Bristol-Myers Squibb (BMS) and Nektar Therapeutics, a biopharmaceutical company, have partnered to develop and commercialize Nektar’s lead immuno-oncology drug candidate in combination with BMS’ immuno-oncology drugs, Opdivo (nivolumab) and Opdivo plus BMS’ Yervoy (ipilimuma), in a deal worth up to $3.63 billion.

Under the agreement, BMS will make an upfront cash payment of $1.0 billion and an equity investment of $850 million (8,284,600 shares of Nektar’s common stock at $102.60 per share). Nektar is also eligible to receive an additional $1.78 billion in milestones, of which $1.43 billion are development and regulatory milestones, and the remainder are sales milestones.

Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with two BMS’ immuno-oncology drugs that function as checkpoint inhibitors that promote an immune response: BMS’ Opdivo (nivolumab), an immuno-oncology drug that functions as a PD-1 inhibitor for treating several types of cancer, and Opdivo plus BMS’ Yervoy (ipilimumab), an immuno-oncology drug that targets CTLA-4. The companies will test NKTR-214 with BMS’ Opdivo and BMS’ Opdivo plus BMS’ Yervoy in more than 20 indications across nine tumor types. It will also test potential combinations with other anti-cancer agents from either of the respective companies and/or third parties. BMS and Nektar have agreed to evaluate NKTR-214 with Opdivo and Opdivo plus Yervoy in clinical trials in tumor types, including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder, and triple-negative breast cancer. Studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.

Opdivo had global 2017 sales of $4.9 billion, and Yervoy had 2017 sales of $1.2 billion.  NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.

Nektar will book revenue for worldwide sales of NKTR-214, and the companies will split global profits for NKTR-214 with Nektar receiving 65% and BMS 35%. BMS will retain 100% of product revenues for its own medicines. The parties also will share development costs relative to their ownership interest of medicines included in the trials. For trials in the joint clinical development plan that include NKTR-214 with Opdivo only, the parties will share development costs with 67.5% allocated to BMS and 32.5% allocated to Nektar. For trials in the joint clinical development plan that include NKTR-214 with Opdivo and Yervoy, the parties will share development costs with 78% allocated to BMS and 22% allocated to Nektar.

Both BMS and Nektar have agreed for a specified period of time to not commence development with overlapping mechanisms of action in the same indications as those included in the joint clinical development plan. The parties are otherwise free to develop NKTR-214 with their own pipeline assets and/or any other third-party compounds. Both parties have agreed to initiate registration-enabling studies in the joint clinical development plan within 14 months of the effective date of the agreement, subject to allowable delays.

Both parties will jointly commercialize NKTR-214 on a global basis. BMS will lead global commercialization activities for NKTR-214 combinations with BMS medicines and Nektar will co-commercialize such combinations in the US, EU markets, and Japan. Nektar will lead global commercialization activities for NKTR-214 combinations with either Nektar medicines and/or other third-party medicines.

Nektar and BMS partnered in September of 2016 to evaluate the potential for the combination of Opdivo and NKTR-214.

Source: Bristol-Myers Squibb