MASON — Procter & Gamble Co. sees 15 million female consumers who need its product, and billions of dollars in potential sales.

        Those women see the ability to enjoy sex again.

Dr. Johna Lucas, a Procter & Gamble researcher, holds the company's Intrinsa female testosterone patch. (Michael Snyder photo) | ZOOM |

        That's the marketing match driving research on the product that P&G hopes will be its next billion-dollar blockbuster.

        It's called Intrinsa, a testosterone patch to increase the sex drive of post-menopausal women. And it's a long way from the Crest toothpaste, Ivory soap and Tide detergent that have defined P&G for more than a century.

        While clinical trials are continuing and Intrinsa won't hit the market for several years, the stakes are high for P&G.

        The Cincinnati-based giant will spend several hundred million dollars on Intrinsa, and it needs lots of home runs in the fledgling pharmaceutical business to establish itself as a major player and a consistent profit center.

        “Intrinsa is a pretty strong statement that P&G is looking at unmet needs of women,” said Mark Collar, president of P&G Pharmaceuticals. “I view female sexual dysfunction as a place where we have an opportunity to help a lot of women and create a lot of shareholder value.”

        Many think the time is ripe. Four out of every 10 women aged 18 to 59 experience sexual dysfunction, such as low libido or inability to achieve orgasm.

        And three years ago, drug giant Pfizer reached the parallel market for men with Viagra. Pfizer has reaped the benefits with more than $1.5 billion in annual sales.

        Pfizer — and television pitchman Bob Dole — put sexual dysfunction into everyday conversation. Researchers at P&G's sprawling Health Care Research Center off Mason-Montgomery Road are avoiding the Viagra comparison, not wanting to position Intrinsa as a “lifestyle drug.”

        But after interviewing hundreds of post-menopausal women in focus groups, they have heard the message that sexual dysfunction is not merely an inconvenience and not a joke.

        “I haven't researched this situation for men, but I know for women this is not a Friday-night problem,” said Melisse May, brand manager for Intrinsa in Mason. “It's an everyday problem.”

        The patch, nearly transparent and about the size of an egg, is worn on the abdomen, just below the navel. It is changed about twice a week.

        P&G, and its partner Watson Pharmaceuticals, which originally developed the technology, have been interviewing women in focus groups about female sexual dysfunction for several years.

        “It wasn't that I wasn't able to climax and really enjoy it,” said one patient named Carol, in comments provided by P&G. “It was that I couldn't even get aroused.

        “It was like I was just dead, and it really bothered me.”

        That is the message that marketing groups at P&G already are preparing, that Intrinsa can restore post-menopausal women to their natural estrogen levels, leading to increased sexual enjoyment.

        “They feel almost cheated,” said P&G's Ms. May, who has listened to several P&G focus groups on the subject. “For them, sex is part of being healthy.”

A medical problem

        Dr. Molly Katz remembers the day several years ago when a doctor appeared on the Oprah Winfrey Show and touted a new vaginal testosterone gel. By the next day, she had an indication of how widespread the problem of female sexual dysfunction had become.

        “Our message machine was full the next morning,” she said.

INTRINSA TESTS

Tristate women who have gone through menopause can participate in the next level of testing of Procter & Gamble Co.'s new Intrinsa female testosterone patch.     This spring, P&G will start recruiting women for its Phase III clinical trials. Several of the 150 global sites will be in this region, including one at the University of Cincinnati.     The test will include about 2,000 women worldwide, including close to 50 in the Tristate.     They will wear the clear adhesive patch on their lower abdomen for a year, with nine visits to be evaluated. Some will wear placebo patches.     To be eligible, patients must:     • Have gone through menopause, either surgically or naturally.     • Be on estrogen replacement therapy.     • Be suffering from low libido.     The data from the Phase III trials will form Procter's New Drug Application to the U.S. Food and Drug Administration. The FDA will determine if P&G will be allowed to market the drug.     For more information or to register, call (877) 290-2379 and leave your name and contact information.

        Dr. Katz, whose gynecological practice is in Mount Auburn, was a principal investigator in P&G's Phase II clinical trials for Intrinsa that finished last year, and her practice will be one of three Greater Cincinnati sites for the Phase III trials starting later in February.

        She said low sexual desire is a consistent problem with women starting in their 40s. Intrinsa will be welcome because it returns post-menopausal women to the testosterone levels they had before menopause, she said.

