Commercialisation Of Yondelis(R) For The Treatment Of Soft Tissue Sarcoma Approved In Russia

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Nov 2008 - 4:00 PST

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The Russian regulatory body has approved YONDELIS® (trabectedin) for the treatment of soft tissue sarcoma in adults. This represents another approval for YONDELIS® for treatment soft tissue sarcoma (STS) following upon its approval in Europe in September 2007, which opens up new opportunities in markets with enormous growth potential. Under the licensing agreement with Ortho Biotech Products, L.P., PharmaMar will receive royalties on sales of YONDELIS® in Russia.

According to the licensing agreement, PharmaMar has rights to market the compound in Europe and Japan, while Ortho Biotech Products, L.P. has marketing rights for the product in the rest of the world.

YONDELIS® is currently being marketed in the European Union for the treatment of STS in adults after the failure of standard therapy. PharmaMar plans to submit a Marketing Authorization Application for YONDELIS for the treatment of ovarian cancer to the EMEA in December 2008.

YONDELIS® has been designated orphan drug for the treatment of STS and ovarian cancer in the European Union, United States and Switzerland. There are also 2 ongoing studies: A multicentre, phase III study of YONDELIS as a first-line therapy in patients with tumours bearing translocations, and a Phase II in children with recurrent rhabdomyosarcoma, Ewing sarcoma, and non-rabdomyosarcomatous STS.

YONDELIS is also being studied by PharmaMar as a treatment for high incidence and prevalence solid tumours such as prostate, breast, and lung cancer.

Soft tissue sarcomas

STS are a diverse group of more than 50 types of tumours that appear in fatty tissue, muscle, nerve tissue, tendons and blood and lymph vessels. Nearly half of them affect the extremities.

According to data from GEIS (Spanish research group in sarcomas) soft tissue sarcomas (STS) have an incidence of around 3/100,000 new cases per year, which represents 2% of the overall mortality from cancer. The highest incidence is situated in patients around 50 years of age.

The five-year survival rate of patients with STS is around 90% when detected early (stage I), that is, when the tumour is small and with no metastasis. However, the five-year survival rate in patients with metastatic disease is 10-20%1. The estimated life expectancy in metastatic patients is 8-12 months after receiving the first line of cytotoxic therapy2.

PharmaMar

PharmaMar is the world leader biopharmaceutical company of the Zeltia Group, committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines. PharmaMar has five novel compounds in clinical development: YONDELIS® has received Authorization for Commercialization from the European Commission for advanced soft tissue sarcoma. YONDELIS® is also in phase III for ovarian cancer and phase II for prostate, breast and paediatric cancers. Aplidin®, Kahalalide F, Zalypsis® and PM02734 are in clinical trials. PharmaMar also has a rich pipeline of preclinical candidates, and a strong R&D program.

1 Stojadinovic A, Leung DH et al. (2002) "Primary adult soft tissue sarcoma: time-dependent influence of prognostic variables." J Clin Oncol 20(21): 4344-52

2 Brennan MF, Casper ES, et al. (1997). Soft tissue sarcoma, Cancer: principles and practice of oncology. V. T. De Vita, S. Hellman and S. A. Rosenberg. Philadelphia, Lippincott-Raven Publishers: 1738-88. Blay JY, van Glabbeke M, Verweij J, et al. Advanced soft-tissue sarcoma: a disease that is potentially curable for a subset of patients treated with chemotherapy. Eur J Cancer 2003; 39(1): 64-69.

Santoro A, Tursz T, Mouridsen H, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol 1995;13(7): 1537-45.

Important note

PharmaMar, based in Madrid, Spain, is a subsidiary of Grupo Zeltia (Spanish Stock Exchange, ZEL) that is quoted in the Spanish Stock Exchange since 1963 and the Spanish continuous market since 1998. Grupo Zeltia is currently part of the Ibex Nuevo Mercado (New Market).

This document is a press release, not a brochure. This document does not constitute nor is part of any offer or invitation to sell or issue any application of purchase, offer or shares subscription of the Society. Likewise, this document nor its distribution is part or can be of base for any contract or investment decision and does not constitute any kind of recommendation in relation with the shares of the Company.

PharmaMar