On July 12, 2016 — Merck has entered into an agreement with PCAS S.A. (Longjumeau, France) to expand Merck’s excipients portfolio. Under the agreement, Merck will be the exclusive, global distributor of the Expansorb® line of biocompatible and biodegradable polymers.
The portfolio will include 38 polymers for sustained release of small molecule and selected peptide injectables, allowing customers to optimize and precisely control release kinetics of final drug products. The ability to better control and sustain the release of drugs allows for delivery via reduced numbers of injections with the same therapeutic efficacy, improving patient comfort and compliance.
“The pharmaceutical industry is increasingly interested in controlling the release of small molecules and selected peptides delivered via injection,” said Andrew Bulpin, Head of Process Solutions at the life science business of Merck. “The addition of the Expansorb® polymers to our broad portfolio of excipients improves drug developers’ ability to protect molecules with short in vivo half-lives and achieve the desired therapeutic effect while enhancing patient comfort and compliance.”
Poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) polymers are biocompatible and biodegradable synthetic substances that have already been approved by the United States Food and Drug Administration and the European Medicines Agency with several drug products on the market and many more drug products in clinical development.
Expansorb® PLA and PLGA polymers are manufactured under cGMP conditions by PCAS and are expected to be sold under Merck’s industry-leading Emprove® program once rigorous evaluations and certifications are complete. The pharmaceutical manufacturing industry relies on Emprove® products for documentation and regulatory information to facilitate risk assessment workflows and supplier qualification.
“PCAS is excited to bring our Expansorb® polymers to Merck and together offer the potential of significant value creation for pharmaceutical customers,” said Didier Combis, Head of Custom Synthesis & Pharma Chemicals, PCAS. “This is an important collaboration, allowing us to broaden access to this powerful technology through Merck’s global network and facilitate development of improved therapeutic solutions for patients.”
Nanosphere and microsphere formulations based on PLGA polymers have been studied extensively for use in the delivery of peptides, therapeutic proteins, hormones and antibiotics. Future applications are expected to include the development of targeted drug-containing nanoparticles using site-specific ligands.
