GPhA lauds Congress for increased FDA funding
ARLINGTON, Va. The Generic Pharmaceutical Association has openly applauded Congress for approving a $6 million increase in the budget for the Food and Drug Administration’s Office of Generic Drugs. The increased funds were part of a group of appropriations bill.
The office is responsible for the review and approval of all generic drugs in the U.S. and they have been facing a backup that is now around 1,300 applications waiting to be reviewed. This has changed the approval time for an application from 180 days to 17 months.
“OGD plays a vital role in ensuring that safe, effective and affordable generic medicines are available to consumers,” said GPhA President and chief executive officer Kathleen Jaeger. “These additional funds are a good first step toward enabling OGD to hire more reviewers and process generic applications in a timely manner. Generics save consumers and federal and state governments billions of dollars a year. Investment in the timely approval of generics will reap significant dividends in terms of cost savings and improved health. And it’s an investment that Congress must continue to make as it grapples with escalating health care costs and a shrinking domestic federal budget.”
The GPhA went further to add that the generic pharmaceutical industry is willing to help the FDA any way they can to help speed up the review process, so more affordable drugs can reach the market.
BioSante makes milestone payment of $875,000 to Antrares for Elestrin
EWING, N.J. Antares Pharma has received an additional payment of $875,000 from BioSante Pharmaceuticals in relation to a marketing agreement with Bradley Pharmaceuticals for the drug Elestrin.
Elestrin is a low dose transdermal estradiol therapy that is used for the treatment of hot flashes in menopausal women. Antares allowed BioSante to use its advanced transdermal delivery gel system for the drug. Additional sales based milestone payments could bring the deals total value to more than $13 million, not including royalties based on third party sales.
“We look forward to continued marketing progress with Elestrin in 2008. The December 2006 FDA approval of this product has validated our ATD gel system and that has been a significant milestone for Antares and our potential pipeline products including Anturol—our proprietary ATD gel based overactive bladder product—currently in pivotal trials,” said Jack Stover, president and chief executive officer of Antares Pharma.
GSK, Santaris ink deal worth a potential $700 million
LONDON GlaxoSmithKline has signed a deal with the biotech company Santaris Pharma to develop new antiviral medicine, in a deal that could be worth more than $700 million, according to Reuters. The deal involves drug candidates discovered and developed under the agreement in up to four different viral disease programs.
As part of the deal, Santaris will receive an upfront payment of $3 million for the first antiviral program and an equity investment of $5 million. The deal could be worth more than $700 million based on upfront payments and development and regulatory milestone payments, depending on the success on early-stage research in RNA antagonist compounds.
Santaris will also get high single- to double-digit percentage royalties on worldwide sales of marketed products. GSK will have the option to develop drug candidates in up to four different viral disease programs. It also has an option to include as an additional program Santaris’ pre-clinical hepatitis C compound SPC3649.