Wyeth-Ayerst will adopt a biannual price increase strategy for the hormone replacement therapy Premarin, the company told analysts during its second quarter earnings call July 24.

"We've performed one so far this year, and we will look at this situation later this year," Pharmaceuticals President Bernard Poussot said. "Premarin remains one of the cheapest products prescribed in the U.S. at 60[cents] per day, so we have some room for expansion."

Wyeth increased the price of Premarin by 8.4% in the first quarter. A second price increase is expected later this year, "although we've been changing...the timing of those increases," Poussot said.

Premarin family sales increased 20% worldwide to about $428 mil. in the second quarter. Sales for the first half were approximately $1.1 bil., an increase of about 18%. "Price increases we've taken in the last year have contributed significantly to this performance," he said.

Poussot agreed that speculation regarding pricing dates could lead to more active stockpiling by wholesalers. Thus far, however, there have been "no substantial increases in our trade inventory levels for Premarin."

"We should be able to maintain good growth in the second half of the year...largely driven by price increases," Poussot said. Wyeth has predicted that the Premarin franchise will grow to $2.55 bil. by 2004 (¹ Also see "Wyeth Low-Dose PremPro Osteoporosis sNDA Filing Planned For June" - Pink Sheet, 21 May, 2001.).

Wyeth expects "low-dose PremPro to help us regenerate volume growth with newcomers," Poussot said. The HRT drug has been "approvable" at FDA for vasomotor symptoms since April 13.

"We are continuing our discussions with FDA since receiving our 'approvable' letter and expect to launch the low-dose PremPro later this year," he said. AHP also continues to discuss Premarin manufacturing issues with the agency. Since December, Wyeth has issued five Premarin recalls due to dissolution failure.

Looking ahead, "the market dynamics [for Premarin] are favorable, as a large number of women are entering menopause over the next couple of years, including another 3 mil. additional women by 2002," he noted.

The American Heart Association's decision July 24 to stop recommending estrogen as preventive therapy for cardiovascular disease, however, could set back Wyeth's efforts to grow its Premarin franchise.

"For post-menopausal women who have had a heart attack or stroke, the guidelines recommend that HRT not be initiated for secondary prevention," the association said. "Firm recommendations for primary prevention await the results of ongoing, randomized clinical trials."

AHP is not changing its growth projections for Premarin and does not expect any fall-out from the announcement, the company said. Premarin is not approved for cardiovascular disease, although Wyeth has tried to gain the indication.

Premarin, in addition to Protonix, Prevnar and Effexor, contributed to AHP's 15% increase in U.S. pharmaceutical sales and 8% worldwide during the quarter, Poussot said.

Protonix sales jumped to $132.1 mil., an increase of 211% compared to the second quarter of 2000, when the drug was launched. Protonix held a 9.5% share of new prescriptions, and an 8% total prescription share of the North American proton pump inhibitor market for the week ending June 29.

Protonix delayed-release tablets received a maintenance indication June 12 for erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with GERD.

In response to a question on whether there has been movement to switch the PPI class over-the-counter, AHP Senior VP-Global Consumer Healthcare David Olivier said, "We see no indication of activity at the agency....It is in the pipeline for self-medication, but we haven't seen a great deal yet." Protonix' patent expires July 19, 2005.

Sales of the pneumococcal conjugate vaccine Prevnar reached $196 mil. in the second quarter with year-to-date sales of $403 mil., a 269% increase over 2000.

Wyeth's intranasal influenza vaccine was reviewed by FDA's Vaccines & Related Biological Products Advisory Committee July 26-27 (see related story, p. 4). FluMist's FDA action date is Aug. 31.

Wyeth Premarin Biannual Price Increases To Boost "Cheap" 60[cents] Daily Cost

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