West Coast Editor
Aiming its apparently multipurpose Actimmune (interferon gamma-1b) at ovarian cancer, InterMune Inc. said it has begun enrolling patients in a Phase III trial that will study the drug in 800 recently diagnosed patients as an adjunctive, first-line treatment for the fast-moving, often-relapsing disease.
Brisbane, Calif.-based InterMune’s multicenter, randomized trial will evaluate efficacy and safety of Actimmune combined with chemotherapeutic agents carboplatin plus paclitaxel. The endpoints are measures of progression-free survival and overall survival.
“We’ll have an interim look in mid- to late 2005, to look at progression-free survival, and based on that, we may have an opportunity to file a [biologics license application],” said Tim Lynch, chief financial officer for InterMune.
“A condition of approval in 2005 will be that we finish out the trial as planned, and we expect it to finish in 2007,” he said, with an endpoint of overall survival. “If all goes well, we will have a label in 2005 or 2006 and we’ll be able to sell to ovarian cancer patients,” Lynch added.
Ovarian cancer strikes about 23,000 new patients each year, and now afflicts about 100,000 women, making it a leading cause of cancer death. The indication represents a potential market of about $500 million.
“It’s a significant market, it’s a terrible disease, and there’s nothing else out there,” as an adjunctive, first-line therapy, Lynch said.
Actimmune is already marketed in the U.S. for chronic granulomatous disease and severe, malignant osteopetrosis. Planned or under way are multiple Phase II and Phase III clinical studies of Actimmune in such conditions as idiopathic pulmonary fibrosis, cryptococcal meningitis, cystic fibrosis and atypical mycobacterial infections.
In cryptococcal meningitis, InterMune reported positive results from its Phase II trial with Actimmune as an adjunct to conventional antifungals. The drug brought about more rapid clearance of cryptococcus fungus from cerebral spinal fluid, when compared to conventional antifungal therapy alone bolstering InterMune’s commitment to pushing the drug forward, the company said. (See BioWorld Today, Dec. 19, 2001.)
InterMune’s interest in infectious disease led to its buying rights to the late-stage product oritavancin from Indianapolis-based Eli Lilly and Co. for at least $50 million last fall, aiming to pair it with Actimmune as a potential blockbuster. Like Actimmune, oritavancin a semi-synthetic glycopeptide seems to have broad application, and is in development for a range of resistant Gram-positive bacterial infections. (See BioWorld Today, Sept. 21, 2001.)
The same month, InterMune entered a pact worth up to $60 million with Maxygen Inc., of Redwood City, Calif., for help in developing the next generation of Actimmune. Under the terms, InterMune will take into the clinic the potential products created by Maxygen during the next two or three years. (See BioWorld Today, Sept. 6, 2001.)
“We’re plugging along on that,” Lynch said, adding that the companies hope to decide on a lead candidate toward the end of the year and move forward.
Last June, InterMune licensed the FDA-approved hepatitis C therapeutic Infergen (interferon alfacon-1) from Amgen Inc., of Thousand Oaks, Calif., for $21 million in up-front payments, $8 million in near-term milestones, and royalties. (See BioWorld Today, June 18, 2001.)
“We think of Infergen as right up there as another potential blockbuster,” Lynch told BioWorld Today. “We just re-launched it with some important Phase IV data, and it hasn’t been detailed in a couple of years. Now, we’re working on a pegylated version, and we’re looking to get into that near 4-million-patient market.”
The pegylated version would have a $500 million to billion-dollar market, and HCV is a potential $3 billion market, he said.
InterMune’s stock (NASDAQ:ITMN) closed Tuesday at $41.38, up $2.93.