Kenji Yasukawa, Ph.D., the new Astellas CEO, pledged to push the Japanese drugmaker further into gene and cell therapies for ocular, oncology and other diseases. Now the company says it will invest more than $250 million on manufacturing and R&D facilities in Japan and the U.S. to realize those ambitions.
The company has three projects up first, including investing ¥10 billion ($88 million) on an API facility and ¥5.0 billion ($44.2 million) on a clinical supply and early commercial manufacturing facility, both in Japan. It says it will also invest ¥14.0 billion ($123.6 million) to relocate and outfit a new R&D facility in the U.S.
“Astellas has, with a view to the future progress of development and commercialization of these programs, decided to construct R&D facilities in Japan and overseas, as well as facilities for the manufacture of clinical trial materials (CTM) and for the initial commercial production of these products,” the company said in an announcement today.
The four-story, 8,000-square-meter API facility will be built at Astellas’ Toyama production site. It will be able to manufacture antibodies for use in both CTM and commercial products as well as APIs for use in cell therapies and other products, the company said. Work is slated to begin in November and be completed by September 2019. Work on a two-story, 1,800-square-meter facility to produce clinical supplies for cell and gene therapies actually began in September in Tsukuba and is expected to be completed by next March.
The biggest chunk of change will be spent on relocating and building a new R&D facility in Westborough, Massachusetts, about 10 miles down the road from its current facility in Marlborough. Astellas is outfitting a two-story, 24,000-square-foot facility that will be upgraded to allow it to accelerate its R&D in regenerative medicine and cell therapy, it said. It will also be designed to allow Astellas “to meet the demands of commercial production.” Work began in September and is slated for completion during January 2020.
Shortly after being named CEO, Yasukawa rolled out a strategic plan that to some extent was consistent with his predecessor’s, focusing the company on such R&D therapeutic areas as ophthalmology, muscle diseases, immunology and oncology. That restructuring also included Astellas cutting 600 jobs and shutting down two subsidiaries focused on R&D and sales and marketing.
Astellas' moves come as its key moneymaker, prostate cancer drug Xtandi that it shares with Pfizer, is facing more competition. The two recently accelerated trial timelines for the oncology med drug in two studies in patients with hormone-sensitive prostate cancer. The trial changes come as Pfizer and Astellas face prostate cancer rivals in Johnson & Johnson’s Zytiga and its newer Erleada.
The moves also come as Astellas is often mentioned as a buyout target. The Japanese pharma had its own share of M&A activity recently, having acquired German cancer player Ganymed Pharmaceuticals for up to $1.4 billion in late 2016 and just recently scooping up GPCR specialist Ogeda for €500 million ($534 million) upfront.