Pharmstandard JSC, one of Russia’s leading pharmaceutical companies, and Viriom Ltd., the company developing innovative pharmaceutical products, signed an Agreement of Intent. 

The parties declared their determination to launch production of domestic innovative product ELPIDA® (international nonproprietary name: Elsulfavirine) for treatment of HIV infection at Pharmstandard. The project is intended to improve access to innovative medical therapy, expand therapy coverage in accordance with the Strategy HIV 2020 targets, and enhance development of the Russian pharmaceutical industry.

ELPIDA® is a new-generation anti-HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), an innovative anti-HIV product with full-cycle manufacturing in Russia, both in the finished dosage form (20-mg capsules), and in the form of pharmaceutical preparation.

The product is developed by Viriom in cooperation with F.Hoffmann-La Roche, Switzerland, with the support of Ministry of Industry and Trade of the Russian Federation (within the framework of the Federal Targeted Program “Pharma 2020”).

Now, the experience in the product-based therapy is being expanded in Russia’s regions (Moscow, Saint Petersburg, Leningrad, Novosibirsk, Astrakhan, and Rostov Regions, the Krasnodar Territory, the Khabarovsk Territory, the Yamal-Nenets Autonomous District, the Khanty-Mansiysk Autonomous District, and others).

Viriom is a marketing authorization holder and a holder of exclusive license with the right to transfer all patent rights and know-how for development, research, manufacturing, use, and distribution of ELPIDA® within Russia and CIS countries.

Having an extensive experience in localization of production of high-technology medicinal products in accordance with good practices and international standards, Pharmstandard has been distributing ELPIDA® in the Russian market since 2018.

Within the framework of the project, Viriom shall review quality of Pharmstandard’s manufacturing facilities, whereupon the parties will be able to start technological transfer of ELPIDA® to manufacturing facilities of Pharmstandard’s subsidiaries already in 2018, for subsequent full-cycle manufacturing of the product and its promotion in the Russian market.

‘Combating HIV is of great importance not only in our country but also beyond its borders. Naturally, we are committed to development of production of innovative pharmaceutical products for this disease.

As ELPIDA® distributors, we are reinforced in comprehension of the product prospects. Its manufacturing at Pharmstandard will be the beginning of our cooperation with Viriom Ltd.

In future, we contemplate collaboration in terms of development of combined and prolonged forms of ELPIDA®, including by means of loan financing of the developments or having a share in Viriom’s equity capital. We hope that our cooperation will help thousands of HIV-positive people in our country and contribute to further development of the Russian pharmaceutical industry,’ - noted Grigory Potapov, Chief Executive Officer of Pharmstandard JSC.

Cooperation with Pharmstandard with respect to ELPIDA® is a momentous event not only for Viriom but also generally for pharmaceutical industry of Russia and CIS countries where we expect to register the product in the nearest time. The partnership with one of Russia’s leading pharmaceutical companies will be instrumental in expansion of access to advanced treatment of those in need and achievement of powerful export potential of the product.

Undoubtedly, the project will herald new stage in development of Viriom’s HIV-portfolio, which travelled a long way from a license agreement with F.Hoffmann-La Roche in 2009 to the product registration in Russia in 2017.

We got a strong support underway, both from the government (in particular, the project was approved by the Committee on Modernization and Technological Development of Economy under the President of the Russian Federation), the Ministry of Industry and Trade of the Russian Federation within the framework of the Federal Targeted Program “Pharma 2020” for clinical research study, and a pharmaceutical community, including Pharmstandard.

In the longer term of our cooperation, we may consider introduction of new Elsulfavirin-based forms, developed with the support of Skolkovo Innovation Centre, - a fixed-dose combination with non-nucleoside reverse transcriptase inhibitors (1 tablet a day), as well as long-acting injections with less frequent dose schedule (once a month and potentially as often as once every 2-6 months), aimed at higher compliance to treatment and resistance prevention,” – said Elena Yakubova, Chief Executive Officer of Viriom Ltd.

About the product

ELPIDA® (international nonproprietary name: Elsulfavirine) is a new-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), registered in Russia on June 30, 2017 (marketing authorization No. LP-004360), with full-cycle manufacturing in Russia.

The product may be used in the first-line therapy of Efavirenz- or protease inhibitor-intolerant patients and special groups (patients suffering CNS disorders or elderly patients).