US biotech major Amgen (Nasdaq: AMGN) has announced its plans to establish the production of its antitumor drug blinatumomab at the facilities of Russian Pharmstandard next year, according to the companies, reports The Pharma Letter’s local correspondent.
To date, they have already reached an agreement for the establishment of a full cycle production of blinatumomab, which is used for the treatment of acute lymphoblastic leukemia, and is marketing by Amgen under the trade name Blincyto. In the third quarter of 2017, Blincyto generated global sales of $52 million, up from $29 million in the like 2016 quarter.
Under the terms of the agreement, Amgen will transfer production technologies to Pharmstandard, while the Russian company will promote the drug in the local market.
Planned production volumes are 50,000 bottles per year. Amgen will remain an owner of the registration certificate of the drug.
Localization is planned at the Pharmstandard plant in Ufa in two stages. Next year, a secondary package of the drug will be organized. At the same time, starting from 2021 a full-scale production of the drug will be launched.
The value of investments is not disclosed. Amgen's general director in Russia Oleg Paroshin expects the payback period of the project will be about seven years. It is assumed that this high-priced drug (priced at about 300,000 roubles ($5500) per bottle) will be sold through public procurements.
However, to date, the drug has not been included in the program of seven high-cost ‘nosologies’, (which is a program in Russia, which involves purchases of the most expensive drugs for state needs).
Amgen is for the first time implementing a project which involves localization of full production cycle of its drug in Russia. To date, the company has mostly focused on secondary packaging of its drugs at the facilities of local Pharmexo company.