NKTR-BMY bempeg (214) amendment:
<On January 9, 2020, Nektar Therapeutics, a Delaware corporation (“Nektar”), entered into an Amendment No. 1 (the “Amendment”) to its Strategic Collaboration Agreement (the “Collaboration Agreement”) for developing bempegaldesleukin (“bempeg,” NKTR-214, a CD122 preferential IL-2 pathway agonist) with Bristol-Myers Squibb Company, a Delaware corporation (“BMS”).
Pursuant to the Amendment, Nektar and BMS agreed to update the joint development plan under which we are collaborating and developing bempeg. The updated joint development plan includes the ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC), and now also includes two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer, as well as a Phase 1/2 dose escalation and expansion study to evaluate bempeg plus nivolumab in combination with axitinib in first-line RCC in order to support a future Phase 3 registrational trial. The cost sharing for collaboration studies in the updated joint development plan remains unchanged from the Collaboration Agreement. In addition, BMS has also agreed to conduct a Phase 1/2 dose optimization and expansion study in first-line non-small-cell lung cancer with bempeg and nivolumab as an independent study that is sponsored and funded by BMS.
Under the terms of the Amendment, Nektar is eligible to receive an additional non-refundable, non-creditable milestone payment in the amount of $25.0 million following the achievement of the first patient, first visit in the registrational adjuvant melanoma trial studying the combination of bempeg and nivolumab. Nektar is also eligible to receive a non-refundable, creditable milestone payment in the amount of $25.0 million following the achievement of the first patient, first visit in the registrational muscle-invasive bladder cancer trial studying the combination of bempeg and nivolumab, and a non-refundable, creditable milestone payment in the amount of $75.0 million following the achievement of the first patient, first visit in a registrational first-line non-small-cell lung cancer trial studying the combination of bempeg and nivolumab. With regard to the two creditable milestones, BMS is entitled to deduct the amounts paid pursuant to these milestones from future development milestones due to Nektar under the Collaboration Agreement.
Pursuant to the Amendment, Nektar and BMS have revised the collaboration therapies that neither party may develop independently outside the Collaboration Agreement for a set period (whether on its own or in collaboration with any third party) to include any therapy using an IL-2 agonist in combination with a small or large molecule that binds to the PD(L)-1 target in adjuvant and first-line melanoma, first-line RCC, first-line and muscle invasive bladder cancer, and non-small-cell lung cancer (each a “Competing Combination”). The aforementioned period (the “Limited Indication Exclusivity Term”) remains unchanged from the Collaboration Agreement and is defined as the period prior to the later of the (i) first commercial sale of bempeg or (ii) April 3, 2021. During the three years after the end of the Limited Indication Exclusivity Term, neither Nektar nor BMS may develop a Competing Combination in collaboration with any third party, but each party may do so on its own as a stand-alone entity and, if such party is acquired, the acquiring party is free to develop a Competing Combination with its proprietary compounds.
BMS shall have the right, at its sole discretion, to terminate co-funding its share of the development costs for the adjuvant melanoma collaboration study if the metastatic melanoma collaboration study fails to meet the primary endpoint of progression free survival. If BMS exercises such right, Nektar shall have the right, in its sole discretion, to continue the adjuvant melanoma study as a combined therapy independent study pursuant to the Collaboration Agreement.
secfilings.nasdaq.com
FilingID=13839499&RcvdDate=1/10/2020&CoName=NEKTAR%20THERAPEUTICS&FormType=8-K&View=html
Cost/profit sharing scheme (in Amendment) did not change, so BMY can do *on its own* as is please. Problem is that NKTR can not continue with Pembro NSCLC combination until 4/2021. (If I am correct here?) |
