Piramal Pharma Solutions Announces Sterile Fill/Finish Program with Theratechnologies Inc. for TH1902 Peptide-drug Conjugate
Piramal Pharma Solutions (PPS) is providing drug product formulation and manufacturing from the company's Lexington, KY site in the U.S.
- Drug product material will be used in a first-in-humans clinical study
MUMBAI, India, Jan. 25, 2021 /PRNewswire/ -- Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today announced that it is providing Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) with GMP manufacturing of sterile fill/finish drug product to support their developmental product as it enters into a first-in-humans clinical study.
The clinical material is being produced at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is recognized globally for its expertise in sterile fill/finish services. It will be used in a Phase I trial for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I trial design includes a dose escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies.
According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients."
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 like development and manufacture of highly potent APIs and antibody drug conjugation. 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 an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it 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.
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
Related Links https://www.piramalpharmasolutions.com/