InterMune Inc. licensed worldwide rights to develop and commercialize pirfenidone for all fibrotic diseases, including renal, liver and pulmonary fibrosis a drug candidate that plays right into the company’s field of expertise.
InterMune, of Brisbane, Calif., signed an exclusive license agreement with Marnac Inc., of Dallas, and with the company’s co-licensor, KDL GmbH in Basel, Switzerland. In return, InterMune will make an undisclosed up-front payment and pay milestones, as well as royalties.
“As the company continues to grow, we will continue to in-license earlier-stage compounds,” said CEO Scott Harkonen, explaining that it will enable the company’s future growth, and that the company will look at Phase I and preclinical drug candidates.
Harkonen noted that InterMune began with products already approved and on the market. Drug candidates such as pirfenidone nicely complement InterMune’s growing development pipeline, he said.
Pirfenidone, which is at the Phase II stage, is a small-molecule chemical entity and not a biotech drug candidate, like the company’s Actimmune, or injectable interferon gamma-1b, said James Pennington, executive vice president of medical and scientific affairs at InterMune.
Pennington said InterMune scientists were “very impressed” during the due diligence process regarding the drug candidate’s performance in animal models and with other unpublished data.
“It’s still several years away from completing a Phase III and filing a registration,” Pennington said.
He said the drug appears to down-regulate cytokines that cause fibrosis, including growth factor beta and tumor necrosis factor-beta.
Harkonen said InterMune became aware of pirfenidone through investigators and specialists in the field of fibrosis, noting that this is an advantage to being focused on a particular therapeutic field.
“We know what is on the cutting edge in fibrotic diseases,” Harkonen said.
Pirfenidone is very similar in some ways to Actimmune, the company’s lead drug. Actimmune is approved in the United States for chronic granulomatous disease and severe, malignant osteopetrosis, and is just completing a Phase III trial in pulmonary fibrosis. The results of that trial are expected to be available in October or November.
Actimmune also is in a Phase III trial for ovarian cancer, and in a number of Phase II trials, including one for liver fibrosis, or cirrhosis, caused by hepatitis C virus. (See BioWorld Today, Feb. 6, 2002.)
Another big opportunity for InterMune, Harkonen said, is oritavancin, which it in-licensed from Eli Lilly and Co., of Indianapolis, for at least $50 million in September. Oritavancin is a semi-synthetic glycopeptide in development for a range of Gram-positive bacterial infections, and is considered a potential blockbuster drug. (See BioWorld Today, Sept. 21, 2001.)
InterMune’s stock (NASDAQ:ITMN) rose 28 cents Monday to close at $30.10.