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Pharmacyclics Gets $75 Million as Fda Accepts Cancer Drug Filing

Awardee Story Pharmacyclics Gets $75 Million as Fda Accepts Cancer Drug Filing
Date: Aug 29, 2013
Author: Ron Leuty
Source: bizjournal ( click here to go to the source)

Aug 29, 2013, 11:58am PDT Updated: Aug 29, 2013, 12:41pm PDT
Ron Leuty

As an experimental cancer drug pushes toward approval, Pharmacyclics Inc. said Thursday that it will snag a $75 million payout from its partner.

The Sunnyvale drug-development company (NASDAQ: PCYC) will receive the milestone payment from Janssen Biotech Inc. a unit of Johnson & Johnson (NYSE:JNJ) after the Food and Drug Administration accepted Pharmacyclics' application to review the cancer drug ibrutinib.

The initial application is for ibrutinib's use in previously treated mantle cell lymphoma and previously treated chronic lymphocytic leukemia.

Pharmacyclics won Breakthrough Therapy Designation from the FDA for both of those indications, which could shave months off the approval process.

Janssen licensed ibrutinib from Pharmacyclics in December 2011. The companies are collaborating in developing and, eventually, selling the drug.

If ultimately approved by the FDA, ibrutinib would have peak sales of about $6 billion, Goldman Sachs said, according to FierceBiotech.

"We are very excited to have received the official FDA acceptance of our first NDA filing for ibrutinib," Pharmacyclics' head of regulatory affairs, Dr. Urte Gayko, said in a press release. "We look forward to continuing to work with the FDA as they complete their review of the ibrutinib application, which includes the new Breakthrough Therapy Designation process."

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