        “I think it's a wonderful idea, but I also think that expectations need to be realistic,” Dr. Katz said. “The relationship is different for women than it is for men. It's not just a matter of getting them to want to have sex. They want to have an interaction.

        “It isn't going to fix everybody,” she said. “It's going to be a relatively subtle effect.”

        Testosterone is a hormone usually linked to male sex drive, but at some levels, it also is a driver of female libido. In post-menopausal women, testosterone production is reduced, studies have shown.

        A New England Journal of Medicine article on previous clinical studies showed that at higher doses, the percentage of women who had sexual activity at least once a week increased two to three times compared with those who had not taken the testosterone.

        Dr. Johna Lucas, medical director overseeing of the project for P&G, said one of the major advantages of Intrinsa was the patch, which keeps a constant flow of testosterone into the system and enables the delivery of natural testosterone.

        “You shouldn't get peaks and valleys like you do with gels or creams,” Dr. Lucas said.

        She also said that in clinical trials so far, there has been no difference between the Intrinsa patch and placebo patches in side effects for patients.

        Dr. Katz agreed that in clinical trials, most women seem to prefer a patch.

        Dr. Denise Davis, a gynecologist based in Montgomery, said decreased sexual desire is a frequent complaint of women in their 40s and 50s.

        “It's a very trying time in a woman's life cycle because she's got the stresses of her kids and she's got stresses of her parents,” Dr. Davis said.

        “Most people now know that there are things we can do. When they come in, it's on their list to talk about.”

A business case

        Intrinsa is only one of about 30 products in the pharmaceutical pipeline at P&G's Mason facility. The unit introduced the Actonel osteoporosis drug in 1999, and that product rang up $275 million in sales in calendar year 2001.

        P&G Pharmaceuticals has turned the corner into profitability, with $1 billion in sales in calendar 2001.

        While Actonel is the current standard-bearer, Intrinsa is one of a handful of pipeline products that have that kind of potential, Mr. Collar said.

        That's important in what he called a “shots-on-goal business.”

        Other products in the pipeline include Stedicor, an anti-arryhthmia drug, and Pexelizumab, for patients undergoing coronary bypass surgery.

        That's critical in helping pharmaceuticals meet P&G's standards, chief executive A.G. Lafley said in a recent conference call with Wall Street investors.

        “I believe w're still very much on a steep learning curve in pharmaceuticals,” Mr. Lafley said. “We're getting up it really fast, but we've got to remind ourselves we've only been in this business for 15 years, and only really been investing in it for seven or eight years.”

        In P&G's corporate structure, pharmaceuticals is lumped with Iams pet food and Crest toothpaste in the Health Care group. That group is easily the fastest-growing in the company, with sales up 17 percent in the just-announced second quarter.

        With the pharmaceutical unit now profitable, P&G is positioned to get some benefit, said Bill Steele, who studies P&G for Banc of America Securities in San Francisco.

        “They've been investing behind these initiatives for a while now, and it looks like they're very close to bearing some fruit,” he said.

        Intrinsa meets all of P&G's traditional criteria for new products: a consumer need not met by any other product, high technological barriers that P&G might attack more easily, and a target audience full of women and baby boomers.

        That has worked with some products, such as Actonel and Whitestrips teeth whitener. It has not with others, such as Olean fat substitute and the Dryel home dry-cleaning kit.

        P&G first licensed the technology on the natural testosterone delivery from a company called TheraTech starting in the mid-1990s, and is continuing to file for patents as the technology progresses, a spokeswoman said.

        A spokesman at Watson Pharmaceuticals, the company that bought TheraTech, referred all comment to P&G.

        Seeing the same consumer opportunity as Procter, several big drug companies are testing alternatives. They range from battery-operated devices to pills to creams to other transdermal patches.

        But there is nothing on the market specifically indicated for female sexual dysfunction, Mr. Collar said.

Hopes tempered

        Dr. Katz warned against high expectations.

        “Unless you have that satisfactory relationship, it's not going to make that much difference,” she said.

        Mr. Collar said P&G has started informal discussions with health insurers about whether Intrinsa can be covered. He's aware of the controversy over Viagra, which is covered by most health plans.

        But one thing P&G will not allow is “lifestyle” prescriptions to customers who do not medically face a testosterone deficiency.

        “We'll work very hard to label it appropriately for women who have a sexual dysfunction and see it prescribed only to women who need it,” Mr. Collar said.

        But that is enough people that P&G thinks it can quickly get Intrinsa to a market-leading position.

        “It reinforces for me that we can compete effectively in areas in which we choose to focus.”
       

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