InterMune Inc. has sold its anti-infective drug, Amphotec, to Three Rivers Pharmaceuticals LLC as part of a previously announced plan to narrow its therapeutic focus.

As a result, Three Rivers, based in Cranberry Township, Pa., gains worldwide ownership to Amphotec, approved for the treatment of invasive aspergillosis, a fungal infection that occurs in patients with compromised immune systems. Though financial terms were not disclosed, the transaction was described as a "complete divestiture" and will not affect InterMune's revenue guidance of $140 million to $160 million for 2005, said Judy Hayes, spokeswoman for InterMune.

The Brisbane, Calif.-based company began reorganizing in early 2004 to reduce its burn rate and refocus its drug development efforts on the "product pipelines that had the most promise," Hayes said, namely hepatology and pulmonology. (See BioWorld Today, Feb. 12, 2004.)

Amphotec (amphotericin B cholesteryl sulfate complex for injection), which InterMune had acquired from Mountain View, Calif.-based ALZA Corp. in January 2001, "just didn't fit in with that strategy," Hayes told BioWorld Today.

Last year, sales of Amphotec plus other revenue totaled about $3.7 million. In contrast, InterMune's top-selling drugs, Actimmune and Infergen, posted sales of $125 million and $22.3 million, respectively.

While InterMune is narrowing its pipeline, Three Rivers has been working to expand its own. Founded in 2000, the privately held, specialty pharma firm has one drug on the market, a generic version of ribavirin approved in April to treat hepatitis C virus. Amphotec will be the company's second marketed product and first original formulation drug.

"We're very pleased to have this in our portfolio," Paul Fagan, executive vice president of Three Rivers, told BioWorld Today. Amphotec "fits into our niche" of products and "presents an opportunity for us domestically and internationally."

The acquisition agreement was signed and executed May 20.

With its refocused pipeline, InterMune is developing several late-stage programs. In hepatology, the company has initiated a Phase III trial for once-daily dosing of Infergen plus ribavirin to treat chronic HCV patients who are "PEG nonresponders," meaning they have not responded to pegylated interferon alpha-2 plus ribavirin. About 50 percent of HCV patients do not respond to first-line treatment, Hayes said.

The 500-plus-patient trial is expected to complete enrollment during the third quarter, with data available in the first half of 2007.

The company already markets Infergen (interferon alfacon-1) as a three-times-per-week administration in HCV patients with compensated liver disease and in patients who failed to respond to prior interferon therapy. A Phase IIb study also is ongoing to evaluate daily Infergen in combination with daily Actimmune (interferon gamma-1b).

Researchers reported positive preclinical data from its HCV protease inhibitor program earlier this month at the Digestive Disease Week meeting in Chicago. Two small-molecule compounds demonstrated that they selectively targeted the liver, did not present adverse impacts to the heart or liver, and were well tolerated.

On the pulmonary side, the company has an ongoing Phase III study of Actimmune in idiopathic pulmonary fibrosis (IPF). About 600 patients are expected to be enrolled by the end of this year for two years of treatment. Data are expected early in 2008.

Actimmune has received FDA approval in two indications: chronic granulomatous disease and severe, malignant osteoporosis.

The company also plans to initiate a Phase III trial of pirfenidone, an oral, small molecule licensed from Dallas-based Marnac Inc., in IPF during the first half of 2006.

When putting its refocused corporate strategy into play last year, InterMune ceased activities on all programs not related to hepatology or pulmonology, except for one ongoing trial of Actimmune in ovarian cancer. Hayes said the company decided to keep that program because "we'd already enrolled the majority of the patients and the investment was already made."

The trial has enrolled more than 800 patients, and an interim analysis is expected during the fourth quarter.

InterMune posted a net loss of $15 million, or 47 cents per share, for the first quarter. As of March 31, the company had $166.4 million in cash, cash equivalents and marketable securities.

Shares of InterMune (NASDAQ:ITMN) lost 20 cents Wednesday to close at $11.93.