FDA rejects expanded use of Pegintron
KENILWORTH, N.J. The Food and Drug Administration has rejected an approval application for an additional use for a hepatitis C drug.
Schering-Plough Corp. announced Friday that it had received a complete response letter – an FDA notice of rejection – for Pegintron (pegylated interferon alfa-2b) as a treatment for stage 3 malignant melanoma. The FDA’s Oncologic Drugs Advisory Committee had recommended approval of the drug for the disease by vote of 6 to 4 in October.
Schering-Plough said it would work with the FDA to respond to the agency’s concerns. The drug is already approved for treating chronic hepatitis C in combination with Schering-Plough’s Rebetol (ribavarin).
BIO responds to GPhA letter to Obama
WASHINGTON The Biotechnology Industry Organization has asked the Obama administration and members of Congress to disregard a request by the Generic Pharmaceutical Association to strike biosimilars language from the healthcare-reform bill.
In a letter to President Barack Obama Tuesday, GPhA president Kathleen Jaeger asked Obama to urge Congress to either reduce the 12-year period of market exclusivity provided in the bill’s language, determining the amount of time a potential manufacturer would have to wait before making a biosimilar to compete with the innovator company’s product, or eliminate the biosimilars language from the bill altogether.
“GPhA’s request to the administration is a cruel trick to the millions of patients who are awaiting the benefits of biosimilars,” a BIO statement in response to the letter read. “GPhA is asking the Obama administration to hold patients and consumers hostage unless it gets its way on this critical provision of healthcare reform.”
BIO has stated that it prefers an exclusivity period of 14 years, saying that the unique properties of biosimilars would allow a potential biosimilar manufacturer to circumvent an innovator company’s patents and arguing that additional time is needed to determine whether a biosimilar would have the same safety and efficacy as its innovated counterpart. GPhA, meanwhile, wants five-year exclusivity periods, similar to the ones that pharmaceutical drugs have before facing generic competition. GPhA says that 14-year exclusivity periods would deprive patients of more affordable alternatives to biotech drugs, which can cost tens of thousands of dollars per year. The Obama administration has called for a seven-year exclusivity period.
“Biosimilars, often erroneously referred to as ‘generic biologics,’ can bring the benefits of expanded competition to biologics, breakthrough medicines that are extending and saving the lives of patients living with diseases such as cancer, diabetes, Parkinson’s and Alzheimer’s,” BIO’s statement read.
Warner Chilcott completes acquisition of P&G’s pharmaceutical arm
ARDEE, Ireland Warner Chilcott has completed its acquisition of a global brand’s pharmaceutical business.
Procter & Gamble’s branded prescription pharmaceutical business complements Warner Chilcott’s existing presence in women’s health care and adds new therapeutic and geographic markets. At closing, approximately 1,900 employees of P&G’s pharmaceuticals business joined Warner Chilcott and the company added manufacturing facilities in Germany and Puerto Rico.
“This is a transformational acquisition that extends our presence to include many of the major pharmaceutical markets around the World and significantly enhances the scale and diversity of our business,” said Roger Boissonneault, president and CEO Warner Chilcott. “Importantly, the increased scale afforded by this deal provides us with the ability to pursue a broader range of R&D projects to fuel our long-term growth.”
To finance the acquisition, the company used a combination of cash on hand and borrowings under new senior secured credit facilities.