Piramal Pharma Solutions To Collaborate With Epirium Bio On Exclusive Integrated Development & Manufacturing Program For Orphan Drugs

• Integrated program encompasses formulation development, drug substances and drug product manufacturing
• Project involves three Piramal Pharma Solutions (PPS) sites in India
• New, specialized technologies have been added in a dedicated area

Mumbai, India /PRNewswire/ - Piramal Pharma Solutions, a leading contract development and manufacturing organization (CDMO), today announced that the company will be partnering with Epirium Bio on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.

The Piramal Pharma Solutions (PPS) team is providing Epirium with an integrated program that encompasses formulation development, supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product. The work is being completed across three PPS sites in India, with the seamless alignment of information, technology, and project management that will speed timelines and bring the drugs to market faster.

According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "This program with Epirium exemplifies the ways we lead the market in delivering integrated services. We've back-integrated our supply of intermediates to ensure supply chain security and quality, we've invested more than $1 million to add a dedicated area to our plant with the specialized technologies required to produce Epirium's product, and we've developed a fully integrated process that utilizes the expertise of our teams at three sites."

Dr. Sundeep Dugar, Chief Technology Officer for Epirium, added that "Our scientific insights have led to the discovery of a novel pharmacological approach for the treatment of diseases characterized by mitochondrial depletion and dysfunction. Proof of concept has been established in early human studies and we intend to advance our clinical candidate as a potential treatment for certain relevant rare diseases with high unmet need. We expect our partnership with PPS to expedite these efforts and help us bring high-quality orphan drugs to market."

The first cycle of drug substance to drug product has been successfully completed through the integrated program. Additional cycles are in progress, as are further evolutions that will benefit future indications and new clinical programs.

About Piramal Pharma Solutions:
Piramal Pharma Solutions 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. For more information and updates, please visit: www.piramalpharmasolutions.com | Social Media: Twitter, LinkedIn

About Piramal Enterprises Limited:
Piramal Enterprises Limited (PEL) is one of India's large diversified companies, with presence in Financial Services and Pharmaceuticals. PEL's consolidated revenues were ~US$1.7 billion in FY2020, with ~34% of revenues generated from outside India.

Piramal Pharma Solutions is a part of PEL's Pharma business that provides an entire pool of pharma services (including in the areas of injectable, HPAPI etc.) and sells a portfolio of niche differentiated pharma products leveraging its end-to-end manufacturing capabilities across 14 global facilities and a large global distribution network to over 100 countries. PEL is also active in the Consumer Products segment in India.

PEL also has a strong presence in Indian financial services sector. PEL is listed on the BSE Limited and the National Stock Exchange of India Limited in India. For more information and updates, please visit: www.piramal.com | Social Media: Facebook, Twitter, LinkedIn

About Epirium Bio:
Epirium Bio is a clinical-stage biopharmaceutical company that uses unique insights related to the biology of mitochondrial function and tissue regeneration to pursue novel and clinically significant therapeutic approaches for neuromuscular, neurodegenerative and mitochondrial disorders. The Company has identified and established an IP-protected platform of small molecules that constitute a new class of therapeutics with the potential to improve mitochondrial structure and function, as well as stimulate mitochondrial biogenesis and tissue regeneration. Epirium has advanced its first clinical candidate (EPM-01) in Becker muscular dystrophy and plans to follow with drug development targeting other disorders associated with mitochondrial dysfunction and tissue degeneration. To learn more, please visit www.epirium.com.