PHARMACY

Study reveals that American healthcare system saves bundles with generics

BY Alaric DeArment

ARLINGTON, Va. The American healthcare system has saved more than half of $1 trillion over the last decade from using generic drugs, according to a study released Thursday.

The Generic Pharmaceutical Association released results of an analysis commissioned from healthcare industry analysis firm IMS Health showing that the healthcare system saved more than $734 billion between 1999 and 2008, including about $121 billion in savings in 2008. The organization released the analysis as part of its year-long celebration of the Hatch-Waxman Act of 1984, which created a regulatory pathway for generic pharmaceutical drugs.

“In 1984, it was predicted that the Hatch-Waxman Act would save our country $1 billion in the first decade,” GPhA president and CEO Kathleen Jaeger said in a statement. “Now, generic medicines save more than that every three days.”

In the mid-1990s, an analysis by the Congressional Budget Office of the first 10 years of the Hatch-Waxman Act showed that savings from generics were $8 billion to $10 billion a year. By 1999, according to the new analysis, that figure had become $49 billion.

The growth resulted from several factors, especially an increase in the use of generics, from 61% in 2006 to 69% in 2008, and the loss of patent protection for several blockbuster drugs, including Sanofi-Aventis’ Ambien (zolpidem tartrate), Merck & Co.’s Fosamax (alendronate sodium) and Pfizer’s Zoloft (sertraline hydrochloride).

The Pharmaceutical Care Management Association, an organization that represents pharmacy benefit managers, said the study highlighted generic drugs as an important cost-saving tool.

“Since 1984, the potential for generics to offer savings has been routinely underestimated,” PCMA president and CEO Mark Merritt said. “PBMs and others have consistently found new and innovative ways to promote generic utilzation and competition in the prescription drug marketplace.”

The GPhA and PCMA said the study indicated that biosimilars could have a similar effect of lowering costs. Both organizations have endorsed legislation introduced in March by Rep. Henry Waxman, D-Calif. – a sponsor of the original Hatch-Waxman Act – that would establish a regulatory pathway for biosimilars similar to that of generic pharmaceutical drugs.

That bill, H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act, competes with H.R. 1548, the Pathway for Biosimilars Act, introduced days later by Rep. Anna Eshoo, also a California Democrat. As of Thursday, Waxman’s bill had 10 co-sponsors and a companion bill introduced in the Senate by Sen. Charles Schumer with six co-sponsors, while Eshoo’s bill had 69 co-sponsors.

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Pfizer signs licensing agreement with Wisconsin Alumni Research Foundation

BY Alaric DeArment

MADISON, Wis. The world’s largest drug maker has signed a licensing agreement with a patenting and licensing organization for the Univeristy of Wisconsin-Madison to use human embryonic stem cell patents to develop new drug therapies.

Pfizer said that under its agreement with the Wisconsin Alumni Research Foundation, the license will the company the rights to work with hES cells for drug research and discovery.

“Our license with WARF provides us with information and materials that will allow us to use their cell lines to explore a whole range of therapies,” Pfizer Regenerative Medicine chief scientific officer Ruth McKernan said. “Stem cells can be used to create specialized human tissue. Our scientists will determine how new medicines may be able to improve the way stem cells regenerate damaged tissues.”

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GlaxoSmithKline to sell U.S. Wellbutrin XL rights to Biovail Corp.

BY Alaric DeArment

RESEARCH TRIANGLE PARK, N.C. A drug maker announced Wednesday that it would give up U.S. rights to the extended-release formulation of a popular antidepressant.

GlaxoSmithKline said it would divest full commercial rights to Wellbutrin XL (bupropion hydrochloride) in the United States, selling it to Biovail Corp. for $510 million. Generic competition to Wellbutrin XL began at the end of 2006 for the 300-mg tablets and during the second quarter of 2008 for the 150-mg tablets. The drug had sales of $60 million in first quarter 2009.

“We are actively reshaping our U.S. business and managing the transition occurring in our product portfolio,” GSK president North American pharmaceuticals Deirdre Connelly said. “This transaction is one of a series of actions we are taking to maximize the value of our current assets and to enable us to resource and invest in new products and upcoming launches.”

Under the terms of the agreement, GSK will transfer the regulatory approval application and trademark for Wellbutrin XL to Biovail for use in the United States, though it will retain rights to the drug for other countries.

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