After a tumultuous but momentous year in 2010, biotechnology company Exelixis Inc. (EXEL) looks ahead to realizing its goal of making a new addition to the oncology landscape, if things pan out the way as expected.
For readers who are new to Exelixis, here's a brief overview of the company and its upcoming milestones...
Founded in 1994, Exelixis went public on the NASDAQ in April 2000, offering its shares at $13 each. The company is focused on developing small molecule therapies for the treatment of cancer. The most advanced solely-owned product candidate is Cabozantinib, which is being evaluated in multiple cancer indications.
Cabozantinib is an oral drug that targets MET, VEGFR2 and RET, which are key kinases involved in the development and progression of many cancers. 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.
Under an agreement signed in December 2008, Exelixis and Bristol-Myers Squibb Co. (BMY) had agreed to co-develop Cabozantinib. But in June 2010, Exelixis regained full rights to Cabozantinib, following the decision of Bristol-Myers Squibb to terminate the collaboration, solely as to Cabozantinib, on a worldwide basis.
Cabozantinib is currently in a pivotal phase 3 trial for medullary thyroid cancer and in phase II trials for metastatic castration-resistant prostate cancer, ovarian cancer, melanoma, breast cancer, non-small cell lung cancer, and hepatocellular cancer, and in a phase 1 trial in renal cell carcinoma and differentiated thyroid cancer.
In January 2011, the FDA granted orphan drug designation to Cabozantinib for the treatment of follicular, medullary and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer.
Exelixis expects to report top-line data from the ongoing phase III pivotal trial of Cabozantinib in patients with medullary thyroid cancer, known as the EXAM trial, in September/October, 2011. The results of the EXAM trial, which were originally slated for release in the middle of this year, were extended by three months to provide additional time for the trial to reach the pre-specified number of progression-free survival events required for un-blinding of the data.
The company plans to submit Cabozantinib New Drug Application for medullary thyroid cancer on a rolling basis - initiating a rolling submission in the fourth quarter 2011 and completing the file in the first quarter of 2012. If all goes as planned, the company anticipates a commercial launch of Cabozantinib in medullary thyroid cancer in the second half of 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. MTC can occur spontaneously, or be part of a genetic syndrome. According to the National Cancer Institute, about 44,600 new thyroid cancer cases were diagnosed in the United States during 2010, and about 1,690 people died from the disease. Medullary thyroid cancer is estimated to represent 3 to 5 percent of all thyroid cancer and its estimated incidence in the U.S. for 2010 is about 1,300 to 2,200 patients, making it one of the rarer forms of thyroid cancer.
AstraZeneca plc's (AZN) Vandetanib, approved in April 2011, is the only medication to receive FDA approval specifically for use in patients with advanced MTC.
The larger market opportunity for Cabozantinib will be in the indication of prostate cancer. The American Cancer Society estimates that each year, about 218,000 men in the United States get prostate cancer and about 32,000 patients die of this disease. The pricing environment for prostate cancer drugs is also encouraging, and analysts see a blockbuster opportunity for the new prostate cancer drugs like Dendreon's Provenge and Johnson & Johnson's Zytiga.
In June of this year, Exelixis reported encouraging interim phase II data of Cabozantinib in metastatic castration-resistant prostate cancer. The trial results demonstrated that there was a significant improvement in median progression-free survival in castration-resistant prostate cancer patients treated with Cabozantinib.
The company has also reported positive interim data from an ongoing phase II adaptive randomized discontinuation trial of Cabozantinib, which included 9 tumor types. According to Exelixis, objective tumor responses were observed in 12 of 13 separate tumor types tested, and there has been a dramatic resolution of metastatic bone lesions by bone scan in 5 tumor types, including prostate, renal, breast, thyroid cancers and melanoma.
Using a combined endpoint of pain reduction and bone scan response, the company submitted a protocol for a pivotal trial of Cabozantinib in castration-resistant prostate cancer to the FDA in June 2011 for consideration of a special protocol assessment. Exelixis is aiming to initiate the first pivotal trial in prostate cancer by the end of this year. Additionally, the company is planning to initiate two other pivotal trials of Cabozantinib in castration-resistant prostate cancer for overall survival and bone metastasis-free survival in 2012.
Prostate cancer tends to spread to either lymph nodes or bone. Prostate cancer that has spread to the bone is called metastatic prostate cancer. Bone metastases are the main cause of disability and death in patients with castration-resistant prostate cancer.
Apart from Cabozantinib, Exelixis has a number of out-licensed compounds as well as partnered programs in various stages of development. Exelixis' partner list reads like a who's who of biotech companies, comprising of Bristol-Myers Squibb Company, sanofi-aventis, Roche's Genentech unit, Boehringer Ingelheim GmbH, GlaxoSmithKline and Daiichi Sankyo.
But for now, the company's current strategy is to aggressively advance Cabozantinib through development toward commercialization.
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 March 31, 2011, had an accumulated deficit of $1,210 million.
The company is slated to release its second quarter 2011 financial results on Thursday, August 4, after the markets close.
Seeking to manage costs and focus its resources and development efforts on Cabozantinib, the company implemented two restructuring plans during 2010 and an additional restructuring plan in March 2011 that resulted in an overall reduction in its workforce by 410 employees. Additional reductions in workforce are expected through the end of 2012.
EXEL, which has a 52-week price range of $2.86 to $12.82, closed Monday's trading at $7.89 on a volume of 1.43 million shares.
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