Sanofi-aventis and Ascendis Pharma (Ascendis) announced a global licensing and patent transfer agreement on Ascendis' proprietary TransCon Linker and Hydrogel carrier technology, which allows for a drug compound to be released in the body in a precise, time-controlled fashion, creating a long-acting effect.

The technology creates transient bonds between larger molecules such as proteins and peptides, including insulin, and a carrier. This allows for tailor-made release profiles, with no initial burst and high drug load formulations. The TransCon Linker technology has shown promising results in preclinical studies in delivering insulin.

"We are excited about this promising technology to create next-generation products in the field of diabetes and related disorders," commented Pierre Chancel, senior vice-president, head of the global diabetes division, sanofi-aventis. "Building on our achievements with Lantus, our 24-hour insulin approved for use once a day, we hope to further improve the lives of people with diabetes by developing this innovative technology to offer biologicals that present an extended and controlled release of unmodified parent drugs, including insulin."

Under the terms of the agreement, sanofi-aventis will receive a worldwide license to develop, manufacture and commercialize products combining the technology with active molecules in diabetes and related disorders.  Ascendis will receive an upfront payment and will be eligible to receive development, regulatory, and specified commercial milestone payments.

Ascendis Pharma's clinically proven prodrug technology platform, TransCon, is a proprietary technology enabling linker-assisted transient conjugation of peptides, proteins and small molecules to various carriers such as hydrogels. The technology utilizes Ascendis Pharma's proprietary TransCon Linker families, which are a diverse group of structures with inherent chemical self-cleaving properties, making drug release independent of enzyme activity and tissue conditions.  Ascendis Pharma´s transient conjugation allows for a drug compound to be released in the body in a precise, time-controlled fashion, creating a long-acting effect for the original unmodified drug.

Conjugation technologies, such as conventional PEGylation, are unable to achieve this type of slow-release mechanism, because the polymer cannot release the drug. Furthermore, with conventional PEGylation, the drug is trapped in the blood compartment and is unable to reach the surrounding tissues. As PEGylation reduces the activity of the drug, higher plasma concentrations are needed to ensure efficacy, but this adds to the occurrence of peak concentration-related adverse events. Conjugation of proteins, peptides and small molecules using Ascendis Pharma's TransCon technology therefore offer unprecedented control of pharmacokinetic parameters, without the drawbacks experienced with currently available technology platforms.

Ascendis Pharma A/S is an emerging specialty pharmaceutical company which creates improved, patentable versions of marketed drugs and high-value development-stage opportunities. The company operates within the therapeutic areas of endocrinology, central nervous system disorders, and infectious diseases.

Sanofi-aventis strives to deliver innovative and integrated patient-focused solutions for people living with diabetes. The Company currently has insulin products that are also available in injection pens for people with type 1 or type 2 diabetes, as well as an oral, once-daily sulfonylurea treatment for type 2 diabetes. In order to provide comprehensive care in diabetes management, sanofi-aventis is also introducing devices such as innovative blood glucose monitoring systems.