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Signing a sweet deal
WHITEHOUSE STATION, N.J.—While on the surface, it seems strange for two giant pharmaceutical companies to collaborate on anything, it appears that lately, many are doing just that in order to make an impact in the $35-billion global diabetes drug market.
Collaborations are a trend in targeting the SGLT2 pathway, a sodium-glucose transport protein in the kidneys. Blocking the SGLT2 receptors means blocking excess blood glucose. Many large pharmaceutical companies are working on drugs in this arena.
Thus, it was not so surprising when Merck & Co. Inc. and Pfizer Inc. announced they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729). The investigational oral sodium glucose cotransporter (SGLT2) inhibitor is being evaluated for the treatment of type 2 diabetes. Ertugliflozin is Phase III ready, with trials expected to begin later in 2013.
Merck, through a subsidiary, and Pfizer will collaborate on the clinical development and commercialization of ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin and JANUVIA (sitagliptin) tablets. Merck will continue to retain the rights to its existing portfolio of sitagliptin-containing products. Pfizer has received an upfront payment and milestones of $60 million and will be eligible for additional payments associated with the achievement of pre-specified future clinical, regulatory and commercial milestones.
Merck and Pfizer will share potential revenues and certain costs on a 60/40 percent basis. The companies believe that the global collaboration combines Merck's strengths in diabetes drug development and commercialization with Pfizer's global scale and expertise in primary care.
"We are pleased to join forces with Merck in the battle against type 2 diabetes and the burden that it poses on global health," says John Young, president and general manager of Pfizer Primary Care. "Through this collaboration, we believe we can build on Merck's leadership position in diabetes care with the introduction of ertugliflozin, an innovative SGLT2 inhibitor discovered by Pfizer scientists."
Ertugliflozin will be studied in combination with metformin and in combination with sitagliptin, Januvia (DPP-4 inhibitor) brought to the collaboration by Merck, he explained. Fixed-dose combinations of sitagliptin and ertugliflozin have the potential "to offer physicians and patients alternative effective, safe and well-tolerated treatment options compared to older, generic, oral anti-diabetic medications such as sulfonyl ureas and thiazolidinedione, which are associated with weight gain and hypoglycemia."
Phase III clinical trials are expected to begin later this year. The companies anticipate that they will enter into business transactions, including licensing arrangements, partnerships and others.
"Merck continues to build upon our leadership position in the oral treatment of type 2 diabetes through our own research and business development," says Nancy Thornberry, senior vice president and diabetes and endocrinology franchise head of Merck Research Laboratories.
Merck is going to "focus on research and development as well as collaboration opportunities to further expand our strong portfolio of diabetes treatment options to address the unmet needs of patients globally," she says, adding that the licensing agreement reflects Merck's ongoing commitment to the treatment of type 2 diabetes.
"We believe ertugliflozin has the potential to complement our strong portfolio of investigational and marketed products, and we look forward to our collaboration with Pfizer to develop ertugliflozin," Thornberry adds.
Ertugliflozin differs from other SLGT2 candidates now in clinical trials from other pharmaceutical companies, because it is a highly potent, selective SGLT2 inhibitor, according to Merck. Because it has been efficacious and generally well tolerated in the clinical studies to date, Merck believes this mechanism will be complementary to the DPP-4 mechanism of action.
Also, according to Merck, one distinct advantage of this collaboration, for patients and prescribers, is Merck's ability to potentially combine ertugliflozin with JANUVIA (sitagliptin) tablets, Merck's market-leading DPP-4, which has wide acceptance globally. The collaboration will not only enable potential commercialization of a combination product, but also speed its acceptance worldwide because of Merck's DPP-4 franchise.
Merck plans to continue to invest in the DPP-4 mechanism with JANUVIA and omarigliptin (MK-3102), its once-weekly molecule. The company says it is "very pleased to announce this collaboration with Pfizer to develop and commercialize its SGLT2 inhibitor, ertugliflozin," and "is constantly evaluating other mechanisms."