On the eve of Phase III trials expected to start later this year, Merck & Co. and Pfizer said today they will team up to develop and commercialize Pfizer’s ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for type 2 diabetes.
Merck has agreed to pay Pfizer up to $60 million in undisclosed up-front and milestone payments, and could make additional payments tied to prespecified and also undisclosed future clinical, regulatory, and commercial milestones. Merck and Pfizer did say, however, that they will share potential revenues and certain costs on a 60/40 percent basis.
Under their collaboration, a Merck subsidiary and Pfizer will join in clinical development and commercialization of Pfizer’s ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin and Merck’s Januvia® (sitagliptin) tablets. Merck will continue to retain the rights to its existing portfolio of sitagliptin-containing products, the companies said.
“We believe ertugliflozin has the potential to complement our strong portfolio of investigational and marketed products, and we look forward to collaborating with Pfizer on its development,” Nancy Thornberry, svp and diabetes and endocrinology franchise head, Merck Research Laboratories, said in a statement.
The Merck-Pfizer collaboration is the first significant R&D announcement for Merck since the company named Roger Perlmutter as head of its research and development effort, following years of clinical development setbacks.
The partnership comes a month after Johnson & Johnson became the first drug developer to obtain approval in the U.S. of an SGLT2 drug—Invokana (canagliflozin) tablets for use with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels.
However, not all SGLT2 drugs have overcome regulatory scrutiny. Bristol-Myers Squibb and AstraZeneca won approval in November 2012 from the European Commission for Forxiga, but FDA rejected the drug in January of last year based on concerns about the risk of cancer and liver injury from the drug and asked for more clinical data.
However, Forxiga was approved for use in combination with insulin and other treatments for type 2 diabetes—except in patients who cannot tolerate metformin, who can use Forxiga as a standalone treatment.