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Pharmacyclics Up on Label Expansion Efforts for Imbruvica

Pharmacyclics Inc. (PCYC) was up 2.3% immediately on news that the company has submitted a supplemental New Drug Application (sNDA) to the FDA for Imbruvica. Pharmacyclics is looking to get Imbruvica approved for the treatment of patients suffering from Waldenstrom's macroglobulinemia (WM). Overall, shares are up 3.9% since the announcement.

Pharmacyclics filed the sNDA based on phase II study results. We note that the FDA had granted Breakthrough Therapy designation to Imbruvica for this indication in Feb 2013.

According to information provided in the press release issued by Pharmacyclics, nearly 1,000 to 1,500 new cases of WM are reported each year with 12,000 people in the U.S. suffering from the disease. Once approved, the new treatment will provide significant benefit to the eligible patient population considering the lack of standard-of-care or approved therapies.

Imbruvica is currently approved for three indications including the treatment of patients with mantle cell lymphoma (:MCL) or chronic lymphocytic leukemia (CLL.TO) who have received at least one previous therapy and for CLL patients (treatment naïve as well as experienced) with a deletion of the short arm of chromosome 17 (del17p).

We note that Imbruvica is Pharmacyclics’ sole marketed product. The company has an agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, for Imbruvica. Imbruvica net sales were $165.7 million in the first half of 2014. Imbruvica’s label expansion should boost sales further.

We are encouraged by Pharmacyclics efforts to expand Imbruvica’s label further. Late last week, Pharmacyclics entered into an agreement with Roche (RHHBY) for evaluating the safety, tolerability and preliminary efficacy of Imbruvica, in combination with Roche’s Gazyva. The companies will evaluate Imbruvica and Gazyva in patients suffering from non-Hodgkin lymphoma (:NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Under the deal, a phase III study will be conducted initially by Pharmacyclics in CLL/SLL patients. The companies intend to evaluate the combination in NHL patients later.

We expect investor focus to remain on Imbruvica sales ramp up and the company’s label expansion efforts.

Pharmacyclics currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Lannett Company, Inc. (LCI) carrying a Zacks Rank #1 (Strong Buy).

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