PINE BROOK, N.J.–(BUSINESS WIRE)–Alvogen today announced the launch of RemurelTM (glatiramer acetate), the first generic equivalent of CopaxoneTM in Central and Eastern Europe. The product will be marketed as a once daily subcutaneous 20 mg prefilled syringe under the brand name RemurelTM and will be launched throughout all Central and Eastern European countries from September 2016 onwards.
The product will be launched with a proprietary auto-injector device (AutoxonTM) having multiple features to help support MS patients in their treatment with RemurelTM. Teva‘s CopaxoneTM delivered sales of over EUR 510 million in Europe in 2015, according to IMS Midas data.
Hacho Hatchikian, Executive Vice President at Alvogen in the CEE region, commented: “We are proud to announce the launch of RemurelTM. This product represents an important milestone in our growing portfolio in the region. It is also a landmark for Alvogen and MS patients throughout the CEE region, who will finally have access to an affordable high quality treatment for this chronic and neurodegenerative disease. This is yet another first-to-market complex product in our portfolio, testifying to Alvogen’s commitment in delivering difficult-to-make but affordable treatments to patients. RemurelTM offers a more affordable – but equally effective – treatment option for Multiple Sclerosis patients, offering compelling cost saving opportunities within the Central and Eastern European region.”
RemurelTM is indicated for the treatment of patients with relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. RemurelTM 20 mg was determined by the European health authorities to be therapeutically equivalent to daily CopaxoneTM 20 mg, with the same active ingredients, route of administration, strength and dosage form. This approval was supported by a large-scale, multicenter Phase III study, known as GATE (Glatiramer Acetate clinical Trial to assess Equivalence to Copaxone®). Results of the study demonstrate equivalence in efficacy and safety and support the safety of switching active therapy from CopaxoneTM to RemurelTM.
Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. The company has commercial operations in 35 countries with 2,300 employees and operates four manufacturing and development hubs in the US, Romania, Korea and Taiwan. North America is Alvogen’s single largest market and other key markets include: South Korea, Romania, Bulgaria, Hungary, Russia, Poland, Taiwan, Thailand, Ukraine, West Balkan, Japan and China.
CopaxoneTM is a registered trademark of Teva Pharmaceuticals Industry Ltd.