Pfizer's Geodon for schizophrenia has been added to more than 500 hospital formularies since its March launch, Pharmaceuticals Group President Karen Katen said during an April 18 analysts conference call.

Geodon (ziprasidone) is also on the formulary at the Federal Bureau of Prisons, which covers about 100 institutions, Katen said. In addition, the drug has been placed on Medicaid formularies in 46 states.

Pfizer began detailing Geodon (formally Zeldox) in early April. Starter kits with a three-week supply of the drug were sent to high-prescribing physicians (mostly psychiatrists) in early March.

The "early experience trial program" allowed the physicians to "become comfortable with the product [and] use it on their patients," Katen said. "They've been very positive in their response to the trial."

Geodon sales were $65 mil. in the first quarter, "largely reflective" of initial wholesaler stocking, Pfizer said. The company could see somewhat of a masking effect from the sampling effort. "The impact of the starter program is going to be quite profound," Pfizer CEO Henry McKinnell said.

U.S. sales of Johnson & Johnson's competing antipsychotic Risperdal were up 15% for the quarter to $315 mil. J&J took an opportunity to distinguish Risperdal from Geodon during the firm's April 17 conference call.

J&J pointed to Risperdal's more convenient dosing schedule and improved side effect profile as "key marketing points we're going to [use to] differentiate the products," VP-Investor Relations Helen Short told analysts.

"We're a once-a-day product versus a twice-a-day product with Geodon," Short said. "They have to be taken with food, while the same situation doesn't happen with Risperdal."

The Geodon launch does not threaten Risperdal's market position, Short concluded, because "Geodon is primarily going after [Lilly's] Zyprexa."

Compared to Lilly's antipsychotic Zyprexa, Risperdal has "a lower side effect profile," Short said, "and we know that Zyprexa has a weight gain issue."

Geodon has a 10% incidence of weight gain, with a median gain of .5 kg, labeling states. Weight gain for competing drugs appears to be higher: 29% of Zyprexa patients and 18% of Risperdal patients gained at least 7% of their body weight in similar trials.

Zyprexa had a 47.6% cash share in February, almost 18% higher than Risperdal (¹ Also see "Lilly Consultants To Pre-Inspect Zovant Contract Manufacturing Sites" - Pink Sheet, 23 April, 2001.).

Pfizer is expected to present comparative data on Geodon's clinical endpoints at the American Psychiatric Association's annual meeting May 8-10. The company has made a "substantial submission" that includes comparative data on "various parameters, such as weight...and metabolic parameters," Pfizer said.

Pfizer and Lilly are battling to bring the first intramuscular formulation of an "atypical" antipsychotic to market. Both drugs are held up at FDA; Geodon became "approvable" in March, and Zyprexa IM manufacturing issues led to an "approvable" letter March 29 ('The Pink Sheet' April 16, p. 35).

Geodon IM is one of five Pfizer products pending at the agency. During the quarter, Pharmacia filed for the second-generation COX-2 inhibitor valdecoxib (which will be co-marketed with Pfizer), and Pfizer submitted an NDA for the antifungal Vfend (voriconazole). Relpax and Zyrtec D are "approvable."

Despite a strong start, Geodon's first quarter sales were just one-fourth of Lipitor's $242 mil. U.S. sales increase. Lipitor U.S. sales were up 30% to $1.04 bil. Pfizer has about a dozen studies ongoing for atorvastatin in indications such as peripheral vascular disease and stroke prevention.

Geodon, however, made up for roughly two-thirds of Pfizer's Rezulin revenue loss in the quarter. Lost sales from the anti-diabetic totaled $103 mil.; the first quarter marked the anniversary of troglitazone's March 21, 2000 withdrawal.

Rezulin took 2% off Pfizer's top line for the quarter, and exchange rates decreased revenues by 3.2%, or $229 mil. Pfizer's human pharmaceutical revenues were up 9% to $6.37 bil. and total revenues increased 7% to $7.65 bil.

While Pfizer expects double-digit top line increases over the next two years, McKinnell acknowledged that as the company approaches the $30 bil. sales mark, it is "getting a little harder" to sustain that level of growth.

Approvals could make the goal more easily attainable; Pfizer expects to file three NDAs in 2001: Exubera inhaled insulin (with Inhale Therapeutics); pregabalin for add-on epilepsy and neuropathic pain; and Spiriva for chronic obstructive pulmonary disease (with Boehringer Ingelheim).

The Spiriva NDA will be filed in December. "We think it has every chance...to be the drug of choice for maintenance therapy of COPD," Pfizer Global R&D President John Niblack, PhD, said.

In clinical trials of 3,000 patients, Spiriva (tiotropium) "significantly improved lung function...and showed statistically significant reductions in the exacerbation of COPD that could lead to hospitalization," Niblack told analysts.

Spiriva also had a "significantly improved impact on patient's reported quality of life" and less dyspnea. The inhaled drug was also "extremely well-tolerated," Niblack added. "The most common side effects were dry mouth, which was characterized as mild in the majority of patients."

"I think there's really not much doubt that a product with the toleration and robust activity in this population is going to be a powerful contender," he declared.

Pfizer is conducting head-to-head studies of Spiriva and GlaxoSmithKline's Serevent. "Spiriva appears to work better in chronic constrictive airways," Medical & Regulatory Operations Senior VP Joseph Feczko, MD, said.

Pfizer was unable to offer guidance as to whether Spiriva would receive a priority review. "You're just speculating when you try to guess what the FDA is going to do with respect to accelerated reviews," Niblack said.

"One of the problems with some of our drugs [that will under go regulatory review] is the databases are quite extensive and involved, and so that puts [FDA] under tremendous pressure," he noted.

McKinnell appeared to modify his past declaration of an "across-the-board" slowdown at FDA, suggesting that priority review times have been reduced.

"What is interesting in the overall FDA statistics area is an increasing percent of submissions...are receiving priority reviews, and those receiving priority reviews are showing significant reductions in review and approval time," he said.

Pfizer's Geodon Schizophrenia Drug On 500 Hospital, 46 Medicaid Formularies

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