Roche localizes the full cycle manufacturing of Gaziva® (obinutuzumab) at Pharmstandard-Ufa-VITA plant

30.08.2017

 Roche localizes the full cycle manufacturing of Gaziva® (obinutuzumab) at Pharmstandard-Ufa-VITA plant 

The project will be the first unique experience of manufacturing an advanced biotech product by a foreign company together with a Russian partner in the territory of Russia with intent to distribute outside the Russian Federation.

Photo sourced by Roche

Moscow, Russia – Roche, one of the world`s leading pharmaceutical manufacturers, and Pharmstandard, the leader of the domestic pharmaceuticals industry, announced entering into the Supply and Manufacturing Agreement and the License Agreement to localize the full cycle manufacturing of Gaziva®, and signed the Memorandum of Intent to export the products of the pharmaceuticals industry. On August 29, 2017 the Memorandum was signed by Nenad Pavletic, General Manager of Roche Moscow, and Grigory Potapov, CEO of JSC “Pharmstandard”. The event was held in the TASS news agency.

With the benefit of the extensive joint experience in launching the manufacturing of advanced medicines in Russia in accordance with the good practices and international standards, the companies aim at Gaziva® (obinutuzumab) localization enhancing to the level of finished dosage form manufacturing so that patients have treatment of chronic lymphocytic leukemia (LCC) and follicular lymphoma (FL).

The manufacturing of Gaziva® finished dosage form (obinutuzumab, injection, for intravenous infusion, 1000mg/40mL) will be launched at Pharmstandard-UfaVITA in the Republic of Bashkortostan. The first Gaziva® batches are to be released in late 2018.

Photo sourced by Roche

Gaziva® manufacturing localization in the territory of the RF will ensure the necessary treatment for Russian patients, reducing the waiting period and thereby increasing availability of the high tech therapies, and subsequent plans to distribute outside the Russia can contribute to the increase of domestic pharmaceutical share of the total Russian non-primary exports, as well as to the development of Russia's export capacity as a whole. "As the world`s leading developer of innovative medicines, we consider it our duty to implement and develop unique manufacturing technologies for high-quality medicinal products in Russia. This project can be called unique, as it is the first time when Roche`s innovative product to be manufactured in the Russian Federation with intent to be exported abroad. We will exercise best efforts to timely transfer the technologies, solve regulatory issues and ensure uninterrupted supply for the product to be manufactured in accordance with all regulations," comments Nenad Pavletic, General Manager of Roche Moscow. “We are glad that in this important business our partner is Pharmstandard, the recognized leader in the Russian pharmaceutical market. Gaziva® manufacturing localization in the territory of Russia proves the strong and long-term nature of our economic ties, as well as our readiness to contribute to the implementation of the Pharma-2020 Program to the extent of both manufacturing localization in the Russian Federation and pharmaceuticals export. This project will be a major step in procuring all needy patients suffering from chronic lymphocytic leukemia (LCC) and follicular lymphoma (FL) with innovative therapy of international standard.”

Photo sourced by Roche

The cooperation between Roche and Pharmstandard is aimed at implementing the Federal Target Program on the Development of the Russian Pharmaceutical and Medicinal Industry to 2020. The program facilitates the transition of the Russian pharmaceutical and medicinal industry and healthcare system as a whole to an innovative development model. In particular, attention is given to technological retooling of the domestic pharmaceutical and medicinal industry, to raising competitive capacity of Russian-made medicines and to increasing their exports, which meets the objectives of Roche and Pharmstandard within the scope of the signed Memorandum.

“We strive to develop the pharmaceutical market for patients suffering from oncohematological diseases. The manufacturing localization of innovative medicines, like ones of targeted therapy class, in our opinion, has a huge social significance. Pharmstandard has been long cooperating with Roche in manufacturing of the complex high-tech products. Our cooperation has proved that we can successfully fulfill our commitments. Today we are entering the full cycle localization of another biotech product. Its secondary packaging is already handled at our Ufa plant. We are confident that the finished dosage form manufacturing in our country will ensure that patients have broader access to necessary therapies. The project, as a whole, is a new step in implementing the strategy to enhance manufacturing localization and to develop further the pharmaceutical industry," said Grigory Potapov, CEO of JSC “Pharmstandard”.

