ATLANTA – Pfizer Inc. (PFE) Chairman and Chief Executive Hank McKinnell (search) said Tuesday the pharmaceutical company's suspended arthritis drug Bextra (search) likely would return to the market because it was needed by patients.
"I think it's fairly likely because for many patients it is the best choice or the only choice," McKinnell told Reuters after a speech at an HIV/AIDS prevention meeting in Atlanta. McKinnell, however, did not predict when Bextra might be available again to consumers.
Pfizer, the world's largest drug maker, suspended sales of Bextra in April after U.S. and European regulators said the risk of serious side effects from the drug, including a potentially fatal skin allergy, outweighed benefits.
Bextra is part of a class of drugs known as COX-2 inhibitors (search) that also includes Pfizer's drug Celebrex (search) and Merck & Co Inc.'s (MRK) Vioxx (search), which was withdrawn last year due to increased risks of heart attack and stroke.
The Food and Drug Administration (search) asked Pfizer to pull Bextra from the U.S. market, claiming provided no added advantage as a painkiller and could cause a potentially life-threatening condition called Stevens-Johnson syndrome (search).
The allergic skin reaction usually begins as a blistering of the mouth and lips and can spread to the rest of the body.
"The agency is open to discussions" with Pfizer but continues to believe Bextra's risks outweigh its benefits," FDA spokeswoman Kathleen Quinn said Tuesday.
In an April 6 memo outlining the FDA's views on COX-2 and other painkillers, agency officials said they were open to allowing "limited access" to Bextra in clinical trials if Pfizer proposed new studies.
The agency would reassess the drug if the studies showed an advantage over other arthritis medicines, the memo said.
Pfizer, which disagrees with the regulatory decisions on Bextra, has been exploring options with regulators under which it might be allowed to resume sales of the drug. Bextra had sales of $1.3 billion in 2004.
Analysts said Bextra would face an uphill battle even if it were cleared for a comeback.
"McKinnell is being a bit optimistic about Bextra's chances of returning to the market, but even if it came back it would not be commercially successful because of its perceived risks," said Bridget Collins, a drug analyst for Victory Capital Management.
Shares of Pfizer fell 21 cents, or 0.75 percent, to $27.75 in afternoon trading on the New York Stock Exchange.
Besides its problems with Bextra, Pfizer is also dealing with an FDA request to include a black box warning — the strongest possible — for Celebrex, its older arthritis drug. McKinnell said Tuesday the company was working with the federal agency on the labeling issue.