Following the U.S. approval of its oncology Imbruvica (ibrutinib), Pharmacyclics Inc. (PCYC) inked a supply deal with China based WuXi PharmaTech (Cayman) Inc. (WX). Apart from China, WuXi Pharma also operates in the U.S.
The U.S. regulatory body cleared Imbruvica as a monotherapy for treating patients suffering from mantle cell lymphoma (MCL). The patients were treated at least once previously for the disease. Pharmacyclics has co-developed the drug with Janssen Biotech, a Johnson & Johnson (JNJ) company.
The FDA cleared the drug, after reviewing its new drug application, submitted in Jun 2013, on a priority basis. Pharmacyclics stated in its press release that Imbruvica is one of the first drugs to gain approval from the U.S. regulatory body via the breakthrough therapy designation route. Pharmacyclics is also seeking U.S. approval of the drug for previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
The FDA had granted breakthrough therapy designation to the drug for a few indications earlier in the year. Imbruvica will compete with drugs like Celgene Corporation’s (CELG) Revlimid in the MCL market.
Successful commercialization of Imbruvica in the MCL indication would bring in substantial revenues to Pharmacyclics. The drug is being developed to treat other cancer forms as well.
We are positive on Pharmacyclics’ deal with WuXi Pharma given the expertise of the Chinese contract research firm in the relevant field. Moreover, Pharmacyclics stated in its press release that the FDA issued no form 483 observations after inspecting WuXi Pharma’s manufacturing facilities in August this year.
Pharmacyclics carries a Zacks Rank #2 (Buy). However, its partner WuXi Pharma appears to be more attractive with a Zacks Rank #1(Strong Buy).
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