Updated from 4:09 p.m. EST
on Tuesday reaffirmed its 2004 earnings guidance of $2.12 to $2.14 per share.
The prediction reflects what the company calls adjusted earnings per share, which excludes one-time charges and gains. Analysts polled by Thomson First Call predict full-year EPS of $2.13. Using the GAAP standard, the company expects to achieve EPS of $1.58 to $1.60.
Pfizer executives made financial and research presentations to analysts Tuesday at the company's research facility in Groton, Conn., where they said they expect to meet the goal of filing 20 new drug applications during the five-year period ending in 2006. The company says it will have completed 12 of those applications by year-end.
"As the world's largest privately funded biomedical operation, we are developing and delivering innovative medicines that will benefit patients around the world," said Hank McKinnell, Pfizer's chairman and chief executive.
McKinnell said new drugs will need to make up for the loss of $14 billion worth of current drug revenue due to patent expirations between 2005 and 2007.
"We are in a much different situation than those companies that failed to anticipate or lacked the means to respond to these challenges," he said.
And considering that Pfizer's R&D development pipeline contains 142 novel compounds and 80 product enhancements, "the rumors of the demise of Big Pharma are simply untrue," said Dr. John LaMattina, president of Pfizer Global Research and Development,
Karen Katen, executive vice president and president of Pfizer Global Pharmaceuticals, said the company continues to experience strong growth for Celebrex, its arthritis and pain reliever that belongs to the class of drugs known as COX-2 inhibitors. That's the same class as Vioxx, which was withdrawn from the market by
on Sept. 30 because a company study showed long-term use -- more than 18 months -- increased the risk of cardiovascular problems such as heart attack and stroke.
Katen said three ongoing, long-term studies of Celebrex in cancer and Alzheimer's disease patients have shown no significant cardiovascular safety concerns. Pfizer recently said it would begin studying the long-term potential cardiovascular benefits of Celebrex in osteoarthritis patients who are at high risk for cardiovascular disease.
Pfizer also is conducting new clinical trials of another COX-2 drug, Bextra, to "further study its long-term cardiovascular safety profile." The company looks forward to a "reasoned scientific discussion" about the safety of COX-2 medicines at a Food and Drug Administration advisory committee meeting in early February, said Joseph M. Feczko, president of worldwide development and executive vice president of Pfizer Global Research and Development. Following Merck's withdrawal of Vioxx, Pfizer has continued to emphasize that all COX-2 drugs aren't alike, and executives reiterated that position Tuesday.
However, some clinical trials have raised questions about Bextra. Although clinical trials involving nearly 8,000 patients showed no cardiovascular impairment among people who took Bextra for six weeks to 52 weeks, Pfizer said recently that two clinical trials involving heart bypass-surgery patients showed Bextra was linked to a greater risk of heart-related side-effects.
The two studies showed there was a risk for patients who took Bextra alone or Bextra in conjunction with a Pfizer COX-2 drug, Dynastat, that isn't available in the U.S. The increased cardiovascular risk was not statistically significant for heart bypass patients receiving only Bextra.
Bextra, however, isn't approved for use in the U.S. for surgery patients. Dynastat is available in 45 countries; Pfizer will submit an application for Dynastat to the FDA by year-end.
Pfizer also is negotiating with the FDA on a stricter label for Bextra, which probably will include a "black box" warning about a rare and occasionally fatal skin-rash side-effect. The black box warning is the FDA's strongest warning. The current Bextra label alerts doctors and patients to this side-effect known as Stevens-Johnson syndrome. This warning was inserted in 2002, a year after Bextra was approved by the FDA.
Feczko said the new Bextra label also will include information about the tests involving heart bypass patients as well as information from a recently completed Bextra clinical trial involving general surgery patients, which, he said, shows no increase in cardiovascular risk.
McKinnell added that questions over the safety of individual COX-2 drugs, as well as the COX-2 class, must be resolved by scientists conducting proper studies and meeting in forums such as the upcoming FDA advisory committee. "Let's not debate this in the press," he said. "The bottom line: Don't speculate."
Feczko also outlined the status of drugs now before the FDA and/or foreign regulators. One of those drugs is Lyrica, for which Pfizer is still in talks with the FDA. This compound is seen as a successor to the epilepsy drug Neurontin, whose sales are now being eroded by generic competitors.
On Sept. 2, Pfizer got conditional approval from the FDA for three different uses of Lyrica, but the company hadn't provided much information on what needs to be done to secure final FDA approval. Feczko said Tuesday that no new clinical trials are needed; the key issue is what the drug's label will say.
The conditional approvals cover Lyrica as an add-on treatment for epilepsy, as a medication for nerve pain associated with diabetes and as a treatment for postherpetic neuralgia, which is a nerve pain associated with shingles. The FDA rejected Pfizer's request that Lyrica be approved for patients with generalized anxiety disorder.
Analysts say Lyrica is more potent than Neurontin, is easier to use, can treat a broader range of diseases and has a better safety profile in regard to interacting with other drugs.
The European Commission has approved Lyrica for the treatment of peripheral neuropathic pain and as an add-on for partial seizures in patients with epilepsy. Neuropathic pain, or nerve pain, causes burning and tingling sensations.
Other drugs include Indiplon, an insomnia medication developed by
, and Macugen, a drug for the eyesight-damaging disease called wet age-related macular degeneration. Macugen was developed by
, and the FDA is expected to make a decision by mid-December.
The FDA also is reviewing Zithromax SR, a sustained-release formulation of Pfizer's leading antibiotic that treats bacterial infections in a single dose.
"The new formulation ensures full dosing and compliance," the company said, which are crucial to "slowing the emergence of antibiotic-resistant bacteria." An application also was submitted to German regulators in October.
Coming soon are applications to the FDA for several other drugs, most notably Exubera, an inhaled insulin for treating Type 1 and Type 2 diabetes. The drug is being developed with
. McKinnell said that Pfizer hopes to seek FDA approval early next year; the drug is being reviewed by European regulators.
Studies show the drug's efficacy is "at least equivalent to short-acting injected insulin," the company said. "When approved by regulators, Exubera will be the most important advance in insulin administration since injections were introduced 80 years ago," Feczko said.
Another application that could be filed with the FDA by year-end is for sildenafil as a treatment of pulmonary arterial hypertension (PAH), a disease that can cause heart failure and death. The disease produces high blood pressure in the arteries connecting the lungs with the heart. Sildenafil is the scientific name for Viagra, just one of several examples of Pfizer's efforts to find multiple uses for its drugs.
Pfizer's stock gained 44 cents, or 1.6%, closing at $27.80.