Key events in 2013and post year end

Lyxumia® (lixisenatide) – Sanofi

Feb

European approval FDA acceptance of the New Drug Application (NDA) filed for lixisenatide in the US 

Mar

First European launch 

June

Approval in Japan 

Sep

Sanofi withdrew the NDA for lixisenatide in the US in order to resubmit in 2015 after completion of the ELIXA cardiovascular outcome study 

Dec

Data presented at the IDF World Diabetes congress support flexibility in the timing of Lyxumia® administration

Feb’14

Report of 2013 initial Lyxumia® royalty revenue: DKK 6.5 (€ 0.85) million (Q4: DKK 3.2 (EUR 0.43) million)

Lantus®/Lyxumia® fixed-ratio combination – Sanofi

Feb

Sanofi delays the expected start of the LixiLan Phase III    development program (previously planned for start mid 2013) 

May

Sanofi assigns priority to a Fixed-Ratio combination of      Lantus®/Lyxumia® over the Fix-Flex device for start of Phase III 

June

Sanofi announces expected start of the LixiLan Phase III program in first half of 2014

Jan’14

Approval of the first LixiLan Phase III study protocol; milestone payment of USD 15 (DKK 82) million to Zealand from Sanofi

Feb’14

LixiLan Phase III program started – US regulatory submission targeted for late 2015

ZP2929 and Boehringer Ingelheim collaboration

Jan’14

Change of development program on novel dual-acting glucagon/GLP-1 receptor agonists to a new lead compound – ZP2929 will continue in Phase I development outside the collaboration under Zealand’s sole control

Danegaptide

Mar

Decision to start a large single centre Phase II Clinical Proof-of-Concept study to evaluate this potential first-in-class peptide therapeutic in the prevention of ischemic reperfusion injuries 

Nov

Start of patient dosing in the Phase II PoC study: Completion targeted for the 2nd half of 2015

Elsiglutide

Mar

Helsinn decides to advance into Phase IIb development based on favourable results from Phase IIa 

Other pipeline events and partnering

June

Partnership with D. E. Shaw Research: Potentially adding a new dimension to peptide drug design 

July

Glocagon analogue for liquid formulation: Preclinical data presented at ADA support the outlook for ZP-GA-1 as a potential new treatment of diabetic hypoglycemia in the form of an easy-to-use pen and/or in an artificial pancreas

Aug

Partnership with Lilly – Third diabetes collaboration: Joint design and development of novel peptide therapeutics for Type 2 diabetes and obesity

Sep

GLP-1/gastrin dual agonist: Preclinical data presented at EASD show potential for this compound as a novel approach for the treatment and/or prevention of Type 2 diabetes

Zealand’s organisation

Jan

Agneta Svedberg appointed as new Chief Operating Officer 

Sep

Dr. Torsten Hoffmann appointed as new Chief Scientific Officer