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Lucentis gets Swiss go-ahead

First European approval for AMD drug tipped to dominate the global market 

Novartis has revealed that its drug, Lucentis (ranibizumab), has been approved by Swiss regulators as a treatment for severe age-related macular degeneration (AMD).

Although Lucentis already received a US Food and Drug Administration (FDA) marketing authorisation for AMD in June this year, the Swiss approval makes it the first European country to accept the drug.

While biotech firm, Genentech, majority-owned by Roche, has the commercial rights to Lucentis in the US, it licensed exclusive rights in the rest of the world out to Novartis because of its experience in marketing eye treatments. Novartis has also submitted Lucentis for approval in the European Union and Australia.

ìLucentis is redefining the treatment standards as the first approved drug for wet AMD patients that has been shown to improve vision and return the ability to do life-affirming everyday activities such as reading,î said Nicholas Franco, head of Novartis Ophthalmics. ìWe are excited to make Lucentis available to patients with this devastating disease.î

Pharmaceuticals analyst, Denise Anderson at Kepler Equities, said that the Swiss approval was good news for Novartis, even if it had been largely expected in light of the June FDA approval. She added that EU approval was expected sometime in the second quarter of 2007.

A recent report by research firm, Decision Resources, predicted that Lucentis will dominate the market and become the new standard of care in the treatment of wet AMD by 2015.

Decision Resources analyst, Regina Cebula, said more aggressive education, awareness and screening could significantly increase the number patients receiving treatment for AMD.

ìWe forecast dramatic 23 per cent annual growth in the AMD drug treatment from 2005 through 2010 as a result of more widespread use of premium-priced emerging therapies, including Lucentis,î she said.

AMD is the major cause of blindness in the elderly and is thought to affect over 25 million people worldwide. The $600m market is currently dominated by Novartis' Visudyne (verteporfin), which had sales of around $450m in 2005.

Lucentis will directly compete with Macaugen, a drug made by OSI Pharmaceuticals. Both drugs are administered by injection into the eye.

30th September 2008

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