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. 

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferons are thought to help modulate the body’s immune system and reduce inflammation. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif® is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms). Rebif® is now available in UK, Germany and Denmark, as well as in Canada, in two multidose cartridges [132 micrograms (three doses of 44 micrograms) and 66 micrograms (three doses of 22 micrograms)] for the use with the RebiSmart device.

Rebif® should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

The reformulated version of Rebif® has been approved in the European Union, Switzerland, Australia and Canada. It is under regulatory review in other countries including the United States.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown. 

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.

For more information, please visit www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. 

About Merck

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of ˆ 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.

Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD. 

About Pharmstandard

Pharmstandard OJSC (www.pharmstd.com/ru) – Russia’s leading pharmaceutical company that develops and manufactures high-quality modern pharmaceutical products which meet the requirements of the healthcare system and the expectations of patients.

The Company’s production assets consist of 8 pharmaceutical plants located in Kursk, Ufa, Tomsk, Vladimir, Moscow region and in Ukraine’s Kharkov and 1 medical equipment plant in Tyumen.

Pharmstandard’s shares and GDRs are traded on the RTS-MICEX and LSE, respectively.