SOUTH SAN FRANCISCO—Theravance, Inc., a biopharmaceuticalcompany specializing in small molecules in a range of therapeutic indications,and Alfa Wassermann S.p.A., headquartered in Bologna, Italy, have announced theformation of an exclusive development and commercialization agreement in selectcountries for velusetrag, an investigational 5-HT4 agonist from Theravance thatis currently in development for the treatment of gastrointestinal motilitydisorders.
Per the terms of the agreement, Theravance and AlfaWassermann will collaborate on a two-part Phase II program testing theefficacy, safety and tolerability of the compound in treating gastroparesispatients. Should the studies provide sufficiently positive results, AlfaWassermann will have the right to exercise an exclusive option to develop andcommercialize velusetrag in the European Union, Russia, China, Mexico andselect other countries. Theravance will retain full rights to the compound inthe United States, Canada, Japan and certain other countries.
"We are pleased to enter this agreement withTheravance, with its strong record in partnering, as we strengthen ourlong-term gastroenterology portfolio through development initiatives ininnovative indications and further build our affiliate platform for the EU andemerging markets, where we are increasing our direct presence," StefanoGolinelli, CEO of Alfa Wassermann, said in a press release regarding the deal.
Under the agreement, Alfa Wassermann will fund the Phase IIprogram, and Theravance will be eligible for a $10 million option fee if AlfaWassermann chooses to exercise its option after the Phase II program iscompleted. All told, potential development, regulatory and sales milestonepayments for the agreement could total up to $53.5 million. Theravance willalso be eligible to receive royalties on net sales by Alfa Wassermann, in therange of the low teens to 20 percent.
Velusetrag, also referred to as TD-5108, is a highlyselective agonist with high intrinsic activity at the human 5-HT4 receptor,which is a protein coded by the HTR4 gene. The gene belongs to the family ofserotonin receptors, and the receptors are found in the central nervous systemas well as peripheral tissues. Velusetrag is an oral, investigational,once-daily medicine, and in a Phase II proof-of-concept study in chronicidiopathic constipation, the compound exhibited statistically significantprokinetic activity at all three dose levels among the 400 participatingpatients. At the two lowest dose levels, the medicine was generally welltolerated and displayed a low incidence of adverse events. In healthyvolunteers, velusetrag was shown to accelerate gastric emptying.
Gastroparesis, also known as delayed gastric emptying, is adebilitating condition in which the ability of the stomach to empty itscontents is reduced, without the presence of any kind of blockage orobstruction. The cause is unknown, but PubMed Health notes that the conditionmay be the result of "a disruption of nerve signals to the stomach." Gastroparesisis a common complication of diabetes as well as some surgeries, and symptomsinclude nausea, vomiting, bloating, premature fullness after eating andhypoglycemia. Serotonin antagonist drugs, which target serotonin receptors5-HT4, represent a potential treatment for the condition.
"Gastroparesis represents one of the most significantunmet medical needs in gastroenterology, and we look forward to moving quicklywith Alfa Wassermann to bring this potential medicine to patients who havelimited alternatives today," Rick E. Winningham, chairman and CEO ofTheravance, said in a statement.