Alcami Announces Manufacturing Agreement for Solasia’s Active Pharmaceutical Ingredient Darinaparsin
Date: Nov 9, 2017
Source: Alcami Corporation
DURHAM, N.C., Nov. 9, 2017 – Alcami, a leading provider of custom end-to-end development and manufacturing services for the pharmaceutical and biotechnology industries, today announces it has finalized manufacturing and quality agreements with Solasia Pharma, K.K. (TSE: 4597) for the clinical supply manufacture of the active pharmaceutical ingredient (API) darinaparsin, a novel mitochondrial-targeted agent developed for the treatment of various hematologic and solid cancers.
Solasia is a Japan-based specialty pharmaceutical company dedicated to the development of innovative oncology medicines. In March 2011, Solasia acquired the rights to darinaparsin from ZIOPHARM Oncology, Inc. for the potential treatment of Peripheral T-Cell Lymphoma (PTCL). The agent is currently in Phase II pivotal trials in Asia.
“We are pleased to entrust Alcami with this project,” said Mr. Yoshihiro Arai, President and CEO of Solasia Pharma, K.K. “Finding a responsible partner for the development and manufacturing of our API was a significant step in our clinical program.”
Process development for darinaparsin and clinical manufacturing will begin within Alcami’s new highly potent API suites in Q4 2017, located at its API Center of Excellence facility in Germantown, Wisconsin.
“We are extremely grateful for the opportunity to partner with Solasia as the trusted supplier of darinaparsin. Our relationship is an excellent example of Alcami’s dedication to delivering reliable and high quality medicines across the globe. As we continue to grow our established business in Japan, we look forward to supporting Solasia for its future clinical and commercial success,” stated Syed T. Husain, Chief Commercial Officer of Alcami.
Alcami is a world-class contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With over 1,000 employees operating at eight global locations, Alcami provides customizable and innovative end-to-end services to small and mid-size pharmaceutical and biotechnology companies by offering individualized and integrated services across multiple areas. We connect our clients with innovative solutions for API development and manufacturing, solid-state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services.