Pharmacyclics/Johnson & Johnson Drug Backed for EU Approval


The EU approval of Pharmacyclics (PCYC) and partner Johnson & Johnson’s (JNJ) oncology drug Imbruvica (ibrutinib) appears well on track with the European Medicines Agency's (EMA.TO) Committee for Medicinal Products for Human Use (CHMP) recommending the same. The favorable opinion of the CHMP will now be reviewed by the European Commission with a final decision expected in the next couple of months.

The CHMP has recommended full approval of the drug for treating adults suffering from mantle cell lymphoma (:MCL). Full approval has also been recommended for treating adults suffering from chronic lymphocytic leukemia (CLL.TO) who have been treated at least once before for the disease. The CHMP is also in favor of the full approval of Imbruvica as a first-line therapy for CLL patients unsuitable for chemo-immunotherapy due to a genetic mutation. The CHMP’s favorable opinion was based on encouraging results from studies on Imbruvica for the MCL and CLL indications.

We note that Imbruvica gained accelerated approval for the MCL indication in the U.S. late last year. Accelerated approval is granted by the FDA to drugs that are meant to treat serious conditions and fulfill an unmet medical need based on a surrogate or an intermediate clinical endpoint.

Accelerated approval for the CLL/ small lymphocytic lymphoma (:SLL) indication in the U.S. was gained in Feb 2014. Full approval for the CLL/SLL indication has been sought from the FDA (target date: Oct 7, 2014). We note that the CLL market already has drugs like Gazyva and Rituxan. The FDA approval of Gilead Sciences’ (GILD) Zydelig (idelalisib) has intensified competition in the CLL space.

Johnson & Johnson carries a Zacks Rank #3 (Hold) while Pharmacyclics is a Zacks Ranked #2 (Buy) stock. A better ranked stock in the health care space is Salix Pharmaceuticals (SLXP) with a Zacks Rank # 1 (Strong Buy).

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