|Merck, Pfizer Announce Worldwide Collaboration Deal for Ertugliflozin; Gilead Receives CRL from FDA for Elvitegravir, Cobicistat|
|By Mary Davila|
|Monday, 29 April 2013 19:19|
Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada (“Merck”), and Pfizer Inc. (NYSE: PFE) announced they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for the treatment of type 2 diabetes. Ertugliflozin is Phase III ready, with trials expected to begin later in 2013.
“We are pleased to join forces with Merck in the battle against type 2 diabetes and the burden that it poses on global health,” said John Young, president and general manager, 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.”
Under the terms of the agreement, 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.
“Merck continues to build upon our leadership position in the oral treatment of type 2 diabetes through our own research and business development,” said Nancy Thornberry, senior vice president and Diabetes and Endocrinology franchise head, Merck Research Laboratories. “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.”
Gilead Sciences, Inc. (Nasdaq: GILD) announced the company has received Complete Response Letters from the U.S. FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.
In its communications, FDA states that it cannot approve the applications in their current forms. The letters state that during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed. Gilead is working with FDA to address the questions raised in the Complete Response Letters and move the applications forward.
Elvitegravir and cobicistat are also components of Gilead's once-daily single tablet HIV-1 regimen Stribild^® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), which was approved by FDA in August 2012 for treatment-naïve adults. This regulatory action does not affect the marketing authorization or continued use of Stribild.
Gilead submitted its NDAs for elvitegravir and cobicistat in June 2012. Marketing applications are also pending in Europe.
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has received Complete Response Letters from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.
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Islet Sciences, Inc., (OTC.BB: ISLT) a biotechnology company engaged in the research, development and commercialization of patented technologies for people with diabetes, announced today the receipt of a Japanese Patent for allowed claims, Patent Application No. 2008-529208.
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