Wyeth believes its serotonin-norepinephrine reuptake inhibitor Pristiq (desvenlafaxine) may represent a market opportunity larger than its blockbuster antidepressant Effexor XR in major depressive disorder, U.S. President Geno Germano said during a June 12 presentation at the Goldman Sachs Global Healthcare Conference.

Pristiq was deemed "approvable" by FDA for MDD in January, with final approval contingent on results from a low-dose study and resolution of manufacturing issues at Wyeth's Guayama, Puerto Rico, facility (¹ Also see "Wyeth’s Pristiq Deemed “Approvable” By FDA" - Pink Sheet, 23 January, 2007.).

In April, Wyeth said it plans to submit a complete response letter in August, setting up an estimated February 2008 action date, assuming a six-month review cycle.

The company also is seeking an indication for treatment of moderate to severe vasomotor symptoms associated with menopause; the sNDA previously had an April 23 action date, but FDA extended the date until July to examine data on lower doses.

Wyeth has said that it will launch Pristiq for VMS before MDD, which it believes will help enhance the drug's main positioning as an antidepressant for menopausal women.

"As you know, the SSRI and SNRI category is now full of products, many of which are generic and undifferentiated, and we think the key to success for a product like Pristiq is to create a clearly focused positioning for the product and a ... clearly focused patient type," Germano told analysts.

"With the combination of the vasomotor indication and the experience that we have in the perimenopausal and postmenopausal patient population ... we think we will have the ultimate product for all genders, but [could] particularly be useful for women in the 40-year plus time of their life in depression," Germano maintained.

"If we are able to achieve this, we think there will be a great opportunity for Pristiq that goes beyond the opportunity even for Effexor."

The overall market for Pristiq represents about 35 million women, versus the 20 million-patient market for depression and anxiety in which Effexor XR competes, he noted.

"So it's a market opportunity for Pristiq with this positioning and with this approach and with these indications [that] is actually considerably larger than the market opportunity for Effexor, and ... the two to three million patients that we have globally on Effexor today, [which] is the most prescribed and the largest selling antidepressant in the world."

While Wyeth is bullish on Pristiq's "sizeable opportunity," comparing its potential to that of Effexor XR sets up rather daunting expectations.

Sales of the top-selling antidepressant grew eight percent to $3.7 billion in 2006. Wyeth is seeking to transition patients to Pristiq prior to Effexor XR losing patent exclusivity in July 2010.

-Brooke McManus (b.mcmanus@elsevier.com)

[Editor's note: An in-depth interview with Geno Germano discussing Wyeth's U.S. pharma business appeared in "The Pink Sheet" DAILY ² Also see "Wyeth Pharmaceuticals U.S. President Geno Germano: An Interview With “The Pink Sheet” DAILY" - Pink Sheet, 30 April, 2007..]

Wyeth Suggests Pristiq Could Surpass Effexor XR In Depression Market

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