FDA's Orphan Drug Exclusivity Policy May Face Second Court Challenge
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA denies seven years of orphan drug exclusivity for Eagle Pharmaceuticals' Bendeka (bendamustine) despite district court ruling in Depomed case rejecting agency's "clinical superiority" requirement.
Eagle Pharmaceuticals Inc. is planning to fight FDA's denial of its request for seven years of orphan drug exclusivity for Bendeka, a liquid, low-volume, short-time infusion formulation of bendamustine for treatment of chronic lymphocytic leukemia and non-Hodgkin lymphoma.
FDA apparently rejected orphan exclusivity because Eagle did not demonstrate that Bendeka is clinically superior to a previously approved bendamustine product. The company said in a March 28 release that its case "closely mirrors" that of Depomed Inc., in which the agency withheld orphan exclusivity for Gralise (gabapentin) for post-herpetic neuralgia because Depomed did not show it was clinically superior to Pfizer Inc.'s Neurontin.
Depomed won a suit against the agency when a district court ruled that Gralise was entitled to orphan exclusivity since FDA had designated Gralise an orphan drug and it was approved for marketing (Also see "FDA May Modify Orphan Exclusivity Reg, But Label Carve-Out Policy Is Intact" - Pink Sheet, 15 Sep, 2014.).
FDA backed down and awarded Gralise orphan exclusivity. But it said the court's decision in the case was limited and it intended to continue to apply its existing regulations on orphan drug exclusivity, that drugs that are the "same" as a previously approved drug must show clinical superiority to qualify (Also see "FDA Grants Gralise Orphan Exclusivity But Rejects Policy Change" - Pink Sheet, 30 Dec, 2014.).
It did so in denying orphan exclusivity to Bendeka, which is intended to be an improvement over Teva Pharmaceutical Industries Ltd.'s Treanda liquid formulation of the drug. Teva is a partner on Bendeka, and when the drug was launched in January, Eagle and Teva said they expect it to replace Treanda.
Eagle said that it believes FDA's decision is incorrect and that Bendeka was entitled to orphan drug exclusivity upon its approval in December. The agency had previously granted orphan drug designation for both indications.
Eagle cited the district court ruling that overturned FDA's Gralise decision, but declined to comment further. Its release notes that the agency subsequently granted orphan exclusivity for Gralise without a clinical superiority demonstration "but has continued to require the clinical superiority demonstration for other orphan designated drugs, such as Bendeka."
Eagle may similarly file suit against FDA. The company said it is "evaluating all options to challenge the FDA's decision."
Bendeka Patent Protection Extends Through 2033
The Gralise litigation had raised questions as to whether FDA would change how it handles requests for orphan drug designations for "me-too" drugs and require sponsors to show clinical superiority before granting the designation. District of Columbia District Judge Ketanji Brown Jackson had suggested that FDA could prevent a drug from obtaining orphan exclusivity simply by not designating it an orphan drug.
While it did not receive seven years orphan exclusivity, Eagle said its market protection for Bendeka will be in effect beyond the orphan exclusivity term since it has six patents listed in FDA's Orange Book extending from 2026 through 2033, plus additional pending applications.
Teva has exclusive rights to market Bendeka in the US and Canada [See Deal]. Eagle received $30m up front and a $15m milestone payment from Teva upon FDA approval of the drug in December. It will receive a 20% royalty on net sales of Bendeka, plus a potential incremental step-up royalty upon the achievement of a future milestone.
The denial of orphan exclusivity is the second time Eagle has received negative news from FDA this month.
On March 18, the company announced that FDA had sent Eagle a "complete response" letter for its Kangio (bivalirudin), a "ready to use" stable I.V. formulation of the anticoagulant bivalirudin (The Medicines Co.'s Angiomax) that requires no reconstitution or initial dilution. FDA said it wants to see "further characterization of bivalirudin-related substances in the drug product" before approving it (Also see "Keeping Track: Approvals Aplenty As FDA Clears Taltz, Cinqair And Anthim" - Pink Sheet, 28 Mar, 2016.).