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Celgene's Surprising New Hope for Blood Cancer


The stock soars on strong study results.

Celgene saw some unexpected stock activity Friday morning after the company announced results from a late-stage study of its cancer drug Revlimid.

Celgene's (CELG) stock jumped more than 10% to linger near $56 in midday trading.

Friday morning the National Cancer Institute announced the results of a phase 3 study that showed patients on Revlimid had a 58% reduction in disease progression compared to a placebo.

Revlimid was being studied in patients with multiple myeloma, a blood cancer, who had received a stem cell transplant. The stem cells had been removed from the bone marrow of the patient prior to chemotherapy and then implanted again after treatment. The cells are expected to produce healthy new blood cells. The stem cell procedure occurs simultaneously with high doses of chemotherapy, usually GlaxoSmithKline's (GSK) Alkeran.

"[W]e do not believe this was expected and we would anticipate a positive impact on the stock," said Leerink Swann analyst Howard Liang in a note to investors. "This trial adds support to the maintenance concept in multiple myeloma and could lead to market expansion."

(See also, Biotechs to Watch in the Blood Business)

The study included 568 patients who had received no more than a year of prior therapy and didn't have any other transplants. "Although no survival data are available, it would appear that this magnitude of improvement would likely translate into survival benefit," added Liang. He speculates that the market for the drug could open up significantly if Revlimid is adopted for this use, adding that the current duration of treatment is under a year and could increase to as much as five years.

"This study answers the important question for multiple myeloma patients regarding maintenance Revlimid therapy starting at 100 days following transplant," said Philip L. McCarthy, Jr., M.D., associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study. "We now know that prolonged maintenance therapy with Revlimid when compared to placebo will delay disease progression."

Celgene said that more of the data from the study would be released by the NCI in 2010.

Revlimid is already approved by the US Food and Drug Administration for a combination treatment of multiple myeloma, a disease that currently affects 46,000 Americans. According to the NCI, 20,580 people will be diagnosed with multiple myeloma in the United States in 2009.

Onyx Pharmaceuticals (ONXX) recently announced underwhelming data from an early-stage study that showed its drug carfilzomib offered a few extra months to patients with relapsed multiple myeloma over Takeda's Velcade. Meanwhile, Bristol-Myers Squibb (BMY) and its partner Facet Biotech (FACT) are also developing a treatment for relapsed multiple myeloma that is in early- to-mid stage development.
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