Under the deal, Teva will be responsible for all US commercial activities for the product including promotion and distribution, while Eagle’s responsibility include securing all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.
The deal will also see Teva waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102.
As part of the deal, Eagle will receive an upfront cash payment of $30m and is eligible to receive up to $90m in additional milestone payments.
Additionally, Eagle will also secure double-digit royalties on net sales of the product, assuming FDA approval.
Eagle has also submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for this product to treat patients with CLL and with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
The NDA is based on data from Eagle’s recently-completed clinical trials which showed that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50ml admixture.
The product candidate has also secured orphan drug status from the FDA for both CLL and indolent B-cell NHL.