Establishing First-line Therapy Use is the Biggest Challenge Facing Companies in the Colorectal Cancer Market.

PALO ALTO, Calif. -- Developing drugs and establishing them as standardized first-line therapy in the U.S. colorectal cancer market is becoming increasingly complicated as companies struggle to identify the best combination in which they should test and market their drugs. This is a strong challenge due to the complexity of colorectal cancer treatment that often requires the use of three drugs for first-line therapy and two drugs for second-line therapy.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Emerging Therapeutics in the U.S. Colorectal Cancer Market, reveals that revenue in this market totaled $1,897.0 million in 2004 and projects to reach $2,110.0 million in 2011 but also anticipates to peak at $2,584.9 million in 2006.

If you are interested in a virtual brochure, which provides manufacturers, end-users and other industry participants an overview of the latest analysis of the Emerging Therapeutics in the U.S. Colorectal Cancer Market - then send an email to Melina Gonzalez- Corporate Communications at [e-mail] with the following information: your full name, company name, title, telephone number, fax number and email. We will send you the information via email upon receipt of the above information.

"Finding the right combination of drugs is important not only for extended patient survival, but also for generating higher revenues," remarks Frost & Sullivan Research Analyst Jason McKinnie. "A drug in first-line therapy always holds greater revenue potential than one that is consigned to second- or third-line treatment."

The cytotoxic therapy drug Camptosar, illustrates the significance of first-line therapy use in the colorectal cancer market. Despite being an integral part of the groundbreaking Avastin clinical trial data, commercial success for Camptosar did not mimic that of Avastin. Instead, oncologists cited other data and preferred the combination of Eloxatin as part of the FOLFOX regimen with Avastin in the first-line setting.

Several factors accounted for the preferential use of Eloxatin over Camptosar but the superb clinical trial planning of Sanofi-Aventis proved one of the most important. The company positioned their drug in clinical trials that showed its superiority to the older Camptosar-based IFL regimen. This data drove revenues for Eloxatin making it the market leader despite data showing the newer Camptosar-based FOLFIRI regimen is equivalent to FOLFOX.

The fourth quarter of 2004 and first quarter of 2005 showed Camptosar is gaining market share but is still considerably lower than Eloxatin. Both drugs have indications for first-line therapy but Camptosar generated less than half the revenues of Eloxatin and that is partially attributable to drug positioning in clinical trials.

Since monotherapy is not a standard option in the treatment of colorectal cancer, every company is in some capacity depending on other companies' drugs to achieve success. Proper planning and positioning of clinical trials expects to remain imperative and continues to challenge participants in the colorectal cancer market. Conducting a clinical trial with the right combination of drugs can lead to great revenue potential as part of first-line therapy, otherwise the drug will have limited revenue generation.

Avastin's landmark achievement of extending average survival period for patients and its subsequent approval by the Food and Drug Administration (FDA) in February 2004 set new standards for colorectal cancer drugs. This has placed companies developing novel targeted therapies under huge pressure to achieve the same, if not a higher, level of success to capture significant market share.

In fact, the FDA's emphasis on survival data is so great that it restricts companies from developing drugs for the colorectal cancer market. Among the various factors, companies examine before determining which cancer market, they should develop their drugs in, the cost and length of development is one of the most crucial.

"With the emphasis on survival data and on showing improved survival with a new therapy over an old one, clinical trials in colorectal cancer are lasting longer than ever with costs continually escalating," notes McKinnie. "Some Phase III clinical trials for colorectal cancer are estimated to take more than six years with costs exceeding $200 million."

Some regulators and physicians are arguing the case for using tumor time to progression (TTP) as a substitute for overall survival data. While using this system would help drastically reduce cost and length of clinical trials, some fear TTP is not the best estimate for predicting overall survival and believe that some drugs may show improvement in patients' health, but in reality may not really enhance survival.

Emerging Therapeutics in the U.S. Colorectal Cancer Market, part of the Pharmaceutical (9611) subscription, which also includes market insights on Cancer Therapeutics (9631), examines two distinct market segments in the colorectal cancer therapy market: cytotoxic therapy and targeted therapy. The study provides individual drug forecasting for marketed drugs and for those anticipated to gain approval by 2011. It provides detailed patient growth forecasts by stage and additional forecasts by line of therapy help understand the revenue potential of each line. These features can aid companies in making strategic plans for the development of a particular drug. Interviews are available to the press.

Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership services and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community, by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics.

Emerging Therapeutics in the U.S. Colorectal Cancer Market

F205

Keywords in this release: Drug development, biotechnology companies, U.S., colorectal cancer, patient survival, first-line therapy, second-line therapy, third-line therapy, Avastin, IFL regimen, FOLFOX regimen, Eloxatin, targeted therapies, Food and Drug Administration, FDA, clinical trials, tumor time to progression, TTP, research, information, market, trends, technology, service, forecast, market share, first-line