Washington Editor

Taking the opportunity to leverage its commercial expertise with the product TOBI, Chiron Corp. acquired exclusive worldwide development and commercial rights to a product being developed by Novartis AG.

The product, aerosolized cyclosporine, referred to by the companies as ACsA, is a therapy under evaluation for the treatment of acute rejections in lung transplant recipients.

And TOBI, a tobramycin solution for inhalation, is marketed for the management of cystic fibrosis patients infected with Pseudomonas aeruginosa. According to Emeryville, Calif.-based Chiron, cystic fibrosis is a leading cause of lung transplantation, along with emphysema, pulmonary fibrosis and pulmonary hypertension.

"In the grand scheme of things, this is probably a tiny product for Chiron; it's very much a niche product," Tom Shrader, biotechnology analyst with Gerard Klauer Mattison & Co. in New York, told BioWorld Today. "It's a reformulation of cyclosporine, a common immunosuppressant used for transplants and many other things. But this is a slightly different way of delivering it, which is ideal for lung transplant patients."

ACsA is inhaled, so the drug goes directly to the lungs. However, cyclosporine, in its current form, is an oral product, meaning its toxicities could enter other areas of the body.

Shrader said ACsA is a nice fit for Chiron because TOBI's sales force already visits pulmonary physicians. "People with cystic fibrosis, as well as people after lung transplants, are liable to see the same physician, so it's additional revenue for Chiron without having to add a sales force."

Regarding the financial arrangement surrounding the licensing, John Gallagher, Chiron's media relations manager, told BioWorld Today that terms were undisclosed.

ACsA has not received marketing clearance, nor has it been named. Chiron acquired it based on data from a number of clinical studies in lung transplant patients, with about 100 subjects studied at the University of Pittsburgh.

"We're looking at the data with the FDA in hopes that they will accept it as an equivalent to Phase III studies," said Gallagher, who suggested that under the best circumstances, ACsA could reach the market by 2005.

A research note released by Shrader said data from 15 patients presented at the 23rd annual meeting and scientific sessions of the International Society for Heart and Lung Transplantation showed that the aerosolized form of cyclosporine allows for improved lung function in lung transplant patients.

"Importantly, patients who deposited greater amounts of the drug had better lung function over the course of the two-year study than patients who deposited less after inhalation or patients who inhaled a placebo spray - indicative of a dose response," the note said.

While ACsA would be an orphan product in the lung transplant indication, Shrader believes it could be expanded to larger settings.

As an orphan drug in the U.S., ACsA could generate anywhere from $20 million to $50 million annually for Chiron, Shrader said. It would cost between $10,000 and $20,000 per year per patient (the oral form of cyclosporine is about $6,000 per year per patient).

Last year TOBI's worldwide sales were $147 million.

Chiron's stock (NASDAQ:CHIR) closed Tuesday at $40.48, up $1.