Among the most recently announced biopharma partnerships is a joint venture of two global giants focused on HIV that is expanding manufacturing capabilities in Russia by teaming up with a domestic pharma company. Viiv, a venture of GlaxoSmithKline and Pfizer, agreed to supply bulk products, technology, and expertise to Russia’s JSC Binnopharm, which will carry out secondary manufacturing and packaging of HIV treatments Combivir, Kivexa, and Epivir.
The deal, announced in November, follows separate production agreements forged over the past year by each Viiv partner. GSK previously agreed to supply Binnopharm with bulk supplies of vaccines for cervical cancer, pneumococcal, and rotavirus, as well as supply the Russian company with production know-how and technology; Binnopharm in return would secure regulatory approvals. And in March, Pfizer agreed to have its pneumococcal vaccine produced in Moscow by a Russian partner, Petrovax.
In May, Roche granted TeaRx development and commercialization rights for a treatment for patients at risk of thrombosis in Russia and 12 other nations. Roche agreed to provide TeaRx with clinical candidates belonging to a new class of oral Factor Xa inhibitors and manufacture the API for early clinical studies in the U.S. TeaRx agreed to launch clinical studies next year and will be responsible for development and final formulation in Russia.
“Clinical studies are expected to take place from Q3 2012 in Russia, first as a dosing and safety Phase II study in patients after knee and hip replacement and then a double-blinded Phase III study in such patients,” Henrik Konarkowski, TeaRx’ CEO, told GEN. “A first drug, an oral prophylaxis for thrombosis after major orthopedic operation should be available to hospitals and patients in 2014.”
TeaRx is looking at marketing the prospective drug in 12 countries of the former Soviet Union, mostly in Russia, Belarus, Ukraine, and Kazakhstan. “After prophylaxis from thrombosis after elective orthopedic surgery, pulmonary embolism and deep vein thrombosis will be the next indications to be treated by the same drug,” Konarkowski said.
“A new formulation may be developed for a final indication of prophylaxis from stroke for patients in risk group,” he added. “TeaRx is already cooperating with major patient organizations in Russia in preparation of large long-term clinical trials in this indication.”
He said TeaRx is also in talks with several Russian and western biopharma companies to add more drugs to its portfolio: “They could be in similar product lines (other anticoagulants) but with different modes of actions. The company is also deliberating to venture into treatment of patients after stroke, therefore moving into the CNS market segment.”
Russian companies, according to Konarkowski, need to jumpstart their pipelines by licensing promising projects from western big pharma companies and developing them at home until they’re ready for market registration. In this respect, he said, TeaRx is following the example set by the Viriom collaboration of Roche and Moscow-based investment and R&D group ChemRar. TeaRx is located at the ChemRar High Tech Center.
ChemRar is a complex of biopharma research, production, and investment facilities located in Moscow near Sheremetyevo International Airport. At last summer’s BIO International Convention, ChemRar and Pfizer announced a collaboration focused on developing drugs and vaccines for cardiometabolic, infectious, and oncological diseases through technology transfer and out-licensing deals with venture funding.
While global corporate giants and smaller Russian companies have launched numerous partnerships to fulfill both Pharma-2020 and the billion-dollar commitment, Russia is still likely to lag behind China and some other nations emerging as key biopharma players unless it plays to its other strengths such as its sizeable oil and gas industry and its nanotech sector, which is second only to the U.S. in terms of investment.
On the biofuel front, Rusnano earlier this year made a $35 million investment in U.S.-based Joule Unlimited toward building a research center in Russia as well as improving its technology, which produces fuel using carbon dioxide and sunlight. As for leveraging nanotech, Rusnano also played an active role in creating a nanobio cluster through its investments, which also serve to maintain a larger government role than is seen in the U.S or Western Europe. As important as drug discovery may be, Russia can ill afford to develop biopharma at the expense of nanobio or biofuels.