Plus Therapeutics Enters Into Master Services Agreement with Piramal Pharma Solutions, a Leading Contract Development and Manufacturing Organization
Plus Therapeutics (Nasdaq: PSTV) has signed a master services agreement (MSA) with Piramal Pharma Solutions for the development of its Rhenium NanoLiposome (RNL™), aimed at treating rare cancers, including glioblastoma. The agreement entails transferring analytical and microbiological methods, production processes, and stability studies, executed at Piramal's facility in Lexington, Kentucky. This partnership is expected to pave the way for future clinical and commercial supply agreements. The collaboration marks a significant milestone in advancing RNL towards regulatory approval.
- Signed MSA with Piramal Pharma Solutions for RNL development.
- The MSA may lead to clinical and commercial supply agreements.
- Partnership supports development of novel treatment for glioblastoma.
- None.
Agreement covers intermediate drug product for RNL™, a radiotherapy in development for several rare cancer targets
AUSTIN, Texas, March 23, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today 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 (Nasdaq: PSTV) 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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company’s potential 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; the Company’s potential to develop drug candidates currently in its product pipeline; and the Company’s potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA’s accelerated regulatory pathways; and the risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
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FAQ
What is the significance of Plus Therapeutics' recent MSA with Piramal Pharma Solutions?
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