NEW YORK (AP) - Pharmacyclics Inc. said it expects to file for marketing approval of its cancer drug ibrutinib this year. If approved, it would be Pharmacyclics first drug for sale.
Pharmacyclics recently announced that the Food and Drug Administration has deemed ibrutinib a breakthrough therapy as a treatment for mantle cell lymphoma. The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases from what's currently on the market.
Through a partnership with Johnson & Johnson, Pharmacyclics is studying ibrutinib as a treatment for several types of lymphoma and leukemia, including mantle cell lymphoma, chronic lymphocytic leukemia, and diffuse large B-cell lymphoma.
Stifel Nicolaus analyst Joel Sendek said the company is filing for approval sooner than he expected, and said he now thinks ibrutinib will reach the market in late 2014 as a treatment for mantle cell lymphoma and chronic lymphocytic leukemia. He said sales could reach $158 million in 2015.
Pharmacyclics also reported its quarterly results. Over the three months ended Dec. 31, the Sunnyvale, Calif., company said it earned $41.9 million, or 56 cents per share, down from $56.3 million, or 78 cents per share. Excluding one-time items, adjusted earnings totaled 62 cents per share, compared with 82 cents per share in the prior-year period.
Revenue fell to $58 million from $77.9 million as the amount of money that it received for licensing and reaching drug development milestones declined. Most of Pharmacyclics' revenue comes from license payments from its drug development partners. In the latest quarter, that included a $50 million payment from Johnson & Johnson and $5 million from Novo Nordisk AS. Operating costs linked to research and development expenses also increased, shrinking profit margins.
The company is switching from a fiscal year ending in June to one ending in December. Over the last six months Pharmacyclics said its net income nearly tripled to $117.5 million, or $1.58 per share. Revenue more than doubled to $160.7 million from $77.9 million.
Date: February 15, 2013
Source: Associated Press