Bristol-Myers Squibb is looking to its managed care contracting for Glucophage to increase growth in the newer once-daily and combination formulations of the antidiabetic.

"We're continuing to work very closely with managed care to seek favorable contract status and provide reasonable but rational discounts for incenting switches and conversions," Worldwide Medicines Group President Richard Lane told an Oct. 23 conference call.

Bristol wants to move as much of the metformin market as possible away from immediate-release Glucophage to the once-daily (Glucophage XR) and glyburide combination (Glucovance) formulations.

At the consumer level, "we are putting together a number of marketing programs, including looking at how we extend the first-month-free offer to both re-stimulate patient visits and requests, and re-galvanize physician interest," Lane said.

"We have clearly not been making the progress in those conversions over the last several months that we were earlier in the year," Lane said.

Sales of the metformin family increased 44% for the quarter to $702 mil., but the newer formulations represented less than one-third of the total. XR sales were $102 mil., while Glucovance sales were $95 mil.

Through nine months, Glucophage family sales were $2.02 bil., with Glucovance contributing $254 mil. and Glucophage XR $227 mil.

"While we are pleased with the overall performance, the mix of how we got there is not what we had planned," Lane acknowledged.

Generic versions of immediate-release metformin were expected to be introduced during the third quarter, but launch has been delayed pending a decision by FDA on whether three-year Waxman/Hatch exclusivity for pediatric labeling precludes generic approvals (¹ Also see "Metformin Generics Are "Approvable"; Barr Says Delay Helps Other Generics" - Pink Sheet, 15 October, 2001., p. 9).

There may be legislative action before FDA makes a final ruling: the pediatric exclusivity extension bill passed by the Senate includes language intended to allow generics to come to market, and similar language is included in the House version of the bill. Bristol continues to lobby to delete or change the provision (² Also see "Pediatric Bills' Generic Approval "Carve-Out" Needs Refinement, Hatch Says" - Pink Sheet, 22 October, 2001., p. 18).

"We and others believe the language in that amendment is deeply flawed on several levels," Lane declared. "Bristol-Myers Squibb did significant clinical work on children with diabetes and Glucophage, well beyond the requirements for the six-month exclusivity extension," he maintained.

The situation with Glucophage "is a very day-to-day issue," Lane added. "We're monitoring the legislative process and FDA and attempting to get greater clarity on the issue."

Barr CEO Bruce Downey told an Oct. 23 conference call that he expects the "issue will be resolved in the next three or four weeks." Based on the pediatric legislation moving through Congress, "we would expect the generic metformin and other products to be out in this quarter or shortly thereafter."

Bristol is making a similar argument about its pediatric research on the anxiolytic BuSpar (buspirone), which is holding up approval of the second round of generics (³ Also see "Bristol BuSpar Pediatric Labeling May Delay Second Round Of Generics" - Pink Sheet, 1 October, 2001., p. 26).

However, the first generics (five different dosage forms marketed by three manufacturers) have already significantly eroded the franchise: BuSpar sales fell by 84% in the quarter worldwide to $28 mil. For the nine months, sales are down 40% at $320 mil. worldwide.

Lane noted that the sharp decline in the BuSpar franchise would factor into the company's decision on how to proceed following an appeals court ruling overturning the original decision allowing generic approvals (⁴ Also see "BuSpar Generic Decision Favors Bristol: FDA Decision On ANDAs Pending" - Pink Sheet, 22 October, 2001., p. 17).

"We're very pleased at the higher court's decision and certainly it vindicates our long-standing position on the law," Lane said. "We now have a number of options and we are in the process of reviewing those."

Lane noted that BuSpar sales declined during the quarter by more than $140 mil., from "an annual revenue base of $700 mil. to $28 mil. in the last quarter as a result of the original decision." Bristol is "looking hard at the best way to realize value for the shareholders from the court's proper decision," he said.

Bristol Glucophage Managed Care Discounts Will Encourage Switches

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