NovaMedica registers two own-development CNS products, one without equivalents in Russia and the other Ц in the world

15 December 2022

December 15, 2022, Moscow – Russian pharmaceutical company NovaMedica (RUSNANO portfolio company) has developed and registered two innovative drugs to combat disorders of the central nervous system (CNS): Difendum for pain relief and Levroso Long for insomnia therapy. The products will be manufactured in Russia by the Technology Center NovaMedica Innotech (100% subsidiary of NovaMedica).

Difendum is the first drug product in Russia based on Diclofenac Potassium in soft gelatin capsules, which ensure its rapid effect and convenient administration. The product was registered as a result of clinical trials to compare bioequivalence completed in accordance with the EAEU requirements.

Difendum alleviates pain and inflammation and can be taken by adults and children over 14. It helps treat pain syndrome of various origin: from head and toothache to muscle, spine and joint pain, as well as painful menstruation. Diclofenac potassium salt contained in the drug also provides a number of additional benefits.

Levroso Long is a combined modified-release product, which includes molecules of melatonin that improves quality and duration of sleep and diphenhydramine that helps patients to fall asleep quicker. The combination is an original pharmaceutical product registered as a result of full research and development cycle, which has no equivalents in the world.

Both new arrivals do not require prescription and will be sold freely in pharmacies. They are expected to appear on shelves in 2023. The drugs have potential for export, seeing as the marketing authorizations were received following the EAEU procedure.

Elena LITVINOVA, CEO of NovaMedica:

«NovaMedica team is steadily implementing the strategy for development of the company’s own product portfolio in CNS. Spring of this year saw the launch of the original combined drug Mioreol for the treatment of dementia associated with Alzheimer’s disease, which was created by our team. Today, it was joined by two other relevant modern products, in demand among doctors and patients: Difendum and Levroso Long. They will soon be followed by a whole range of other drugs from NovaMedica’s own R&D program, which are at various stages of development and registration; these products are intended to help patients with such problems as neuropathic pain, migraine and cognitive disorders. Our goal is to offer comprehensive solutions in provision of Russian patients with high-quality innovative psychoneurological drug products.

NovaMedica already holds a sound leadership position in the market of antipsychotics and builds information exchange with leading specialists in psychiatry and geriatrics. We are also actively expanding our portfolio in other CNS segments thanks to our own developments and products from our foreign partners».

Zakhar LEIKIN, Medical Director of NovaMedica:

«Combination of state-of-the-art technological capacities of the R&D Center NovaMedica Innotech, competences of the team and unique experience in development of complex dosage forms allows NovaMedica to find ideal solutions for the treatment of a whole range of diseases that significantly affect patients’ working ability and quality of life. Interaction with leading expert clinicians on all stages of drug development helps us better understand their needs and required benefits for patients, to take them into account to the fullest degree when creating the final product. ».

Olga SHPICHKO, Deputy Chair of the Board of Directors of NovaMedica, Managing Director for Investments of RUSNANO Management Company:

«NovaMedica is implementing its long-term strategy to build a portfolio of high-demand drugs not only by adding partners’ products, but also by developing its own innovative medicines and reducing Russian patients’ dependence on western-made pharmaceutics. To create something new is always a difficult choice, especially in such risky business as pharmaceutical production, which requires big and “long” investments. However, if the strategy was selected correctly success is guaranteed, and with all our hearts we wish every success to our portfolio company NovaMedica that actively works to improve national security in provision of drug products to Russians».

Information on the company:

NovaMedica is a Russian pharmaceutical company created in 2012 by RUSNANO and the venture fund Domain Associates LLC. NovaMedica’s strategy is aimed at search and localization in Russia of innovative pharmaceutical products and creation of new drugs under its own R&D program. Some of these products already have marketing authorizations and are available in the market, and NovaMedica’s first own R&D product was included in the portfolio of the German company Bayer under a partnership agreement. NovaMedica actively builds a portfolio of CNS products by means of its own developments and drugs added as a result of licensing deals with partners. NovaMedica has most suitable infrastructure for commercialization and promotion of prescription products. In 2022, the company received a certificate of conformity to the GOST R ISO 9001-2015 standard for its quality management system regarding wholesale trade in drug products for human use, including storage and transportation.

In 2017, NovaMedica opened in Moscow the R&D Center NovaMedica Innotech (100% subsidiary of NovaMedica, Skolkovo resident). NovaMedica Innotech has state-of-the-art technological capacities, carries out research, development and manufacturing of innovative and effective drug products, including on a contractual basis. In 2017, Innotech received a GMP certificate from the Russian Ministry of Industry and Trade. Production capacity of the R&D Center NovaMedica Innotech is up to 150 mln units per year (tablets, soft and hard gelatin capsules with various fillers: microtablets, pellets, granules, powders)

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