MUMBAI, India, March 23, 2021 /PRNewswire/ -- Piramal Pharma Limited's (PPL) Contract Development and Manufacturing Organization (CDMO), Piramal Pharma Solutions (PPS), announced today that the Company has entered into a Master Services Agreement (MSA) with Plus Therapeutics, Inc. for Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics' RNL-Liposome Intermediate Drug Product.
This 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 the PPS drug product facility located in Lexington, Kentucky. The two Companies envision that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.
PPS' Lexington site is recognized as a North American leader in the formulation, development and manufacturing of sterile parenteral drug products. The Lexington site has the capability to support drug development for New Chemical Entities (NCEs), generics, and molecules that might be following the 505(b)(2) regulatory pathway.
Peter DeYoung, CEO, Pharma Solutions, Piramal Pharma Limited, stated that, "We are excited to partner with Plus Therapeutics. We believe that this represents the start of a long, collaborative and mutually beneficial relationship that will address our ultimate objective of reducing the burden of disease on patients."
"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."
About Piramal Pharma Solutions:
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services such as development and manufacture of highly potent APIs and antibody drug conjugation, sterile fill/finish with and without containment and potent solid oral drug product. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide.
About Piramal Pharma Limited:
Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes: Piramal Pharma Solutions, an integrated Contract Development and Manufacturing Organization (CDMO); Piramal Critical Care, a complex hospital generics business; and the Consumer Healthcare business, selling over-the-counter products in India. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.
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.
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SOURCE Piramal Pharma Solutions