Regado backers provide $51M to fuel high-stakes PhIII anticoagulant study

David J. Mazzo, president and CEO of Regado Biosciences

Baxter's venture capital arm has allied itself with the ambitious Russian biotech investors at Rusnano to take the lead on a $51 million Series E venture round for Regado Biosciences, paving the way to a pricey Phase III test of its lead drug, REG1.

The Regado investment was one of three new bets placed by Rusnano today. Reuters reports that Marinus Pharmaceuticals and Lithera are also getting fresh support from the Russian venture operation, backing a total of $93 million in new biotech investments as it continues to follow up with Domain on a plan to sink $760 million into biopharma and healthcare companies.  

The move to raise funds for the Regado Phase III--with backing from a slate of investors that includes Edmond de Rothschild Investment Partners, Domain Associates, Quaker Partners, Aurora Funds and Caxton Advantage Life Sciences Fund--marks a change of strategy for Regado, which had long discussed partnering ahead of a late-stage study. This trial will be conducted at 500 sites around the world, requiring the enrollment of more than 13,000 patients at a total cost of $120 million.

The bold strategy says a lot about the Basking Ridge, NJ-based company's belief in its lead program. REG1 uses two agents--pegnivacogin and anivamersen--to control bleeding during a coronary intervention and open heart surgery. Its researchers believe REG1 can give physicians a tool to manage coagulation, 'dialing' the anticoagulation effect up or down. Pegnivacogin is a Factor IXa inhibitor which can be reversed partially or completely by anivamersen. Faster, safer surgical interventions for this growing patient population comes with the promise of some immediate health benefits as well as the prospect of a reduced number of adverse incidents along with lower hospitalization costs.

Up until now, CEO David Mazzo tells FierceBiotech, new anticoagulants have been approved without ever reaching the maximum efficacious dose due to the severe bleeding risks imposed on patients. "Our approach allows us to get to levels no others can," says the CEO, completely inhibiting Factor IX "because we can turn it off (and eliminate bleeding risk) almost instantaneously."

Mazzo adds that at the end of the day the board decided to go it alone because none of the partnership offers on the table "reflected the intrinsic value of the product." Longtime investor Domain, which has an agreement in place with RusNano to advise it on its investment strategy, brought in the Russians. And the $51 million goes a long way to paying for the trial.

With three interim analyses scheduled between now and a 2015 goal line, the company will have plenty of news to offer and time enough to assess new partnership offers, perhaps look over an M&A offer or two, raise more funds or pull off an IPO. Regado has so far raised $151 million of venture cash, a substantial amount of money by anyone's standards.

- here's the press release
- read the Reuters story on Rusnano

ALSO: San Diego-based Lithera nabbed $20.6 million in venture cash, with Rusnano, Domain and Alta Partners leading the way. Much of that has been earmarked to finance the RESET Trial (CL-16) – a 500-patient, multi-center, randomized, placebo-controlled Phase IIb trial of Lithera's LIPO-202 (Salmeterol Xinafoate for Injection). This trial will measure the effects of three doses of LIPO-202 on abdominal bulging due to excess subcutaneous fat in healthy, non-obese subjects. Release

PLUS: Arno Therapeutics in Flemington, NJ raised about $15 million in the past few weeks. Arno has three anti-cancer programs in the pipeline. Release

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