Pharmacyclics, Inc. (PCYC) announced that it has launched a large, observational, prospective registry, informCLL, which aims to explore the natural history of chronic lymphocytic leukemia (CLL), examine how currently approved targeted therapies including Imbruvica are being used to treat patients with CLL and provide a comparison to treatments using conventional chemoimmunotherapy. Enrollment in the registry is expected to start in the first half of 2015.
Imbruvica is being co-developed and commercialized in the U.S. by Pharmacyclics and Johnson & Johnson (JNJ), while the latter will market Imbruvica in Europe, Middle East, and Africa (EMEA) and in the rest of the world (ex-U.S. territories).
Earlier this month, Pharmacyclics announced that the European Medicines Agency has accepted a type II variation application for Imbruvica for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM) (read more: Pharmacyclics, J&J Seek Imbruvica Label Expansion in EU).
Submission of regulatory application for the WM indication in Europe followed closely on the heels of a supplemental new drug application for Imbruvica for WM to the FDA in Oct 2014.
Imbruvica is currently approved in Europe for the treatment of adults suffering from relapsed or refractory mantle cell lymphoma (MCL), and adults with CLL who have received at least one prior therapy, or in first line in the presence of 17p deletion (del17p CLL) or TP53 mutation in patients with CLL who are unsuitable for chemo-immunotherapy. The product is approved in the U.S. for the treatment of patients with MCL who have received at least one prior therapy and for the treatment of CLL in patients who have received at least one prior therapy.
We note that Imbruvica is Pharmacyclics’ sole marketed product. We expect investor focus to remain on Imbruvica sales ramp up and the company’s label expansion efforts.
Pharmacyclics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Biogen Idec Inc. (BIIB) and Amgen Inc. (AMGN). Both stocks carry a Zacks Rank #1 (Strong Buy).
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