Pharmacyclics, Inc. (PCYC) and Johnson & Johnson (JNJ) 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 the news.
The label expansion in the CLL indication has triggered a $60 million milestone payment to Pharmacyclics from Johnson & 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 Roche (RHHBY) 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. (ALXN). Alexion holds a Zacks Rank #1 (Strong Buy).