Zealand Pharma is a biotechnology company based in Copenhagen, Denmark. It specialises in the discovery, design and development of novel peptide medicines.
The company’s first invented product is Lyxumia® (lixisenatide), a GLP-1 receptor agonist for the treatment of type 2 diabetes, today marketed world-wide ex-US by Sanofi with US NDA submission planned for Q3 2015.
Lixisenatide mimics the function of the native digestive hormone GLP-1 that stimulates the pancreas to produce insulin after meals. GLP-1 based medicines have been heralded by the medical community as a significant new therapeutic approach in the fight against type 2 diabetes. Simon Kiddle, a partner at Mewburn Ellis, has helped Zealand Pharma obtain patents around the world to protect lixisenatide.
With other pharmaceutical companies developing competing drugs for this market, Zealand needed to be confident that commercialisation of lixisenatide would not infringe any third party’s IP rights. Before Lyxumia® was launched Simon provided freedom to operate advice, enabling Zealand Pharma to be confident that the path was clear for their new drug.
As with many pharmaceutical drugs, securing Supplementary Protection Certificates (SPCs) for lixisenatide was of huge financial importance. The often long, drawn-out regulatory approval process for pharmaceutical drugs makes SPCs an essential part of protecting market share beyond the lifespan of a patent. Sam Bailey, a partner in our SPC team has worked closely with Zealand’s in-house counsel to advise about the availability of SPCs. Mewburn Ellis has filed an SPC application in the UK and worked with local counsel to file SPC applications in 15 other jurisdictions across Europe. We also coordinated the filing of corresponding patent term extension applications in Australia, Japan, and Israel. Over two-thirds of these SPC and patent term extension applications are now granted, and the rest are pending awaiting action from the relevant local patent office. Simon Kiddle has successfully represented Zealand as opponent in several European opposition hearings relating to Exendin-4 formulation IP owned by Amylin, (now Astra Zeneca). Simon Kiddle and his team have also successfully defended Zealand IP relating to GLP-1 treatment regimens in a European opposition hearing.