Biotech Values

[DewDiligence]

EU Approves NVS’ Ilaris

[Non-trivial sales for a company of NVS’ size depend on a possible approval for gout.]

http://www.reuters.com/article/healthcareSector/idUSLS32787220091028

›Wed Oct 28, 2009 5:14am EDT

ZURICH, Oct 28 (Reuters) - The European Union has approved Novartis AG's to treat children and adults with a rare but potentially fatal inflammatory disease, the Swiss drugmaker said on Wednesday. Novartis said in a statement the accelerated EU decision follows approvals in the United States and Switzerland.

It said Ilaris is the only approved treatment in the EU for patients who suffer from two forms of cryopyrin-associated periodic syndrome (CAPS), whose symptoms can include debilitating fatigue, rash, fever, headaches, joint pain and conjunctivitis.

Helvea analyst Karl-Heinz Koch said the global market for CAPS was estimated at about $50 million, but noted Novartis recently presented promising data for Ilaris in gout, which could mean peak sales of $400 million.

CAPS is caused by a single gene mutation that leads to overproduction of interleukin-1 beta, which causes sustained inflammation and tissue damage.

Long-term consequences may be serious and potentially fatal, including deafness, bone and joint deformities, central nervous system damage leading to visual loss, and possible kidney failure.‹