Novartis gets US backing for MS pill
Zurich, September 22, 2010
Swiss drugmaker Novartis AG's multiple sclerosis pill Gilenya won US backing, putting it ahead of German rival Merck KGaA in the race to be first with an oral treatment in the United States.
The US Food and Drug Administration's backing was largely expected after a unanimous recommendation by an advisory panel in June for FDA approval to treat US patients with relapsing MS, the most common form of the often debilitating disease.
Gilenya is one of Novartis's biggest drug hopes and the news could further lift sentiment in the stock, which has gained ground in recent weeks as investors focus on its promising pipeline and expect it to wrap up its buyout of Alcon.
"As a result of the broad label granted to Gilenya, we forecast it will generate peak sales of around $3.5 billion, significantly ahead of current consensus expectations which remain below $2 billion," analysts at brokerage Jefferies said in a note.
A spokesman for Novartis said the group was looking to make Gilenya available in coming weeks for patients with the disabling neurological condition that can cause dizziness, fatigue, blurred or double vision and cognitive problems.
"Gilenya's FDA approval as first-line treatment and first oral medicine against MS is very, very good news," one trader said. -Reuters