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Treatment for Lung Cancer Brain Metastases

Pharmacyclics to Submit New Drug Application for Xcytrin for Treatment of Lung Cancer Patients With Brain Metastases

New Analyses and Additional Data from Phase 3 SMART Trial to be Presented at ASCO 2006

SUNNYVALE, Calif., May 9, 2006 -- Pharmacyclics, Inc. today announced that the company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to market Xcytrin (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., lung cancer that has spread to the brain from another part of the body).

The company also announced that new analyses and additional data from its Phase 3 SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial will be presented at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. Details on the oral presentation are as follows:

Abstract #7014: "Motexafin gadolinium (MGd) combined with prompt whole brain radiation therapy (RT) prolongs time to neurologic progression in non-small cell lung cancer (NSCLC) patients with brain metastases: Results of a Phase 3 trial," Minesh P. Mehta, M.D., Dept. of Human Oncology, University of Wisconsin, Madison, Saturday, June 3, 2006, 5:30 - 5:45 p.m.

The presentation will be followed by a discussion by Laurie E. Gaspar, M.D., Professor and Chair of Radiation Oncology at the University of Colorado.

The SMART trial was conducted at 94 centers in North America, Europe and Australia and enrolled 554 patients with brain metastases from NSCLC. This randomized, controlled Phase 3 trial compared the safety and efficacy of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin. The primary endpoint of the study was time to neurologic progression as determined by a blinded events review committee.

"We plan to file an NDA for Xcytrin primarily based on the data from our pivotal SMART trial," said Richard A. Miller, M.D., president and CEO of Pharmacyclics. "New data from the SMART trial, which will be included in the NDA filing, will be presented and discussed at ASCO. We anticipate filing the Xcytrin NDA by the end of 2006."

About Xcytrin

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity to be used in a broad range of cancers. Xcytrin has been granted Fast Track designation by the FDA for use in the treatment of lung cancer brain metastases. This designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.

Source: Pharmacyclics, Inc.

Posted: May 2006

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