Nav: Home

YONDELIS® receives marketing approval in Japan for the treatment of STS

September 28, 2015

PharmaMar announced that its partner in Japan, Taiho Pharmaceutical, received marketing approval for YONDELIS® (trabectedin) by the Japanese Minister of Health, Labour and Welfare for the treatment of patients with soft tissue sarcoma. The indication includes all types of soft tissue sarcoma.

This approval is based on the positive results from a multicenter, randomized, open-label Phase 2 trial in soft tissue sarcoma patients that had chromosomal translocations to compare trabectedin treatment against best supportive care (BSC). Progression-free survival (PFS) was the primary endpoint, which was measured by central radiology review that allows a uniform process of evaluation across centers and patients. Trabectedin treatment reduced the risk of disease progression compared to BSC, achieving a median PFS of 5.6 months for patients treated with trabectedin compared to 0.9 months for the BSC group.

"We are very excited to witness the approval of YONDELIS® in Japan, so this drug can be available to patients with a disease that remains an unmet medical need in this country," said Luis Mora, Managing Director, PharmaMar. "Collaborating with Taiho was crucial to bring this product to the oncology community in Japan."

For the approval of YONDELIS® in Japan, PharmaMar will receive two payments, 600 million Japanese yen from Taiho Pharmaceutical and $5 million from Janssen Products.
-end-
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 others , . It affects about 5,000 people in Japan, where it is estimated that there are 2 to 3 new cases for every 100,000 people . Only 16% of patients with disease that has already spread will achieve a 5-year survivali.

About YONDELIS® (trabectedin)

YONDELIS® (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in 77 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection). Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS® globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About PharmaMar

Headquartered in Madrid, PharmaMar is the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. YONDELIS® is commercially available in 77 countries for the treatment of advanced soft tissue sarcomas and for relapsed platinum-sensitive ovarian cancer. PharmaMar develops and commercializes YONDELIS® in Europe and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, UK and the United States. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.

Disclaimer

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.

Media Inquiries:

Carolina Pola - Communications Director
Paula Fernández - Media Relations
Phone: +34 91 444 45 00
Mobile: +34 608 93 36 77

Investor Relations:
Phone: +34 914444500
Or please visit our website at http://www.pharmamar.com and http://www.zeltia.com

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

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

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

Pharmamar

Related Health Articles:

Public health guidelines aim to lower health risks of cannabis use
Canada's Lower-Risk Cannabis Use Guidelines, released today with the endorsement of key medical and public health organizations, provide 10 science-based recommendations to enable cannabis users to reduce their health risks.
Generous health insurance plans encourage overtreatment, but may not improve health
Offering comprehensive health insurance plans with low deductibles and co-pay in exchange for higher annual premiums seems like a good value for the risk averse, and a profitable product for insurance companies.
The Lancet Planetary Health: Food, climate, greenhouse gas emissions and health
Increasing temperatures, water scarcity, availability of agricultural land, biodiversity loss and climate change threaten to reverse health gains seen over the last century.
With health insurance at risk, community health centers face cut-backs
Repeal of key provisions of the Affordable Care Act, combined with a failure to renew critical funding streams, would result in catastrophic funding losses for community health centers-forcing these safety net providers to cut back on services, lay off staff or shut down clinical sites, according to a report published today.
Study clusters health behavior groups to broaden public health interventions
A new study led by a University of Kansas researcher has used national health statistics and identified how to cluster seven health behavior groups based on smoking status, alcohol use, physical activity, physician visits and flu vaccination are associated with mortality.
Tailored preventive oral health intervention improves dental health among elderly
A tailored preventive oral health intervention significantly improved the cleanliness of teeth and dentures among elderly home care clients.
Study finds that people are attracted to outward signs of health, not actual health
Findings published in the journal Behavioral Ecology reveal that skin with yellow and red pigments is perceived as more attractive in Caucasian males, but this skin coloring does not necessarily signal actual good health.
In the January Health Affairs: Brazil's primary health care expansion
The January issue of Health Affairs includes a study that explores a much-discussed issue in global health: the role of governance in improving health, which is widely recognized as necessary but is difficult to tie to actual outcomes.
University of Rochester and West Health Collaborate on d.health Summit 2017
In collaboration with West Health, the University of Rochester is hosting the third annual d.health Summit, a forum for health care and technology leaders, entrepreneurs, senior care advocates and policymakers to exchange ideas, create new partnerships, and foster disruptive technological and process innovations to improve the lives of the nation's aging population.
Study links health literacy to higher levels of health insurance coverage
The federal Affordable Care Act is intended to make it easier for individuals to buy health insurance, but are the uninsured equipped to navigate the choices faced in the insurance marketplace?

Related Health Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Jumpstarting Creativity
Our greatest breakthroughs and triumphs have one thing in common: creativity. But how do you ignite it? And how do you rekindle it? This hour, TED speakers explore ideas on jumpstarting creativity. Guests include economist Tim Harford, producer Helen Marriage, artificial intelligence researcher Steve Engels, and behavioral scientist Marily Oppezzo.
Now Playing: Science for the People

#524 The Human Network
What does a network of humans look like and how does it work? How does information spread? How do decisions and opinions spread? What gets distorted as it moves through the network and why? This week we dig into the ins and outs of human networks with Matthew Jackson, Professor of Economics at Stanford University and author of the book "The Human Network: How Your Social Position Determines Your Power, Beliefs, and Behaviours".