Pharmacyclics, Inc.PCYC announced the initiation of a phase Ib/II study to evaluate the safety, tolerability and effectiveness of Imbruvica in combination with AstraZeneca's AZN MEDI4736 in patients suffering from relapsed or refractory non-small cell lung cancer, breast cancer and pancreatic cancer.
The multi-center PCYC-1135-CA study is expected to enroll approximately 160 patients. We note that Pharmacyclics has an agreement with Janssen Biotech, a Johnson & Johnson JNJ company, for Imbruvica. While Johnson & Johnson markets Imbruvica in ex-U.S. territories, the two companies jointly commercialize Imbruvica in the U.S.
Imbruvica is Pharmacyclics' sole marketed product. The product gained FDA approval in January this year for all lines of therapy for the treatment of patients suffering from Waldenstrom's macroglobulinemia (WM). This made Imbruvica the first and only FDA approved treatment for this indication.
Imbruvica is also approved for three other indications, including treatment of patients with mantle cell lymphoma (MCL) and CLL who have received at least one previous therapy and for CLL patients with a deletion of the short arm of chromosome 17.
Meanwhile, Pharmacyclics is working on expanding Imbruvica's label further and is evaluating the drug for indications like diffuse large B-cell lymphoma among others.
In the fourth quarter of 2014, Imbruvica's net product revenues in the U.S. rose 31% sequentially to $185 million. For 2015, the company expects Imbruvica U.S. net product revenues to be approximately $1 billion, representing a year-over-year jump of 103%. The increase is expected to be driven by higher market penetration of the four approved indications.
Earlier this year, AbbVie ABBV entered into an agreement to acquire Pharmacyclics in a deal valued at approximately $21 billion. The deal is expected to close in mid-2015.
Pharmacyclics has a Zacks Rank #3 (Hold). A better-ranked stock in the health care space is Theravance, Inc. THRX carrying a Zacks Rank #2 (Buy).