Actelion cardio drug faces EU safety probe
European drug safety regulators are reviewing Actelion’s cardiology drug Uptravi (selexipag) following the deaths of five patients taking the medicine in France.
The news from the European Medicines Agency comes at a delicate time for Actelion, which is about to be acquired by Johnson & Johnson for around $30 billion.
Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) said that Uptravi may continue to be used in line with current prescribing information for pulmonary arterial hypertension, while it investigates the safety signal.
The company's share price dropped in early trading this morning, but has quickly regained most of these losses, suggesting that investors are not overly concerned by the development.
Once the investigation is complete, the PRAC will publish a recommendation, which will then be applied to all EU countries.
In extreme cases the PRAC can recommend the drug is pulled from the market, or it can require restrictions on a medicine's use to improve safety.
Uptravi is one of two PAH drugs Actelion has developed to replace its older medicine, Tracleer (basentan).
Sales of Uptravi amounted to 160 million Swiss francs – around $160 million – in the first nine months of 2016.
However the drug was only launched in the US a year ago, and like Actelion’s other new PAH treatment Opsumit (macitentan), it is expected to become a blockbuster in the coming years.
Uptravi is authorised for use in combination with endothelin receptor antagonists and/or phosphodiesterase type 5 inhibitors when these medicines are ineffective, or as a monotherapy in patients who cannot take these other drugs. It was authorised in the EU in May 2016.
Neither J&J or Actelion made any immediate comment about the news.
J&J and Actelion agreed their $30 billion takeover in late January after talks first began late last year.
J&J beat off competition from Sanofi to secure the deal, paying a 30% premium over Actelion’s share price at the time the agreement was sealed.
As part of the deal J&J will get late-stage pipeline drugs from Actelion - a potential treatment for Clostridium difficile-associated diarrhoea, and a multiple sclerosis drug.
Actelion’s R&D unit will be spun out into a standalone company based in Switzerland, although J&J will hold a 16% substantial minority interest. This means the new biotech will start off with around a billion Swiss francs ($1 billion) to kick start operations.
