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Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
Date:12/21/2007

SUNNYVALE, Calif., Dec. 21 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for the company's new drug application (NDA) for Xcytrin(R) (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases. The NDA for use of Xcytrin in combination with whole brain radiation therapy (WBRT) was filed with the FDA in April 2007.

According to the National Cancer Institute, over 200,000 patients will be diagnosed with lung cancer this year in the U.S. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50% of lung cancer patients.

Pharmacyclics recently completed patient enrollment in three Phase 2 trials evaluating Xcytrin in patients with advanced relapsed NSCLC. These multi-center trials will evaluate Xcytrin as a single agent, in combination with Taxotere(R) (docetaxel), and in combination with Alimta(R) (pemetrexed). Data from these trials is expected in the first half of 2008.

"We are disappointed that brain metastases patients with limited options and serious neurologic problems will not have access to Xcytrin, which we believe has shown important clinical activity in this indication," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. "We continue to believe that Xcytrin is a novel active cancer drug and we will seek a corporate partner to help support future development. In the meantime, we are also advancing our expanding and versatile pipeline of product candidates."

Xcytrin's novel mechanism enables it to selectively concentrate in tumors and induce apoptos
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SOURCE Pharmacyclics, Inc.
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