Date: 2012-10-02
Type of information: Development agreement
Compound: velusetrag (TD-5108)
Company: Theravance (USA) Alfa Wassermann (Italy)
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Type agreement: development
commercialisation
Action mechanism: Velusetrag, also known as TD-5108, is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor. An oral, investigational medicine dosed once daily, velusetrag has completed a 400-patient Phase 2 proof-of-concept study in chronic idiopathic constipation, demonstrating statistically significant prokinetic activity at all three doses tested; at the two lowest doses, velusetrag was generally well tolerated with a low incidence of adverse events. Velusetrag has also been shown to accelerate gastric emptying in healthy volunteers. Velusetrag was discovered by Theravance through the application of its multivalent drug design in a research program dedicated to finding new treatments for gastrointestinal motility disorders.
Disease: gastroparesis, gastrointestinal motility disorders
Details: Theravance and Alfa Wassermann have entered into an exclusive development and commercialization agreement in certain countries for velusetrag, Theravance\'s investigational 5-HT4 agonist in development for gastrointestinal motility disorders. Under the agreement, the companies will collaborate in the execution of a two-part Phase 2 program to test the efficacy, safety and tolerability of velusetrag in the treatment of patients with gastroparesis. If the results of the studies are sufficiently favorable, Alfa Wassermann will have the right to exercise an exclusive option for the development and commercialization of velusetrag in the EU, Russia, China, Mexico and certain other countries. Theravance retains full rights to velusetrag in the US, Canada, Japan and certain other countries.
Financial terms: Financial terms of the transaction include funding of the Phase 2 program by Alfa Wassermann, a $10 million option fee payable to Theravance by Alfa Wassermann if it exercises its option following completion of the Phase 2 program, and potential development, regulatory and sales milestone payments of up to $53.5 million. Theravance is entitled to receive royalties on net sales by Alfa Wassermann ranging from the low teens to 20%.
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