US pharma giant Pfizer and Russia’s NovaMedica, a company established in 2012 by Russian high-technology investment fund Rusnano and American healthcare fund Domain Associates, have completed the last stage of negotiations for a long-term strategic partnership designed to transfer the rights and technologies for the production of more than 30 life-saving and essential drugs from the Pfizer product portfolio.
The deal will enable Pfizer and NovaMedica to improve the health of patients in Russia and modernize the Russian pharmaceutical industry.
As announced in July this year, under the terms of the partnership, Pfizer will invest in NovaMedica and collaborate on the construction of a state-of-the-art aseptic manufacturing facility in the province of Kaluga. The facility is intended to be built in accordance with the highest world-class and current Good Manufacturing Practices (cGMP) standards and requirements of the Russian authorities, which would potentially enable NovaMedica to manufacture for export markets.
As part of the agreement, Pfizer will also transfer technologies for more than 30 sterile injectable products to NovaMedica to enable NovaMedica to manufacture these products. These products, to be manufactured at the new facility, include drugs for the treatment of severe bacterial and fungal infections, cardiovascular disease, inflammatory diseases and cancer. Most of these International Nonproprietary Names (INNs) are on the Russia`s Essential Drugs List (EDL) and several are also included in the federal reimbursement programs Population Drug Coverage (ONLS) and 7 Nosologies (7N).
The drugs will be manufactured using world-class technologies including lyophilization and production of sterile emulsions. The state-of-the-art equipment to be installed at the facility will include full process automation to provide for the required aseptic manufacturing environment. The new facility will be located in the Vorsino Industrial Park, province of Kaluga. Construction/ground breaking is expected to commence in mid-2017.