Pfizer's COX-2 inhibitor brands Celebrex and Bextra appear to have stabilized after an FDA advisory committee review of the class in February, Human Health President Karen Katen told analysts in New York City April 5.

Pfizer is seeing "the beginning of some stabilization of the marketplace after the FDA advisory committee, which supported the need for COX-2 inhibitors to treat patients with chronic pain," she said.

After a three day review of the COX-2 class, the advisory committee voted by a wide margin that Celebrex (celecoxib) should remain on the market, and supported continued availability of Bextra (valdecoxib) by a narrow margin (¹ Also see "Vioxx And Bextra Get Split Votes From FDA Cmte. On Marketing" - Pink Sheet, 18 February, 2005.).

Katen presented IMS Health data showing Celebrex holding 13.6% of total scripts and Bextra 6.3% as of March 25. Those figures are down from shares of approximately 20% and 10%, respectively, before the withdrawal of Merck's Vioxx on Sept. 30.

Since Vioxx was withdrawn, ibuprofen has replaced Celebrex as the category leader, with a 28.9% share. Naproxen is also now back ahead of Celebrex, with a 14.2% share - roughly in line with its pre-Vioxx level. Abbott/Boehringer Ingelheim's Mobic (meloxicam) has gained share, from about 4% to 9.3%.

"The overall prescription market is still depressed versus pre-Vioxx withdrawal levels," Katen added, although there has been an increase in OTC analgesic sales.

Pfizer is predicting that the COX-2 brands will return to growth once new labeling is finalized.

"We look forward to finalizing our U.S. label with the FDA as well as moving ahead with important clinical plans to study the longer term comparative benefit/risk profile of our products," Katen said. Pfizer suspended promotion of Celebrex and Bextra in December; new labeling would allow the company to begin active marketing again.

"In the interim we remain focused on the importance of these medicines for millions of people around the world," Katen said. "Arthritis patients need treatment options. Celebrex and Bextra are important medicines for many patients."

"However, there is still much confusion about them right now. Patients and their physicians don't seem to have a clear sense of their appropriate use. To that point we are committed to conducting longer term comparative benefit/risk studies."

"We believe that with continued development work, continued clinical revelations and appropriate labeling, these medicines will remain critical treatment options for many years to come."

Pfizer believes that a return to growth in the COX-2 class will be an important contributor to the company in 2006 and 2007.

However, CFO David Shedlarz noted, one near term challenge for Pfizer will be a very difficult year-over-year comparison for the COX-2s in the fourth quarter. In the immediate aftermath of the Vioxx withdrawal, both Celebrex and Bextra gained market share, leading to a strong showing in the last quarter of 2004.

- Michael McCaughan

Celebrex, Bextra Stabilizing After FDA Advisory Committee Review, Pfizer Says

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