(NASDAQ:CELG) won US 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 says 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 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 pre-market trading Monday morning. Celgene is one of the biggest US 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 US 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’
(NASDAQ:ONXX) Kyprolis last July. Both drugs were approved through an accelerated FDA process. Other companies, including Array BioPharma
(NASDAQ: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 US in the 1950s and early ‘60s to treat morning sickness.
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.
Copyright 2011 Minyanville Media, Inc. All Rights Reserved.