PHARMACY

Watson, Amgen partner to develop biosimilars

BY Alaric DeArment

PARSIPPANY, N.J. — Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.

The companies said their partnership was based on the idea that biosimilars will take a different form from branded and generic drugs, requiring significant expertise, infrastructure and investment. Most responsibility for developing, manufacturing and initial commercialization of the drugs, while Watson will contribute up to $400 million in co-development costs and work on commercialization and marketing of products in specialty and generic markets. The companies will not, however, make biosimilars of Amgen drugs.

"The pairing of Amgen’s 30 years of experience in biologics, together with Watson’s substantial generics and specialty pharmaceutical experience and complementary commercial and distribution capabilities, provides great potential for worldwide patient access to high-quality oncology biosimilar medicines," Amgen COO and president Robert Bradway said. "Biosimilars provide an exciting long-term growth opportunity for Amgen, We have a dedicated team to leverage existing capabilities and capacity and drive the success of the collaboration."


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Pfizer submits regulatory application for rheumatoid arthritis drug to FDA

BY Allison Cerra

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

“Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options,” said Geno Germano, president and general manager of specialty care and oncology at Pfizer. “We are proud of the comprehensive phase-3 clinical program that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA.”


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Prescription drug access remained stable between 2007 and 2010, study finds

BY Alaric DeArment

WASHINGTON — One-in-eight Americans didn’t fill prescriptions last year because they couldn’t afford to, but despite difficulties with the economy, that proportion remained level, according to a new study conducted by the Center for Studying Health System Change and funded by the Robert Wood Johnson Foundation.

The study, which tracked 17,000 Americans’ access to prescription drugs between 2007 and 2010, found that low-income people, those without insurance, those in fair or poor health and those with multiple chronic conditions continued to have the most serious problems with access to prescription drugs. Meanwhile, uninsured, adults between the ages of 19 and 64 saw a "significant" decrease in unmet prescription drug needs, from 35.9% in 2007 to 29.4% in 2010, the study found, but one reason was likely that fewer people without insurance reported visiting a healthcare provider in 2010 than in 2007. For elderly people eligible for Medicare and Medicaid, prescription drug access problems dropped from 21.7% in 2007 to 8% in 2010, after doubling between 2003 and 2007.

"About one out of two uninsured people in fair or poor health couldn’t afford a prescription drug in 2010, almost double the rate of insured people in the same health," study coauthor and health research analyst Ellyn Boukus said.


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