FDA OKs Celgene's blood cancer drug

Pomalyst for multiple myeloma is a potentially big and important new treatment for the company.

By Minyanville.com Feb 11, 2013 11:10AM
Insurance Money Comstock Images JupiterimagesCelgene (CELG) won U.S. approval to sell Pomalyst, a multiple myeloma drug that analysts and company executives say will be a blockbuster product for the big biotech company.

The drug, which was heavily expected to be approved, is an important one for Celgene, which already sells Revlimid as a secondary treatment for multiple myeloma. Pomalyst is approved for patients who failed at least two other drugs, including Revlimid and Takeda Pharmaceutical's Velcade.

"Treatment for multiple myeloma is tailored to meet individual patient's needs, and today's approval provides an additional treatment option for patients who have not responded to other drugs," the Food and Drug Administration's Richard Pazdur said in a statement. Pazdur heads the agency's office of Hematology and Oncology Products.

Chief Executive Robert Hugin told investors in January that approval of Pomalyst would be a big boost for a company that relies heavily on Revlimid for revenue. Another approved multiple myeloma drug would "extend leadership" in that therapy category, Hugin said. (See on Minyanville: Celgene Rises After CEO Hugin Touts New Drugs, Sales Growth.)

Investors hoping for new products and broader uses of existing drugs bid up Celgene's stock 40% in the past 12 months. The shares rose another 2% to $102.29 in premarket trading Monday. Celgene is one of the biggest U.S. biotech companies with a market cap that exceeds $42 billion.

Multiple myeloma is a form of blood cancer that kills almost 11,000 Americans a year, according to U.S. figures. Almost 22,000 people are diagnosed with the disease each year.

Pomalyst is the second drug to be approved for multiple myeloma in the past year. The FDA approved Onyx Pharmaceuticals' (ONXX) Kyprolis last July. Both drugs were approved through an accelerated FDA process. Other companies, including Array BioPharma (ARRY), are developing their own multiple myeloma treatments.

Pomalyst will carry a warning that it should not be used by pregnant women because of the risk of severe life-threatening birth defects. Like Revlimid, Pomalyst (also known as pomalidomide) is a derivative of thalidomide, the notorious drug sold outside the U.S. in the 1950s and early '60s to treat morning sickness.

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