Public Release: 

PharmaMar announces that its partner Taiho files NDA for Yondelis in Japan for soft-tissue sarcoma

The J-NDA has been granted priority review, as trabectedin received orphan drug designation in Japan

Pharmamar

This news release is available in Spanish.

Madrid, January 5th 2015: PharmaMar announces that Taiho Pharmaceutical, PharmaMar's partner for Yondelis® development and sales in Japan, has filed a marketing authorization application that seeks approval of Yondelis® (trabectedin; development code: ET-743) for the treatment of different subtypes of advanced soft tissue sarcoma in Japan, given the clinical benefit shown in a pivotal Phase II study.

"This is a milestone for PharmaMar and a step forward for Yondelis®, which keeps showing its efficacy as treatment for this type of cancer", said Luis Mora, Managing Director, PharmaMar. "We hope that patients suffering from soft tissue sarcoma in Japan will soon have access to this treatment".

This J-NDA is based on the results from the open-label, randomized Phase II clinical study (JapicCTI-121850) that compared the progression-free survival (PFS) of Japanese patients treated with Yondelis® (trabectedin) against best supportive care (BSC), which was the primary endpoint. The data, presented at the 2014 ASCO, showed a median PFS of 5.6 months for Yondelis® (trabectedin), which was significantly superior compared to the 0.9 months achieved by patients on BSC1.

About Soft Tissue Sarcoma

Soft tissue sarcomas are a rare type of cancer originating in the soft tissues that connect, and support other body structures, such as muscle, fat, and blood vessels, among others2,3. It affects about 3,000 people in Japan, where it is estimated that there are 2 to 3 new cases for every 100,000 people4. Only 16% of patients with disease that has already spread will achieve a 5-year survival2.

About Yondelis® (trabectedin)

Yondelis® (trabectedin) is a new, multimodal, synthetically produced anti-cancer agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug prevents tumor progression through different mechanisms of action, which include the inhibition of activated transcription and proteins involved in DNA repair, as well as the modulation the tumor microenvironment. PharmaMar has granted a license to Taiho Pharmaceutical to develop and sell Yondelis® (trabectedin) in Japan, where it has orphan drug designation.

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Disclaimer

PharmaMar, which is headquartered in Madrid (Spain), is a subsidiary of Zeltia, S.A. (Spanish stock exchange: ZEL), which has been listed on the Spanish Stock Exchange since 1963 and on Spain's Electronic Market since 1998. This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.

PharmaMar Media Relations:
Carolina Pola
Mobile: +34 608 93 36 77

Zeltia Investor Relations:
Phone: +34 91 444 4500

Or please visit our website at http://www.pharmamar.com and http://www.zeltia.com

1 http://meetinglibrary.asco.org/content/132813-144

2 American Cancer Society. What is a soft tissue sarcoma? Available at: http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-soft-tissue-sarcoma

3 General information about adult soft tissue sarcoma. Available at:. http://www.cancer.gov/cancertopics/pdq/treatment/adult-soft-tissue-sarcoma/HealthProfessional

4 Taiho Pharma News Release. Available at: http://www.taiho.co.jp/english/news/20140604.html

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