Stockwatch: When rare is too expensive
This article was originally published in Scrip
When the European Medicines Agency (EMA) declined to approve Amsterdam Molecular Therapeutics’ (AMT’s) Glybera (alipogene tiparvovec) for the rare genetic disease lipoprotein lipase deficiency (LPDL) back in June (scripintelligence.com, 24 June 2011), the CEO of AMT was ‘convinced and confident’ of the approval of Europe’s first gene therapy within five months. At the end of this week, AMT completed the first, and easiest part of that process by filing an appeal against the EMA’s rejection and stated that they expected that the re-examination of the dossier would be completed by the end of 2011 (scripintelligence.com, 8 July 2011). Behind the backdrop of the appeal for re-examination which, history has shown does not have a high chance of success, the AMT annual report for 2010 reveals that the regulatory path for Glybera has been far from smooth.
You may also be interested in...
The Coronavirus outbreak makes its first dent into pharma's 2020 prospects as AstraZeneca admits possible impact, while could AbbVie's aesthetic plans raise the prospect of another GSK-style spin off?
Expensive acquisitions are in the spotlight during earnings season. The purchases of Kite and Celgene by Gilead and Bristol-Myers Squibb are not turning out to be what was written on the tin.
With Brexit and coronavirus depressing markets over the week, earnings season for life science companies shifted into a higher gear with a number of big companies reporting. In time, the effects of Brexit and 2019-nCoV are likely to subside, but the double-edge sword of biosimilar commercialization continues to rise from the full-year financial reports of Pfizer and Roche.