Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., said it's considering a challenge to the FDA's refusal Monday to grant seven-year orphan drug exclusivity to lymphoma drug Bendeka (bendamustine HCI). During its development, the drug was granted orphan drug designation for chronic lymphocytic lymphoma and indolent B-cell non-Hodgkin's lymphoma. Eagle said Bendeka which is marketed in the U.S. by Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel automatically should have been granted exclusivity when it was approved for both indications Dec. 15. The FDA has maintained that orphan drug designation, awarded to drugs that are potentially superior to what's available, does not guarantee exclusivity. Whereas a plausible hypothesis of superiority is good enough to get the designation, that hypothesis must be proved to obtain exclusivity, the agency said in a 2014 policy clarification. Superiority may be measured in terms of safety, efficacy or major contributions to patient care, such as a change that improves administration. The FDA issued the clarification after a federal court ordered it to grant orphan drug exclusivity to Newark, Calif.-based Depomed Inc.'s postherpetic neuralgia drug Gralise (gabapentin), even though the agency said the drug hadn't demonstrated superiority. While Eagle said it is disappointed with the FDA's decision, it expects minimal impact in the near term, as Bendeka is covered by six patents extending from 2026 through 2033 and additional patents are pending. (See BioWorld Today, Dec. 23, 2014.)
The Department of Justice (DoJ) is asking that Novartis Pharmaceuticals Corp., part of Basel, Switzerland-based Novartis AG, be forced to produce thousands of documents to show whether more than 79,000 educational events it sponsored for doctors over a decade were merely a kickback scheme involving the company's cardiovascular drugs. In filing a response Friday to the federal judge presiding over United States v. Novartis Pharmaceuticals Corp., the U.S. Attorney for the Southern District of New York made a case for its request that Novartis provide speaker program slide decks and receipts, along with the records for 25,000 of the 79,000-plus "sham events" that often included lavish meals at high-end restaurants and honoraria for events that allegedly were not held. Novartis has called the request overly burdensome. Since it is already searching for records related to 6,400 of the events the government has identified as shams, Novartis said it shouldn't be "required to produce records related to any additional events, even if such records are readily available to it," according to the DoJ filing. Noting that the information Novartis wants to submit represents just 8 percent of the events in question, the agency said Novartis shouldn't "be permitted to limit its discovery obligations by using the scope of its fraud as an excuse."