CLL

Israel-based Teva Pharmaceutical Industries has signed an exclusive licence agreement with Eagle Pharmaceuticals for its bendamustine hydrochloride (HCl) rapid infusion product.

Under the deal, Teva will take responsibility for all US commercial activities of Eagle ‘s bendamustine, including promotion and distribution.

Eagle will take care of all regulatory approvals, and will carry out post-approval clinical trials, if required, as well as initially product is being supplied by the company to Teva.

Eagle has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the rapid infusion bendamustine product, seeking approval to treat patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL).

Teva Oncology general manager and vice-president Paul Rittman said: "Since 2008, Teva’s bendamustine HCl product, Treanda, has played a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed.

"Under the exclusive licence agreement, Eagle will receive an upfront cash payment of $30m, as well as being eligible to receive up to $90m in additional milestone payments."

Under the agreement, Teva will cease its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which will allow the product to be launched early in the market.

Under the exclusive licence agreement, Eagle will receive an upfront cash payment of $30m, as well as being eligible to receive up to $90m in additional milestone payments.

The deal will also allow Eagle to receive double-digit royalties on net sales of the product, assuming FDA approval.

Eagle Pharmaceuticals president and CEO Scott Tarriff said: "Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimise the market potential of this product."

Both the firms will also resolve the pending patent infringement action between them in the US District Court for the District of Delaware, involving Teva’s US patent no.8,791,270.


Image: High-power magnification (1,000x) of a Wright’s stained peripheral blood smear showing chronic lymphocytic leukemia (CLL). Photo: courtesy of Mary Ann Thompson.