InterMune Inc and MoliChem Medicines Inc announced the initiation of a collaboration to jointly develop and commercialize MoliChem's pulmonary molecule Moli1901 (duramycin) for the treatment of a range of pulmonary indications, including cystic fibrosis.

Moli1901 is a mucoactive drug that the companies believe possesses the capability of modifying mucus composition in the airways. Patients with cystic fibrosis have a deficiency of chloride and water in their airways, which prevents proper removal of mucus. This leads to infections, inflammation, tissue damage, and death. Moli1901 induces the transport of chloride and water in the lungs, which facilitates the removal of mucus from the lungs. Treatment with Moli1901 could reduce recurrent infections, inflammation and tissue damage in patients with cystic fibrosis. Moli1901 is currently in a Phase I clinical trial for the treatment of cystic fibrosis.

Cystic fibrosis is the most common inherited fatal disease among Caucasians in the United States. The average life expectancy of a patient with cystic fibrosis is 32 years. There is no cure for cystic fibrosis, and the standard treatments, including antibiotics and mucus thinning therapies, are sub-optimal.

"We are pleased to add such a promising new drug to our pipeline," said W. Scott Harkonen, President and CEO of InterMune. "This transaction broadens InterMune's product pipeline and maintains our focus on life-threatening pulmonary and infectious diseases. We plan to continue the expansion of our product portfolio through the strategic in-licensing of development-stage and marketed products."

"This joint development and commercialization structure offers both companies great opportunity for expansion and advancement of our respective goals," said Luis Molina, MoliChem Founder and President. "It capitalizes on InterMune's resources and experience in pulmonary disease and provides a shared strategic approach to developing and marketing Moli1901."

The terms of the collaboration include an upfront payment of $1.5 million to MoliChem as well as the payment of development milestones to MoliChem for each indication of use. The parties will jointly develop and commercialize Moli1901 for all indications worldwide, sharing all expenses and profits equally. InterMune will lead the commercialization efforts for Moli1901.

Moli1901 is currently in a Phase I safety and pharmacokinetic study in cystic fibrosis patients by aerosol administration, which will soon be completed. The companies expect to begin a Phase II clinical trial for the treatment of cystic fibrosis in the second half of 2001. Cystic fibrosis affects approximately 30,000 individuals in the United States, which represents an annual market opportunity of up to approximately $500 million.