Chugai Pharmaceutical Opens a North American Hub in Berkeley Heights

On Nov 20, 2015

Today, Chugai Pharma USA, Inc. (CPUSA), a wholly-owned subsidiary of Chugai Pharmaceutical Co, Ltd.(Chugai), officially opened its new office dedicated to translational clinical research, located in BerkeleyHeights. The facility serves as the US hub for Chugai, the research-based pharmaceutical company headquartered in Tokyo. Chugai initiated activities in the US in 1982; in response to increasing industry competition, CPUSA is now focused on Early Development and, in spring of this year established Chugai’s Translational Clinical Research Division(TCRD).

TCRD is Chugai’s first global organization composed of functions in Japan, Europe, and the US (CPUSA). TCRD is dedicated to the late preclinical and early clinical development of Chugai-originated pipeline products. It aims to accelerate the proof-of-concept process by bringing translational research-powered medicines to global development stage, and ultimately to market, as efficiently as possible.

“CPUSA is further evidence of Chugai’s commitment to and belief in the potential of translational research to use best-in-class drug discovery techniques in the development of transformative, patient-focused therapies that fulfill unmet needs and improve patients’ lives across the world,”said Osamu Nagayama, Chairman and Chief Executive Officer of Chugai.

In the words of Athos Gianella-Borradori, MD, Chief Medical Officerof CPUSA, “The establishment of CPUSA will enable the company to strongly enhance relationships with the US Food and Drug Administration (FDA), academia, clinical investigators and patient communities. Our mission is to facilitate Chugai’s expanding clinical activity in the US by increasing awareness of Chugai’s successful track record in discovering and commercializing innovative pharmaceuticals that bring real value to patients and society.”

“New Jersey’s standing as a key market for pharmaceutical innovation will aid in the growth of our US talent and operations, which will in turn support and further strengthen our pipeline of novel therapies designed to fulfill unmet needs and improve patients’ lives across the world,” said Norihisa Onozawa, President and Chief Executive Officer ofCPUSA. “Our team is proud to contribute to Chugai’s global work by inspiring and guiding its therapeutic development efforts to achieve new heights.”

Chugaiplaces strategic priority on advancing treatment in oncology, bone and joint diseases, renal diseases, and autoimmune diseases. A specific focus is placed on bringing innovative therapies to market for conditions where treatment options are limited and patients go underserved. Chugai works in the strategic alliance with Roche, leveraging its resources to pursue cutting-edge biopharmaceutical, antibody, and molecular-targeted research technologies—areas that constitute Chugai’s greatest strengths—as well aschemical synthesis technology.

CPUSA completed early stage development of alectinib and GC33 in the US before out-licensing to Roche. CPUSA currently has the following three ongoing development programs, where Chugai is independently pursuing global development of its original products:

• SA237, anti-IL-6 receptor humanized monoclonal antibody applied with recycling antibody technology (Chugai’s proprietary antibody engineering technology) for neuromyelitis optica (Phase III)
• CIM331, anti-IL-31 receptor humanized monoclonal antibody for atopic dermatitis (Phase II)
• PCO371, PTH1 receptor agonist for hypoparathyroidism (Phase I)

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