Moscow, September 4, 2019. Pharmaceutical company Gilead Sciences has announced the expansion of its partnership with Pharmstandard covering a localization project for the manufacture of medicines for the treatment of socially significant diseases in Russia.
The companies have signed a Protocol of Intent, which covers localization of production of finished dosage forms of medicines for the treatment of hepatitis C (Sovaldi, Epcluse) and HIV (Biktarvi, which is in the process of registration in Russia) at Pharmstandard’s manufacturing facilities. The protocol also foresees the start of the localization process for Genvoya, for the treatment of HIV infection; Vemlidy, for the treatment of hepatitis B; and Harvoni for the treatment of hepatitis C (which is in the process of registration in Russia).
“This is an important step for Gilead, continuing the process of localization of production in Russia, one which we hope will help make life-saving therapies more accessible to patients living with serious illnesses,” said Rudolf Ertl, Senior Vice President, Commercial Operations, EMEA, Gilead. “The decision to launch the production of finished dosage forms of our innovative medicines confirms our serious and enduring intention to deepen local production in Russia and to develop a partnership with the Russian healthcare system.”
“We are pleased that our efforts to expand access to innovative medicines have culminated in the fact that a number of Gilead medicines will soon be produced in Russia. We continue to follow this direction and hope that in the near future we will be able to deliver our medicines to many people living with HIV, and hepatitis B and C. Combining efforts with our partners and regulators, we want to contribute to the fight against the spread of socially significant diseases in Russia,” said Igor Rukavishnikov, General Manager, Gilead Russia.
According to the agreement, over the next two years the partners will prepare and launch the manufacture of finished dosage forms of Sovaldi, Epclusa and Biktarvi at Pharmstandard facilities. In addition, the secondary packaging of Genvoya, Vemlidi and Harvoni will be launched in the near future at its advanced manufacturing site in Kursk, Pharmstandard-Leksredstva (Phs‑Leksredstva).
Grigory Potapov, CEO of Pharmstandard, commented: “Above all, our cooperation with Gilead has considerable social importance. Together, we strive to support patients and the medical community in addressing the pressing challenge of treating HIV, and hepatitis B and C in our country. We look forward to next-generation products coming onto the domestic market, as a result of our cooperation, to satisfy the needs of patients in Russia. Furthermore, this project is aligned with national priorities for the development of the domestic pharmaceutical industry, and, from our point of view, is strategically important to the entire Russian pharmaceutical market.”
In August 2018, Gilead and Pharmstandard concluded a first agreement, under the framework of which the secondary packaging of Sovaldi® for the treatment of chronic hepatitis C and Truvada® for the treatment of HIV has been localized at Phs-Leksredstva. The Phs-Leksredstva manufacturing site is compliant with GMP and ISO quality standards and has comprehensive facilities for the manufacturing of pharmaceutical products, in particular 6 operating workshops incorporating 26 manufacturing areas. The plant has capacity to manufacture over 600 million packs of medicinal products per year.