The U.S. antidepressant market, valued at $8.5 billion in 2000, grew at a 20% annual rate between 1995 and 2000. However, with the loss of patent exclusivity of selective serotonin reuptake inhibitors (SSRIs), beginning with Eli Lilly's Prozac (fluoxetine) last August, the market for SSRIs and similar drugs is poised for decline for the first time in well over a decade. As highlighted in COMPETITIVE LANDSCAPE™, a new service from Decision Resources, Inc., novel therapies now under development for the treatment of depression face greater challenges than ever before.

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The August 2001 arrival of generic fluoxetine will have a profound impact on the depression market in the decade ahead. In addition to eroding the market for branded SSRIs, generic fluoxetine will likely cannibalize sales from other classes of antidepressants. The extent to which prescribers will switch from other branded SSRIs to generic fluoxetine is not yet known. However, a recent PHYSICIAN FORUM™ internet survey conducted by Decision Resources, Inc., of 72 top-antidepressant-prescribing U.S. primary care physicians revealed that generic switching will impact some branded SSRIs, such as Pfizer's Zoloft, more than others. The survey also showed that physicians were unlikely to prescribe generic fluoxetine if a patient previously had a good response to another SSRI or if the patient requested another SSRI.

Growing interest in antidepressants acting at more than one receptor (e.g., serotonin and norepinephrine reuptake inhibitors [SNRIs]) suggests these agents will provide increasingly important alternatives to SSRIs, especially in treatment-refractory patients. This trend will likely be of greatest benefit to American Home Products' SNRI venlafaxine; developmental compounds, such as Eli Lilly's duloxetine, will also enjoy some success. Taking this trend one step further may be triple-acting super neurotransmitter uptake blockers, such as Sepracor's ®-DDMS.

Two other promising new drug classes include NK1 antagonists and corticotropin-releasing factor (CRF) antagonists. Though years away from approval, both classes of drugs could theoretically compete in a variety of depression and anxiety segments with relatively favorable side-effect profiles. However, although NK1 antagonists are further along in development, both of these emerging classes have yet to show evidence of clinical efficacy sufficient to drive significant sales in what is fast becoming a very crowded market.

Whether or not any of these new agents will ultimately be successful at fending off encroachment by generics will largely be determined by an ability to successfully treat a broader base of patients (especially those with comorbid anxiety), a "clean" side-effect profile, and a reduced time to onset of action. The drugs currently in clinical development, though promising in some respects, have yet to display all these desired characteristics.

Decision Resources, Inc., has been a world leader in CNS market analysis for more than 10 years. COMPETITIVE LANDSCAPE, its newest service, is a unique, Web-based decision support tool that highlights and analyzes the competitive aspects of CNS drugs, potential licensing opportunities, and company CNS franchise strength. Decision Resources continues to develop Web-based initiatives in several therapeutic areas to provide its clients immediate access to the most up-to-date information on the ever-changing dynamics of the biopharmaceutical industry.

CONTACT: Joe Walsh, Vice President and Managing Director, North American Sales and Marketing, +1.781.296.2570, jwalsh@dresources.com.

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SOURCE: Decision Resources, Inc.

Contact: Joe Walsh, Vice President and Managing Director, North American
Sales and Marketing, +1-781-296-2570, jwalsh@dresources.com

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