Biotech stars can rise and fall on the key decision of whether or not to “go it alone” and develop their drugs without the help of Big Pharma—it’s a risk that can either make or break a company. But Regado BioSciences, 12-year-old biotech startup based in Basking Ridge, NJ, and its venture backers, led by Princeton, NJ-based Domain Associates, are taking the challenge head on. They believe that the company’s two-pronged, blood clot-fighting system—which allows doctors to control the dosing of a blood-thinner in real time—has only sniffed its potential value, and they don’t want to cede any of it to a big partner just yet.
At some point soon, Regado aims to take itself public in the hopes of raising $75 million from investors. That, in itself, isn’t a big deal—several biotechs have gone public in 2013, or plan to do so at some point this year. But Regado’s reasoning is brazen: the small biotech plans to use the cash to help kickstart a 13,200-patient, 500-site, international, late-stage study for its lead drug, REG-1, on its own. Regado’s goal: to prove that giving REG-1 to patients undergoing angioplasty reduces rates of stroke and other so-called ischemic events by at least 20 percent, when compared to bivalirudin (Angiomax, manufactured by The Medicines Co. (NASDAQ: [[ticker:MDCO]])).
“Without question, it’s clearly a complex undertaking for a biotech company,” says Regado chairman and Domain Associates partner Dennis Podlesak. “We don’t take it lightly, so we are doing everything we can—including [putting in place] what we think is a very good team in place to manage these programs.”
The decision isn’t just a blind leap of faith for Regado, or its venture backers, which include Domain (the company’s largest institutional investor, with a 19.2 percent stake), Rusnano, Aurora Funds, Quaker BioVentures, Rusnano, Caxton Life Sciences Fund, Baxter Ventures (the VC arm of Baxter International), and former Minnesota state senator and Fastenal founder Robert Kierlin, who holds 26.5 percent of the company, the biggest stake of all. They’re doing it with promising data in hand from a 640-patient, mid-stage study, which has convinced them that Regado’s REG-1 can be the proverbial next big thing in a market worth about $3 billion annually, according to the company’s S-1, filed on April 29.
The big advantage the drug has, according to Podlesak, is the amount of control doctors have over its activity.
“The clinician can turn it up or down just like you would control your thermostat,” he says.
Regado’s technology came from the labs of Duke University; Bruce Sullenger, the director of Duke’s translational research institute and the vice chair of its department of surgery, and Chris Rusconi, the head of Duke’s research program in combinatorial therapeutics, invented it in 2001. The two came up with the idea that RNA aptamers—strings of RNA letters that bind to specific molecules—could be used in tandem with drugs that prevent or dissolve blood clots, known as antithrombotics.
Domain came aboard in 2007, with Podlesak coming in as Regado’s chairman. He quickly
