Company in Waiting - Pharmaceutical Executive

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Company in Waiting
Yamanouchi Pharma America Expects Its First Approval


Pharmaceutical Executive



Primed Pipeline
"But it turns out that we were dead wrong. Japan implemented ICH requirements and guidances faster than we implemented them in the West. There was a recognition-typical of the Japanese, perhaps-that in the long term, this would help the Japanese pharma industry by forcing it to globalize."

Under ICH, it was feasible for western pharma companies to launch both new products and a backlog of therapies that had not been marketed in Japan before. That increased the competition, says Lawrence, and caused "Japanese companies to feel threatened on their own ground."

In the same way that Yamanouchi seeks to market its products in the United States, Big Pharma companies may forgo contracting with indigenous companies and sell their drugs directly in Japan. Considering the dearth of NDAs at FDA during the last few years, that means growth opportunities for western pharma companies, according to Datamonitor. It remains to be seen if their growth comes at the expense of revenue for Japanese pharma companies-but it was that threat that finally ushered Japanese companies onto the world stage.

YPA Launch "Yamanouchi is a name that is unknown in the United States as a corporate entity," says Graham. "One of the biggest challenges is to establish it among US healthcare professionals so that when YPA launches a drug, it can focus on product education and selling."


Parent Company
It is true that the company's products have greater name recognition than the corporate brand. Consider Flomax (tamsulosin), a well-known treatment for the symptoms associated with benign prostatic hyperplasia, now marketed by Boehringer Ingelheim. Credit for that goes, in part, to Yamanouchi's business development division which was established in the United States in the early 1980s. Yamanouchi's first agreements from that office also resulted in the licensing of future megabrands such as Cardene (nicardipine) to Syntex (now Roche) and Pepcid (famotidine) to Merck.

Ten years later, Yamanouchi expanded that office to include clinical development capabilities and called it Yamanouchi USA. YUSA consisted of a dozen employees-almost all Japanese expatriates-who worked closely with a clinical research organization to oversee Flomax's development. Despite being new to the agency's guidelines, that group successfully pulled together an FDA submission.

"Unfortunately, we didn't anticipate the opportunity Flomax created early enough to build a [sales and marketing] business for the company," says Desjardins. "Even though it was successful, it had to be out-licensed for marketing. It was clear to me when I interviewed here that Yamanouchi had no intention of letting that happen again."

Although Yamanouchi was one of the first big Japanese companies to arrive in the United States, it was among the last to establish a fully integrated pharma company. But it took steps along that path by creating Yamanouchi Pharma Technologies, which develops drug-delivery systems, in Palo Alto, California, in 1997 and a manufacturing center in Norman, Oklahoma, the following year. In 2000, Yamanouchi Venture Capital opened its doors with the goal of strengthening the company's investments in early-stage biotechnology companies throughout the world.


Roger Graham, Jr.
Corporate Culture Although Matsubara, who company executives affectionately refer to as "Mat," worked at Yamanouchi's Japanese headquarters from 1977 until he came to the United States in 1999, he runs YPA with a decidedly American spirit.

"I didn't find a cultural gap between myself and the American people after I relocated," says Matsubara. "Instead, I feel right at home."

Desjardins says, "Because it is a Japa-nese company, I was concerned that it might be tightly controlled from headquarters or excessively hierarchical. But the style of management is very open and communicative and enjoyable to work in."

Graham adds, "YPA offers the best of both worlds. You are working for an organization which is just getting started in the United States, but there are vast resources to support you."

YPA executives attribute the subsidiary's independence to Takenaka's vision. "In my earliest interview with Dr. Takanaka," says Desjardins, "he said he understood that if we met the standards of product development of the US FDA, we'll meet them anywhere in the world. Certainly, the company has embraced the concept of global product development. And because FDA drives those standards, that places us in a key position here in the United States."


Heavy Competition
Desjardins adds that, although YPA will increasingly play a leadership role, the company will continue to work cross-functionally with its colleagues in Japan and Europe. After all, Yamanouchi conducts all of its discovery research in Japan, but development takes place across the globe. He says, "The ability to file applications for a new chemical entity in many markets at once speaks well of the company's coordination of its development systems and is evidence of its ability to work globally-not a trivial undertaking."

"We were very close to submitting Vesicare in Europe at the same time as in the United States," says Matsubara. "Japan was somewhat later, but in the future we will make product submissions simultaneously."

It is through such thinking that the divisions between Yamanouchi and YPA begin to melt away. "Yamanouchi products and YPA products are really one and the same," says Graham. "Right now, we want to establish Yamanouchi and Vesicare as truly global."

Product Focus Vesicare is an ideal therapy for Yamanouchi's first US marketed product. Yamanouchi scientists discovered solifenacin in Japan, where the overactive bladder (OAB) market is not yet established. However, the company transferred development of the product to the United States, where analysts expect the market to grow as awareness of the condition increases and the stigma decreases. Graham says, "There are 17 million patients who suffer from OAB in the United States, but only 20 percent receive treatment. Part of growing that market is to get the other 80 percent of patients to seek treatment."


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