Print 18 June 2014
“We have worked our way up from the concept of RMI portfolio building to first sales of NovaMedica pharmaceutical company within two years’ time. This pace of development is considered fast in the pharmaceutical industry”, - Vladimir Gurdus, CEO, RMI Partners, Management Company of RMI and NovaMedica said during his speech at 20th Russian Pharmaceutical Forum in St. Petersburg.
He told about projects dynamics, mechanisms of international partnerships and technology transfer collaborative efforts.
Vladimir explained that two tracks may be followed when building proprietary innovative product portfolio. One is to start new pharmaceuticals from nothing by developing own R&D, supporting and building infrastructure to promote the concept, first, and then - the product.
"This idea is being actively promoted by Russian Institutes for development and Russian Academy of Sciences; there are quite challenging developments currently present in the market, whilst, not many", – the speaker noted.
"However, the cycle from the proof of concept to the time to market is long-term; it takes more than ten years and requires considerable expenses. R&D costs per one product are estimated at several hundred million dollars and sometimes, - a billion dollars. Nevertheless, it shall be, needs to be evolved if we want to develop and bring new drugs and technologies to Russia," – the speaker continued.
He emphasized that to localize pharmaceutical innovations in Russia the other way to follow is crucial as well.
"To accelerate building of the innovative portfolio locally, there is an alternative, which is short-term, less cash-consuming and covers transfer of late stage specialty innovations under development to be marketed in Russia in parallel with launching them in the US, Europe and Japan ", - V. Gurdus explained.
"Both ways assume creation of the manufacturing capacities in Russia and are in line with Pharma-2020 strategic objectives", - he emphasized.
The speaker said that with RMI and Novamedica projects up and running, novel mechanisms of the serial transfer of cutting edge technologies and IPs for pharmaceuticals to Russia are being executed and showing a distinctive experience for Russia.
"Our project was established and is being implemented together with Domain Associates, one of the premier U.S. Life Sciences technology venture investment firms, - the speaker continued. RMI, a venture capital company specializing in investments into portfolio companies developing innovative drugs, technologies and medical devices. At the outset, we were dealing with review and selection of projects from Domain Associates portfolio to invest in. In two years we have together succeeded in closing 9 deals and proceed further with our portfolio commitments. With gained experience we extended our sourcing efforts and addressed other markets as well. Now we are reviewing innovative developments of the European research companies, in particular, from Germany, Switzerland and Israel, and operating independently in the US market. There is one deal in RMI portfolio, which has been closed independently ".
V.Gurdus noted that about 230 companies developing innovative products have been reviewed by RMI experts’ team as part of the portfolio building activities; 10 deals have been closed; some 30 projects are under review and being negotiated; In total, the number of companies in RMI’s portfolio is assumed to reach 30-35, and, as such, new biopharmaceutical developments.
"Technology transfer to Russia is mandatory when making a decision on the deal closing. IP for innovative developments is being localized by NovaMedica, which has been established to commercialize and manufacture these products. We are entitled to manufacture, commercialize and promote these products in Russia and CIS on exclusivity terms," – the project leader explained.
He noted that NovaMedica is proactive in building a portfolio of globally established pharmaceutical products.
"NovaMedica’s efforts driven by international cooperation are focused on scouting for established, though not yet present in Russia, products to in-license of established, however not yet present in Russia, products approved by FDA and EMEA, - V.Gurdus said, - For this purpose about 250 products have been review; as a result, several in-licensing deals have been closed to attract 15 more products to NovaMedica’s portfolio. And this process is ongoing."
"After initial ramp-up of the business in May 2012, first sales of NovaMedica are implemented in April this year, which is considered a quite high growth rates in the industry," – the speaker emphasized.
He also told that NovaMedica now is the resident of Skolkovo Innovations Center and has plans to build a center of excellence in nanotechnology, innovations and CMC to adapt innovative drugs, register and launch established products in Russia. According to him, Company has filed applications with Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development of Russian Federation - translator’s note) to be able to market 7 products in Russia, 3 of which are in process of going to the market.
In his address to the conference participants V.Gurdus reported on NovaMedica’s pharmaceutical plant construction works have been started.
"The land plot has been selected for construction in Grabtsevo Technopark in Kaluga region; the end of construction is assumed by the end of 2015, - he told, - the plant will manufacture SVP drugs, mainly, for the hospital segment."
"We expect our commitments and business development opportunities will attract our partners outside Russia as well. The plant will be FDA GMPA compliant and may serve as an interesting opportunity to enter the Russian market and to place new orders to manufacture products locally. We are open to this kind of cooperation," – V.Gurdus summarized.
The RMI group has completed sertain projects
The RMI Group has exited from the capital of portfolio companies:
Marinus Pharmaceuticals, Inc.,
Syndax Pharmaceuticals, Inc.,
Atea Pharmaceuticals, Inc.