NKTR-214 is absolutely worth the price BMY is paying, IMO. Anecdotal info from the Opdivo/NKTR-214 sarcoma IST has some patients with Stage-IV disease obtaining long-lasting responses. NKTR has cited this trial as a possible quick path to FDA approval due to the unmet medical need in sarcoma.
Eisai Co., Ltd. and Merck…today announced that the companies have agreed upon a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA (lenvatinib mesylate), an orally available tyrosine kinase inhibitor discovered by Eisai. Under the agreement, Eisai and Merck will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).
Eisai will book LENVIMA product sales globally, as monotherapy and in combination, and Merck and Eisai will share gross profits equally… Expenses incurred during co-development, including for studies evaluating LENVIMA as monotherapy, will be shared equally by the two companies.
Under the agreement, Merck will pay Eisai an upfront payment of $300 million U.S. dollars and up to $650 million…for certain option rights through 2020…as well as $450 million U.S. dollars as reimbursement for research and development expenses.
In addition, Eisai is eligible to receive up to $385 million U.S. dollars associated with the achievement of certain clinical and regulatory milestones and…up to $3.97 billion U.S. dollars for the achievement of milestones associated with sales of LENVIMA. Assuming the achievement of all development and commercial goals for all indications, the total amount of upfront, option and regulatory and sales milestone payments has the potential to reach up to $5.76 billion.
Lenvima is currently approved as monotherapy for thyroid cancer and in combination with everolimus for second-line RCC. Lenvima monotherapy for HCC is under review in the US, Europe, China, and Japan.
All told, this deal with Eisai looks like MRK’s answer to BMY’s recent tie-up with NKTR for NKTR-214.
Note that the 3-year PD-(L)1 exclusivity period of the BMY/NKTR collaboration, which was announced on 2/14/18, has now expired, enabling NKTR to test Bempeg with any PD-(L)1 agent of its choosing.
p.s. Even after today’s pop, NKTR’s share price is down about 70% from the day of the BMY announcement three years ago.
Nektar Therapeutics and Bristol Myers Squibb (NYSE: BMY) today announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo. These studies and all other ongoing studies in the program will be discontinued.
Bempeg previously failed in a phase-3 trial in combination with Opdivo in melanoma (#msg-168191364), so today’s news is three strikes and you’re out!
Rarely has a cancer drug failed so utterly and completely to live up to initial expectations (#msg-138532013). NKTR’s share price is down 96%(!) from its 2018 high.