MANUFACTURING AND SUPPLY
Our product candidates are engineered for scalability and we are implementing supply chain strategies today to meet tomorrow’s demand
We design and select our injectable and oral product candidates to optimize scalability. The ultra-long half-life of our candidates is intended to enable greater therapeutic effectiveness with less drug substance and fewer injector devices needed, while the high level of potency of our candidates further reduces drug substance requirements. Our MOMENTUMTM oral delivery platform is designed to harness these improvements in half-life and potency, alongside improvements in bioavailability, to overcome the scalability limitations of oral NuSH analog peptides.
Our supply agreement with Amneal Pharmaceuticals was designed to enable us to secure reliable, cost-effective supply, including through the construction of two manufacturing facilities, one for drug substance and one for drug product. We believe our expertise in novel drug development, coupled with Amneal’s extensive cGMP manufacturing capabilities across both oral and injectable products, as well as our additional partnerships with world-leading CDMOs, has the potential to facilitate an effective and rapid commercial launch in a competitive, high-volume market.
