Teva and Russia’s Nanolek partnered on the biopharmaceutical plant at Nanolek’s facility in the Kirov region, according to a release provided by the Russian drugmaker. Teva agreed to transfer technology, including final quality control and intellectual property rights, and will train Nanolek staff. Some of the equipment will be partially owned by Teva, which intends to make APIs at the new facility.
The project will begin with production of glatiramer acetate, the API in Teva’s MS drug Copaxone. The first commercial supplies of finished dosage forms are slated for H2 2017 and the full production cycle should be in place in Q4 2018, Nanolek said.
Anna Yarvits, general manager of Teva Russia, said in a statement the Israeli firm had spent three years looking for a partner that met its standards.
“Teva is the biggest Israeli investor in the Russian economy. As part of our long-term development strategy in Russia, we are progressively localizing production of the medicines that enjoy strongest demand from patients and doctors,” Yarvits said. “Cooperation with Nanolek to localize sterile injectables in pre-filled syringes is the next step in our strategy for localizing production assets.”
Nanolek President Vladimir Khristenko said that in exchange, it will provide Teva with quality production facilities, quality control system and a solid team.
“We highly appreciate that our foreign partner trusted us the production of its medicines at our plant in the Kirov region,” Khristenko said in the statement. “In collaboration with Teva we receive unique technologies, know-how and production expertise of the world-wide known company with more than 100 years of history.”
About five years ago, Teva built a $50 million solid dosage form plant in Yaroslavl, Russia, which it says currently is moving to make 500 million tablets a year with the potential to be increased to 1 billion, including for full-cycle medicines.
Teva also has a sterile injectables plant in Gödöllő, Hungary, which the company opened in 2012 to expand its injected drug capacity. The $110 million, 15,000-square-meter (approximately 160,000-square-feet) plant has six production lines and the capacity to churn out 160 million to 200 million units of injectable meds annually.
Production at that facility, however, is currently suspended to make upgrades following an FDA inspection in January that found a number of manufacturing issues. The FDA followed that up in late May when it issued an import alert for the facility, banning all but two essential products from it: cancer treatment bleomycin and antibiotic amikacin. Teva is now recalling all four drugs manufactured there for the U.S.