By Mary Welch

Bringing its respiratory therapeutic, INS365, to the deal, Inspire Pharmaceuticals Inc. entered its first corporate partnership: a $17.5 million partnership with Kissei Pharmaceutical Co. Ltd.

Matsumoto City, Japan-based Kissei, which has focused on asthma treatments, will use the development of Inspire's drug to enhance its respiratory product line.

"This agreement is exclusive to Japan," said Christy Shaffer, vice president of development for Durham, N.C.-based Inspire. "We will be in talks with major pharmaceutical companies for the rest of the world in the near future."

Under the terms of the agreement, Inspire will receive $17.5 million, consisting of an up-front cash and equity investment, plus milestone payments. Kissei gets rights to market the product in Japan, and access to second-generation analogs of INS365 for respiratory uses.

The inhaled drug stimulates mucociliary clearance by activating the P2Y2 receptor. The receptor is located on the apical surface of specialized cells within the respiratory tract. INS365 is under development for treatment of chronic obstructive pulmonary diseases, including chronic bronchitis.

INS365 recently finished Phase I trials in the United Kingdom. A Phase I trial in the U.S. for mucociliary clearance involving 24 subjects, many of whom are smokers, is expected to finish early next year, with preliminary results likely in October. A second Phase I trial involving 48 children and 48 adults with cystic fibrosis is slated to start in November.

Greg Mossinghoff, senior director of operations and strategic planning for Inspire, said the company first was envisioned as an expert in respiratory ailments. (See BioWorld Today, Oct. 3, 1997, p. 1.)

"That focus has been expanded to include muscosal hydration and epithelial cell biology," he said. "The targets involving these cells are found throughout the body, and we're in the process of initiating a number of preclinical projects around these opportunities. For instance, we're looking at INS365 for dry eye, an ophthalmogical disorder." The drug has shown preclinical efficacy in that indication, Mossinghoff said.

In the collaboration on INS365 for respiratory uses, Kissei will fund development and manufacturing liaison positions for Inspire, and pay royalties on any resulting product sales. *