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17.11.2020 – 08:58

Stada Arzneimittel

STADA and PharmaMar sign agreement to commercialize Yondelis® (trabectedin) in the MENA region

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Press Release

STADA and PharmaMar sign agreement to commercialize Yondelis® (trabectedin) in the MENA region

  • PharmaMar has granted to STADA a license to market the Yondelis® (trabectedin) marine-derived cancer treatment in 15 Middle East-North Africa countries.
  • According to Luis Mora, Managing Director of PharmaMar's Oncology Business Unit: "We see STADA's infrastructure and internal capabilities playing a key role in helping us to maximize the access to this unique drug for as many sarcoma and ovarian cancer patients as possible."
  • Carsten Cron, Executive Vice-President of Emerging Markets at STADA, commented: "This alliance with PharmaMar for the Yondelis unique treatment option for sarcoma and ovarian cancer significantly strengthens our specialty pharmaceuticals portfolio in the MENA region."

Madrid, Spain; Bad Vilbel, Germany; 17 November 2020 - PharmaMar (MSE:PHM) and STADA Arzneimittel have today announced a commercial licensing agreement for Yondelis® (trabectedin) with the STADA Arzneimittel AG's subsidiary in the United Arab Emirates named STADA MENA DWC-LLC (herein together referred to as "STADA") in Algeria, Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates (UAE) and Yemen.

Under the terms of the license and commercialization agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including a regulatory milestone payment. PharmaMar will retain exclusive production rights of trabectedin and will sell the product to STADA for its clinical and commercial use on an exclusive basis in the 15 MENA markets.

This new agreement follows PharmaMar's announcement on August 26th, 2019, regarding the agreement entered into with Janssen Products LP (Janssen), by which PharmaMar recovered the commercialization rights of the product in more than 40 countries, formerly licensed to Janssen, where Yondelis® has already been approved.

Yondelis® is currently registered and marketed in several MENA countries for the treatment of soft tissue sarcoma and relapsed ovarian cancer. Through this licensing agreement, and once the marketing authorizations are formally transferred, STADA will be authorized to commercialize and distribute the product in MENA countries on an exclusive basis.

According to Luis Mora, Managing Director of PharmaMar's Oncology Business Unit: "This new agreement with STADA will allow us to bring trabectedin to patients throughout the 15 MENA countries covered by the deal. We see STADA's infrastructure and internal capabilities playing a key role in helping us to maximize the access to this unique drug for as many sarcoma and ovarian cancer patients as possible."

Carsten Cron, Executive Vice-President of Emerging Markets at STADA, commented: "This alliance with PharmaMar for the Yondelis® unique treatment option for sarcoma and ovarian cancer significantly strengthens our specialty pharmaceuticals portfolio in the MENA region. This builds on our purpose of "Caring for people's health as a trusted partner."

"The agreement," he added, "is also testament to how STADA is using its position as a go-to-partner for specialty pharmaceuticals, as well as for generics and consumer healthcare products, to build a broad oncology offering."

Legal disclaimer

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: ZepzelcaTM (lurbinectedin, PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

About STADA Arzneimittel AG

STADA Arzneimittel AG is headquartered 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 120 countries. In financial year 2019, STADA achieved adjusted Group sales of EUR 2,608.6 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 625.5 million. As of December 31, 2019, STADA employed 11,100 people worldwide.

About Yondelis®

Yondelis® (trabectedin) is a novel, synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. Yondelis® exerts its anticancer effects primarily by inhibiting active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent.

PharmaMar Media Contact:

Alfonso Ortín - Communications Director aortin@pharmamar.com Mobile: +34 609493127

Miguel Martínez-Cava - Communication Manager mmartinez-cava@pharmamar.com Mobile: +34 606597464

Álvaro Mateo - Communication Manager amateo@pharmamar.com Mobile: +34 650726009

Phone: +34 918466000

STADA media contact:

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

Or visit us on the Internet at www.stada.com/press