When Three Rivers Pharmaceuticals finally gets a product to market, the biggest expenses won't have been for research and development, manufacturing facilities, glitzy marketing or any of the big-ticket items usually associated with launching prescription drugs.
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Instead, the money it spent breaking into the business will be lining lawyers' pockets.
The upstart generic developer has been locked in litigation with pharmaceutical industry heavyweights since October 2001, two months after it sought U.S. Food and Drug Administration approval for a generic version of Ribavirin, one of the leading drugs used to treat the liver disease Hepatitis C.
The battle so far has cost $5 million, said Three Rivers President Donald Kerrish.
But last week, Three Rivers and two other generic developers made significant headway, winning a U.S. District Court ruling that their products don't infringe patents held by Ribapharm Inc. or its majority owner, ICN Pharmaceuticals. Ribapharm, which makes Ribavirin, and ICN said they'd appeal and warned that any company that proceeds based on FDA approval alone might be subject to stiff federal penalties if it's ultimately found to be infringing on patents.
Neither Kerrish nor Paul Fagan, Three Rivers' executive vice president and general counsel, would say whether the company is prepared to take that risk.
But Three Rivers isn't waiting for the outcome to move forward with a business agenda that's expanded quite a bit in the two years since the company filed the Ribavirin application, its first, with the FDA.
"We would love to go from one drug to maybe as many as six to 10 very quickly," Kerrish said.
The company, funded by private investors, expects to file at least one more application with the FDA by year-end.
Citing the competitive and litigious nature of the industry, Kerrish and Fagan declined to disclose specifics about the drug candidates Three Rivers is pursuing.
But they said the kinds of compounds the company generally is targeting aren't those with sales in the hundreds of millions of dollars that bigger players usually need to pursue.
"Not every drug we go after has to be a quote, unquote, 'blockbuster,' " said Fagan. "I don't think we'd ever do a generic Prozac. We look for those smaller, lower-volume but unique kinds of drugs."
Nor is Three Rivers limiting its opportunities to copies of brand drugs coming off patent.
It's developing a proprietary product in a venture with Par Pharmaceuticals, a subsidiary of Pharmaceutical Resources Inc., based in Spring Valley, N.Y., Kerrish said. Par and Three Rivers a year ago forged an agreement under which Par would market Three Rivers' version of Ribavirin.
Three Rivers also is looking at some drugs that already exist in generic form.
For example, existing generics can offer opportunities to new players who come up with "a twist," such as greater palatability or convenience, said Kerrish.
Those might sound like ambitious plans for a company that still hasn't landed a drug approval or won the final battle in the courtroom war over Ribavirin. But if it does, it would likely soon have a war chest for any future legal challenges: Ribavirin's worldwide sales are estimated at more than $1 billion, and the form of Hepatitis it is used to treat is becoming epidemic -- transmitted in contaminated blood, often among drug users sharing needles.
Although Three Rivers said it wants to play a role in bringing down the cost -- more than $10 a tablet -- winning a portion of the market still would enable the company to fund projects without feeling as though "you need to hit a home run on every product," Fagan said.
With only seven employees, Three Rivers has kept a tight rein on expenses, running almost as a virtual company, obtaining many of the services it needs rather than staffing them.
And although it intends to maintain a conservative posture, Fagan said, "In a couple of weeks, it may be radically different here than it is today."