BioWorld International Correspondent

LONDON - Ardana Bioscience Ltd. acquired the outstanding marketing rights to Teverelix, a gonadatrophin-releasing hormone antagonist, in Japan, Korea and Taiwan, and took full rights to the microcystalline suspension technology underpinning the drug's sustained-release formulation.

The terms of the deal with Zentaris GmbH, of Frankfurt, Germany, were not disclosed, but Simon Best, CEO of Ardana, told BioWorld International there was no increase in costs over the existing deal. "We are shifting from payments against milestones to a series of fixed payments to be paid on a particular date," he said.

Best said the development of Teverelix is going so well that Edinburgh, Scotland-based Ardana wants to lock down all rights. Zentaris, a subsidiary of AEterna Laboratories Inc., of Quebec City, Quebec, will continue to provide development services and supplies of the drug.

Ardana acquired all other rights to Teverelix in July 2002 when it bought Zentaris subsidiary Paris-based Europeptides GEIE, a specialist in peptide drug delivery, for €28 million. Since then, the drug, which has the potential to treat prostate cancer, benign prostate hyperplasia (BPH) and endometriosis, has progressed through Phase I in the male indications. (See BioWorld International, July 17, 2002.)

At the time of the acquisition, Ardana said it would select one indication for further development, but now Best said the drug "is looking so good we intend to take it forward in all three indications, and this strengthens our desire to control the full rights."

Phase II trials in prostate cancer and BPH will start later this year, along with a Phase I trial in endometriosis. "The dosage regimens we have worked on so far are in the male indications, and as females respond differently to these drugs we need to do another Phase I for endometriosis," he said.

Ardana also has its first product launch coming up later this year, after partner Columbia Laboratories Inc., of Livingston, N.J., last month won UK marketing approval for Striant, a controlled-release formulation of testosterone for male hypogonadism.

"It will take a few weeks for Columbia to transfer the marketing rights to us, but we have ordered supplies of the product and expect our first sales before the end of the second quarter," Best said. Ardana also has begun the mutual recognition process to get Striant, a testosterone patch that adheres to the gums, registered in other European countries, and has hired a contract sales force.

Ardana previously announced its intention to in-license another near-market product, and Best said due diligence is complete and the company has started contract negotiations. Although he declined to give details, he said the product would be aimed at the same doctors who prescribe Striant.

Best is "watching the opportunity" for an initial public offering and has appointed advisers, but said the company would not be under pressure to raise money via that route if the market was not receptive. "We are in the nice position that we can raise money privately or publicly. The current investors are keen to give us more [money], and we will also have revenues very shortly," he said.

"We have got so many [news] events in the next six to nine months that will add value, so there is a trade off between [an earlier IPO] and waiting until then," he added.

Ardana was set up to commercialize research from the UK Medical Research Council's Human Reproductive Sciences Unit. That has yielded promising research, but the projects are at an early stage, and Best's strategy has been to pursue later-stage products. The company has raised £34.5 million (US$66.4 million) since its formation in July 2000.