• Evaluation of potential development and commercialization collaborations around Xbrane’s preclinical biosimilars Xcimzane and Xdivane and other biosimilars.
   
• CEO Peter Goldschmidt: “We are happy to provide Xbrane with our capabilities and resources to make this collaboration a success for both sides.“
  
  

Bad Vilbel, May 31, 2019 – STADA Arzneimittel AG and Xbrane Biopharma AB have expanded their strategic biosimilar development partnership. This allows both companies to evaluate potential development and commercialization collaborations around Xbrane's Xcimzane and Xdivane preclinical biosimilars and additional biosimilars that fit both companies' portfolios. “This partnership is a great opportunity for STADA to accelerate the expansion of our biosimilar portfolio and to strengthen our market position in this segment. Since our approach is that external becomes internal, we assume ownership of all products we commercialize, no matter where they are developed, we are happy to provide Xbrane with our capabilities and resources to make this collaboration a success for both sides”, says CEO Peter Goldschmidt.

Xbrane and STADA will focus on biosimilars to originator products with patent expiration 2025-2030 and have identified two programs in Xbrane´s pre-clinical biosimilar portfolio for potential future collaboration: Xcimzane (Certolizumab pegol (Cimzia^®) biosimilar) and Xdivane (nivolumab (Opdivo^®) biosimilar). Up until initiation of the products’ clinical trials STADA and Xbrane will evaluate and negotiate a potential development and commercialization agreement around these products. During this period of evaluation, Xbrane has granted to STADA a Right of First Refusal for a license of Xcimzane and Xdivane for Europe. Furthermore, in the near future both companies will evaluate potential collaboration around the development and commercialization of additional biosimilars.

"We believe that STADA is the perfect partner for us to commercialize our biosimilars in Europe, MENA and selected APAC countries. We are therefore very happy to enter into this strategic partnership and jointly launch several biosimilars to provide access to biological therapies to a broader population", says Martin Åmark, CEO Xbrane.

STADA and Xbrane have already entered into a co-development agreement for Xlucane, a Lucentis^® (ranibizumab) biosimilar, in July 2018. The agreement contains that both companies will equally contribute to development expenses and share profits from commercialization in a 50/50 split. STADA will hold the marketing authorizations and will be responsible for sales and marketing of the product across all territories included in the agreement. The co-development agreement covers Europe, the US and a variety of MENA and APAC markets.

About Xbrane
Xbrane Biopharma AB is a biotechnology company which develops, manufactures and produces commercial biosimilars. Xbrane has a patented protein production platform for development of biosimilars and world-leading expertise within biosimilars. Xbrane's head quarter is located in Solna, outside Stockholm, and the company has research and development facilities in Sweden and in Italy. Xbrane has been listed on Nasdaq First North since 3 February 2016 with the ticker XBRANE. Avanza Bank AB is Xbrane's Certified Adviser. For more information see www.xbrane.com.

About STADA Arzneimittel AG
STADA Arzneimittel AG is a publicly-listed company with headquarters in Bad Vilbel, Germany. The company focuses on a two pillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription Consumer Health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 130 countries. In financial year 2018, STADA achieved adjusted Group sales of EUR 2,330.8 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 503.5 million. As of December 31, 2018, STADA employed 10,416 people worldwide.

Additional information for journalists
STADA Arzneimittel AG / Media Relations / Stadastrasse 2–18 / 61118 Bad Vilbel – Germany / Phone: +49 (0) 6101 603-165 / Fax: +49 (0) 6101 603-215 / E-Mail: press@stada.de

Additional information for capital market participants
STADA Arzneimittel AG / Investor & Creditor Relations / Stadastrasse 2–18 / 61118 Bad Vilbel – Germany / Phone: +49 (0) 6101 603-4689 / Fax: +49 (0) 6101 603-215 / E-mail: ir@stada.de