Germany's Schering has been granted approval throughout the European Union for Angeliq (oestradiol and drospirenone), its new low-dose hormone replacement therapy. The news is a boost to the prospects of the drug, which has been caught in the fall-out from the HRT health scare that hit the headlines last year.
The US Food and Drug Administration turned down Schering's application to market Angeliq last October, in the wake of the Women's Health Initiative trial, which raised questions about the safety of the market-leading HRT products with regards to breast cancer and cardiovascular risk. At the time, analysts at Julius Baer were so concerned about the impact on Schering that they stripped out all Angeliq revenues from its their forecasts for the firm.
The EU approval has been granted after mutual recognition of Angeliq's clearance in the Netherlands last December, and Schering now plans to roll out the product in EU countries in the autumn.
Angeliq, along with the low-dose oral contraceptive Yasmin (ethinyl estradiol) is a key component of Schering's strategy to expand its presence in the US market. The company has made no secret of its ambition to double its US sales to $2 billion (€1.77bn) by 2006, and Angeliq is central to this effort. Schering has a peak sales forecast of more than €250 million for the product.
One of the main reasons for Schering's optimistic appraisal of Angeliq's prospects is a new clinical study, reported last month at the firm's R&D meeting for analysts. This found that the drug had a blood pressure lowering effect in addition to its benefits on menopausal symptoms.
Analysts are sceptical about Schering's chances of getting this hypotensive effect listed on its labelling, however, as the study had just 212 patients and was too small to be statistically reliable.
Meantime, Schering has acquired exclusive worldwide development and marketing rights from Italy's Philogen Srl for an antibody-based therapeutic fusion protein. The drug is expected to exert a therapeutic effect by stimulating an immunological response to solid tumours. Financial terms were not disclosed.