Alcami Announces Manufacturing Agreement for Solasia’s Active Pharmaceutical Ingredient Darinaparsin

DURHAM, NC, USA – November 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.

Solasia is a specialty pharmaceutical company based in Asia, with a mission of "Better Medicine for a Brighter Tomorrow". In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient's healthy living and to provide treatment options for the healthcare providers. Additional information is available at

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. For more information, please visit

Catherine Hanley
Senior Director, Marketing & Corporate Communications
+1 910.254.7273



【ダーラム(米ノースカロライナ州)2017年11月9日PR Newswire=共同通信JBN】製薬業界やバイオテクノロジー業界向けカスタム化エンドツーエンド開発・製造サービスの有数な提供者であるAlcamiは9日、医薬品有効成分(API、原薬のこと)ダリナパルシン(darinaparsin)臨床供給製造向けにソレイジア・ファーマ株式会社(東京証券取引所:4597)との製造・品質契約を最終的に締結した発表した。医薬品有効成分(API)ダリナパルシンは、各種血液がんと固形がんの治療用として開発されたミトコンドリア標的新薬である。

ソレイジアは日本に本拠を置くスペシャリティ医薬品企業であり、革新的な抗がん剤の開発に注力している。ソレイジアは2011年3月、末梢性T細胞リンパ腫(PTCL)の治療可能性を確かめるため、ZIOPHARM Oncology, incからダリナパルシンの権利を取得した。この薬品は現在、アジアで重要な第II相試験中である。


ダリナパルシンのプロセス開発と臨床製造は、2017年第4四半期に米ウィスコンシン州ジャーマンタウンのAPI Center of Excellence施設にある、Alcamiの新しい極めて強力なAPIスイート内で始まる。



ソレイジアはアジアを拠点とするスペシャリティ医薬品会社であり、「明るい未来のために、より良い医薬品を提供」することを使命としている。腫瘍領域内で満たされない医療ニーズの応えるため、同社は患者の健康的な生活に貢献し、医療供給者に治療選択肢を与えるために、革新的な医薬品を開発している。詳しい情報は を参照。



ソース:Alcami Corporation


Catherine Hanley
Senior Director, Marketing & Corporate Communications
+1 910.254.7273

Topics: Company News