Evaluating Late-Stage Pipelines and Potential - Pharmaceutical Technology

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Evaluating Late-Stage Pipelines and Potential
Will 2011 be a more promising year for new molecular entities? A review of Big Pharma's late-stage pipeline shows what might lie ahead.

Pharmaceutical Technology
Volume 35, Issue 2, pp. 52-56

Bristol-Myers Squibb . Bristol-Myers Squibb pointed to five key potential product approvals in 2011 based on a company overview presented in January 2011. These candidates include ipilimumab, an anticancer immunotherapy; belatacept, a co-stimulation blocker developed as an alternative therapy in solid-organ transplantation; apixaban, an oral Factor X inhibitor as an anticoagulant; dapagliflozin, an antidiabetes treatment; and a subcutaneous formulation of Orcenia (abatacept) to treat rheumatoid arthritis. The company also highlighted four drug candidates that potentially may move to Phase III development in 2011. These drugs include: elotuzumab, a humanized monoclonal antibody to treat multiple myeloma; a peptide functioning as a gamma secretase inhibitor to treat Alzheimer's disease; PEG-IFN lambda, an interferon to treat hepatitis C; and a small-molecule NS5A inhibitor to treat hepatitis C.

Other companies . AstraZeneca had 10 NMEs as drug candidates in late-stage development (Phase III or in registration) and 12 products being developed as line extensions as of July 29, 2010. Merck & Co. reported on its research pipeline as of Oct. 22, 2010, which included 19 programs in Phase III development. Eli Lilly reported as of October 18, 2010, that it had eight drug candidates in Phase III development and three drugs under regulatory review. One recent setback reported by Eli Lilly on Jan. 12, 2011, was a recommendation of a FDA advisory committee for nonapproval of liprotamase, an oral, nonporcine pancreatic enzyme-replacement therapy for treating exocrine pancreatic insufficiency. The committee had questions about the degree of efficacy of liprotomase and recommended additional studies to be conducted before approval.

Looking ahead

As companies navigate late-stage development, they face moderate industry growth in 2011. The global pharmaceutical market is expected to grow 5–7% in 2011 to reach $880 billion, slightly better than the 4–5% growth in 2010, according to estimates by IMS Health in October 2010. Five potential blockbuster products—defined as those exceeding $1 billion annually in peak sales—are expected to be approved and launched globally by the end of next year, projects IMS. In 2011, products with sales of more than $30 billion are expected to face generic competition in the major developed markets.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072,


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