NovaMedica to localize in Russia one of the most popular anti-migraine drugs in the world

21 March 2023

March 21, 2023, Moscow – Russian pharmaceutical company NovaMedica (investment project of RUSNANO) registered its own-development product Relonova (INN Rizatriptan) for migraine-related headache relief. This is the first Rizatriptan-based drug in Russia that is fully localized in the country, from development to manufacturing and introduction in prescription practice. Relonova will be manufactured in Moscow at the Technological Center NovaMedica Innotech (100% subsidiary of NovaMedica), which will enable uninterrupted supplies of the drug and its availability for Russian patients.

Migraine is a socially significant disease considering its prevalence and negative impact on the patients’ quality of life. According to the World Health Assembly, migraine comes second after stroke in the list of neurological diseases causing disability and death, as well as reducing the duration of healthy and productive life[4]. Relonova is intended for urgent treatment of migraine-related headache (with or without aura) in patients over 18 years of age. It can also be used in case of long history of migraine, when effectiveness of other painkillers has significantly decreased. The drug will be released in 10mg tablets and will be sold in pharmacies by prescription.  

According to the analytical agency IQVIA, in 2022, the Russian anti-migraine market was about 2 bln rubles, which is 24% more than in 2021.

Elena LITVINOVA, CEO of NovaMedica:

“Migraine has an extremely negative effect on the physical condition of patients, as well as on their work performance, family relations and social life. Rizatriptan is one of the most popular active ingredients in the world for relief and reduction of migraine symptoms [6]. This is why we wanted to provide Russian doctors and patients with uninterrupted access to this state-of-the-art treatment option at an acceptable price, and ensured its full localization in Russia. Creation of the modern drug Relonova is an important contribution to development of pharmacological support for Russian patients. This is already the fourth product registered by NovaMedica in the last year”..

Zakhar LEIKIN, Medical Director of NovaMedica:

“When we talk about migraine treatment, we expect simple and clinically meaningful results. These include quick reduction or complete relief of the pain suffered by the patient. Absence of pain two hours after administering the drug is the key indicator for assessment of product effectiveness in abortive migraine treatment in accordance with the recommendations on clinical trials of the International Headache Society. Unfortunately, less than 50% of patients achieve this result by using the drugs available in the Russian market today, which necessitates the search for new ways and approaches to resolve this problem. The outcomes of the meta-analysis of 74 double-blind randomized clinical trials with 7 triptans [5] show beyond reasonable doubt that registration of Rizatriptan in Russia will significantly expand the capacities of specialists fighting this complex and many-faced disease and increase the doctor community’s confidence in the therapy prescribed”.

Olga SHPICHKO, Deputy Chair of the Board of Directors of NovaMedica:

“We are glad to see that due to the joint efforts of the shareholders and NovaMedica team the Russian pharma market becomes more stable and less dependent on import of western medicines. NovaMedica has been developing a portfolio of products for the treatment of CNS diseases since 2018. It covers the most essential areas: Alzheimer’s disease, vascular cognitive disorders, schizophrenia and bipolar disorders, migraine, neuropathic pain, sleep disturbances, and others. NovaMedica will continue actively working to create relevant high-quality drugs and to increase availability of modern treatments for Russian patients”.

Information on the disease:

Migraine is one of the most prevalent diseases affecting the quality of life and work performance of the adult population. According to the WHO, in one year, 50-75% of people aged 18-65 in the world will suffer from headache, and more than 30% of them have reported migraines. 1.7 – 4% of the world’s adult population experience headaches for 15 or more days every month [3]Adult women are 2.5-3 times more prone to the disease than men. Frequency and intensity of migraine attacks reach their maximum at the age of 35-45[1,2].

At the same time, according to the 75th session of the World Health Assembly (May 2022), disorders of the nervous system are the main cause of disability-adjusted life years (DALY) and the second leading global cause of death: 9 million people in the world die due to neurological disorders every year. Migraine (16.3%) is second after stroke (42.2%) in terms of frequency of DALY neurological factors[4].

In Russia, according to the results of population studies cited in the Clinical Recommendations of the Ministry of Health [1]yearly prevalence of migraine is 15.9%-20.8% among adults (aged 18 to 65).

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).

Sources

1. Clinical recommendations of the Russian Ministry of Health on Migraine, approved in 2021 https://cr.minzdrav.gov.ru/recomend/295_2

2. Osipova V.V., Tabeeva G.R. Primary headaches: diagnostics, clinical picture, therapy: Practical guidelines. M.: Publishing House Medical Information Agency LLC, 2014; p. 336

3. Headache disorders. Website of the World Health Organization. https://www.who.int/ru/news-room/fact-sheets/detail/headache-disorders

4. Draft intersectoral global action plan on epilepsy and other neurological disorders for 2022–2031. Seventy fifth session of the World Health Assembly. A75/10 Add.4 April 27, 2022 ãhttps://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_10Add4-ru.pdf

5. Thorlund K, Mills EJ, Wu P, et al. Comparative efficacy of triptans for the abortive treatment of migraine: A multiple treatment comparison meta-analysis. Cephalalgia. 2014;34(4):258-267. doi:10.1177/0333102413508661

6. Diener, H.-C., Holle-Lee, D., Nägel, S., Dresler, T., Gaul, C., Göbel, H., … Lampl, C. (2019). Treatment of migraine attacks and prevention of migraine: Guidelines by the German Migraine and Headache Society and the German Society of Neurology. Clinical and Translational Neuroscience, 3(1), 2514183X1882337 https://ihs-headache.org/wp-content/uploads/2020/06/3426_dmkg-treatment-of-migraine-attacks-and-prevention-of-migraine.pdf

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