Pharmacyclics, Inc. PCYC announced positive long-term follow-up data on Imbruvica in treatment-naive and relapsed/refractory patients suffering from chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The results are analysis of outcomes from the phase I/IIb study (PCYC-1102) and the ongoing extension study (PCYC-1103). Results revealed that patients receiving Imbruvica (420 mg) experienced a 91% overall response rate while 14% of the patients achieved a complete response. Data also revealed early and sustained improvement in hemoglobin and platelet counts.
The results were presented at the annual meeting of American Association of Cancer Research (AACR).
In a separate press release, the company announced that Imbruvica was effective in the treatment of pancreatic ductal adenocarcinoma as far as results from a transgenic mouse model and an in-vivo model of patient-derived xenograft mice (grafts of tissue taken from a pancreatic cancer patient and grafted into a mouse) are concerned. These results were also presented at the AACR annual meeting.
We note that Pharmacyclics has an agreement with Johnson & Johnson JNJ 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. 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 suffering from 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.
In 2014, Pharmacyclics recorded U.S. Imbruvica net product revenues of $492 million. For 2015, the company expects Imbruvica U.S. net product revenues to be approximately $1 billion. The increase is expected to be driven by higher market penetration of the four approved indications.
The drug is also being developed for other indications like diffuse large B-cell lymphoma.
Pharmacyclics is getting acquired by AbbVie ABBV as per an agreement entered in March this year. The deal, valued at approximately $21 billion, is expected to close in mid-2015. We expect investor focus to stay on this news.
Pharmacyclics has a Zacks Rank #3 (Hold). A better-ranked stock in the health care space is Biogen Inc. BIIB carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment