Pharmacyclics, Inc. PCYC announced that an Independent Data Monitoring Committee after reviewing the phase III HELIOS study has unanimously recommended that the study be unblinded based on clinically meaningful and statistically significant treatment benefit in patients receiving Imbruvica.
The international, randomized, double-blind and placebo-controlled HELIOS trial is comparing Imbruvica in combination with bendamustine and Rituxan (rituximab) versus placebo in combination with bendamustine and Rituxan in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study has met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS).
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. We are encouraged by the label expansion of Imbruvica.
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.
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.
Earlier this month, 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 (read more: Pharmacyclics Set to Be Acquired by AbbVie for $21B).
Pharmacyclics holds a Zacks Rank #3 (Hold). A better-ranked stock in the health care space is Theravance, Inc. THRX carrying a Zacks Rank #2 (Buy).
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