From: Reuters
Published March 20, 2008 05:44 PM

Cephalon wins U.S. approval for leukemia drug

By Lisa Richwine

WASHINGTON (Reuters) - Cephalon Inc won U.S. approval to sell a chemotherapy drug to treat patients with a slow-growing type of leukemia, the company said on Thursday.

The Food and Drug Administration cleared the injectable drug, called Treanda, after a study showed it helped more patients than a common treatment for chronic lymphocytic leukemia, or CLL.

CLL most often hits older adults with an average age of 70 and is more common in men than women. About 15,000 new cases of CLL will be diagnosed in the United States in 2008, according to American Cancer Society estimates.

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Cephalon, known for its sleep drug Provigil, is counting on Treanda to give it a bigger presence in the cancer market. Industry analysts project Treanda's eventual peak annual sales could reach between $300 million and $500 million. It also is under FDA review for a type of non-Hodgkin's lymphoma.

Cephalon's total 2007 sales were $1.7 billion.

For Treanda, the company submitted a study of 301 previously untreated CLL patients who were randomly assigned to receive the Cephalon drug or another chemotherapy treatment called chlorambucil.

Fifty-nine percent of patients responded to Treanda, compared with 26 percent who were treated with the other drug, Cephalon said.

Eight percent of patients given Treanda had a complete remission of their leukemia, compared with less than 1 percent in the other group.

For patients overall, the leukemia got worse after a median of 18 months with Treanda, compared with 6 months for chlorambucil.

"Treanda is an effective new option that offers a delay in disease progression," Dr. Bruce Cheson, a Georgetown University oncologist, said in a statement issued by Cephalon.

Potential side effects including nausea, vomiting and fever occurred more frequently in Treanda patients. Eighty-nine percent in the Treanda group had at least one event recorded, compared with 79 percent with the comparison drug.

Neutropenia, a drop in white blood cells that can make patients vulnerable to infections, occurred in 28 percent of Treanda patients compared with 14 percent in the other group.

Treanda also is under FDA review for treating a different type of blood cancer, indolent B-cell non-Hodgkin's lymphoma. A decision on that use is expected by October 31.

JP Morgan analyst Adam Greene projected $20 million in Treanda sales this year and about $320 million by 2012.

"Although this approval was expected, it should help investor sentiment which has been waning recently on sluggish Provigil (prescriptions)," Greene said in a research note.

Cephalon expects Treanda, known generically as bendamustine, to be available for U.S. physicians and patients in April. The product has been designated as an orphan drug for a rare disease, which gives Cephalon exclusive marketing rights for CLL until March 2015, the company said.

Cephalon spokeswoman Jenifer Antonacci said the company would not disclose Treanda's price until the drug was launched.

Cephalon shares gained $1.56, or 2.5 percent, to close at $64.17 on Nasdaq.

(Reporting by Lisa Richwine; editing by Dave Zimmerman; Editing by Andre Grenon)

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