20/12/2017 |

Amgen localizes production in Russia


Another foreign pharmaceutical company announced plans to localize the production of its drug at the facilities of Pharmstandard. American Amgen intends to establish by 2021 the release of 50 thousand bottles per year of the antitumor drug “Blinatumomab”, hoping to get into the program of seven high-cost nosologies. Pharmstandard intends to lobby this idea in the Ministry of Health. But there is little chance, since the Finance Ministry is not ready to allocate additional funds to increase the volume of public procurement.

Yesterday, the Russian subsidiary Amgen and Pharmstandard announced the signing of an agreement on the localization of the American company’s full cycle of production of the drug Blinatumomab for the treatment of acute lymphoblastic leukemia. In particular, Amgen will transfer production technologies to Pharmstandard, while remaining the owner of the registration certificate of the drug, and the Russian company will promote the medicine in the country. Localization is planned at the “Pharmstandard” plant in Ufa in two stages: in 2018, a secondary package of the drug will be organized, after three years the release of the completely produced drug in Russia will start. Amgen’s general director in Russia, Oleg Paroshin, explained that the production capacity could amount to 50,000 bottles of “Blinatumomab” per year.

The parties do not disclose the volume of investments, explaining only that it is equal to the “eight-digit figure”. Mr. Paroshin expects that the company will pay back the project in about seven years. It is assumed that the expensive drug “Blinatumomab” (its price, according to open data, is almost 300 thousand rubles per bottle) will be sold through public procurement. But neither the list of drugs under the program of seven high-cost nosologies (VZN), which includes malignant neoplasms of the hematopoietic and lymphoid tissues, is not included in the list of Vaginum “Blinatumomab” yet. The general director of “Pharmstandard” Grigory Potapov has no doubt that the drug will be included in the list of VED drugs already in 2018. To include the drug in the VZN list, Pharmstandard wants to propose the Ministry of Health a “change in the format” of the program or the creation of “separate federal programs”. He stressed that the company’s portfolio of a large number of drugs included only in the VED list and not experiencing problems with purchases.

In early December this year, the Swiss Roche, which invested 1.5 billion rubles. in the localization of the antitumor drug “Gaziva” also at the facilities of “Pharmstandard” in Ufa, stated that it can not return its investments because the medicine was not included in the VZN program. It got only in the list of VED, but the company fears that this does not guarantee it sales on government purchases.

American Amgen for the first time is implementing a project to localize the full production cycle of its drug in Russia, where for the time being it only deals with secondary packaging of drugs at Pharmexo facilities. According to “SPARK-Interfax”, the revenue of LLC “Amgen” in 2016 amounted to 5.4 billion rubles., Net profit – 460.8 million rubles. Pharmstandard, whose beneficiaries are Viktor Kharitonin and Yegor Kulkov, concluded in 2017 state contracts for 29.9 billion rubles. Its revenue in 2016 was 25.9 billion rubles, net profit – 6.6 billion rubles.

According to the portal of public procurement, “Blinatumomab” in recent years was not purchased at all. Director of the Institute of Healthcare and Medical Management David Melik-Huseynov notes that before the pharmaceutical companies did not come up with a proposal to change the state’s approach to providing patients with expensive drugs. According to Deputy Director General Stada CIS Ivan Glushkov, the pharmaceutical companies are constantly in dialogue with the Ministry of Health about the possibility of expanding the list of drugs for the VZN, but their effectiveness is low because of tight budget constraints. “The reason is that the Ministry of Health can not convince the Ministry of Finance of the need to allocate additional funds for medicines,” Mr. Glushkov explains.

Author: Maria Kotova

Article in Russian: Kommersant

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