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In November 2012 the FDA approved Cometriq (generic name: cabozantinib) made by Exelixis (NASDAQ:EXEL) to treat medullary thyroid cancer that has spread to other parts of the body.

Exelixis is a small company from South San Francisco and Cometriq is its first approved drug.

Medullary thyroid cancer, or MTC for short, develops in cells in the thyroid gland that make a hormone called calcitonin, which helps maintain a healthy level of calcium in the blood.

This type of cancer may occur spontaneously or in families through genetic mutations.

The thyroid is a hormone-creating gland that regulates blood pressure, body temperature, heart rate and weight.

Patients who were given Cometriq in the "Exam" trial, lived an average of 11.2 months without tumor growth compared with an average of four months in patients receiving placebo.

Results also showed that 27 percent of patients treated with Cometriq had reductions in tumor size lasting an average of 15 months, while patients in the placebo arm of the trial saw no reductions.

Treatment with Cometriq did not extend patients' lives.

Small market

The American Cancer Society estimates that there will be about 56,460 new cases of thyroid cancer and 1,780 deaths from it in the US this year.

Medullary thyroid cancer comprises only about 3% to 4% of all thyroid cancers.

Which makes it a very small market for Cometriq.

The only other drug approved in 2011 for the same illness, is Caprelsa from AstraZeneca (NYSE:AZN). Caprelsa sales for the first nine months of 2012 were only $19 million, according to Stifel Nicolaus analyst Joel Sendek.

Sendek predicts that Exelixis' drug will have $42 million in yearly sales by 2014 from treating the thyroid cancer. The entire market for treating the condition is less than $100 million.

This hardly justifies the many years of work and hundreds of millions of dollars spent to develop the drug. Yet the first approval is important as Exelixis hopes to get approvals for other cancers.

CEO Morrissey said that Exelixis is making only a modest investment to launch the drug for its newly approved use. He referred to the approval as a "transitional" rather than transformative event for the company.

The drug will be priced at just under $10,000 per month.

Other cancers

There are a number of trials in progress for the treatment of metastatic castration-resistant prostate cancer, or CRPC, non-small cell lung cancer, multiple myeloma and other tumor types.

Encouraging results from the Phase 2 trials of CRPC moved the drug into two Phase 3 trials.

Comet-2 is evaluating Cometriq for metastatic castration-resistant prostate cancer with a pain palliation endpoint and it was initiated in December 2011, while Comet-1 aims at an overall survival endpoint and was initiated in May 2012.

The study results of the Comet trials are expected in 2014.

Compared to thyroid cancer, prostate cancer offers a larger market opportunity. According to the National Cancer Institute, each year, about 218,000 men in the United States get prostate cancer and about 32,000 patients die from it.

Cometriq's unique feature is its dual activity by inhibiting two pathways, MET and VEGF. These two pathways are implicated in a number of cancers.

Cometriq has shown activity in 12 different tumor indications so far, including some major ones such as breast melanoma, non-small cell lung, RCC (renal cell carcinoma), HCC ( hepatocellular carcinoma), and prostate.

Since Comeriq is active in both metastatic soft tissue and bone lesions, this duality in action is very useful in a variety of cancers, particularly in metastatic prostate cancer.

Also, Exelixis discovered and moving to the clinic a second compound for the treatment for melanoma.

EXEL collaborated with Roche and Genentech in a small phase 1b trial testing its MEK inhibitor GDC-0973 in combination with Roche's approved Braf inhibitor Zelboraf in patients with metastatic melanoma carrying a BRAFV600 mutation.

All 24 patients had a decrease in tumor size from baseline and additional follow-up will determine the objective response rate.

GDC-0973 is now moving forward into a phase 3 trial.

EXEL has retained a significant economic interest in GDC-0973. Under the terms of the agreement with Genentech, Exel is entitled to an equal share of U.S. profits and losses from the first $200 million of U.S. sales, and the share decreases to 30% over $400 million of US sales. EXEL will get royalties from foreign sales.

In addition to GDC-0973, compounds are advanced with various partners, including the two PI3K inhibitors with Sanofi (NYSE:SNY), foretinib with Glaxo (NYSE:GSK), the hedgehog antagonist XL139 or BMS-833923 with Bristol-Myers (NYSE:BMY), and the MR antagonist, XL550 or CS-3150 with Daiichi Sankyo.

Investor's summary

For the third quarter Exelixis reported a loss of $32.8 million or $0.20 per share, compared to a profit of $77.9 million or $0.59 per share in the prior-year quarter.

Revenues totaled $13.3 million, down from $128.3 million last year.

Looking ahead to the fiscal-year 2012, the company lowered its revenues outlook to a range of $160.0 million to $180.0 million. This compares to the previous range of $190.0 million to $220.0 million.

In spite of that, Exelixis is in a strong financial position. It ended the third quarter with $675 million in cash and that gives it the financial strength needed to pursue the broad range of trials it is involved with.

In the third quarter Exel has raised $416.1 million through concurrent offerings of common stock and 4.25% convertible senior subordinated notes due 2019.

Exelixis is 100 percent owner of Cometriq which is a unique and comfortable position for a small biotech company at this stage of development.

The stock's 52 week range was $4.05 - 6.95

Mike Morrissey, President and CEO said during a recent earnings call:

"We view the approval of Cometriq in (thyroid cancer) as the first of many critical milestones along the path to building a robust oncology franchise around this drug."

This company has a promising future.

Source: Exelixis's Promising Pipeline Of Drugs