B-MS REVEALS PMS PLANS FOR ZERIT

Bristol-Myers Squibb launched Zerit (stavudine) for AIDS to American wholesalers on July 8, after the June 24 approval of the drug in the USA (Marketletter June 27). The company has set an average wholesale price of $186.72 for a 30-day supply of 40mg tablets, which equates to a daily cost of therapy of around $6.22.

Because Zerit was approved using the Food and Drug Administration's accelerated approval procedure, B-MS has agreed to carry out further "adequate and well-controlled studies to verify and describe clinical benefit." The company has two studies underway to measure clinical endpoints (protocols AI4455-019 and AI455-020), and will also carry out optimal dosing studies. If the studies, which require that B-MS supply quarterly data on deaths, clinical endpoints, patients lost to follow-up and study medication discontinuation, do not verify the safety and/or efficacy of the drug, the company will have to withdraw the drug.

AI455-019 is expected to be the key trial for this post-launch phase, as the interim results of this study were the basis of the accelerated approval. B-MS also has Phase IV studies planned to study Zerit in the USA and Europe as a first-line therapy in early infection, and is also carrying out a Phase I study in children.