Johnson & Johnson, PharmaMar seek U.S., European approval for trabectedin for soft tissue sarcoma

By E. Janene Geiss

Philadelphia, June 1 - Johnson & Johnson Pharmaceutical Research & Development, LLC and PharmaMar gave an update Thursday on plans for the regulatory filings of trabectedin, an investigational treatment for soft tissue sarcoma, which the two companies are developing in partnership.

PharmaMar said it has been working with the regulatory authorities toward submission of trabectedin in soft tissue sarcoma for marketing authorization, according to a company news release.

As a result of this process and after a meeting held Wednesday with the European Medicines Evaluation Agency, PharmaMar said it confirms that it will submit the dossier for marketing approval of trabectedin in soft tissue sarcoma, based on STS 201, a phase 2 randomized trial, within the next two to three months.

Johnson & Johnson said it plans to file a New Drug Application with the Food and Drug Administration for trabectedin in soft tissue sarcoma based on the STS 201 phase 2 data, once a phase 3 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 soft tissue sarcoma, trabectedin is being studied in a phase 3 study in ovarian cancer. It was designated orphan-drug status for soft tissue sarcoma by the European Commission in 2001 and by the FDA in 2004, and orphan-drug status for ovarian cancer by the European Commission in 2003 and by the FDA in 2005.

If key studies are successful and support marketing approval, the partnership agreement between Johnson & Johnson and PharmaMar provides that PharmaMar will market trabectedin in Europe, including Eastern Europe, while Ortho Biotech Products LP will market it in the United States and Janssen-Cilag will market it in the rest of the world.

PharmaMar is a Madrid, Spain, biopharmaceutical company with a focus on developing marine-derived medicines for cancer. It is a subsidiary of the Zeltia Group.

Johnson & Johnson Pharmaceutical Research & Development is part of New Brunswick, N.J.-based Johnson & Johnson, a pharmaceutical and health care products company.

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