Zealand Pharma: FDA acceptance to proceed into Phase 3 trial
(CercleFinance.com) - Denmark's Zealand Pharma said that the US FDA has accepted to proceed with a Phase 3 trial on glepaglutide for short bowel syndrome.
Zealand expects to initiate the pivotal Phase 3 trial, which will enroll up to 130 patients in the US, EU and Canada in the third quarter of 2018.
The biotech firm also said that sales of Soliqua, a combination of lixisenatide and insulin glargine, which is marketed by Sanofi, reached 9 million euros (around 11 million dollars) in the first quarter.
Soliqua is approved in the United States as a therapy for type 2 diabetes inadequately controlled on basal insulin or lixisenatide alone.
While the products is marketed by Sanofi, Zealand receives 10% of global net sales.
Zealand Pharma said that Suliqua's first-quarter sales, another teatment of type 2 diabetes that is marketed by Sanofi, reached 5.5 million euros (6.7 million dollars) in the first quarter.
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