TTY Biopharm Company Ltd (“TTY”) and PharmaMar (MSE:PHM) announced today an exclusive licensing agreement for the import, use, marketing, sale and distribution of the marine-derived anticancer drug Yondelis® (trabectedin) in Taiwan, Hong Kong and Macao.
Under the terms of the agreement, PharmaMar shall receive a non-disclosed upfront and will also be eligible for an additional regulatory milestone payment. PharmaMar will retain exclusive production rights of the product, which will be sold to TTY for its clinical and commercial use.
This new agreement follows PharmaMar's announcement on August 26th, 2019 regarding the agreement entered with Janssen Products LP (Janssen), by which PharmaMar recovered from Janssen the commercialization rights of the product in all countries previously licensed to Janssen with the exception of U.S., including rights in more than 40 countries where trabectedin has already been approved.
Through its partner TTY in Taiwan, PharmaMar expects patients to have broader access to the product once full reimbursement for Yondelis® (trabectedin) will be granted by health authorities.
Yondelis® (trabectedin) received regulatory approval in Taiwan for the treatment of Soft Tissue Sarcoma, and TTY will now seek reimbursement from the National Health Insurance Administration (NHIA). In Hong Kong, Yondelis® is also approved for Recurrent Ovarian Cancer.
“Sarcoma is a relatively rare cancer and treatment options are limited for patients with the advanced stage and it is our commitment and dedication to provide a better access to the therapy to patients in need. For this mission, we are delighted to collaborate in a partnership with one of the long-standing leaders in the field of oncology and hematology in Taiwan" said Heiner Pieper, Vice-President of Business Development & Licensing at PharmaMar.
Announcing the new licensing collaboration, TTY’s Chief Operating Officer, Mr. Chun Liang Shih said, “Trabectedin is regarded as a global standard of care to treat soft tissue sarcoma. We are delighted to continue providing this important therapy to patients in Taiwan, Hong Kong and Macao with better access to the product. We will be immediately seeking P&R approval from the National Health Insurance Administration (NHIA) to ensure that the patients have full reimbursement for the therapy in Taiwan.”
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.
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: 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 TTY Biopharm
TTY is committed to building itself as a biotech pharmaceutical company advanced in drug development and international marketing. On one hand, TTY is continuously improving its ability to gear to international developments in areas such as international technical documentation formats (CMC, CTD), execution of international clinical trials, and manufacturing process which matches EMA and FDA specifications. On the other hand, TTY continues to carefully select the most suitable collaborative partners for new drug development around the world and various target markets. Other than continuing operation in the core channels (medical centers, regional hospitals, district hospitals with development potentials) in Taiwan, TTY will enter the international market through developing high barrier and concept-proved new drugs and biologics with innovative Injectable liposomal and PLA/PLGA microsphere formulations. In the future, TTY will continue its cultivation of Asian target markets (home market) to build up its local strength to become the best partner with the best drug development and marketing capabilities for international innovation and biotech companies in target market. Additional information can be found at http://eng.tty.com.tw/.
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.