Company in Waiting - Pharmaceutical Executive

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Company in Waiting
Yamanouchi Pharma America Expects Its First Approval


Pharmaceutical Executive


The Prostate Cancer Education Council reports that overactive bladder affects all ages and both sexes, although women are twice as likely as men to have the condition. The council estimates that 15–30 percent of people over the age of 60 who live at home are incontinent as well as at least half of the 1.5 million Americans who reside in nursing homes.

"It is possible that the size of the market may double over the next ten years," says Kat Neumeyer, a Decision Resources analyst specializing in the OAB market. "There is the baby boom factor. We know the marketers of drugs that target 'old age indications' are going to be very successful. A lot of that has to do with a change in attitudes about medical treatments for non-life-threatening conditions. That growth will be primarily driven by the US because it doesn't have the same issues as Europe does with pharma reimbursement cost control."

Vesicare is the first Yamanouchi therapy to have the same brand name in all markets. "There are synergisms associated with using a common trade name because most professional meetings are attended internationally," says Desjardins. "The American Urological Association (AUA) meeting in Chicago, for example, had a very heavy attendance from Europe and Japan."

Study abstracts, recently presented at the AUA and the American Geriatrics Society, found the efficacy and side effect profile favorable: once-daily administration of Vesicare reduced the major symptoms of OAB, including number of urinations, incontinence episodes, and the urge to urinate.

"There are no head-to-head studies in the United States comparing solifenacin with products already on the market, but according to Phase III data from Europe and the United States, the efficacy looks excellent," says Marc Gittleman, MD, medical director of South Florida Medical Research, who presented the drug's data at the AUA meeting in May.

Gittleman says that most OAB products' efficacies are generally in the same range and typically have the same side effects, such as dry mouth and constipation. But he notes that there is room in the OAB category because patients respond to certain drugs better than others. (See "Heavy Competition," page 46.)

Graham says the company plans to distinguish Vesicare from the other OAB products by playing to the product's strength. That is particularly true if Vesicare has a better side-effect profile than other therapies, says Dan Ollendorf, vice-president of analytic and consulting services for PharMetrics, a provider of longitudinal patient-level data. The results of a survey the company conducted of 250,000 OAB patients found that more than half the sample did not receive any pharmaceuticals. Says Ollendorf, "Physicians are reticent to prescribe prescription OAB therapies because a good many of them carry significant side effects."

Neumeyer says, even if HMOs don't cover the product, Vesicare still has the potential to make its sales mark. "Viagra is hardly reimbursed by anyone anywhere, but it is a blockbuster drug," she says. "There are certain lifestyle drugs that patients will pay for even if they are not reimbursed."

Given the stiff category competition and the fact that Vesicare will be the company's first product marketed in the United States, YPA is looking for a marketing partner to cover primary care physicians. "We will leverage our experience with the urology specialty group and pay for that out of our own coffers," says Graham. "At the same time, partnering with someone who has success in primary care helps manage the risk. It allows us to grow, rather than jump, into the marketplace."

At press time, the company had not yet announced who that partner would be. With approval expected in the first quarter of 2004, that doesn't leave much time to launch a coordinated sales effort. But Graham says YPA is spearheading all premarketing activities right now and will turn over the primary care market when they find the right partner. "We'll be fully prepared when FDA gives us the go-ahead."

The Road Ahead Yamanouchi Pharma America has a lot riding on Vesicare. "If solifenacin is successful, they can afford to reinvest more in the United States, launch more products, and conduct more R&D, which perpetuates growth," says Ferguson. "On the other hand, if it is not successful, they won't have that revenue to reinvest. Vesicare is critical because it will give them an idea of what they can achieve. If it fails, it will set them back quite a long way."

YPA executives are confident about their ability to succeed-and lead the company into a new era. "In the next five years, I would like to establish the urology franchise and then enter into the next franchise to create an even broader and bigger phase of opportunity for Yamanouchi," says Matsubara.

That opportunity will depend on how the company harvests its products in development. (See "Primed Pipe-line," page 40.)

"From a probability of success perspective, Yamanouchi has a blend of low- and high-risk products in development ," says Desjardins. "Developing a drug like Vesicare is a tremendous challenge, but its efficacy is fairly predictable. On the other hand, we're pursuing other drugs such as the hyponatremia/heart failure vasopressin antagonist YM087.

"There are none like it on the market. There is good science behind them, but the ability to predict with certainty that those drugs will work in people is not high. Yet, philosophically, Yamanouchi has the courage, energy, and resources to go after those targets. That certainly makes our job on the science side more interesting."


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