Production of one of the world's most sought-after drugs for migraine therapy starts in Moscow

The Russian pharmaceutical company NovaMedica has announced the production and market launch of the first large batch of the drug Relonova^® intended for relief of migraine-associated headaches. The drug is based on the Rizatriptan molecule, which for the first time is fully localized in Russia, from development and manufacturing to introduction in the specialist prescription practice. Rizatriptan is one of the most sought-after molecules in the world for relief and alleviation of migraine symptoms.

Relonova^® is designed for acute treatment of headaches caused by migraine attacks (with or without aura) in patients over 18 years of age. It can be used for a long history of migraine, when the effectiveness of other painkillers is significantly reduced.

Relonova^® is manufactured at the capacities of the Technological Center NovaMedica Innotech (100% subsidiary of NovaMedica, portfolio company of RUSNANO) located in Technopolis Moscow. To date, the facility has produced more than 140 thousand packs of the new drug, which is released in the form of 10mg tablets. Relonova^® was launched in the market on July 7 and will be available for purchase in pharmacies and for ordering as early as this month.  

According to the IQVIA analytical agency, in 2022, the volume of the Russian market of drugs for the treatment of migraine amounted to about 2 billion rubles, which is 24% more than in the previous year.

About the disease:

Migraine is one of the most common diseases affecting the quality of life and work capacity of the adult population. According to the WHO, 50-75% of people aged 18-65 in the world will have a headache within one year, and more than 30% of them reported migraine. Between 1.7% and 4% of the world's adults suffer from headaches lasting 15 or more days every month^[3]. Adult women are afflicted 2.5-3 times more often than men. The frequency and intensity of migraine attacks reaches a maximum at the age of 35-45.^[1,2]

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

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

Information on the Company:

NovaMedica is a Russian pharmaceutical company created in 2012, a portfolio company of RUSNANO JSC. 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. NovaMedica actively builds and expands a portfolio of CNS products, which is formed by its own developments. The Company has most suitable infrastructure for commercialization and promotion of both its own and partners’ drugs. 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). The Center has state-of-the-art technological capacities, carries out research, development and manufacturing of innovative and effective drug products, including on a contractual basis. Innotech is GMP-compliant and has been issued a GMP certificate by the Russian Ministry of Industry and Trade. Production capacity of the R&D Center is up to 150 mln units per year (tablets, soft and hard gelatin capsules with various fillers: microtablets, pellets, granules, powders).

See more information at www.novamedica.com

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Sources

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

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

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 2022–2031. 75^th World Health Assembly. A75/10 Add.4 April 27, 2022 г. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_10Add4-ru.pdf

5. Láinez MJ. Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2006 Sep;2(3):247-59. doi: 10.2147/nedt.2006.2.3.247.

6. Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x

7. Wellington K, Plosker GL. Rizatriptan: an update of its use in the management of migraine. Drugs. 2002;62(10):1539-1574. doi:10.2165/00003495-200262100-00007

8. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators (2017). Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet (London, England), 390(10100), 1211–1259. https://doi.org/10.1016/S0140-6736(17)32154-2