Biologics Dominate the Autoimmune Market but Small Molecules Still Have Some Fight Left, Says Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - June 30, 2009) - Biological drugs are the big winners in the market for autoimmune disorders. According to "Autoimmune Market Forecast to 2014," the latest therapeutic market forecast from Cutting Edge Information, 11 of 14 drugs projected to reach blockbuster status are biologics. In fact, sales of biologics marketed for at least one autoimmune disorder topped $29 billion in 2008. In the same year, small molecules earned only $9 billion.

With projected biologics sales projected to hit $55 billion in 2014, nearly all of the major pharmaceutical companies have acquired or partnered with biotechnology firms to develop biologics with potential in this area.

Companies have not abandoned small molecules altogether, however.

Two promising small molecules in an up-and-coming class called JAK Inhibitors, Pfizer's CP-690,550 and Incyte's INCB18424, have cleared Phase II trials and entered Phase III. These drugs are a few years away from reaching the market -- neither expects regulatory approval, if it comes, before 2011.

In the meantime, to reinvigorate revenue streams, companies have looked to new delivery mechanisms for older classes of small molecules. Shire took Pentasa, a 5-aminosalicyd acid (5-ASA) that has been on the market for over 15 years, and combined it with Cosmo Pharma's MMX extended release technology to create Lialda.

Lialda, a treatment for ulcerative colitis, was approved in 2007 and challenged the long-time market leader in the 5-ASA class, Procter & Gamble's Asacol. Lialda's extended release tablet appeals to both doctors and patients because it can halve the number of daily doses.

Lialda grabbed market share away from Asacol in its first full year on the market, 2008. According to CEI's study, Lialda sales could outpace those of Asacol by 2013.

"Biologics have proven more effective against immune-related diseases than small molecule treatments and are more lucrative," says Shaylyn Pike, the report's lead author. "But because of the adverse events and modes of administration associated with biologics, researchers are searching for the 'holy grail' of autoimmune drugs -- a small molecule compound taken orally that is as effective as targeted biologics. This compound would eclipse the currently biologic-driven autoimmune market."

Until then, pharma continues to support their small molecule research through revenues from blockbuster biologics.

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Contact Information: CONTACT: Shaylyn Pike 919-433-0385