Date: 2017-08-30
Type of information: Production agreement
Compound: Gaziva® (obinutuzumab)
Company: Roche (Switzerland) Pharmstandard (Russia)
Therapeutic area: Cancer - Oncology
Type agreement: bioproduction - manufacturing
Action mechanism:
- monoclonal antibody. Obinutuzumab is a glycoengineered, fully humanized IgG1 monoclonal antibody with potential antineoplastic activity. Obinutuzumab, a third generation type II anti-CD20 antibody, selectivity binds to the extracellular domain of the human CD20 antigen on malignant human B cells. The Fc region carbohydrates of the antibody, enriched in bisected non-fucosylated glycosylation variants, contribute to its higher binding affinity for human FcgammaRIII receptors compared to non-glycoengineered antibodies, resulting in enhanced antibody-dependent cellular cytotoxicity (ADCC) and caspase-independent apoptosis.
Disease:
Details:
- • On August 30, 2017, Roche and Pharmstandard have entered into a supply and manufacturing agreement and a license agreement to localize the full cycle manufacturing of Gaziva® 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.
- 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. Gaziva® manufacturing localization in the territory of the Russian Federation will ensure the necessary treatment for Russian patients 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.
- 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.
Financial terms:
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