Johnson and Johnson Pharmaceutical R&D (NJ) Release: Update On Regulatory Filing Plans For Investigational Compound Trabectedin In Soft Tissue Sarcoma
RARITAN, N.J. and MADRID, Spain, June 1 /PRNewswire-FirstCall/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) and PharmaMar today provided an update on plans for the regulatory filings of trabectedin, an investigational treatment for soft tissue sarcoma (STS), which the two companies are developing in partnership.
PharmaMar has been working with the regulatory authorities towards submission of trabectedin in STS for marketing authorization. As a result of this process and after a meeting held yesterday evening with the European Medicines Evaluation Agency (EMEA), PharmaMar confirms that it will submit the dossier for marketing approval of trabectedin in STS, based on STS 201, a Phase II randomized trial, within the next two to three months.
J&JPRD plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for trabectedin in STS based on the STS 201 Phase II data, once a Phase III confirmatory trial is underway.
Trabectedin originally was isolated from the marine tunicate Ecteinascidia turbinata, but now is manufactured by chemical synthesis. It is believed that trabectedin has a multi-modal mechanism of action that interferes with various cell processes at the DNA level.
In addition to STS, trabectedin is being studied in a Phase III study in ovarian cancer. It was designated Orphan Drug status for STS by the European Commission (E.C.) in 2001 and by the U.S. FDA in 2004, and Orphan Drug status for ovarian cancer by the E.C. in 2003 and by the U.S. FDA in 2005.
Trabectedin is being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. If key studies are successful and support marketing approval, the agreement between the parties provides that PharmaMar will market trabectedin in Europe (including Eastern Europe) while Ortho Biotech Products, L.P., will market it in the U.S., and Janssen-Cilag, will market it in the rest of the world.
PharmaMar is the world's leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar's clinical portfolio currently includes six compounds. Trabectedin is PharmaMar's most advanced compound in clinical development.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL).
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is part of Johnson & Johnson, the world's most broadly-based producer of healthcare products. J&JPRD, with its headquarters in Raritan, New Jersey, has eleven sites throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. Combining innovation and experience, the company's major therapeutic areas of focus include hematology, oncology, infectious disease, neurology and psychiatry, pain and women's health.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Ortho Biotech Products, L.P. and Janssen-Cilag all are part of the Johnson & Johnson Family of Companies.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company's Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
CONTACT: Doug Arbesfeld for J&JPRD, +1-908-218-7592, Mobile:+1-908-347-9877, or Analyst Contacts for Johnson & Johnson: StanPanasewicz, +1-732-524-2524, or Louise Mehrotra, +1-732-524-6491