05.10.2012 - Italian Alfa Wassermann has acquired an exclusive licence for Theravance’s serotonin 5-HT4 agonist velusetrag.
The US biotech partner can bag up to US$63.5 plus royalties for the exclusive development and commercialisation rights of the treatment for gastrointestinal motility disorders such as constipation, irritable bowel syndrome, functional dyspepsia, and gastroparesis. The Bologna-headquartered pharma firm Alfa Wassermann, will fund Phase II clinical trials and grant Theravance a US$10m option fee payable if Alfa Wassermann exercises its option for Europe, Russia, China, and other key markets after clinical proof-of-concept. The San Francisco-based biotech firm also is set to receive development, regulatory and sales milestone payments of up to US$53.5m. Additionally it may earn royalties on net sales of velusetrag (TD-5108) up to 20%.
What makes velusetrag so attractive to the Italians is its, up-to-now, beneficial safety profile. Previous treatments for gastrointestinal (GI) dysmotility targeting the 5-hydroxytryptamine(4) receptor, modified the function of the cardiac HERG potassium channel leading to severe adverse effects. Within the Phase II programme, the Italian firm will evaluate the efficacy, safety and tolerability of once-daily oral velusetrag in the treatment of patients with gastroparesis. The disorder has few therapeutic options and it is characterised by delayed gastric emptying in the absence of a mechanical obstruction with symptoms that include early satiety, nausea, vomiting and bloating. Velusetrag has been shown to accelerate gastric emptying in healthy volunteers.
Theravance will retain the full rights to the drug in the US, Canada, Japan and certain other countries. The US firm has completed a 400-patient Phase II proof-of-concept study in chronic idiopathic constipation for the drug. In the trial the compound demonstrated statistically significant prokinetic activity at all three doses (15 mg, 30 mg, and 50 mg) tested.
It was generally well tolerated and showed a low incidence of adverse events at the two lowest doses.
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