Photo sourced by Roche

More than 4,000 new cases of chronic lymphocytic leukemia (LCC) and 2,000 new cases of follicular lymphoma (FL)[1] are annually identified in Russia. According to the official data of the Register of the Russian Society of Oncohematologists[2] and the Moscow Register for Chronic Lymphocytic Leukemia, at the moment Russia has 1,030 primary patients suffering from chronic lymphocytic leukemia (LCC) who cannot be treated with the standard therapy due to concomitant diseases like diabetes (15%) and kidney disease (11%). According to the same data, 1170 patients with follicular lymphoma (FL) can develop early recrudescence or resistance to the standard therapy. Gaziva® manufacturing localization in the territory of the RF will ensure the procurement of all needy patients with the advanced innovative therapy.

Roche

Roche is one of the global leaders in diagnostics and pharmaceuticals industry, being the largest manufacturer of biotech products for treatments of cancer, ophthalmic and autoimmune diseases, acute viral infections and central nervous system disorders.

In 1896 the company was founded in Switzerland and for 120 years it has been manufacturing advanced diagnostic tools and innovative pharmaceuticals for prevention, diagnosis and treatment of serious diseases, making a significant contribution to development of global healthcare. 29 medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. For eight consecutive years, Roche has been recognized as a leader within the Pharmaceuticals, Biotechnology and Life Sciences Industry in the Dow Jones Sustainability Indices (DJSI).

Roche representative office in Russia was opened in 1991. In the territory of the Russian Federation, Roche successfully responds to such tough challenges like increasing availability of the most advanced methods of diagnosis and treatment of socially significant diseases, implementing projects to improve medical personnel development, expanding clinical trial programs for new medicines, as well as technology transferring and localizing the manufacturing of innovative medicines that facilitates the optimum use of budgetary funds and health gain in reducing mortality and extending life expectancy. Over the past five years, the total Roche contribution to the economy and healthcare system of the Russian Federation has amounted to about 50 billion Rubles. In June 2017, Roche signed an agreement on cooperation with I.M. Sechenov First Moscow State Medical University. The cooperation is aimed at implementing joint international projects within applied and basic science, increasing the academic mobility of Russian scientists, as well as transferring the global Roche experience in development of the pharmaceutical and medical industry.

Pharmstandard Group

JSC “Pharmstandard” – Russia`s leading pharmaceutical company committed to development and manufacture of advanced, high-quality and affordable medicines. The Company is included in the List of Strategically Important Companies of the country.

Pharmstandard Group manufactures approximately 250 medicines of various pharmacotherapeutic groups, including those for treatments of cardiovascular diseases, diabetes, growth hormone deficiency, gastroenterological, neurological, contagious diseases, metabolic disorders, cancer and other diseases. Over 120 medicines are included in the Vital and Essential Drugs List.

Pharmstandard Group priority is the quality of the manufactured products. The Group manufacturing sites, using the state-of-the-art processing and laboratory equipment, comply with the requirements of the Good Manufacturing Practices and are GMP-certified.

Pharmstandard Group supplies its products to 16 countries worldwide, more specifically: Azerbaijan, Armenia, Bulgaria, Georgia, Kazakhstan, Latvia, Lithuania, Moldavia, the Republic of Belarus, Serbia, Kyrgyzstan, Turkmenistan, Uzbekistan, Ukraine, Montenegro and Estonia.  



[1] «Malignant neoplasms in Russia in 2015 (morbidity and mortality). Ed. A.D. Kaprin, V.V. Starinskii, G.V. Petrova. M.: MNIOI im. P.A. Gertsena – filial FGBU «NMIRTs» Minzdrava Rossii. 2017. ill. 250 p.

[2] «The Russian LPD Register of the Russian Society of Oncohematologists. I.V. Poddubnaya, National Hematology Congress, 2016



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