Shares of Pharmacyclics, Inc. soared to a 52-week high of $102.05 on Jul 10, 2013 buoyed by its submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for oncology candidate, ibrutinib.
Approval has been sought for a couple of oncology indications- mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Pharmacyclics has requested the FDA to review the NDA on a priority basis. The NDA was submitted on the basis of encouraging data from phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL.
The NDA submission was preceded by a couple of positive developments regarding ibrutinib. In Apr 2013, the FDA granted breakthrough therapy designation to ibrutinib as a monotherapy for treating CLL/SLL in patients with deletion of the short arm of chromosome 17. Earlier in the year, the US regulatory body granted breakthrough therapy designation to ibrutinib also as a monotherapy for treating MCL patients.
The designation, which was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act, is granted to potential new treatments for serious or life-threatening diseases or conditions where the initial clinical data shows that the treatment has the potential to demonstrate substantial improvement on one or more clinically significant endpoints compared to existing treatments. The designation should help fasten the development and review process for the candidate. Ibrutinib is being developed for other indications also.
Pharmacyclics is co-developing ibrutinib with Janssen Biotech, Inc., a Johnson & Johnson (JNJ - Free Report) company. We are positive on the company’s collaboration with Janssen for ibrutinib. Janssen is a suitable partner for Pharmacyclics. Janssen’s strong global presence bodes well for the commercialization of ibrutinib, once it is approved.
Pharmacyclics currently carries a Zacks Rank #5 (Strong Sell). Companies such as Biogen Idec Inc. (BIIB - Free Report) and Jazz Pharmaceuticals Public Limited Company (JAZZ - Free Report) appear to be more attractive. Both stocks carry a Zacks Rank #1 (Strong Buy).