Bristol Pravachol New Rx Up 22% Since Baycol Withdrawal, Company Says

New prescriptions for Bristol-Myers Squibb's Pravachol have increased 22% since the withdrawal of Bayer's Baycol, Bristol CEO Peter Dolan told a Bear Stearns healthcare conference call Sept. 25.

"New prescriptions are up more than 22% since the withdrawal of Baycol," Dolan said. "Total share has moved from 12.5% before the Baycol recall to 14.7%, and we're seeing excellent growth outside the U.S. as well."

Bayer announced the withdrawal of its cholesterol drug Baycol (cerivastatin) Aug. 8 due to reports of rhabdomyolysis.

Pravachol (pravastatin) began gaining market share in the early days following the Baycol withdrawal. According to prescription tracking data from the newly formed ArcLight service, Pravachol held just over 11% of the statin market before the Aug. 8 announcement; as of Aug. 10, its share had moved up about five percentage points (¹ (Also see "Baycol Withdrawal Gives Boost To Pravachol; Will Crestor NDA Be Affected?" - Pink Sheet, 13 Aug, 2001.)).

Since the Baycol withdrawal, Bristol's promotional efforts have focused on the safety profile of Pravachol.

"One of the reasons that you saw the significant share gain by Pravachol during that initial period of time was...the very rapid response by our sales force and marketing team...to re-disseminate information on our safety profile," Bristol U.S. Medicines and Global Marketing President Richard Lane said.

"We are aggressively sending the message that extensive long-term clinical trials show the safety profile of Pravachol to be unsurpassed," Dolan added.

The company emphasized the 20,000-patient safety database generated through the recent pooling of three long-term, placebo-controlled Pravachol studies: CARE (Cholesterol and Recurrent Events), LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) and the West of Scotland Coronary Prevention Study.

The "analysis provides reassuring data that during a prolonged exposure, [pravastatin] 40 mg is well tolerated with no augmentation in non-cardiovascular serious adverse events including liver function abnormalities and laboratory and clinical evidence for myositis," a study abstract states. Data from "the prospective pravastatin pooling project was presented at the European Society of Cardiology annual meeting" held in Stockholm, Sweden Sept. 1-5, Dolan said. Worldwide Pravachol sales for the first half of 2001 increased 10% to $955 mil.

Bristol is conducting a head-to-head comparison trial, PROVE IT (Pravastatin or Atorvastatin Evaluation and Infection Therapy), between Pravachol and Pfizer's Lipitor (atorvastatin).

Launched in November 1999, the 4,000-patient study is comparing the effects of the statins in reducing the risk of heart attacks and other cardiac events. Bristol hopes the trial will show that "it isn't necessarily how much you lower cholesterol that provides the mortality benefit," Lane said. The trial is targeted for completion in 2003.

Bristol is also evaluating Pravachol in "the PROSPER study, which is looking at the use of Pravachol in elderly patients to evaluate whether there is a benefit in cognitive function," Lane said. Results of the five-year study are expected in late 2002.

Pfizer is evaluating Lipitor for the treatment of patients with mild Alzheimer's disease. The Institute for the Study of Aging is providing $450,000 towards the Phase II placebo-controlled trial. Final results from the trial, being conducted at the Sun Health Research Institute in Sun City, Ariz., are expected in 2003.

Bristol updated analysts on its plans for the antihypertensive Vanlev (omapatrilat), announcing that it plans to re-file an NDA for treatment of hypertension by year-end. Bristol withdrew the NDA for Vanlev in April 2000 due to FDA concern about the incidence of angioedema (² (Also see "Bristol Vanlev Launch Resources Will Shift To Pravachol; NDA Withdrawn" - Pink Sheet, 24 Apr, 2000.)).

"We've now completed our analysis of the results of the OCTAVE [Omapatrilat Cardiovascular Treatment Assessment Versus Enrollment] clinical study for Vanlev," Dolan said. "We're trying to get our submission of this very large study to the agency by year-end."

The scheduling of an advisory committee review for Vanlev will be discussed after the NDA is re-filed, Chief Scientific Officer Peter Ringrose, PhD, said. "There is a meeting for the cardiovascular division scheduled for I think May of next year, so we will know near the time of that."