RusnanoMedInvest and Domain Associates to invest $93m in development of three next-generation pharmaceuticals

U.S. venture capital firm Domain Associates, Rusnano subsidiary RusnanoMedInvest (RMI) and a group of co-investors will invest a combined $93m in Marinus Pharmaceuticals, Inc., Lithera, Inc., and Regado Biosciences, Inc., all of which are developers of advanced pharmaceutical products.

All of the companies receiving financing are Domain Associates portfolio companies. The investors are providing Marinus Pharmaceuticals with $21m, Lithera with $20.6m, and Regado Biosciences with $51m. Stage IIa and IIb clinical trials have indicated the effectiveness and safety of the pharmaceuticals. The investments will be used to register the medications and conduct further clinical trials in the U.S. and Russia.

“These investments demonstrate that the unique model of cross border co-financing created by Rusnano and Domain Associates is a viable source of late stage financing,” said Brian Dovey, partner in Domain Associates. “In today’s challenging investment environment, this is benefiting Domain’s portfolio companies and moving products closer to market.”

Marinus is developing Ganaxolone for the treatment of neurological and psychiatric disorders such as adult partial onset seizures, post-traumatic stress disorder and fragile-X syndrome. Ganaxolone was licensed in 2003 from Purdue Pharma and has been reformulated and optimized using the Marinus patented nanotechnology platform. Phase II clinical results indicate a significant reduction in seizure frequency among adult epileptics and confirmed an excellent therapeutic safety profile of the drug. Additional clinical trials have been planned and are underway to study the effectiveness of the drug for the treatment of other central nervous system disorders. Marinus will use the funds to conduct Phase II studies in the U.S. and Russia.

Lithera is a clinical stage company developing pharmaceutical and biomedical products addressing both lifestyle and medical indications in aesthetic medicine and ophthalmology.  Using FDA-registered drugs approved for use in other indications, Lithera’s products target and stimulate natural fat tissue metabolism to achieve non-ablative, non-surgical fat tissue reduction in specific locations. Lithera’s lead product candidate, LIPO-202 (Salmeterol Xinafoate for Injection), is a novel injectable pharmaceutical product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). LIPO-202 is currently under development for the aesthetic reduction of abdominal bulging due to excess subcutaneous fat.  LIPO-102 (Salmeterol Xinafoate and Fluticasone Propionate for Injection) is currently under development for the treatment of symptomatic exophthalmos (protrusion of the eye from the orbit) associated with thyroid-related eye disease (the thyroid condition is also known as Graves’ Disease).

Regado Biosciences, Inc. is a privately held company leading the development of antithrombotic aptamers with active control agents. The proceeds from the financing will be used to advance Regado’s comprehensive antithrombotic pipeline. The primary focus will be to initiate Phase 3 clinical trials for its lead novel compound, REG1 for patients undergoing Percutaneous Coronary Intervention (PCI) and Open Heart Surgery (OHS).  REG 1 is a highly differentiated innovative anticoagulant system that will be positioned to simultaneously reduce both ischemic and bleeding complications unlike any other currently marketed anticoagulant or one in development. Additionally, REG1 promises very favorable pharmacoeconomic benefits which further enhance its’ profile and “raises the bar” as the ideal anticoagulant. The ability to address both unmet medical needs while offering significant costs savings to the myriad healthcare systems contributes to REG1’s blockbuster potential.  

As part of the transaction, the intellectual property rights to the three pharmaceuticals in Russia and CIS countries will be transferred to the pharmaceutical company NovaMedica, which was founded as part of an agreement between Domain and Rusnano to commercialize, manufacture and distribute pharmaceuticals in Russia.

The investment in Marinus Pharmaceuticals, Lithera and Regado Biosciences also represents the further realization of an investment partnership between Rusnano and Domain Associates, which was established in March. The partners agreed to jointly invest in emerging life sciences technology companies with the aims of fostering the transfer of technology into Russia and establishing manufacturing facilities there. Rusnano and Domain completed their first joint transaction in June of this year by investing $40m in CoDa Therapeutics, the developer of Nexagon, a pharmaceutical for the treatment of diabetic foot ulcers and venous leg ulcers.

The investment project has a total budget of $760m. Rusnano and Domain Associates established RMI and Domain Russia Investments (DRI), respectively, to execute the agreement. The partners have also retained the management company Team Drive.

“These deals represent the result of the thorough and multifaceted investment opportunity appraisal and due diligence work performed by the RMI team throughout the year. Essentially, we took the best of the venture capital industry expertise and deal-by-deal valuation best practice we could absorb from our US partners, then complemented these knowledge assets with our Russian expertise and experience,” commented Leonid Melamed, the CEO of Team Drive. “It is important to note that for each of these drugs our pharmaceutical company NovaMedica has developed a commercialization pathway with clear regulatory, marketing and market access strategies and timetables for the Russian market and we would expect these innovative medicines to become available to the Russian consumer within a 4-5 year timeframe.”  

Notes for editors:

Rusnano was founded in March 2011 as an open joint stock company through the reorganization of state corporation Russian Corporation of Nanotechnologies. Rusnano's mission is to develop the Russian nanotechnology industry through co-investment in nanotechnology projects with substantial economic potential or social benefit. The Government of the Russian Federation owns 100 percent of the shares in Rusnano. www.rusnano.com

Venture Pharmaceutical Company RusnanoMedInvest (RMI) is a subsidiary company of Rusnano. RMI was founded in 2012 to realize advanced projects in medicine and pharmaceuticals involving the transfer of intellectual property rights and modern pharmaceutical production technology to Russia.

Domain Associates, LLC is a venture capital firm with an exclusive focus on life sciences. With $2.4 billion of capital under management, Domain is headquartered in Princeton, NJ with a second office in San Diego, CA. Partners of Domain have been involved in the formation and growth of more than 235 life-sciences companies. Domain has an investment portfolio of 80 companies.

Domain Russia Investments (DRI) is a subsidiary of Domain Associates, LLC, founded in 2012 to realize its partnership with Rusnano to transfer intellectual property rights and production technologies for next-generation medications to Russia.

Team Drive was founded in 2011 by Leonid Melamed and Vladimir Gurdus, both of whom have high-profile experience governing large corporations. The core competence of Team Drive is implementing progressive management strategies to maximize clients’ business value in a dynamic, efficient and transparent manner, as well as creating maximum value for startups.