Greetings

SPERA PHARMA was established as a new company on July 1, 2017, through a strategic partnership between Bushu Pharmaceuticals and Takeda Pharmaceutical Company in the area of CMC business operations. Under their agreement, Bushu Pharmaceuticals took over Takeda’s facilities in the Juso area (Yodogawa-ku, Osaka City), taking responsibility for part of the Pharmaceutical Science Department (formerly the CMC Center) and its employees. As Takeda Pharmaceutical’s strategic partner, SPERA PHARMA will be engaged in developing drug substance processes, designing drug formulations, developing test methods, manufacturing investigational drugs, and conducting related business operations.

SPERA, in Latin, means both hope and trust. The name embodies our desire to give hope to patients, and to fulfill the trust placed in us by society and our customers.

Approximately 200 specialists will play a central role at SPERA PHARMA, including process chemists, and technicians involved in drug formulation or who analyze drug products; these professionals have worked in the CMC area at Takeda Pharmaceutical Company for many years, accumulating extensive experience in the research & development, and industrialization stages of drug development. As a partner company that supports R&D at Takeda Pharmaceutical Company, we will continue to enhance our technologies and solidify our business foundations.

Bushu Pharmaceuticals has moved away from the conventional business model, which has focused on contract manufacturing of commercial drug products. It has designed a structure that allows it to manage the whole drug development process within the Bushu Pharmaceuticals Group, from one of the upstream processes, developing new substances, to manufacturing investigational drugs and submitting applications for approval.

Initially, business will center around Takeda Pharmaceutical’s contract operations. By enhancing our technological capabilities, efficiency, and capacity in the medium- to long-term, we aim to accept CMC-related consignments from a wide range of customers, growing to become a company that can contribute broadly to the development of the pharmaceutical industry. In particular, by transforming ourselves into a Contract Development and Manufacturing Organization (CDMO), capable of providing with a one-stop CMC business resource that can manage the whole drug development lifespan—from initial stages to the application process and market launch (through the support of auxiliary business operations specializing in development of drug substance process, formulation design, test method development, investigational drug manufacturing, and application preparation and submission)—we aim to meet the ever more wide-ranging needs of our customers.

SPERA PHARMA has just begun. As the development of new drugs becomes increasingly difficult, we will hone our technologies even further, bringing about new developments in drug R&D and contributing to building an even healthier society through the creation of outstanding new drugs. We ask for your continued support and assistance.

Toshio Yoshioka, President

SPERA provides CMC solutions from early-stage through new drug application