Friday February 22, 2013
by John McCamant, editor The Medical Technology Stock LetterPomalyst, developed by
Celgene (
CELG), was approved by the FDA for the treatment of multiple myeloma (MM) patients who have failed two prior therapies.
Celgene already has a dominant position in MM with Revlimid., but "Pom" provides another major growth driver in a potentially large market.
CELG has priced Pom at $10,500 per month, which is a tad higher than Onyx’ recently approved MM drug Kyprolis which costs $9,900 per month. Krypolis launch has been impressive and strong sales for Pom are likely as well.
A sizable population exists in refractory MM, Pom offers an oral option (vs. Krypolis) and Celgene has a dominant franchise in multiple myeloma with Revlimid. Pom is also being tested in various combinations, to enhance existing response rates, in a variety of patients.
While the Pom approval was on time and widely expected -- given the strong combination data and the fact that Krypolis was also approved on Phase II results -- it is another example of an accommodating FDA that has been getting important new drugs to patients faster.
A favorable FDA environment is a positive fundamental for biotech stocks as it removes some regulatory risk. Pom’s timely FDA approval is a win for refractory MM patients who have run out of treatment choices and CELG’s burgeoning new product line-up. CELG is a buy under $95 with a target of $115.
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