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PricewaterhouseCoopers: Personalized medicine market to grow 11% annually

BY Allison Cerra

NEW YORK Personalized medicine, which targets individualized treatment and care based on personal and genetic variation, is creating a booming market, but is a disruptive innovation that will create both opportunities and challenges for traditional health care and emerging market participants, according to a new report published by PricewaterhouseCoopers.

The report, The Science of Personalized Medicine: Translating the Promise into Practice, projects that the market for a more personalized approach to health and wellness will grow to as much as $452 billion by 2015. PricewaterhouseCoopers’ estimates are based on a broad view of the market opportunity beyond drugs and devices to also include demand for high-tech storage and data-sharing as well as low-tech products and services aimed at consumers’ heightened awareness of their own health risks.

“Medical science and technological advancement have converged with the growing emphasis on health, wellness and prevention sweeping the country to push personalized medicine to a tipping point,” said David M. Levy, M.D., global healthcare leader, PricewaterhouseCoopers. “We are now seeing a blurring of the lines between traditional healthcare offerings and consumer-oriented wellness products and services. The market potential is enormous for any company that learns to leverage the science, target individuals and develop products and services that promote health.”

The promise of personalized medicine has been predicated upon genomic testing, which enables physicians to identify an individual’s susceptibility to disease, predict how a given patient will respond to a particular drug, eliminate unnecessary treatments, reduce the incidence of adverse reactions to drugs, increase the efficacy of treatments and, ultimately, improve health outcomes.

“There is an urgent need to increase the value of health care, but we can’t get there by fixing the health care of yesterday. We need to replace our current focus on treating disease with a better approach that is personalized, preventive, predictive and participatory, the basic tenants of personalized medicine,” said Gerald McDougall, principal in charge of personalized medicine and health sciences, PricewaterhouseCoopers. “Greater collaboration around personalized medicine should be a key strategy for health reform.”

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Celgene Corp. to acquire Gloucester Pharmaceuticals

BY Alaric DeArment

SUMMIT, N.J. Celgene Corp. plans to acquire Cambridge, Mass.-based Gloucester Pharmaceuticals in a deal worth more than $300 million, Celgene announced Monday.

The Summit, N.J.-based biopharmaceutical company said the acquisition of Gloucester for $340 million plus $300 million in future milestone payments would give it a leadership position in developing disease-altering therapies through innovative approaches for patients with blood cancers.

The Food and Drug Administration approved Gloucester’s Istodax (romidepsin) in November as a treatment for cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy. The agency also gave the drug orphan drug designation for treatment of non-Hodgkin’s T-cell lymphomas like CTCL and peripheral T-cell lymphoma and fast-track status for PTCL.

“This acquisition reflects our ongoing commitment to improving the lives of patients worldwide through innovative medicines discovered and developed both in-house and through external opportunities,” Celgene chairman and CEO Sol Barer sstated.

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FDA rejects EMD Serono’s MS drug

BY Alaric DeArment

ROCKLAND, Mass. The Food and Drug Administration has declined to file a regulatory approval application from the U.S. subsidiary of Merck KGaA for a multiple sclerosis drug.

EMD Serono announced that the FDA had responded to its application seeking approval for cladribine tablets with a refuse-to-file letter, which indicates that the application is incomplete. EMD Serono said it would request a meeting with the FDA concerning the application.

“The company will work closely with the FDA to fully understand FDA’s concerns and define a path forward for a successful resubmission of this application at the earliest point in time,” Merck KGaA head of pharmaceuticals and board member Elmar Schnee said in a statement. “We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options.”

Merck KGaA is a separate company from the U.S.-based Merck & Co.

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