Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

May 31, 2017

"Given its novel biological activity, positive impact on glucose control and cardiovascular safe profile, we believe CYCLOSET represents an attractive new option for the treatment of patients with type 2 diabetes," said Gerald T. Proehl, president and chief executive officer of Santarus. "We view CYCLOSET as an excellent product to leverage our sales organization, with complete overlap of the endocrinologists and primary care physicians we call on for GLUMETZA?."

Charles P. Sutphin, co-chairman, president and chief executive officer of S2 Therapeutics said, "We are excited about the distribution and license agreement with Santarus for CYCLOSET and the strategic fit with its organization. We look forward to working with Santarus to commercialize CYCLOSET in the U.S."

Anthony H. Cincotta, PhD, president and chief scientific officer of VeroScience said, "Having worked on the research and clinical development of CYCLOSET for decades, it is gratifying to know that very soon the medical community will have access to this first and only centrally acting dopamine agonist antidiabetic agent that has the potential to be an important new therapy for patients with type 2 diabetes."

CYCLOSET was the first and to date, the only drug for the treatment of type 2 diabetes to be approved subsequent to the FDA's Guidance to Industry titled, "Diabetes Mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes" that met the recommendations in this guidance relative to study design and outcome with demonstrated cardiovascular safety pre-approval. This FDA Guidance, issued in December 2008, requires clinical studies to demonstrate that medicines for diabetes do not increase cardiovascular risk, especially in patients with existing or potential heart problems.

Source : Santarus