Date: 2014-07-01
Type of information: Production agreement
Compound: Rebif® (interferon beta-1a)
Company: MerckSerono (Germany) Pharmstandard (Russia)
Therapeutic area: Neurodegenerative diseases
Type agreement:
Action mechanism:
Disease: multiple sclerosis
Details: * On July 1, 2014, Merck and 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. Now 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.
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. 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.
Financial terms:
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