TOKYO -- Takeda Pharmaceutical's state-of-the-art research and development center in the waterfront city of Shonan has yet to yield a blockbuster treatment since its founding a decade ago -- a weak track record the Japanese drugmaker is determined to improve.
"The Shonan base has made a significant contribution to neuroscience," said Takashi Ichikawa, who heads the company's neuroscience research unit, on a conference call explaining Takeda's R&D efforts. "Shonan's pharmaceutical science level is recognized globally," he said.
Takeda's most notable research at Shonan Health Innovation Park, about 50 km southwest of Tokyo, is on a drug candidate for narcolepsy, a neurological disorder that causes sudden daytime sleepiness.
In addition to excessive sleepiness, it can cause hallucinations and could lead to a serious sleep disorder. The number of patients is estimated at around 3 million worldwide.
The drug is one of several neurological disorder treatments the company has been trying to develop. Takeda hopes to turn it into a blockbuster developed with genuine homegrown technology.
This candidate is the ace in the hole Takeda has been working on for nearly 20 years. If successfully commercialized, it could generate peak annual sales of $6 billion -- a figure that would compensate for the expected sales decline from patent expiration on the Crohn's disease treatment Entyvio.
Takeda's eagerness to tout its work on the narcolepsy treatment reflects the hard truth that the 140 billion yen ($1.3 billion) R&D site has not produced a top seller.
The facility was created under the leadership of then-President Yasuchika Hasegawa by consolidating research centers in Tsukuba and Osaka. The hub with a floor space of 300,000 sq. meters on a 250,000-sq.-meter lot was hailed as one of the largest research facilities in Japan.
But despite high expectations within the company, its track record has been lackluster. President Christophe Weber, who took over in 2014, moved ahead with further streamlining. The Shonan site once boasted more than 1,200 staffers but now has about 650.
Takeda's research site in Cambridge, Massachusetts, is the largest in the group, having overtaken the Shonan facility.
The bulk of research on rare diseases and oncology, areas of focus for the company, has moved to the U.S. Neurological diseases present the Shonan facility its last chance to prove its prowess in drug discovery.
Entyvio was developed by Millennium Pharmaceuticals, which Takeda acquired in 2008 for 900 billion yen. The 2019 purchase of Irish peer Shire has added multiple drug candidates for rare diseases to the pipeline. But with the limited number of patients, they are unlikely to turn into blockbusters.
Launching a homegrown top seller that will bring in more than 500 billion yen in global sales has been a long-cherished goal of Takeda.
On a conference call in early April, Weber promised to increase R&D spending to up to 550 billion yen for the year ending March 2022. The company will focus on clinical trials on 10 candidates, including the one for narcolepsy, with the aim of applying for approval for the narcolepsy medicine as early as the year ending March 2025.
"If narcolepsy and other treatments are commercialized, Takeda would be able to demonstrate its Japanese base's research capability," said Shinichiro Muraoka of Morgan Stanley MUFG Securities.
Releasing homegrown medicines not obtained through acquisitions on the global market is crucial as Takeda seeks to catch up to U.S. and European megapharmas. The fate of the narcolepsy treatment will test Takeda's abilities as a drugmaker, from R&D to global marketing.