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Like a freight train barrelling down a mountainside, biotech Celgene (NASDAQ: CELG ) continues to build momentum. The company today announced positive results from a phase 3 study of pomalidomide with low doses of dexamethasone taken by patients with refractory multiple myeloma.
This follows a string of good news for Celgene in recent months. In November, the company announced positive results from a phase 3 study of oral apremilast in treating psoriatic arthritis. Celgene also released phase 3 results that same month showing that Abraxane improved overall survival rates for patients with advanced pancreatic cancer. Just a month earlier, the Food and Drug Administration approved Abraxane for first-line treatment of non-small-cell lung cancer.
What it means
Today's news was no surprise, since Celgene first announced that pomalidomide met its primary endpoint of improvement in progression-free survival back on Oct. 23. However, the details of the phase 3 study results provided today were impressive.
In the clinical study, 455 multiple myeloma patients who had not responded to previous treatments with Takeda's Velcade or Celgene's Revlimid were separated into two arms. Patients in one arm of the study were given pomalidomide with low-dose dexamethasone, while patients in the other group were given high-dose dexamethasone.
Patients taking the pomalidomide regimen had progression-free survival rates of 3.6 months compared with 1.8 months in the other group. The results were encouraging enough that the independent committee overseeing the study recommended that patients who had not yet progressed in the group taking high-dose dexamethasone should switch over to take pomalidomide.
The phase 3 study results appear to bode well for Celgene's chances as it moves forward in seeking regulatory approval for pomalidomide. The company submitted a Marketing Authorization Application to the European Medicines Agency in May and expects a decision in the second half of 2013. The FDA is scheduled to make a decision on the New Drug Application for pomalidomide on Feb. 10.
If Celgene is successful in gaining regulatory approval, its primary competitors include Takeda, which claims 60% market share for Velcade in first-line treatment of multiple myeloma and 50% share for second-line treatment. Celgene would also battle for market share against Onyx Pharmaceuticals (UNKNOWN: ONXX.DL ) . Earlier this year, the FDA approved Onyx's Kyprolis in treating multiple myeloma.
Other companies are also working on new drugs for the blood cancer. Bristol-Myers Squibb (NYSE: BMY ) and Abbott (NYSE: ABT ) are collaborating on the development of elotuzumab, for which two phase 3 studies are under way.
Even with challenges from these rivals, the potential for a tag team of Revlimid and pomalidomide in the multiple myeloma market looks promising for Celgene. With encouraging prospects for Abraxane and apremilast also, I look for Celgene's momentum to continue full steam ahead.
With Celgene's broad portfolio of drugs and a strong pipeline to boot, many investors see it as a smarter way to play the biotech investing game. While Celgene might be a safer stock than its small biotech brethren, investors need to know about the key opportunities and risks facing the company. We run through them all in The Motley Fool's brand new premium report on Celgene. To claim your copy today, simply click here now.