Teva partner sues FDA over orphan drug exclusivity for next-gen cancer med


Eagle Pharmaceuticals isn’t pleased with the FDA’s recent decision not to grant its new cancer med, Bendeka, orphan drug exclusivity. So the company is taking the agency to court.

Eagle, which licensed the drug to Teva ($TEVA) in the U.S., is suing the FDA for refusing to give Bendeka 7-year exclusivity after it was approved in late last year. In March, regulators said that they wouldn’t grant it orphan drug exclusivity because the companies couldn’t prove that Bendeka was clinically superior to other therapies. Eagle said that it was “evaluating all options to challenge the FDA’s decision.”

Now, the company wants the agency to declare that its refusal to give Bendeka orphan drug exclusivity is illegal, that Eagle is entitled to orphan drug exclusivity and that its regulations run afoul of the law. Eagle also wants to prevent the FDA from approving any other similar cancer drug until Dec. 7, 2022, when its exclusivity for Bendeka would expire, according to FDA Law Blog.

The case echoes one for Depomed’s shingles med, Gralise. In 2012, the company sued the FDA after the regulator did not grant Gralise orphan drug exclusivity. U.S. District Court Judge Ketanji Brown Jackson ended up ruling in favor of Depomed, saying that the agency should give the med exclusivity.

The FDA did not appeal Jackson’s decision. Instead, it published a notice discussing the case and reaffirming its pre-Depomed regulations, FDA Law Blog points out. It said that Jackson’s ruling was limited to Gralise and that it would use its current standards for granting orphan drug exclusivity.

Unsurprisingly, Eagle isn't satisfied with this response. “Had FDA respected Judge Jackson’s (Depomed) ruling in 2014, this case would not be necessary,” Eagle said, as quoted by FDA Law Blog. “Unfortunately, FDA’s defiance of this Court’s prior order leaves Plaintiff no choice but to file this suit.”

Teva and Eagle have a lot riding on Bendeka. Teva is marketing the drug as a next-generation version of its cancer med Treanda. But the drug could face some obstacles regarding reimbursement.

Earlier this year, Bernstein analyst Ronny Gal said that Bendeka would need its own J-code, or Medicare billing code, to succeed in the market. But Gal didn't see that in Bendeka’s future, as the drug shares an active ingredient with Treanda and thus would more likely share a code with its predecessor, he said. 

Gal's predictions proved correct last month after the CMS recommended against giving Bendeka its own J-code. The development could be a costly one for Benedka, whose future is "materially dependent" on getting a unique code, Gal said at the time.

Teva could try to argue against the CMS' recommendation at an upcoming hearing. But the agency's "preliminary decision usually holds," Gal said.

- get more from FDA Law Blog

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