FDA OKs Cephalon drug

Mar 21, 2008 (The Philadelphia Inquirer - McClatchy-Tribune Information Services via COMTEX) -- CEPH | news | PowerRating | PR Charts -- Cephalon Inc. received clearance from regulators yesterday to begin selling Treanda as a treatment for a rare form of leukemia.

The medicine will be a new option for about 15,000 people in the United States diagnosed annually with the slow-progressing form of leukemia known as chronic lymphocytic leukemia, or CLL.

The Frazer, Pa., biotech company said it hoped to make Treanda the foundation for a growing oncology business.

"We are extremely excited about the future of our oncology business, particularly Treanda, which is a much-needed alternative for patients," chairman and chief executive officer Frank Baldino Jr. said after word of the approval by the Food and Drug Administration.

For Cephalon, launching Treanda could bring a much-needed boost. The company has seen its share price plunge about 29 percent since June, largely because of slowed prescription growth of Provigil, a therapy prescribed for narcolepsy, sleep apnea, and shift-work sleep disorder. Last month, shares hit a 52-week low of $56.20.

Cephalon shares rose yesterday on the FDA's decision, closing at $64.17, up 2.5 percent on the Nasdaq market.

Baldino told investors in Boston this week that Cephalon could begin selling Treanda as a tumor-shrinking treatment by early next month.

The company derived most of its $1.7 billion in 2007 sales from pain relievers and treatments for central-nervous-system disorders.

It acquired Treanda in 2005 as part of an effort to diversify its product line with new cancer drugs. Baldino said Cephalon also was seeking FDA approval to market Treanda for patients with relapsed indolent non-Hodgkin's lymphoma and expected a decision in October.

Cephalon won orphan-drug status for Treanda to treat CCL, meaning it will have marketing exclusivity in that area until March 2015.

The American Cancer Society estimates that more than 15,000 new cases of CCL, a slowly progressing blood and bone-marrow disease, will be diagnosed in the country this year.

Treanda works by damaging DNA in tumor cells. It triggers a process known as apoptosis, by which such cells deteriorate and die off. It also disrupts normal cell division, Cephalon said.

Cephalon holds exclusive U.S. rights to Treanda, known chemically as bendamustine hydrochloride, under a license from Tokyo-based Astellas Pharma Inc.

The drug may generate $444 million in sales in 2014, according to Aaron Gal, an analyst with Sanford C. Bernstein & Co. Inc. in New York.

Treanda will compete with fludarabine, the standard chemotherapy agent used in the United States, and Genzyme Corp.'s Campath, Cephalon said.

This article contains information from Bloomberg News.

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