Biopharmaceutical company Arecor Therapeutics plc (AIM: AREC) announced on Monday that it has entered into an exclusive licensing agreement for its ready-to-dilute (RTD) liquid drug product, AT351, with a subsidiary of one of the world's largest independent chemicals marketing companies. The agreement follows a successful formulation study collaboration using Arecor's proprietary Arestat technology platform.
Under the terms of the deal, Arecor receives an undisclosed upfront payment and is eligible for further milestone payments across development, regulatory and commercial stages, along with royalties on global sales. The licensee gains exclusive worldwide rights to develop, commercialise and seek regulatory approval for AT351, with an FDA filing under the 505(b)(2) pathway expected within three years.
AT351 is an undisclosed critical care therapy that could become the first RTD liquid formulation of the product, offering significant advantages over current treatments by simplifying preparation and improving point-of-use care, thus reducing costs across the supply chain.
Arecor is focused on transforming patient care and will continue to leverage its Arestat platform to enhance existing therapies and develop new products, particularly in diabetes and other indications.
Yingli Pharma's linperlisib Phase 3 registration study approved by US FDA
Organon acquires US rights to TOFIDENCE from Biogen
Oncopeptides secures FDA approval to resume OPD5 clinical development
Bonesupport submits FDA application for CERAMENT V
Spinogenix starts enrolment for SPG302 Phase 2 trial in schizophrenia
DDL opens new GMP laboratory for drug-device combination product testing
Langhua Pharmaceutical passes US FDA's on-site inspection
PTC Therapeutics announces opinion regarding Translarna's (ataluren) European renewal authorisation