FDA approves Solvay Pharmacueticals’ Creon
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating cystic fibrosis and exocrine pancreatic insufficiency, the agency announced Thursday.
The FDA approved Solvay Pharmacueticals’ Creon (pancrelipase), the first FDA-approved delayed-release pancreatic enzyme replacement drug to be marketed in the United States as a result of the agency’s unapproved drugs initiative.
The agency had required Solvay to submit a risk evaluation and mitigation strategy, including a medication guide, to advise patients on the risks associated with high doses of Creon. The FDA Center for Drug Evaluation and Research’s Office of Compliance and Office of New Drugs had worked with Solvay through the agency’s unapproved drugs initiative to help the company come into compliance with regulations by obtaining approval for Creon.
Pfizer signs licensing agreement with Wisconsin Alumni Research Foundation
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.”
GlaxoSmithKline to sell U.S. Wellbutrin XL rights to Biovail Corp.
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.