) 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
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,
Johnson & Johnson
) 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.
Jazz Pharmaceuticals Public Limited Company
) appear to be more attractive. Both stocks carry a Zacks Rank #1
BIOGEN IDEC INC (BIIB): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
PHARMACYCLICS (PCYC): Free Stock Analysis
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