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revamped the company’s executive team, which was largely a venture capital-centric group, and brought in a group of seasoned pharmaceutical executives to run a big operation, he says.
Podlesak recruited former Aeterna Zentaris CEO Dave Mazzo to head Regado, and then added Steve Zelenkofske, who had experience running the cardiovascular units of Sanofi and Novartis, to the board. Rusconi is still part of the group, which also includes Ellen McDonald (former chief business officer at Aeterna Zentaris) and Alexander Giaquinto (former executive at Schering-Plough). Regado then moved from its home base at Duke to Basking Ridge to be within earshot of all the Big Pharma companies in New York and New Jersey.
With its pieces in place, Regado pursued its big idea: creating a line of anti-clotting drugs that give physicians performing coronary procedures the ability to precisely control, second by second, how effective the drug is. In theory, this makes a procedure such as angioplasty safer to carry out because an interventional cardiologist can boost or decrease the dose to best fit the situation, reducing the risk of a clot, heart attack, or stroke.
REG-1 is Regado’s first attempt to do just that. The system uses injections of pegnivacogin, an anticoagulant, and anivamersen, an RNA aptamer that binds to pegnivacogin, blocking its activity. Physicians can dial the clot-busting effect up or down in real time during a procedure by adjusting the relative amounts of the two drugs. According to Regado, this makes it superior to the current standard of care, injectable anticoagulants bivalirudin and heparin, because neither of those drugs have a control agent to modify their effects, and too much anticoagulation can lead to dangerous bleeding.
Regado will begin its big late-stage clinical trial in the fourth quarter of 2013, and is currently staffing up to execute it. The biotech wants to add roughly ten former pharmaceutical executives with experience running large global cardiovascular studies to work under its senior management team in medical-monitoring or clinical-operations roles. Regado hopes REG-1 can prove in the study that it is more predictable and less risky to use during angioplasties than bivalirudin, and then roll the drug out in other coronary procedures, such as open-heart surgeries and aortic valve replacements.
Regado got its first glimpse of REG-1’s potential in its mid-stage study, a 640-patient, randomized test, completed in November 2010, that compared the use of REG-1 to heparin during angioplasty. In the study, patients treated with REG-1 had a 66 percent fewer ischemic events (which include death, strokes, and heart attacks) and 60 percent fewer incidents of bleeding during the procedure, according to Regado’s S-1.
All of which is why Domain, Baxter Ventures, Rusnano and the rest of the company’s backers aren’t afraid to have the company run a massive, pricey trial on its own and fund it with an IPO—even though Regado has already raised $132 million through five rounds since 2007, according to the S-1. Regado has even rejected potential partnerships along the way.