Bristol Glucophage XR Launch Price Is 5% Discount To Metformin

Bristol-Myers Squibb is launching Glucophage XR at a 5% discount to immediate-release metformin.

The average wholesale price listed by First DataBank for metformin extended-release is $65.67 for a 100-count bottle of 500 mg tablets. A 100-count bottle of 500 mg tablets for the original Glucophage formulation lists for $69.08 AWP. Glucophage XR (NDA 21-202) cleared FDA Oct. 13 for treatment of type 2 diabetes (¹ (Also see "Bristol-Myers Squibb Glucophage XR" - Pink Sheet, 16 Oct, 2000.)). Glucophage XR will be available Nov. 3.

Glucophage XR labeling includes information from a study of patients switched from the immediate-release to the extended-release formulation which suggests that the dosage for both formulations is comparable.

Results of the trial "suggest that patients receiving Glucophage treatment may be safely switched to Glucophage XR once daily at the same total daily dose, up to 2,000 mg once daily," labeling says.

The price point reflects Bristol's intention to switch as many patients as possible from the immediate-release to the sustained-release metformin formulation. Bristol expects generic competition to Glucophage during the second-half of 2001. Glucophage XR will have a minimum of three years of Waxman/Hatch exclusivity, and Bristol will presumably assert patent protection for the new formulation as well.

"It is our intention to cannibalize most or as much as we can of the Glucophage franchise with" the Glucovance (metformin/glyburide) combination product and Glucophage XR, Bristol Worldwide Medicines President Richard Lane said during an Oct. 19 investor conference call.

Glucophage prescriptions continued to grow through the third quarter despite the launch of the metformin/glyburide combination Glucovance. "About 40% of the Glucovance prescriptions are coming...from Glucophage," Lane noted, but the launch of the product may also be having a "halo effect" that is driving increased use of the original formulation as well, he added.

"With the launch of Glucophage XR you will begin to see the real conversion," Lane declared. "It is a much easier switch to take people straight off from Glucophage twice a day to Glucophage XR so I think you should look to see serious cannibalization of the existing Glucophage franchise by the XR formulation even as we continue to push Glucovance for both cannibalization and market expansion." Glucophage sales increased 25% in the quarter to $435 mil. Glucovance contributed $54 mil. after its August launch.

Bristol is also using a pricing incentive to encourage switches to Glucovance: the lowest dose of the product (250 mg metformin/1.25 mg glyburide) carries the same AWP as Glucophage XR and is about 5% less than the lowest Glucophage dose.

The 500/2.5 mg Glucovance dose lists for about 12% more than Glucophage 500 mg, but patients switching at that dose would presumably also be paying for glyburide.

Bristol's pattern of aggressive price increases for Glucophage over the past two years provided ample room for the company to come in at a lower price point with the line extensions.

One potential complication for Bristol is that Glucophage XR will be available only in the 500 mg formulation, meaning that patients on higher doses may need to take up to four pills at once. Labeling recommends that patients who do not respond adequately to a once-daily dose of 2,000 mg should be given 1,000 mg of Glucophage XR twice daily.

The Glucophage XR delivery system is "a dual hydrophilic polymer matrix," labeling states. Metformin "is combined with a drug release polymer to form an 'inner' phase, which is then incorporated as discrete particles into an 'external' phase of a second polymer," labeling states.

"After administration fluid from the gastrointestinal tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly by a process of diffusion through the gel matrix that is essentially independent of pH," labeling states.

"The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract," labeling adds. "The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."