BioWorld International Correspondent

LONDON - Reproductive health specialist Ardana Bioscience Ltd. made further progress with its target of transforming from a research-based start-up to a fully fledged pharmaceutical company, acquiring marketing rights to a novel testosterone patch.

The US$8 million deal with Columbia Laboratories Inc. gives two-year-old Ardana rights in all key European markets, excluding Italy, on a product that is expected to launch at the start of 2004.

Ardana has no sales and marketing operation. CEO Simon Best told BioWorld International that Columbia was persuaded to do the deal because "Ardana has the necessary expertise and know-how." The management team includes Chief Operating Officer Maureen Lindsay, a former marketing director of Pharmacia UK, who was responsible for launching a number of drugs in the UK in the late 1990s. She also ran Pharmacia's New Zealand operations.

"In other words, my right-hand person has very strong sales and marketing skills," Best said.

Ardana has made a pro forma agreement with a contract sales company and it will now be finalized.

The $8 million will be paid in tranches of $4 million in the first 12 months against further regulatory milestones, $2 million on approvals and $2 million on sales targets.

Columbia is handling all approvals for the product, a controlled- and sustained-release bioadhesive patch containing 30 mg of testosterone, which it submitted for FDA approval in August.

"The package has been converted for Europe and will be filed in November," Best said. "We don't foresee any problems, as this is a new way of delivering an existing therapy."

The primary indication is male hypogonadism, experienced by men who produce insufficient levels of testosterone. The patch adheres to the patient's gums, raising levels of the hormone for 12 hours. "Testosterone is difficult to deliver and we think this product will expand the market," he said.

Ardana, based in Edinburgh, has raised £14.6 million (US$22.6 million) in two rounds since it was spun out of the Medical Research Council's Human Reproductive Sciences Unit in July 2000. All the programs based on MRC research are preclinical, but in July Ardana secured two products in clinical trials when it acquired Europeptides GEIE of Paris, for €28 million.