December 15, 2008 / 10:53 PM / 11 years ago

UPDATE 1-Genzyme says FDA OKs stem cell transplant drug

NEW YORK, Dec 15 (Reuters) - Genzyme Corp GENZ.O said on Monday that U.S. health regulators approved its Mozobil drug for stem cell transplantation in patients with the blood cancers non-Hodgkin’s lymphoma and multiple myeloma.

The Food and Drug Administration also granted Mozobil orphan drug status, Genzyme said. The designation, used to encourage development of treatments for rare conditions or diseases, gives the company seven years of marketing exclusivity before a similar drug can be approved.

Genzyme, which specializes in treatments for rare genetic disorders, said it believes Mozobil can achieve eventual peak annual sales of $400 million, and its shares rose 0.7 percent in after-hours trading.

The Cambridge, Massachusetts-based company expects European approval of the drug in the second half of 2009. It is also seeking approval in Australia and Brazil, and said approval applications in up to 60 countries were planned.

In clinical trials, Mozibil demonstrated that it can rapidly and effectively increase the number of stem cells in circulation in patients with non-Hodgkin’s lymphoma and multiple myeloma. Once circulating in the blood, the stem cells can be collected for stem cell transplant.

“This product should become an integral part of the treatment regimen for transplantation because of the benefits it offers to patients, physicians and transplant centers,” Dr. John DiPersio of Washington University in St. Louis said in a statement.

“For many cancer patients, moving on to a transplant is their only hope for remission or a cure,” DiPersio said.

Hematopoietic stem cells transplants are commonly used to treat patients with blood cancers. Prior to the procedure, a minimum number of about two million stem cells per kilogram (2.2 pounds) of body weight must be collected, Genzyme said.

Mozobil is approved for use with blood growth factor stimulating agents, which help bone marrow cells to become mature and begin circulating in the blood stream.

The combination with Mozobil appears to make the process faster and more efficient than current procedures. Mozobil may also reduce the number of patients who need a second mobilization procedure due to a failure to mobilize sufficient numbers of cells using current therapy, Genzyme said.

Genzyme shares rose to $64.11 in extended trading from their Nasdaq close at $63.65. (Reporting by Bill Berkrot; Editing by Toni Reinhold)

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