Bristol-Myers Squibb's metformin/glyburide combination product Glucovance has a 1.5% share of the diabetes market one month after launch, Bristol told securities analysts Sept. 28 in New York City.

"Glucovance is off to an incredible start," President Peter Dolan said, "gaining a one-and-a-half share point of the diabetes market in just four weeks." Glucovance is the "second best diabetes launch ever," according to Bristol. SmithKline's Avandia, which is co-promoted by Bristol, had the fastest uptake in the diabetes market.

"What's more, we've seen the total Glucophage/Glucovance combined market share increase, providing an indication that we are expanding the market, in addition to converting Glucophage users to Glucovance," Dolan said.

Bristol presented a breakdown of Glucovance patients showing that 39% are conversions from Glucophage. The company's goal is to convert as many Glucophage patients as possible to the new product (and to a pending once-daily metformin formulation) ahead of generic competition to Glucophage expected in 2001 (¹ Also see "BMS Counting On Initial Combo Use For Glucovance To Supplant Glucophage" - Pink Sheet, 7 August, 2000.).

The 61% of patients who are not being converted from Glucophage are about evenly divided between conversions from other therapies (29%) and first-line patients (32%).

"So far 60% of [Glucovance] use has been new uses beyond where Glucophage was being used," Worldwide Medicines President Richard Lane observed. However, "the switch rate from Glucophage to Glucovance has met our optimistic expectations."

Bristol plans to continue "to use the brand to drive overall use of Glucovance into [new] areas, even as we will continue a very strong and committed effort to cannibalize Glucophage directly into Glucovance," Lane said.

The cannibalization strategy should get a boost from direct-to-consumer print ads for Glucovance scheduled to begin running Oct. 9 in publications including Parade, People and Reader's Digest.

"Now there's something even better than Glucophage," the ad declares. Glucovance is "proven to lower blood sugar better than the leading brand of diabetes pill," the ad says.

Bristol is projecting a 20% growth rate for the Glucophage family in 2001, building on the 45% growth rate in metformin this year. Bristol expects the approval of the Glucophage XR once-daily formulation soon.

The diabetes franchise appears to be critical for Bristol to meet its revenue and earnings targets in 2001 in the face of new generic competition to Taxol and Buspar. The company told analysts to expect 11% growth in earnings per share in 2001 despite the patent expirations (² Also see "Bristol Rx Expansion Plans Include Biologics Manufacturing" - Pink Sheet, 2 October, 2000.).

Lane was pressed to offer projections for the Glucophage family in 2002, reflecting a full year of generic metformin competition. "I'm not going to predict 2002," Lane responded.

"What I will say is that we're committed to the category," Lane added. "I think it's a huge opportunity for us, and obviously the only way we could grow the franchise 20% next year is if both Glucovance and Glucophage XR are tremendously successful products in their own right. Whatever we achieve in 2001 I think that those two products have enormous opportunity for growth as long as they have exclusivity."

Glucovance was approved with three years of Waxman/Hatch exclusivity, and Bristol intends to apply for a six-month pediatric exclusivity extension.

Bristol hinted it has ideas for extending Glucovance's exclusivity beyond that period. Lane responded to a question about the exclusivity period by saying "I'm not going to make any statements about where we're at." Lane advised analysts to "factor into your considerations our intent to do pediatric studies" for the drug. "And who knows what else," CEO Charles Heimbold added.

Bristol also sees its co-promotion of Avandia (rosiglitazone) as a significant revenue opportunity. Lane projected that Bristol's revenues from the co-promotion "could more than double next year."

Lane maintained that the pending merger between Glaxo and SmithKline will not affect the co-promotion. Given the long-standing speculation about a merger with Glaxo, Bristol presumably protected itself from a change in control of SmithKline when it entered the Avandia agreement in 1999.

Bristol highlighted its long-term commitment to the diabetes market by providing preliminary sketches of compounds in "exploratory development" in the metabolism area.

"We - like a number of other companies - are developing a PPAR compound for diabetes," Chief Scientific Officer Peter Ringrose, PhD, said. "However, our PPAR agonist works at both alpha and gamma sites, which could provide both lipid-lowering as well as glucose-lowering efficacy."

Bristol is also studying "a mechanistically novel glucose-lowering compound that works through the sodium/glucose transporter channel in the kidney, regulating blood sugar levels," and "a unique novel-mechanism compound that could be active across diabetes, obesity and atherosclerosis," Ringrose said.

Bristol has more modest growth expectations for the cholesterol-lowering agent Pravachol (pravastatin). Lane projected that sales would top $2 bil. "in the next couple of years." Sales for 1999 were $1.7 bil.

Pravachol's market share is "holding steady at 14%," Lane said, and "sales are growing appreciably because the overall market for statins in the U.S. is expanding at a healthy 15% clip."

Lane outlined Bristol's marketing strategy for Pravachol. The company is focusing on "a committed core of physician users, loyalists to the brand Pravachol." Those physicians "really do believe that Pravachol is better and that 'lower is better' isn't the only issue in treating patients at risk of heart attacks."

In addition, Bristol's research has shown "that there [is] a significant role for the consumer here. Our tests with our DTC have shown that it makes a difference," both by "driving the patients to see their physicians" and in "supporting the efforts of those physicians who are loyal to Pravachol."

Bristol's upcoming DTC campaign will "stress differentiation of the product." The company is "hammering home the message that 'Pravachol is the only drug of its kind proven to prevent both first and second heart attacks.' We've added to that a recently-approved mortality claim, 'so that you can live a longer, healthier life,'" Lane stated. "This is a message that is playing well in consumer tests."

A final focus of Bristol's support for Pravachol is in the area of medication compliance or "persistency." Bristol has "some very interesting ideas" for Pravachol compliance that have shown "early success, albeit not at a level I'd like to see," Lane commented.

Dolan identified "persistency programs" as a potential significant contributor to Bristol's growth across its pharmaceutical business in coming years.

Bristol is guiding analysts to expect Plavix (clopidogrel) to take over Pravachol's role as the focus of growth for the company's cardiovascular business.

"We believe by year-end this product will approach the $1 bil. mark in sales, on its way to becoming our first $3 bil. product before 2005," Lane said. Bristol co-promotes the anti-thrombotic under a license from Sanofi-Synthelabo.

Dolan acknowledged that Bristol did not initially anticipate that Plavix would become such a large product. "Plavix, like Glucophage in its early days, has been a pleasant surprise for many of us."

"Our goal is to make Plavix an essential part of risk management to prevent atherothrombotic events," Lane said. Research is focusing on peripheral arterial disease and unstable angina as new markets.

"Assuming approval of the full range of indications for this product, an estimated 60 mil. people are potential candidates for Plavix," Lane added.

Bristol's next launch will be for the facial hair removal agent Vaniqa (eflornithine), which the company will market via a collaboration with Gillette. Bristol hopes for sales "to approach the $500 mil. mark by perhaps 2005, if not earlier," Lane said.

"A recent one-time ad in Parade magazine - that described the condition but did not name the product - resulted in 2,300 calls in one day to an 800 number," Lane said. Bristol is pursuing "partnership arrangements...with a wide array of women's media."

³ See chart: Glucovance Prescription Breakdown.

Bristol Glucovance Has 1.5% Share; 60% Of Patients Are New To Metformin

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