Sanofi-Aventis, Debiopharm sue W.C. Heraeus over Eloxatin patent
BRIDGEWATER, N.J. Sanofi-Aventis and Debiopharm have filed a lawsuit in the U.S. District Court for the District of New Jersey against W.C. Heraeus, in which they accuse the company of helping generic drug makers infringe a patent on their active ingredient for the colorectal cancer drug Eloxatin.
In the suit, the plaintiffs claim that Heraeus manufactured the active pharmaceutical ingredient in Eloxatin for Mayne Pharma, Sandoz and Ebewe Pharma. The three companies independently submitted applications to sell generic versions of the drug before the 2013 expiration of the ‘874 patent.
Sanofi and Debiopharm have asked the court to issue a permanent injunction restraining Heraeus and its officers from selling and importing generic oxaliplatin products claimed in the patent into the U.S.
Currently, there are no FDA-approved generic versions of the drug, which had worldwide sales of $2.35 billion in 2007, according to Sanofi.
Ziopharm’s Palifosfamide receives orphan designation
NEW YORK Ziopharm Oncology has received orphan drug approval from the Food and Drug Administration for Palifosfamide, for the treatment of soft tissue sarcoma, according to published reports.
Ziopharm will receive seven years of exclusivity of marketing for the drug once it has been approved, as well as an accelerated review process, grant funding, tax benefits, and an exemption from other fees.
Ziopharm’s chief executive Jonathan Lewis said that the drug stands to bring in as much as $400 million in revenues annually in the U.S. alone once it is approved. “Developing drugs for rare diseases is going to become increasingly more important because more and more the way we define diseases is into smaller and smaller subsets,” said Lewis. “In addition, we are looking to develop this for other indications starting with sarcoma.”
The intravenous form of Palifosfamide is currently in phase II studies and the oral form is expected to enter Phase I studies in early 2009.
Delhaize banners offer discounted generics
LAS VEGAS Shoppers at several supermarket chains in the eastern U.S. can buy hundreds of generic drugs at a discount.
Belgian food retailer Delhaize Group is offering a generic drug discount program at several of its U.S. chains, including Nashville, Ga.-based Harveys Supermarkets, Salisbury, N.C.-based Food Lion, Tampa, Fla.-based Sweetbay Supermarkets and Scarborough, Maine-based Hannaford Bros.
Participating stores offer 30-day and 90-day supplies of hundreds of generic drugs, though Harveys only offers 90-day supplies. Sweetbay offers more than 400 drugs, including the psychiatric drug haloperidol, thyroid hormone levothyroxine and respiratory drug albuterol, charging $4 for 30-day supplies and $10.99 for 90-day supplies.