InnoCore Pharmaceuticals and Merck KGaA (operating as MilliporeSigma in the US and Canada) have entered into a global cooperation agreement for InnoCore’s proprietary SynBiosys® biodegradable polymer platform. The drug delivery platform will be used to develop sustained release solutions for biologicals in injectable formulations.
“Until now, formulating large biological active pharmaceutical ingredients such as proteins and large peptides into long acting sustained release formulations has been difficult, if not impossible,” said Andrew Bulpin, head of Process Solutions at the Life Science business sector of Merck. “This collaboration will bring long-acting release of protein therapeutics to market, allowing new and potentially life-changing treatments. It will also improve patient compliance by reducing dosing frequency and maintaining drugs at therapeutic levels longer.”
Sustained release solutions play an increasingly important role in drug formulation because they enhance patient adherence. The new proprietary technology developed by InnoCore Pharmaceuticals allows the development of injectable sustained release biological formulations with conserved bioactivity of these sensitive molecules. The SynBiosys® platform can be used for subcutaneous, intramuscular and site-specific injectable formulations in the form of microparticles and implants.
Merck and InnoCore will support customers with formulation, process development and manufacturing services in using this technology to develop injectable sustained release drug products and overcome formulation challenges — especially for large peptides and proteins. This new, large biomolecule formulation and delivery capability complements Merck’s existing portfolio of biodegradable polylactic acid and polylactic glycolic acid (PLA/PLGA) polymers for sustained release in liquid/parenteral formulations. The PLA/PLGA technology applies primarily to small molecules, small hormones and peptides.
Poor compliance in the treatment of chronic diseases is a significant problem. The cost of non-compliance in the U.S. alone is estimated at between $100 billion and $290 billion per year, according to a January 2018 article published by the U.S. National Library of Medicine National Institutes of Health.
“We are very excited that we have been able to set up this important collaboration with Merck, a company that is widely recognized in providing drug formulation solutions for the global life sciences industry,” said Jan Hendriks, CEO, InnoCore Pharmaceuticals.