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Things are looking up for Zealand

17.12.2011

Copenhagen/Paris – Danish biopharma­ceuticals company Zealand Pharma A/S has received some positive news. Ever since French partner Sanofi Aventis submitted a marketing authorisation application for Lyxumia (lixisenatide) in Europe, the chances that Zealand will be able to cash in on its once-daily GLP-1 receptor agonist have risen. Although no direct payments are linked to the MAA, there is a milestone payment involving completion of the full GetGoal Phase III programme expected in the first quarter of 2012. Zealand Pharma is also eligible for low double-digit royalties on worldwide sales of lixisenatide, and of any combination product that includes it. Under the agreement with Sanofi, Zealand Pharma is eligible to receive remaining milestone payments of up to €170m, covering different formulations and combinations of the compound. Submission for regulatory approval in the US is expected at the end of 2012. Sanofi is completing Phase III development of the drug as a monotherapy and as an add-on to existing diabetes type 2 treatments, preferably Sanofi’s Lantus. The actual filing is based on the Phase III GetGoal study, which comprises data from nine other studies and more than 4,300 patients

Politics / Law

23.03.2012

Brussels/Strasbourg – Health claims are set to be drastically limited in the EU. On Wednesday 21 March the Environment Committee of the European Parliament confirmed a proposal of the European Commission to prohibit 1,600 health...

Politics / Law

15.03.2012

Parma/Stockholm – Foodborne bacteria such as Salmonella and Campylobacter are becoming more and more resistant to antimicrobial drugs, according to a joint report published by the European food watchdog EFSA and the European...

BioFunding

09.03.2012

In mid-February, scientists and entrepreneurs from nine EU countries met at the Center for Genomic Regulation (CRG) in Barcelona to launch the 4DCellFate project. Positioned within the FP7 Programme, the consortium will receive...

BioFunding

09.03.2012

Brussels – The EU’s Innovative Medicines Initiative (IMI) will establish the European Lead Factory, an EU-wide public-private partnership aiming to facilitate drug discovery efforts. The Lead Factory will comprise a...

Editorial

07.03.2012

T    he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the...

Tech Review

07.03.2012

Intellectual Property (IP) is without question one of the most vital aspects of any bio­tech venture, a key and undisputed factor for success. However, most bio­tech companies are still incapable of unlocking the value of their...

Clinical Trial

07.03.2012

Schlieren – Swiss Cytos Biotechnology Ltd. has been authorised to restructure a convertible bond by Canton of Zurich authorities. The company does not have enough cash to pay it back. Negotiations with bond holders failed in a...

Clinical Trial

06.03.2012

Munich – German 4SC AG jumped 39% to €2.05/share after oncology drug candidate resminostat met the primary endpoint of at least a 20% progression-free survival rate in a Phase II trial to treat patients with hepatocellular...

Editorial

06.03.2012

The start of 2012 witnessed the tides turning in favour of small and mid-cap names in the European Life Sciences sector. Major global biotechnology indices like the NBI, BTK, and BIOTK are up over 15% year to date. The pace of...

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