OREANDA-NEWS. Merck and “Pharmstandard OJSC” (further “Pharmstandard”) concluded a number of partnership agreements aimed at long-term collaboration in the field of production, distribution and marketing of Rebif®. Production of the medicine will be done at Pharmstandard-UfaVITA plant in Ufa.

Rebif® is used as first-line MS therapy according to international standards for MS treatment. Ministry of Health of Russian Federation has been purchasing interferon beta-1a and particularly Rebif® for MS patients within 7 Nozologies program (Reimbursement of Costly Drugs) during last several years. Today approximately 15% of patients with relapsing-remitting MS who are indicated for medical treatment receive Rebif®. Thanks to the production localization in RF Rebif® will become more accessible for this patients' category.

In October 2013 localized Rebif® was registered by Ministry of Health of Russian Federation and Pharmstandard-UfaVITA OJSC was approved as production facility for secondary packaging, quality control and release to the market of the medicine.

Within the course of 2013, both companies were undergoing the process of transfer of analytical methods for production. The process took approximately 9 months. And was finalized by “Technological transfer Protocol” signing. This is the first time in Merck history that company transferred rights for production, quality control and marketing of biotechnological medicine to a third party (Partner company).

Cooperation between Pharmstandard and Merck began in July 2012, when a decision to implement secondary packaging of Rebif® was made. In addition to the secondary packaging Pharmstandard carries out quality control of the finished products. Nowadays an active process of methodology transfer for fill&finish production was started. It is anticipated that the full production cycle will be launched in the fourth quarter of 2015. Marketing support of Rebif® drug in Russia will be carried out by Pharmstandard.

"Conclusion of the agreement on the local production of Rebif and technologies' transfer were the first steps in the implementation of the company's development program in Russia, which is a strategic market for us. At the present moment, the possibility of further investments to the localization of Merck Serono drugs included in the Vital and Essential drugs. List is considered. Production in Russia will facilitate access to innovative treatment for Russian patients"- said Rogier Janssens, director Merck Serono Russia and CIS.

Pharmstandard proved to be a reliable partner thanks to the high level of the production facilities, which meet international standards. "The collaboration with Merck in the areas of production and marketing of a socially important drug is another strategic step in the implementation of the "Pharma 2020" program, aimed at the development of the pharmaceutical industry in Russia", - said Igor Krylov, CEO of Pharmstandard.