Pfizer ( PFE - Get Report) says it will delay the launch of its inhaled insulin Exubera until September, several weeks later than originally planned. Previously, Pfizer said the drug
would be available in mid-July. Although Exubera was approved by the Food and Drug Administration in January and made available in Germany and Ireland in May, Pfizer executives said Thursday that they wanted to make sure U.S. educational programs for doctors, pharmacists, diabetes educators and patients cover all the bases. "We will never get a second chance" to introduce the first inhaled insulin, said Hank McKinnell, Pfizer's chairman and CEO, in a telephone conference call with analysts. "Our education programs and manufacturing preparations are time-consuming, but we are taking the time necessary to do the job right," said Karen Katen, a vice chairman who is in charge of Pfizer's human-health products. "We are working to meet not only initial demand for the medicine, but also continued demand from prescription refills. Initial supplies of Exubera will be available across the U.S. beginning in September." Pfizer will be providing "starter kits" to selected physicians next week. The kits will contain the dry-powder insulin that's administered through an inhaler. The samples will be sent to doctors who are heavy prescribers of insulin to control diabetics' blood sugar levels. Exubera is prescribed for both type 1 and type 2 diabetics. Most diabetics belong to the latter category, meaning their bodies can't produce enough insulin or can't properly process insulin. Type 1 diabetics can't produce insulin, the hormone that converts sugar into fuel for the body's cells. Company officials told analysts they don't have enough information on sales in Germany or Ireland to assess Exubera's progress, and they said they wouldn't be able to gauge its U.S. performance until late 2006 or early 2007. The company didn't comment on Exubera's pricing, although at least one analyst has said it will be 33% to 40% higher than injectable insulin.
Exubera will require doctors and patients to
make adjustments. The training program starts next week and "will be rolled out in phases," the company said. "This will include training and demonstration of the proper use of the insulin delivery device and drug for physicians, diabetes educators and other healthcare professionals." Peter Brandt, a senior vice president, said manufacturing will be coordinated with the progress of the education program, adding that supply will meet demand. Brandt predicted there would be "high" acceptance by managed-care firms of Exubera. Pfizer's Exubera partner is Nektar Therapeutics ( NKTR - Get Report). The San Carlos, Calif., company said Thursday that it's increasing its revenue guidance for Exubera manufacturing and royalty revenue from a range of $60 million to $80 million to between $70 million and $90 million. Nektar will provide full-year guidance for 2006 on Aug. 3 when it issues its second-quarter results. Meanwhile, Pfizer also provided updates on other new products, including one delayed launch and one upcoming product. Although a Pfizer press release said the antismoking medication Chantix will be available in early August, McKinnell said the drug would reach the market next week. Chantix was approved by the FDA in May, and Pfizer is also seeking approval from the European Union. Chantix is the first new prescription drug for smoking in nearly 10 years. The twice-a-day pill will be distributed as part of a patient-support program to deal with behavioral aspects of smoking addiction. The question is whether insurers will pay for it. Brandt said stop-smoking products haven't received much coverage by managed-care firms. He predicts these companies, which usually take six month to 12 months to evaluate new products, will provide some coverage for Chantix, although not at the levels of drugs such as Lipitor.
Pfizer also said there would be another regulatory delay for Zeven, an experimental antibiotic that Pfizer acquired when it paid $1.9 billion for Vicuron Pharmaceuticals last year. Vicuron had two drugs in late-stage development -- Zeven, then called dalbavancin, and the antifungal Eraxis, which reached the market last month. Zeven has been delayed until next year. The FDA had been expected to act in June 2005, but the agency extended its review for 90 days. Pfizer later confirmed that it had received conditional approval from the FDA, meaning the agency wanted some form of additional information before it would clear the drug. Pfizer didn't disclose the conditions or a timetable for meeting them. On Thursday, Pfizer said it received another conditional-approval letter from the FDA on June 21, adding that it was working with the agency to resolve the unspecified matter. "We now expect approval and launch of Zeven in 2007," the company said.