Raising $50 million in a Series E financing, Intarcia Therapeutics Inc. intends to advance its lead breast cancer drug, Atamestane, through late-stage trials, while ramping up development on its second product for hepatitis C.

Having raised a total of $150 million since its 1997 inception, Intarcia's latest financing is a big one and should last the Emeryville, Calif.-based company well into 2006, said its president and CEO, Alice Leung.

"The $50 million will allow us to continue our Phase III program for Atamestane and allow us to move forward with Omega Duros in hepatitis C," Leung told BioWorld Today. "We're very excited about these programs."

Intarcia is focused on developing therapies to treat cancer, as well as immunological and infectious diseases. The company changed its name in September from Biomedicines Inc. The new name comes from an Italian art form called Intarsia in which Renaissance artisans created inlaid mosaics out of various types of hardwoods.

"We feel that it actually approximates what we do and how we think about things," Leung said, "because we all have different experiences and a different knowledge base."

Leung joined Intarcia in April after serving as vice president, general manager of the oncology business unit at Berlex Laboratories, the U.S. affiliate of Berlin-based Schering AG.

Intarcia's lead product, Atamestane, is an oral steroidal aromatase inhibitor. In a Phase II trial, the product was shown to be active as hormonal therapy in women with hormone receptor-positive advanced breast cancer. The women enrolled in the trial had recurrent breast cancer that had progressed while on tamoxifen. Intarcia acquired rights to the product in 1999 from Schering.

Data in more than 1,000 patients indicate Atamestane is well tolerated and has adverse events similar to other aromatase inhibitors. The compound entered Phase III testing in the U.S. and Europe in 2002.

Intarcia aims to demonstrate that Atamestane in combination with an estrogen receptor blocker with low intrinsic estrogenic activity will be more effective than existing therapies in preventing disease progression. A second Phase III trial is being initiated in the U.S. and Europe.

The market is large, Leung said, because there are few options for women who fail other therapies. Five-year sales of the drug could reach $500 million worldwide, she said.

"If we are fortunate, we could be on the market in 2007," Leung said. "The first Phase III will complete accrual by the end of this year."

Another product in Intarcia's pipeline, omega interferon, is a naturally occurring human Type I interferon manufactured using a genetic engineering process that came from Boehringer Ingelheim GmbH, of Ingelheim, Germany. Intarcia has completed Phase Ib testing in the U.S. in patients with interferon-resistant hepatitis C, and Phase II testing in Europe in interferon-na ve hepatitis C. Results show dose-related antiviral activity, and the company now is studying the therapy given as an injection in combination with ribavirin.

Omega Duros enables the continuous delivery of omega interferon for three or more months with a single administration via a subcutaneous implant, according to data from animal studies. Intarcia acquired rights from ALZA Corp., of Mountain View, Calif., to the FDA-approved delivery system, and intends to file a U.S. investigational new drug application in 2005 to start clinical testing. Currently approved therapies for hepatitis C require injections from 48 to 336 times each year.

"It would certainly be a new way to deliver interferon," Leung said. "It would allow patients to be a lot more compliant to therapy."

Intarcia also is studying earlier stage products, such as Biomed 101, an oral drug designed to inhibit inflammation and damage to tissues or cells caused by chemotherapy. The therapy most recently was in Phase Ib/II testing in patients with renal-cell cancer.

"These programs are still in our portfolio but because of prioritization they haven't receive a lot of active development," Leung said.

Intarcia's current strategy is to partner its products for commercialization, but one day would like to market its products alone.

Key investors in the Series E were Alta Partners, of San Francisco; New Enterprise Associates, of Baltimore; Venrock Associates, of Menlo Park, Calif.; and new investor Granite Global Ventures, of Menlo Park, Calif.

As part of the financing, David Ebersman, Joel Kellman and Glen Sato were appointed to the company's board. Ebersman is South San Francisco-based Genentech Inc.'s senior vice president of product operations and a member of the executive committee. He will become Genentech's chief financial officer in March 2005. Kellman is a founding managing director of Granite Global Ventures, and Sato serves as Fremont, Calif.-based Protein Design Labs' senior vice president and chief financial officer.

Two current board members, Brian Atwood and Paul Nicholson, are stepping down.

Intarcia filed for an initial public offering in late 2000, hoping to raise $57.5 million, but the company withdrew the filing the following April due to market conditions. (See BioWorld Today, Nov. 7, 2000.)

Leung said that with appropriate market conditions and valuation, Intarcia would try for another IPO.

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