) recently announced that the U.S. Food and Drug Administration
(FDA) will review the company's New Drug Application (NDA) for
its oncology candidate ibrutinib on a priority basis. The news
impacted Pharmacyclics' stock price positively.
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We note that the U.S. regulatory authority generally reviews
those drugs on a priority basis which offer major advances in
treating diseases having no adequate therapy. Applications for
priority review designated drugs are reviewed by the FDA within
eight months of submission as against the usual twelve months.
The company is looking to get ibrutinib approved for two oncology
indications: previously treated mantle cell lymphoma (MCL) and
previously treated chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL). The NDA was submitted to the FDA on
Jun 28, 2013.
The positive move by the FDA triggered a milestone payment of $75
million to Pharmacyclics from partner Janssen Biotech, a
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.
Successful development and commercialization of ibrutinib would
bring in substantial revenues to Pharmacyclics. The candidate is
being developed to treat other cancer forms as well.
We remind investors that in Apr 2013, the FDA had granted
breakthrough therapy designation to ibrutinib for treating
CLL/small lymphocytic lymphoma patients with a deletion of
chromosome 17p. Earlier in the year, the U.S. regulatory body
granted breakthrough therapy designation to ibrutinib for
treating mantle cell lymphoma patients as a monotherapy. The FDA
granted a similar status to the candidate for treating patients
suffering from Waldenström's macroglobulinemia also as a
monotherapy. We expect investor focus to remain on the
development of ibrutinib.
Pharmacyclics, a biopharmaceutical company, carries a Zacks Rank
#2 (Buy). However, biopharma stocks that appear to be more
Gilead Sciences Inc.
). Both the stocks carry a Zacks Rank #1 (Strong Buy).