Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovar... (iarrhea (26% versus 19%); Liver e...)

Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer

Date:11/20/2008

iarrhea (26% versus 19%);

Liver enzyme (transaminase) elevations were more common in the combination arm, but were generally reversible and not associated with evidence of chronic liver damage or other clinical consequences. These included increased alanine aminotransferase (55% versus 9%) and increased aspartate aminotransferase (40% versus 10%); and

Fatigue (46% versus 36%).

Additionally, commonly associated DOXIL adverse events, such as hand-foot syndrome (HFS) and stomatitis, occurred in fewer patients receiving the combination compared to DOXIL alone (24% versus 54% and 20% versus 33%, respectively).

About Trabectedin

Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the Caribbean tunicate, Ecteinascidia turbinate ("sea squirt"). The compound is now produced synthetically. Trabectedin binds to the minor groove of DNA, interfering with cell division and genetic transcription processes and DNA repair machinery. Trabectedin is currently in Phase III development in ovarian cancer and to expand its uses in sarcoma.

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.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in anemia
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Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovar...(iarrhea (26% versus 19%); Liver e...),Health