BAD VILBEL, Germany I November 18, 2014 I STADA Arzneimittel AG and the biotech specialist mAbxience have agreed to negotiate over the in-licensing of an Adalimumab (Humira®) biosimilar. The letter of intent stipulates that the two negotiating parties will come to a decision within the next six months. The original product, Humira® is the world’s top-selling biopharmaceutical with a sales volume in 2013 of approximately 10.66 billion US dollars in 2013.

With these negotiations, STADA continues its longstanding strategy of targeted in-licensing of selected biosimilars; a strategy with which the Group is continuously expanding its portfolio of quality products at comparably favorable conditions.

A biosimilar is a drug with an active pharmaceutical ingredient produced using biotechnology and which is developed in comparison to an original product already on the market. The biosimilar is so similar to the original product that it has proven therapeutic equivalence and is comparable in terms of safety and quality. A biosimilar is thereby an equivalent successor product of an off-patent biopharmaceutical product.

mAbxience is a fast-growing, fully-integrated biotech company specialized in research, development and manufacturing of biosimilars. Through its business model, its five products in development will have a global presence in over 50 countries. It is planned to develop and manufacture the biosimilar adalimumab at the Genhelix biopharmaceutical plant located in Leon, Spain.

Due to the fact that numerous blockbuster biologics, including Adalimumab, will lose their patent protection in the next few years, it can be assumed that biosimilars, as high-quality yet cheaper alternatives to the original products, will be even more important for patient care in the future.

Further information on biosimilars can be found at www.stada.com/biosimilars.

About STADA Arzneimittel AG

STADA Arzneimittel AG is a publicly-listed company with headquarters in Bad Vilbel, Germany. STADA consistently focuses on a multi-pillar strategy of generics and branded products (OTC) with an increasingly international market orientation. The Group is the only independent generics producer in Germany. As of December 31, 2013, STADA was represented in 29 countries with 47 sales companies. Branded products such as Grippostad, Ladival and Mobilat are among the highest selling in their product category in Germany. In financial year 2013, STADA achieved Group sales of Euro 2,014.4 million, adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of Euro 415.2 million and adjusted net income of Euro 160.6 million. As of December 31, 2013, STADA employed 9,825 people worldwide.

About mAbxience

mAbxience is a global fully integrated biopharmaceutical company specialized in research, development and manufacturing of biosimilars for the treatment and/or prevention of several diseases in diverse therapeutic areas. mAbxience is acting worldwide, creating a broad and balanced presence in all major pharmaceutical markets to address global opportunities and customers’ needs, with full-line research and manufacturing capabilities and highly qualified professionals worldwide. mAbxience is a wholly-owned subsidiary of CHEMO Group, a well-established Spanish based global healthcare corporation.

SOURCE: STADA