FIRST APPROVAL FOR AMPHOCIL

The UK's Medicines Control Agency has become the first regulatory authority in the world to approve Liposome Technology's Amphocil (liposomal amphotericin B). Amphocil has been approved for treating fungal infections in cases where toxicity or renal failure precludes the use of conventional amphotericin B, widely-used as a broad-spectrum antifungal agent, or in cases where prior systemic antifungal therapy has failed.

Liposome Technology has announced an agreement with Zeneca Pharmaceuticals covering the European marketing and distribution of Amphocil (Marketletter August 23). The deal gives Zeneca exclusive rights to market and distribute Amphocil in Europe; Liposome Technology will sell the product to Zeneca for distribution and, based upon achievement of other regulatory and sales goals over the lifetime of the agreement, will receive upfront and milestone payments totalling approximately $20 million.

In addition to the UK, Liposome Technology has filed for approval for Amphocil in Ireland and Austria, and with Zeneca will now expedite regulatory filings over the rest of Europe. And the development of Amphocil continues - Phase III trials of Amphocil in patients with underlying kidney malfunction for whom conventional amphotericin B therapy is contraindicated, and in patients with systemic fungal infections such as aspergillosis, are ongoing. Liposome Technology plans to file a New Drug Application with the US Food and Drug Administration as soon as current Phase III studies are complete.