Johnson & Johnson
) received encouraging news with Imbruvica's label being expanded
in the U.S. as a monotherapy for patients suffering from chronic
lymphocytic leukemia (CLL) with a history of receiving at least
one prior therapy. Pharmacyclics' shares were up more than 3% on
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The label expansion in the CLL indication has triggered a $60
million milestone payment to Pharmacyclics from Johnson &
This is the second approval for Pharmacyclics' lead and only
product, Imbruvica. The drug was earlier approved by the U.S.
Food and Drug Administration (FDA) in Nov 2013 as a monotherapy
for treating patients suffering from mantle cell lymphoma (MCL).
The drug has been approved to treat MCL patients who have been
treated at least once for the disease. We note that both the
indications for Imbruvica are based on overall response rates,
while improvements in survival or disease-related symptoms have
not been established.
We are encouraged by Pharmacyclics' progress with Imbruvica.
Imbruvica is currently under review in the EU for CLL and MCL.
Meanwhile, companies like
) also have a presence in the CLL market.
Pharmacyclics is also developing Imbruvica for the treatment of
multiple myeloma (phase II) and diffuse large B-cell lymphoma
(phase II), follicular lymphoma (phase II) and Waldenstrom's
macroglobulinemia (phase II).
Pharmacyclics, a biopharma company, currently carries a Zacks
Rank #2 (Buy). A better-ranked stock in the same sector is
Alexion Pharmaceuticals, Inc.
). Alexion holds a Zacks Rank #1 (Strong Buy).