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Awaiting The Last Word On Exelixis' EXAM

Awaiting The Last Word On Exelixis' EXAM
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Exelixis Inc. (EXEL: Quote) is just days away from knowing whether its lead compound, Cabozantinib, would pass regulatory muster in the indication of metastatic medullary thyroid cancer.

Formerly known as XL184, Cabozantinib, wholly-owned by Exelixis, is said to work by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor.

The New Drug Application for Cabozantinib was submitted based on a phase III trial, dubbed EXAM, which demonstrated that the median progression-free survival of medullary thyroid cancer patients treated with Cabozantinib was 11.2 months compared to 4 months on the placebo arm.

The Cabozantinib NDA was submitted under the FDA's Fast Track designation and has a priority review designation with the decision date set for November 29, 2012.

Medullary thyroid cancer, or MTC for short, refers to the cancer of what are called "C-cells", that are located in the thyroid gland.

AstraZeneca plc's (AZN) Vandetanib, approved in 2011, is the only medicine to receive FDA approval specifically for use in patients with advanced medullary thyroid cancer.

The American Cancer Society estimates that there will be about 56,460 new cases of thyroid cancer and 1,780 deaths from thyroid cancer in the United States this year. Medullary thyroid cancer comprises 3% to 4% of all thyroid cancers.

Cabozantinib is also being evaluated as a potential treatment for metastatic castration-resistant prostate cancer, or CRPC, non-small cell lung cancer, multiple myeloma and other tumor types.

The larger market opportunity for Cabozantinib will be in the indication of prostate cancer. According to the American Cancer Society, each year, about 218,000 men in the United States get prostate cancer and about 32,000 patients die of this disease.

A phase III trial, dubbed COMET-2, evaluating Cabozantinib for metastatic castration-resistant prostate cancer with a pain palliation endpoint was initiated in December 2011, while another phase III trial, dubbed COMET-1, with an overall survival endpoint was initiated in May 2012. The study results of the COMET trials are expected in 2014.

According to Exelixis, the dual activity of Cabozantinib in both metastatic soft tissue and bone lesions represents an innovative paradigm for treating a variety of cancers, most notably metastatic prostate cancer.

Apart from Cabozantinib, Exelixis has a number of partnered compounds in various stages of development.

A quick look at the balance sheet...

The company has no marketed drug and derives its revenue from license fees, milestone payments and collaborative agreement reimbursements. Exelixis has incurred significant losses, and as of September 30, 2012, had an accumulated deficit of $1.2 billion.

In the third quarter of 2012, net loss was $32.8 million or $0.20 per share, compared to net income of $77.9 million or $0.60 per share in the year-ago quarter, due to decreases in revenues.

Revenues in Q3, 2012 plunged to $13.3 million from $128.3 million in the comparable period in 2011 as a result of termination of its agreements with Bristol Myers-Squibb Co. and Sanofi related to certain compounds.

The company ended Q3, 2012, with $674.7 million in cash.

Founded in 1994, Exelixis went public on the NASDAQ in April 2000, offering its shares at $13 each.

Exelixis shares have thus far hit a 52-week low of $3.94 and a 52-week high of $6.95. The stock closed Tuesday's trading at 4.91, up 1.82% on a volume of 2.19 million shares.

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by RTT Staff Writer

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