Pharmstandard JSC declares the reduction in the maximum selling price for medicinal product Daklinza®(daclatasvir), film-coated tablets, 60 mg. The price reduction records have been entered in the State Register of Maximum Manufacturer`s Selling Prices for Medicines.

Daklinza® is an inhibitor of Hepatitis C virus (HCV) non-structural protein 5À (NS5A), direct-acting antiviral to treat Hepatitis Ñ within complex therapy for adult patients (Marketing Authorization RU LP-003088 of 07.14.2015)¹.

Within our country the number of infected  with Hepatitis C virus may reach 4.2 million patients that is 2.9 percent of the adult population.²  For the period from January to November 2019³ 41.5 thousand patients were officially first diagnosed with Chronic Hepatitis C (CHC).  The increasing of CHC patient coverage  provided with the effective treatment by direct-acting antiviral is a measure to improve the epidemiological situation.⁴

In our country before the reduction, the maximum selling price for Daklinza® 60 mg was 67,946.67 Rubles per pack (excluding VAT and regional additional charges). After  the re-registration, the price has been brought down by 41 percent to 40,000 Rubles per pack. Thus, a full 12-week course of treatment with Daklinza® costs 120,000 Rubles.

“The decision to reduce the price for this medicinal product is of great importance not only for the medical and patient communities, but also for the Russian society as a whole. It is an additional opportunity to move forward in fighting against socially significant infectious diseases and to ensure an access to innovative iterferon-free therapy for as many patients living with Hepatitis C virus in our country” – highlighted the importance of decision Grigory Potapov, CEO of Pharmstandard JSC.

It is worth reminding that in July 2019 Pharmstandard and Bristol-Myers Squibb (BMS) executed the agreement to assign to the Russian company the rights to manufacture, sell and distribute medicinal product Daklinza® within the territory of Russia and EAEU countries. BMS has transferred  Daklinza Marketing Authorization and IP rights to Pharmstandard with the ability to use Daklinza Trademark and BMS Logo for the limited period under BMS License Agreement.

About Pharmstandard

Pharmstandard is one of the leading  pharmaceutical companies of Russia, which priorities are development and manufacture of advanced, high-quality and affordable pharmaceutical products compliant with the patients` needs and Russian healthcare requirements.

Pharmstandard manufactures more than 450 medicines, given all forms, dosages and export products. Over 140 of which are included in the List of Vital and Essential  Drugs. The pharmaceutical portfolio of the company comprises products for treatments of cardiovascular diseases, diabetes mellitus, growth hormone deficiency, metabolic and neurological disorders, oncology, gastroenterological, contagious diseases, and others

Pharmstandard manufacturing facilities are located in the city of Kursk (Phs-Leksredstva JSC), city of Ufa (Pharmstandard-UfaVITA JSC), city of Tomsk (PHS-Tomskhimpharm JSC), Volginsky settlement of Vladimir region (Lekko CJSC).The company’s manufacturing sites are managed in compliance with Good Manufacturing Practice requirements and GMP certified. At Phs-Leksredstva JSC 8 manufacturing areas are compliant with European Union Good Manufacturing Practices and EU GMP-certified.

Pharmstandard is one of the leading market players in the field of localization of innovative pharmaceutical product manufacturing in Russia within the frames of partnership agreements with international pharmaceutical companies.

The company’s products are supplied throughout the Russian Federation and  abroad.

 

1 Instruction for medicinal use of medicinal product Daklinza®. https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=40765ab8-90da-4c11-bfe3-b18f09cfff25&t=

2 Tchulanov V.P., Pimenov N.N., Ìàìînova N.À., Sàgàlova Î.I., Shestakova I.V., Pokrovsky V.I. Chronic Hepatitis Ñ as a problem of healthcare of Russia today and tomorrow. Therapeutic archive (archive until  2018). 2015;87(11):5-10. https://doi.org/10.17116/terarkh201587115-10

3 http://iminfin.ru/areas-of-analysis/health/perechen-zabolevanij?territory=17000000

4 Kuznetsova À.V. Antiviral therapy as a strategy of Hepatitis C prevention /À.V. Kuznetsova, Å.B. Gontcharov, À.Å. Rogatchikova, Å.V. Dubotolkina, L.I. Tchernog, V.V. Sulima, À.Å. Butakova, Ò.À. Kostakova // Clinical pharnacology and therapy. – 2014. – V. 23, ¹ 4. – P. 65–68.