IRISYS To Expand Drug Delivery Technology Capabilities & Services in China
– IRISYS Announces Joint Venture with Zhejiang Yangtze River Delta Biotech Management for New Drug Delivery Systems Platform in Hangzhou –
San Diego, July 9, 2018 – IRISYS, LLC, a San Diego-based provider of contract pharmaceutical product development and manufacturing services, today announced that it has entered into a memorandum of understanding for a joint venture with Zhejiang Yangtze River Delta Biotech Management to co-build and co-run a new Drug Delivery Systems platform as a key part of the International Accelerator in Hangzhou, Zhejiang province, China.
IRISYS possesses multiple drug delivery technical platforms, with proven know-how in this area and more than 20 years of operational experience. “IRISYS has a successful history of developing novel formulations, utilizing drug delivery systems, for both new chemical entities and generic products,” said Gerald Yakatan, Ph.D., Chairman, CEO and founder of the Company.
“Establishing a Drug Delivery Systems platform in Zhejiang province will allow IRISYS to address the needs of Chinese pharmaceutical companies directly, serving them from a local base. It will also enable IRISYS to assist U.S. pharma and biotechnology companies interested in entering the Chinese market,” Yakatan noted.
Zhejiang Yangtze River Delta Biotech Management, which operates the Hangzhou International Accelerator, was “seeking a company with proven technical know-how and experience, as well as the global vision to co-build and run this platform,” a representative stated.
In addition to its formulation development and cGMP manufacturing capabilities, IRISYS has a thorough understanding of both the Chinese and U.S. pharmaceutical industries in terms of regulatory affairs and market access. The company has long-standing relationships with pharmaceutical companies in China that use IRISYS’ services to help take their drug candidates through the U.S. FDA regulatory process.
The focus of the Drug Delivery Systems (DDS) platform will be to provide contract research organization (CRO) services to Chinese companies, with an emphasis on specialized formulations for “difficult to develop” drug candidates. IRISYS’ unique DDS technologies for tablets, capsules, and oral solutions will be the first services offered. It is envisioned that other formulations within IRISYS’ broad expertise, including inhalation, patches, sterilized injections, liposomes, and other encapsulation products, will be introduced later. Regulatory application services will also be available.
The IRISYS and Zhejiang Yangtze River Delta Biotech Management joint venture, which will also include Park Investment Company, will be the operation and management company for the DDS platform.
About IRISYS (irisys.com)
IRISYS was founded in 1996 to provide contract pharmaceutical product development and manufacturing services, specializing in formulation development, cGMP manufacturing of clinical trial materials and commercial pharmaceutical products, and strategic consulting related to the drug development process. IRISYS’ custom approach to drug development is supported by the Company’s scientific and regulatory experience in moving more than 100 drug products from discovery to clinical development and commercialization
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