Acrux sees opportunity in competitor's FDA hiccup

Acrux (ASX:ACR) CEO Igor Gonda says the failure of Proctor and Gamble (P&G) to gain approval from an FDA advisory panel for its testosterone patch to treat low libido in surgically menopausal women presents a good opportunity for Acrux and its US development partner Vivus to catch up.

Acrux and Vivus are developing a testosterone spray based on Acrux's metered dose transdermal spray (MDTS) technology, and expect to commence Phase III trials next year.

"A problem for a competitor is an opportunity for us," Gonda told Australian Biotechnology News. "The gap has been significantly narrowed."

With P&G now expected to delay its launch of its product Intrinsa until 2006 or 2007, Gonda said its own product development could catch up and the company potentially launch its testosterone spray soon after Intrinsa reaches the market, giving it the chance to capture a greater market share.

Gonda said it was too early to know exactly what the consequences of the FDA advisory panel's Intrinsa decision would be for Acrux. But the company is meeting with the FDA in the first quarter of 2005 to plan its Phase III trial and is likely to work closely with the agency on the trial design.

One difference between Acrux's product and P&G's is that while P&G has only tested Intrinsa in surgically menopausal women treated with oestrogen, Acrux has already gathered some evidence from the use of its treatment in pre-menopausal women with libido problems.