Applications for regulatory approval of Lyxumia® in Type 2 diabetes have also been submitted in several other countries around the world and are currently under review. In the US, a decision on NDA filing acceptance is expected from the FDA in Q1 2013.Financial guidance for 2013 and the terms of the Sanofi agreement As earlier announced, there is no milestone payment to Zealand Pharma associated with the approval of Lyxumia® in Europe. The company will provide financial guidance for 2013 in connection with the release of its 2012 full-year announcement on 14 March 2013. Under the license agreement with Sanofi, which covers lixisenatide and combination products, including lixisenatide, Zealand Pharma is eligible to receive remaining development, regulatory and sales milestone payments of up to USD 215 million, which include USD 40 million for a depot formulation of Lyxumia® not currently in active development 2. Further, the company is entitled to tiered low double-digit percentage royalties on global net sales of Lyxumia® and fixed low double-digit percentage royalties on full net sales of combination products, including lixisenatide 2. References
- http://clinicaltrials.gov/ct2/results?term=GetGoal. Date accessed: December 2012.
- Zealand Pharma pays 13% to Alkermes (former Elan) and 0.5% to SIP® technology inventor on all income from lixisenatide.