Pharmacyclics reports Q1 cash at $34.7 million, on track for Xcytrin filing

By Jennifer Lanning Drey

Portland, Ore., Oct. 26 - Pharmacyclics, Inc. reported cash, cash equivalents and marketable securities of $34.7 million at Sept. 30, compared to $40.5 million at June 30, according to a company news release.

The company's GAAP net loss for the first quarter 2007 was $6.5 million, or $0.31 per share, compared to a net loss of $10.2 million, or $0.51 per share, in the first quarter of 2006.

Pharmacyclics remains on track to file a New Drug Application for Xcytrin (motexafin gadolinium) in combination with radiation therapy for treatment of brain metastases from non-small cell lung cancer by the end of the year, Richard A. Miller, Pharmacyclics' president and chief executive officer, said Thursday during a company conference call.

The company's pivotal phase 3 Smart trial showed a strong trend in favor of brain metastases patients treated with Xcytrin plus whole brain radiation compared to those treated with whole brain radiation alone, he said.

Pharmacyclics is also developing Xcytrin for indications beyond brain metastases and has a series of phase 1 and phase 2 clinical trials under way evaluating the drug in solid tumors and hematologic malignancies, he said.

"Based on the activity observed in the Smart trial, a major objective of our ongoing clinical development strategy is to establish Xcytrin as a systemic treatment for patients with lung cancer that have failed prior chemotherapy regiments," Miller said.

Pharmacyclics plans to start a pivotal randomized phase 3 trial with Xcytrin in combination with Taxotere for second-line lung cancer treatment in the first half of 2007, he said.

The company is also moving forward with development of the multiple products it acquired from Celera Genomics, including an HDAC inhibitor, which has demonstrated oral bioavailability and sustained pharmacologic effects following oral administration in a phase 1 study.

Pharmacyclics has retained the worldwide rights to all of its products in development and plans to continue to retain the U.S. rights to its oncology products. The company will look to establish corporate partnerships for territories outside of the United States, Miller said.

Pharmacyclics, located in Sunnyvale, Calif., develops products to treat cancer and other serious diseases.

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