IriSys Contract with NCI for Manufacturing Clinical Trial Materials is Doubled in Value

IriSys Contract with NCI for Manufacturing Clinical Trial Materials is Doubled in Value — Award Increased to Up To $6,000,000 Over Five Years – San Diego, April 20, 2017 – IriSys, LLC, a San Diego-based provider of contract pharmaceutical product development and manufacturing services, today announced that it was awarded an increase in the ceiling of its five-year prime vendor contract, which was doubled to up to $6,000,000, by the National Cancer Institute (NCI)’s Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD). The contract is for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI. It was initiated in June 2015 and will be in effect through June 2020. Under this contract, IriSys will continue to manufacture oral, topical, and injectable dosage forms to be used in NCI-sponsored and/or investigator-initiated clinical trials in humans. IriSys is responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control and quality assurance. The significant increase in the contact amount threshold allows NCI to place new task orders with IriSys to satisfy their changing needs. The manufacturing of pharmaceutical formulations for clinical trials and commercial pharmaceutical products under U.S. Current Good Manufacturing Practices (cGMP) regulations is one of IriSys’ specialized services. The Company produces materials in all dosage forms, including solid oral dosage forms such as tablets and capsules, as well as liquids, injectables, and topical ointments, creams and gels, in its state-of-the-art facility in San Diego. “IriSys’ consistent delivery of quality clinical trials materials to NCI on a timely basis is an example of our client-focused approach. Our highly experienced technical staff is responsible for IriSys’ successful track record developing and manufacturing therapeutic agents of all classes and physicochemical properties. We look forward to producing additional material as needed by NCI for their important work,” said Gerald Yakatan, Ph.D., Chairman, CEO and founder of IriSys. This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201500009I. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.   About IriSys, LLC 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.   IriSys Contacts Louis Scotti Vice President Business Development +1-858-281-7943 lscotti@irisys.com   Gwen Rosenberg Rosenberg Business Communications +1-858-525-5484 gwen@rosenbergbc.com   Download this press release in...

IriSys Awarded Long Term Contract by NCI for Manufacturing Clinical Trial Materials

IriSys Awarded Long Term Contract by NCI for Manufacturing Clinical Trial Materials — Valued at Up To $3,000,000 Over Five Years – SAN DIEGO, July 15, 2015 /PRNewswire/ – IriSys, LLC, the San Diego-based pharmaceutical contract development and manufacturing organization, today announced that it was awarded a five year contract worth up to $3,000,000 by the National Cancer Institute (NCI)’s Developmental Therapeutic Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI. Under this agreement, IriSys will be supplying NCI with oral, topical and injectable dosage forms to be used in NCI-sponsored and/or investigator-initiated clinical trials in humans. IriSys will be responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control and quality assurance. “IriSys has a technical staff with a high number of advanced degrees that reflects our success in developing and manufacturing clinical trial materials for complex molecules. This NCI contract renewal demonstrates our ability to consistently deliver on NCI’s needs for quality clinical trials materials on a timely basis,” said Gerald Yakatan, Ph.D., chairman, CEO and founder of IriSys.   About IriSys 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 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 over 100 drug products from discovery to clinical development and commercialization.   IriSys Contacts Gerald Yakatan, Ph.D. Chairman, CEO and Founder +1-858-281-7939 gyakatan@irisys.com   Louis Scotti Vice President Business Development +1-858-281-7943 lscotti@irisys.com   Download this press release in...

IriSys Receives MetroConnect Award & California Competes Tax Credit

IriSys Receives MetroConnect Award & California Competes Tax Credit Helps Support IriSys Expansion Plans in San Diego and Internationally SAN DIEGO, July 10, 2015 /PRNewswire/ – IriSys, LLC, the San Diego-based pharmaceutical contract development and manufacturing organization, today announced the achievement of two significant financial milestones. On July 1, IriSys was awarded the MetroConnect prize to assist in expanding its international business presence. Managed by San Diego Regional EDC, and presented by JPMorgan Chase, the MetroConnect Prize grants 15 San Diego companies financial support to assist with developing international business opportunities. Each company receives up to $10,000 in matching funds to cover up to 50% of the costs associated with the company’s next step to going global. The companies were selected from a group of 64 applications by a panel of judges including representatives from Biocom, CONNECT and the San Diego Regional EDC. “IriSys has been rapidly growing in recent years and its custom pharmaceutical development and manufacturing services should be of great interest to international clients. This award provides our team the resources to investigate opening our first international office in Shanghai, China,” said Gerald Yakatan, Ph.D., chairman, CEO and founder of IriSys. “In addition to our capabilities in formulation and novel drug delivery techniques, our FDA consulting services will be of value to small Japanese and Chinese pharmaceutical companies that want to bring products to the U.S. for development. Our Shanghai office will help us develop business opportunities in China, Japan and other Asian countries.” Another milestone was achieved on June 18, when the California Competes Tax Credit Committee granted IriSys a five-year, $100,000 tax credit in return for the company’s commitment to expand its facilities and hire additional skilled researchers. The California Competes Tax Credit (CCTC) is an income tax credit available to businesses that want to come to California or stay and grow in California. Tax credit agreements are negotiated by GO-Biz (California Governor’s Office of Business and Economic Development).   About IriSys IriSys was founded in 1996 to provide contract pharmaceutical product development and manufacturing services, specializing in formulation development, cGMP manufacturing of clinical trial material, commercial pharmaceutical products and 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 over 100 drug products from discovery into clinical development and commercialization.   IriSys Contacts Gerald Yakatan, Ph.D. Chairman, CEO and Founder +1-858-281-7939 gyakatan@irisys.com   Louis Scotti Vice President Business Development +1-858-281-7943 lscotti@irisys.com   Download this press release in...