Genta completes submission of new drug application
Tuesday December 9, 8:39 am ET
NEW YORK, Dec 9 (Reuters) - Genta Inc. (NasdaqNM:GNTA - News) said on Tuesday it completed its application to U.S. regulators for approval of its cancer drug in combination with a chemotherapy.
The Berkeley Heights, New Jersey-based company, which has submitted its application in portions under an accelerated review program known as "fast track," said it has submitted its final portion to market the drug Genasense in combination with the chemotherapy dacarbazine for the treatment of skin cancer.
Typically, a drug submitted under the fast-track program is reviewed within six months of the date of the completed submission.
Dominic Valder, an analyst with Bear Stearns in London, said completion of the filing is in line with expectations.
Genasense is being developed with Aventis (Paris:AVEP.PA - News) and is being tested in a range of cancers, including multiple myeloma, chronic lymphocytic leukemia, lung cancer and prostate cancer.
Valder said he expects the drug to generate sales of 700 million euros ($857 million) by 2007, assuming it is launched by then to treat four other types of cancer in addition to skin cancer.
Genasense is one of a new type of drugs that uses a technology known as antisense. Unlike conventional drugs, which interact with disease-causing proteins, antisense drugs aim to prevent such proteins from being created in the first place by working at the genetic level inside cells. |
