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Novartis' dermatology plans advance with Xolair approval

Green light for use in chronic spontaneous urticaria
Novartis building

Novartis' asthma drug Xolair has been approved in Europe for a new indication, the treatment of a severe form of hives known as chronic spontaneous urticaria (CSU).

Xolair (omalizumab) has been given the go-ahead as an add-on therapy alongside antihistamines for CSU in patients aged over 12 who do not respond to antihistamines alone. The EU is the first major market to approve the new indication, although Novartis said a green light in the US is expected in the coming weeks.

CSU affects around 1 per cent of the population and can be enormously debilitating, with severe itching and swelling that can resist even very high doses of antihistamines.

"Our aim is to help ensure that the up to 50 per cent of patients who suffer from CSU and don't respond to approved doses of antihistamines have access to Xolair as quickly as possible in the EU,” said David Epstein, head of Novartis Pharmaceuticals.

Xolair for CSU is one of two drugs nearing the market in the dermatology category that Novartis has high hopes for. The other is secukinumab, a candidate treatment for psoriasis, which was re-filed for approval last year and loos set to mount a challenge to Amgen/Pfizer's Enbrel (etanercept), the market leader among biologics for psoriasis.

Epstein told the Cowen & Co healthcare conference this week that Xolair for CSU and secukinumab together represent a high-margin, $2b-$3bn opportunity in specialty dermatology that complements Novartis' acquisition of generic dermatological drug specialist Fougera for $1.53bn in 2012.

CSU could represent a $500m opportunity for Novartis outside the US, where the Swiss drugmaker has a profit-sharing, co-promotion arrangement for Xolair with Genentech, and the drug could enjoy having the CSU market to itself for up to 10 years, as there are no competitors on the horizon at the moment. For its asthma indication, Xolair pulled in $613m last year, a rise of more than 22 per cent on 2012.

Epstein suggested that Novartis has the scale it needs now in dermatology to become "one of the biggest players in the market".

In addition to the EU, Xolair has been approved for the treatment of CSU in five countries, namely Egypt, Turkey, Guatemala, El Salvador and Bangladesh.

It is also under regulatory review in more than 20 countries, including the US, Canada, Australia and Switzerland.

7th March 2014

From: Sales

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