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Plus Therapeutics, Inc., a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, announced that it has entered into a master services agreement (MSA) with Piramal Pharma Solutions (PPS) for the development, manufacture, and supply of Plus’ Rhenium NanoLiposome (RNL™) intermediate drug product.
The MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing and stability studies. The transfer will be performed at PPS’s drug product facility in Lexington, Kentucky. Plus anticipates that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.
PPS’s Lexington site is recognized as a North American leader in formulation development and manufacture of sterile parenteral drug products.
“This agreement represents another significant milestone for Plus as we work to advance development of RNL as a novel treatment option for patients diagnosed with glioblastoma,” said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “The team at PPS has the knowledge, experience and expertise to support our needs, both now and in the future as we advance RNL towards regulatory approval.”
“We are thrilled to enter into this agreement with Plus Therapeutics,” said Peter DeYoung, Chief Executive Officer of Piramal Pharma Solutions. “Our expectation is that this MSA represents the start of a long, mutually beneficial relationship that will address our ultimate collective objective of reducing the burden of disease on patients.”
About Plus Therapeutics, Inc.
Plus Therapeutics is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization offering end-to-end development and manufacturing solutions across the drug life cycle. They serve clients through a globally integrated network of facilities in North America, Europe and Asia. This enables them to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent active pharmaceuticals ingredients and antibody drug conjugation. PPS’s capability as an integrated service provider and experience with various technologies enables them to serve innovator and generic companies worldwide.
