- TheracosBio recently received FDA approval for Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor
- Piramal supported TheracosBio with starting materials, active pharmaceutical ingredient (API), and oral solid dosage formulation
- Integrated drug development & manufacturing program involved multiple Piramal sites in India and Europe
MUMBAI, India, March 30, 2023 /PRNewswire/ -- Piramal Pharma Solutions, a patient-centric Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd (PPL), (NSE: PPLPHARMA) (BSE: 543635), today announced that the company has completed the successful integrated development and manufacturing of drug substance and drug product for Brenzavvy (bexagliflozin), TheracosBio's recently approved treatment for type 2 diabetes.
The U.S. Food and Drug Administration (FDA) approved Brenzavvy, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, in January 2023. The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 participants.
Piramal Pharma Solutions and TheracosBio began their bexagliflozin partnership at Piramal's Ahmedabad, India site, where the manufacturing process for the tablet form was first established. Next, the project shifted to the Morpeth, UK site for manufacture of the actual pill. The relationship grew from there, with Piramal's site in Ennore, India producing the regulatory starting materials and its Digwal, India site producing the active pharmaceutical ingredient (API).
"The recent FDA approval represents a significant milestone for TheracosBio and provides an important treatment option to patients who suffer from type 2 diabetes. We are extremely pleased with the work the Piramal team has done to help make the approval possible," said Albert R. Collinson, Ph.D., President and CEO of TheracosBio. "During the course of this program, we have developed an extensive relationship with Piramal. Working with different managers in different countries on various elements of the manufacturing process has turned out well."
According to Peter DeYoung, Chief Executive Officer, Piramal Global Pharma, "Our partnership with TheracosBio is an important example of how an integrated services offering can benefit a client. This program has been extensive, crossing continents over years of development. We're pleased that we've been able to support their needs every step of the way. We are very proud of the work we have done and we congratulate TheracosBio on reaching this important milestone."
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 customers 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 the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug product. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies, we believe, makes us a partner of choice for innovator and generic companies worldwide.
For more information visit: www.piramalpharmasolutions.com | Facebook | Twitter | LinkedIn
About Piramal Pharma Ltd:
Piramal Pharma Limited (PPL), (NSE: PPLPHARMA) (BSE: 543635), offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market and a minority investment in Yapan Bio. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.
For more information visit: www.piramal.com/pharma | Facebook | Twitter | LinkedIn
Disclaimer:
Piramal Pharma Limited is proposing, subject to receipt of requisite approvals, market conditions, and other considerations, a rights issue of its equity shares in the near future and has filed a draft letter of offer with the Securities and Exchange Board of India.
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