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United States. Food and Drug Administration

Teva and Eagle Pharmaceuticals Enter Exclusive License Agreement for Bendamustine Hydrochloride Rapid Infusion Product

Strategic Insights

— 2 min read

Teva Pharmaceutical Industries and Eagle Pharmaceuticals have entered into an exclusive license agreement for Eagle's bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Under the agreement, Teva will be responsible for all U.S. commercial activities for the product, while Eagle will be responsible for obtaining regulatory approvals and initially supplying the product to Teva. The product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval.

Key Takeaways:

  • The exclusive license agreement is for Eagle's bendamustine hydrochloride (HCl) rapid infusion product for the treatment of CLL and indolent B-cell NHL.
  • Teva will be responsible for all U.S. commercial activities for the product, including promotion and distribution.
  • Eagle will be responsible for obtaining regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying the product to Teva.
  • The product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and may be eligible for seven years of exclusivity upon approval.
  • The New Drug Application (NDA) for the rapid infusion bendamustine product has been submitted to the FDA, with Priority Review requested.
  • The product has received Orphan Drug Designations for both CLL and indolent B-cell NHL.
  • Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, allowing the product to come to market more quickly.
  • Eagle will receive an upfront cash payment of $30 million and is eligible to receive up to $90 million in additional milestone payments.
  • Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval.

Statistics:

  • The NDA for the rapid infusion bendamustine product has been submitted to the FDA.
  • The product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL.
  • The product has a substantially shorter infusion time, with the rapid infusion bendamustine HCl product able to be administered in ten minutes in a low-volume, 50 mL admixture.
  • The product candidate is eligible for seven years of exclusivity upon approval.
  • Teva will receive double-digit royalties on net sales of the product, assuming FDA approval.

Sources:

  • Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) press release, Feb. 17
  • Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) press release, Feb. 17
  • United States District Court for the District of Delaware, involving Teva's U.S. Patent No. 8,791,270.

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