BioWorld International Correspondent

LONDON - Ardana Bioscience Ltd. further cemented its relationship with Columbia Laboratories Inc. as they entered a licensing and development agreement for Columbia's Chronodyne for the treatment of dysmenorrhea, endometriosis and infertility caused by endometriosis.

Ardana will buy into the program, currently in Phase I, with a $250,000 up-front fee and a further $250,000 on completion of Phase II. The partners will share the costs of Phase II trials and all subsequent development.

In October the two companies signed an $8 million deal, giving Ardana European rights to a testosterone patch that Columbia has developed for the treatment of male hypopgonadism. The product, called Striant, was filed for UK approval in December, triggering a $1 million milestone payment from Ardana to Columbia.

Ardana CEO Simon Best told BioWorld International, "We are delighted to get another deal through before the end of the year."

Phase II trials of Chronodyne (terbutaline), a vaginal gel, are planned to take place in the U.S. and Germany in 2003. Best said if they are successful he would expect to complete Phase III early in 2005 and the product to be on the market in 2006.

"This is a global co-development partnership in which we will share costs and marketing rights," he said. Columbia, of Livingston, N.J., will have U.S. rights, Ardana European rights, and the two will share equally revenues from elsewhere.

Terbutaline is already registered for the treatment of preterm labor. "What is different [about Chronodyne] is the formulation for vaginal delivery, which opens up its potential use in these other indications," Best said. "There are few safety issues, and the scale of the trial required to show efficacy in these new indications will be quite small."

Best said endometriosis is a growing market, with the condition causing direct problems of pain, but also being linked to one-third of infertility cases.

"Chronodyne could be a new route to addressing this problem," he said. "We hope this could provide a new option for women before they plunge into IVF [in vitro fertilization]."

The agreement furthers Edinburgh-based Ardana's ambition to transform from a research-based start-up to a fully fledged pharmaceutical company. The company was spun out of the Medical Research Council's Human Reproductive Science Unit in July 2000. All programs based on MRC research are preclinical, but Ardana secured two other products in clinical development when it acquired Europeptides GEIE of Paris in July for €28 million.