterial thrombotic conditions, including deep-vein thrombosis and pulmonary embolism.

According to the agreement, Pfizer will pay $250 million upfront to BMS and will fund 60% of development costs from January 1, 2007 onward. BMS will pay the remaining development costs. Pfizer may make as much as $750 million in additional payments to BMS, depending on the achievement of developmental and regulatory milestones. The companies will share responsibility for devising the clinical and marketing strategies for apixaban and will divide commercialization expenses, profits, and losses equally.

BMS and Pfizer also agreed to cooperate on the research, development, and commercialization of a Pfizer discovery program. Among the program's focuses are advanced preclinical compounds that potentially could treat metabolic disorders such as obesity and diabetes.

Under this agreement, Pfizer will supervise all research and early-stage development activities for the metabolic-disorders program. The companies will conduct Phase III development and commercialization activities jointly. BMS will pay Pfizer $50 million upfront as part of the agreement. Pfizer will assume 60% of development and commercialization expenses, and BMS will assume the remaining portion. The companies will share profits and losses the same way.
-Erik Greb


BIO Calls for 14-Year Data-Exclusivity Period for Biologics

Washington, DC (May 3)—The Biotechnology Industry Organization (BIO, published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity. The organization defines data exclusivity as the time period after the innovator's product is approved during which the US Food and Drug Administration (Rockville, MD, may not approve a follow-on biologic (FOB) product that relies on the innovator product's safety and effectiveness.

"For biologics to receive the same length of effective market protection that small-molecule drugs receive under the Hatch-Waxman Act, the period of data exclusivity in any FOBs framework must be no less than 14 years," said Jim Greenwood, BIO's president and CEO in a prepared statement. "Anything less could skew investment away from biologics research and development, jeopardizing the development of future pioneering biomedical advances."

BIO asserts that protecting biologics is not entirely analogous to protecting small-molecule drugs. Unlike a generic small-molecule drug, which must be the same as an innovator product, a follow-on biologic may be only "similar" to the corresponding innovator product. In addition, because biologic products are large molecules produced by living cells, patent protection for such products is often narrower and easier to "design around," than that of small-molecule drugs.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
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