Oxford Biomedica. 2005 to see 'Huge value creation' (Panmure Gordon)

UPDATE 2-Genentech applies for approval of eye disease drug
Friday 30 December 2005, 11:46am EST
Printer Friendly | Email Article | Reprints | RSS

(Updates with sales figures, background, more trial data; adds byline)

By Toni Clarke

BOSTON, Dec 30 (Reuters) - Genentech Inc. (DNA.N: Quote, Profile, Research) said on Friday that it has applied for U.S. approval to market its drug Lucentis for the treatment of wet age-related macular degeneration, the leading causes of blindness in the elderly.

Genentech has requested that the U.S. Food and Drug Administration review the drug -- which some analysts believe could come to dominate the increasingly competitive market -- on a priority basis. If a review is granted, the FDA would have six months to decide whether to approve the drug.

Genentech would market the drug in North America, while Swiss drugmaker Novartis AG (NOVN.VX: Quote, Profile, Research) would market it elsewhere.

If approved, the drug would compete with Visudyne, made by Canada's QLT Inc. (QLT.TO: Quote, Profile, Research) (QLTI.O: Quote, Profile, Research) and co-marketed by Novartis; and Macugen, made by Pfizer Inc. (PFE.N: Quote, Profile, Research) and OSI Pharmaceuticals Inc. (OSIP.O: Quote, Profile, Research), which acquired the drug's developer Eyetech Pharmaceuticals Inc. (EYET.O: Quote, Profile, Research) in November.

Analysts at SG Cowen said in a report released earlier this year that Lucentis could generate sales of $750 million in 2009. QLT said earlier this month it expects 2005 sales of Visudyne to be $480 million, down from a previous forecast of $500 million to $530 million. In June Eyetech predicted 2005 sales of Macugen would be between $175 million and $190 million.

Age-related macular degeneration affects about 1.7 million people in the United States. While the dry form of the disease is the most common, accounting for about 90 percent of all cases, the wet form is the most devastating.

Patients with the wet form can go blind within a matter of days of developing the condition, caused by the build-up and rupture of blood vessels behind the eye.

Genentech's application is based on late-stage clinical trials showing that 95 percent of patients treated with Lucentis either maintained or improved their vision.

One trial showed that 95 percent of patients maintained or improved their vision compared to 64 percent of those taking Visudyne, the current standard of care.

The South San Francisco, California-based company has not yet released figures showing exactly what percentage of those patients improved, as opposed to maintained, their vision compared to those taking Visudyne. It plans to release that data in January.

A separate trial showed that between 25 percent and 34 percent of patients taking Lucentis saw an improvement in their vision of 15 letters or more, depending on dose, compared to patients who were given a sham injection.

Lucentis and Macugen both work by blocking a protein, known as VEGF, that is involved in the growth of blood vessels. The drugs work, albeit differently, by starving the vessels of nutrients needed to grow in a process known as anti-angiogenesis.

Genentech, which is majority-owned by Roche Holding AG (ROG.VX: Quote, Profile, Research), used the same broad technique to develop its successful cancer drug Avastin.