Celgene Corp. (CELG:US), the world’s fourth- largest biotechnology company, said its experimental medicine for multiple myeloma helped fight the cancer after other therapies failed.
Patients taking Celgene’s pomalidomide plus a low dose of the steroid dexamethasone lived a median 3.6 months without their disease worsening, compared with 1.8 months for patients taking a high dose of the steroid alone, according to data presented at the American Society of Hematology meeting in Atlanta today. Pomalidomide also helped with overall survival.
The U.S. Food and Drug Administration is set to make a decision on approval of pomalidomide by Feb. 10. European regulators are expected to decide in the second half of 2013, Summit, New Jersey-based Celgene said in a statement today. Pomalidomide, given orally, may draw more than $1 billion in annual revenue by 2017, according to the average of four analysts’ estimates compiled by Bloomberg.
“Coming out of the presentations, we believe pom has a high likelihood of approval and will have an important role in refractory multiple myeloma,” Brian Abrahams, an analyst with Wells Fargo Securities, wrote in a research note today from the hematology meeting. The data “continue to support pom’s strong profile.”
Celgene rose 2 percent to $82.08 at the close of New York trading. The shares have gained (CELG:US) 21 percent this year.
The 455-person study, from the third and final phase of clinical trials generally required for approval, consisted of participants who had already taken Celgene’s Revlimid or Takeda Pharmaceutical Co. (4502)’s Velcade. The prognosis in multiple myeloma patients for whom those therapies have stopped working is poor, with a median survival time of nine months, research has shown.
Multiple myeloma is a cancer of the white blood cells that will be diagnosed in an estimated 21,700 Americans this year, according to the National Cancer Institute. About 10,710 people will die from the disease in 2012, the institute estimates.
A pomalidomide approval would follow the July clearance of Onyx Pharmaceuticals Inc. (ONXX:US)’s Kyprolis, a drug given by injection, for use in multiple myeloma patients who had tried other therapies including Velcade.
Revlimid is Celgene’s top-selling drug, bringing in $3.2 billion in revenue last year. Celgene trails Amgen Inc. (AMGN:US), Gilead Sciences Inc. (GILD:US) and Biogen Idec Inc. (BIIB:US), the top three biotechnology companies in the world, in revenue and market value.
Takeda’s Velcade is the market leader in multiple myeloma, with more than 60 percent share in first-line use and more than 50 percent share as a second-line therapy, according to a presentation the Osaka, Japan-based company’s Millennium business unit made yesterday at the hematology meeting. Celgene said its Revlimid is the market leader, with a more than 50 percent share in front-line use.
Takeda also presented data on its experimental therapy for multiple myeloma, MLN9708, at the meeting. The drug, a once- weekly pill, met the goals of a mid-stage study evaluating its use in combination with Revlimid and dexamethasone in patients who haven’t tried other therapies. Such a regimen may provide patients the option of avoiding needles; Velcade is given through an injection under the skin or intravenously.
Celgene’s pomalidomide was associated with a risk of neutropenia, or a low white blood cell count. Some patients on Takeda’s MLN9708 regimen had peripheral neuropathy, or nerve problems leading to numbness or pain in the hands or feet.
Based on the pomalidomide overall survival data, the study’s monitoring committee recommended that patients in the other arm of the trial who hadn’t seen their disease worsen be switched to the Celgene drug group.
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