Pharmstandard and Bristol-Myers Squibb (BMS) have concluded an agreement to transfer the rights to Daklinza for the treatment of Chronic Hepatitis C

30.10.2019

Pharmstandard JSC and Bristol-Myers Squibb (BMS) have signed agreements to transfer the rights to manufacture, sell and distribute medicinal product Daklinza (INN-Daclatasvir) in the territory of Russia and EAEU countries to Pharmstandard. As per the executed agreements, BMS will transfer Daklinza Marketing Authorization and IP rights to Pharmstandard with the ability to use Daklinza Trademark and BMS Logo for limited period under executed BMS License Agreement.

Daklinza (INN-Daclatasvir) is approved as a medicine of new generation and highly specific direct-acting antiviral agent to treat Hepatitis C. It is intended for use within complex therapy for adult patients. In 2014, 390-410 million cases of Chronic Viral Hepatitis (CVH) were reported across the globe, of which 150-170 million cases of Chronic Hepatitis . 1 Currently, Russia ranks 5th in the world for the disease incidence. According to various estimates, 2.5-5 million people suffer from Chronic Hepatitis C in our country. As reported by Rospotrebnadzor, 48 thousand people2 with Chronic Hepatitis C (CHC) were officially registered within the Russian Federation in 2018. The Subject matter experts estimate that 45-65% of those living with HIV are infected with CHC.

Despite the large-scale spreading of the disease, the medication therapy coverage is only about 2-5%3 in our country. Therefore, it is a top-priority task to provide Russian patients with innovative interferon-free therapy. “Thanks to the world science developments, today those living with Viral Hepatitis C have realistic chances to significantly improve their quality of life. Unfortunately, the nature of this disease is such that, for years one can suffer from Chronic Hepatitis C without obvious symptoms. That enormously complicates the detection of the disease. The preventing, diagnosing, and, if the virus is detected, providing patients with modern innovative medications, in our opinion, are matters of paramount importance.

We are pleased that Pharmstandard with this agreement with Bristol-Myers Squibb, can provide patients in Russia and the EAEU countries with new generation therapy”, said Grigory Potapov, CEO of Pharmstandard JSC. By 2021, when the technology transfer is expected to be completed, the fully localized product at Phs-Leksredstva JSC site will be launched under a new Pharmstandard brand. Up to that point, Pharmstandard will supply the Russian market with Daklinza manufactured by BMS, thus maintaining the availability of therapy for patients.

About Pharmstandard

Pharmstandard is a leading Russian pharmaceutical company which develops and manufactures high-quality, affordable and innovative pharmaceutical products to satisfy the needs of patients and the Russian healthcare system. Pharmstandard manufactures more than 330 medicines, 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. The manufacturing capabilities of Pharmstandard are represented by five manufacturing plants and located across the Russian Federation. Pharmstandard’s state-of-the-art manufacturing facilities are compliant with GMP standards and certified by Russian and EU regulatory authorities. Under partnership agreements with international pharmaceutical companies, Pharmstandard has localized and manufactured high quality innovative pharmaceutical products. Pharmstandard is one of the leading market participants and biggest distributors of pharmaceutical products in Russia. The company supplies its products throughout Russia and abroad.

 


 

 

1 Shestakova I.V. Infectious Diseases: News, Opinions, Training. 2017; (3): 11–20
2 Rospotrebnadzor data for 2018
3 V.P. Chulanov. Epidemiological surveillance of viral hepatitis. Viral hepatitis monitoring system in the Russian Federation for 2011-2016.

Back Print out