NovaMedica registered a unique for Russia and rare for the world drug for treatment of proctologic disease

07 June 2018

Moscow, June 27, 2018 – The Russian pharmaceutical company NovaMedica (RUSNANO's portfolio company) has registered a unique drug Fissario® for proctologic diseases treatment, based on a new mechanism of action not used in products currently on the market. This is the first drug developed within own R&D program of NovaMedica. It is planned that it will be available to patients already in 2019.

“When developing our new drug Fissario®, nanotechnologies were used. With their help, we were able to combine in the form of a gel incompatible previously active ingredients and multiply improve their physicochemical characteristics," says Rustam Iksanov, Vice President of pharmaceutical operations at NovaMedica. “As a result, we obtained a new combinatorial technological solution on the edge of two therapeutic areas: gastroenterology and pain management. I am confident that this approach and the proven high efficacy of the new drug will ensure its commercial success in the market, it will be appreciated by both doctors and patients”.

Fissario® is a fixed combination of two active ingredients for the treatment of proctologic diseases, which have both therapeutic and analgesic effects. It is available in the form of a water-based gel, which is more effective and convenient for use with respect to other dosage forms currently available in the market. Now worldwide a similar combination of molecules for similar therapeutic indications is registered only in the cream form and only in three countries.

In the process of a multicenter, open, randomized clinical trial phase III, Fissario® confirmed the high level of efficacy and safety data obtained in the early stages of the drug study, and also proved its superiority over the comparator drug, which is one of the market leaders in this therapeutic field. Fissario® also successfully passed the pharmaceutical quality assessment at the Scientific Center for the Expert Evaluation of Medicinal Products (FSBI “Scientific Centre for Expert Evaluation of Medicinal Products”)

Innovativeness of Fissario® is confirmed by two Russian patents for inventions (No. 2606858 and No. 2641570) and two international applications. In the near future two Eurasian applications will also be submitted for registration.

NovaMedica is a modern Russian pharmaceutical company founded in 2012 by Domain Associates LLC, leading U.S. venture capital firm, and RUSNANO, JSC. NovaMedica's strategy is aimed at search, registration and localization in Russia of intellectual property rights for innovative pharmaceuticals products and technologies, as well as at development and implementation of own R&D projects and creation of a modern GMP manufacturing facility. NovaMedica possesses a well-developed infrastructure for promotion and sales of pharmaceutical products. 

In April 2017 NovaMedica launched its R&D Center with state-of-the-art technological capabilities which were previously unavailable in the Russian pharmaceutical industry.End 2017 R&D Center of NovaMedica received a manufacturing license and Russian GMP certificate from the MIT of Russia. This center is already working under 8 R&D projects.

NovaMedica became key partner of Pfizer in Russia in 2016. Partners agreed on localization in Russia of more than 30 EDL products from the Pfizer portfolio and following this aim on construction of a contemporary plant for manufacturing of injectable drug products in the Kaluga region. The ground-breaking ceremony took place on May 30, 2017. In March 2018 NovaMedica, Ministry of Industry and Trade and the Kaluga region signed Special Investment Contract (SPIC) regarding creation of a new pharmaceutical manufacturing facility.

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