Alvogen Launches First Generic Equivalent of CopaxoneTM in Europe

• First Generic and clinically validated product for Multiple Sclerosis in Europe
• Provides an affordable high quality alternative to MS patients, complemented by a range of support services including Autoxon^TM

PINE BROOK, N.J.--(BUSINESS WIRE)--Alvogen today announced the launch of Remurel^TM (glatiramer acetate), the first generic equivalent of Copaxone^TM in Central and Eastern Europe. The product will be marketed as a once daily subcutaneous 20 mg prefilled syringe under the brand name Remurel^TM 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 (Autoxon^TM) having multiple features to help support MS patients in their treatment with Remurel^TM. Teva‘s Copaxone^TM 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 Remurel^TM. 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. Remurel^TM 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."

Remurel^TM 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. Remurel^TM 20 mg was determined by the European health authorities to be therapeutically equivalent to daily Copaxone^TM 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 Copaxone^TM to Remurel^TM.

About Alvogen

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.

Copaxone^TM is a registered trademark of Teva Pharmaceuticals Industry Ltd.