An Ode To Pharmacyclics...

(RTTNews) - Though biotech stocks can be highly speculative bets, some have proved to be worth the gamble like Pharmacyclics Inc. (PCYC). We first alerted our readers to PCYC back in February 2010 when it was trading around $4. The second time we alerted this stock in July 2011, it was trading around $11, and since then it has had a terrific run. PCYC, which touched an all-time high of $154.89 on Feb.3, 2014, trades around $91 as of this writing.

Granted, the company's share price has now fallen more than 40 percent from its all-time high, but the story about its approved cancer drug Imbruvica just keeps getting better.

Imbruvica, formerly known as Ibrutinib or PCI-32765, received FDA approval for mantle cell lymphoma in November 2013 and for chronic lymphocytic leukemia as recently as February of this year. Both indications were approved under the FDA's accelerated approval program.

The drug is being jointly developed and commercialized by Pharmacyclics and Johnson & Johnson's subsidiary Janssen Biotech Inc.

According to the recently released results from a phase 1b/2 study of Imbruvica in combination with GlaxoSmithKline Plc's (GSK) blood cancer drug Arzerra (ofatumumab) in heavily pretreated patients with chronic lymphoma leukemia and related diseases, compelling results have been demonstrated - with the patients on the study achieving 100% response rates lasting over long durations, according to Samantha Jaglowski, an investigator on the clinical study.

In a phase III trial, dubbed RESONATE, which made a head-to-head comparison of Imbruvica with GlaxoSmithKline Plc's Arzerra (ofatumumab) in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma, Imbruvica significantly improved progression free survival, overall survival and overall response compared to Arzerra.

Commenting on the encouraging data, Bob Duggan, CEO and Chairman of the Board of Pharmacyclics said, "We are at the beginning of a transformational shift which will provide patients a new alternative to chemotherapy".

Pharmacyclics filed the RESONATE study data with the FDA in April 2014 and expects a review by the agency to be completed within the first half of 2015.

Some analysts estimate peak sales of Imbruvica to range between $4 billion and 6.5 billion, as new indications keep adding to the drug's label.

Pharmacyclics gets a 50% share of revenue associated with Imbruvica sales while Johnson & Johnson is entitled to the remaining 50%.

To date, 11 phase III trials have been initiated with Imbruvica, according to the company. Stay tuned for the clinical trials updates and news.

Related reading:

A Second Look At Pharmacyclics (http://www.rttnews.com/story.aspx?Id=1201206)

Revisiting Pharmacyclics (http://www.rttnews.com/1662554/revisiting-pharmacyclics.aspx)