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1、Lucentis versus Avastin for the Treatment of Wet Age-related Macular Degeneration,George A. Williams, M.D. Larry Gorkin, PhD Gorkin & Cheddar Wendy Bedale,It is about a miracle drug for macular degeneration, or rather Two miracle drugs: Lucentis and Avastin, one expensive, the other almost dirt chea
2、p. It is about the drug company, Genentech, that developed both drugs, and the difficult and controversial decisions made in developing and marketing these drugs. It is about pioneering doctors who want to help their patients, and patients who take risks for the chance to see again.,PROVIDER COSTS,A
3、vastin and Lucentis, the result is approximately $9.7 billion in global sales in 2010, and arguably the second leading drug in sales behind Pfizers Lipitor（$10.7 billion）patent expi:2011-11-30 Accordingly, Lipitor might drop below $10 billion in fullyear 2011 revenue, creating this unorthodox opport
4、unity for combined Avastin and Lucentis to lead in global sales.,Normal Retina,The macula is part of the retina, the part that is in the back central region of the eye. It is responsible for the clear, sharp central vision needed to drive, read, embroider or paint,Normal Anatomy,Optic nerve,Macula R
5、etinal blood vessels,AMD is the leading cause of vision loss in the elderly Affecting about 1.5% of the population over the age of 40,AMD Classification Two main types of AMD Dry = 90% of those affected Vision loss due to atrophy 10% of those with severe vision loss,The dry form of the disease can p
6、rogressed to the wet form,AMD Classification,Two main types of AMD Wet = 10% of those affected Vision loss from bleeding and leakage from abnormal blood vessels 90% of those with severe vision loss,Wet AMD,Growth of vessels from choroidal compartment into the subretinal space with secondary damage t
7、o the overlying retina New blood vessels behind the eye start to grow in AMD patients. The new blood vessels grow and grow. Blood and otherfluids leak from these blood vessels, damaging the macula .,AMD Symptoms,AMD Risk Factors,Non-modifiable Genetic Gender female Age Modifiable Diet low anti-oxida
8、nt intake Cigarette smoking Physical activity/obesity,Estimated Prevalence of US Adults With Advanced AMD by Age and Gender,Prevalence of Neovascular AMD or Geographic Atrophy in Either Eye,No. of cases (millions),Based on US Census 2000. Friedman et al. Arch Ophthalmol. 2004;122:564.,1.6,2.0,0.05,0
9、.06,1.2,0.8,0.4,0,0.09,0.15,0.24,1.1,0.57,1.17,1.75,55-59,60-64,65-69,70-74,75-79, 80,All men,All women,Total,Age (y),50-54,40-49,0.06,0.02,Increasing Prevalence of Advanced AMD,No. of individuals (millions),Number of Individuals With Neovascular AMD or Geographic Atrophy (any location),2000,2020,Ye
10、ar,59% increase,Friedman et al. Arch Ophthalmol. 2004;122:564.,AMD Decreases Quality of Life,Increased incidence of depression in advanced AMD (Depression increases mortality risk) Increased mortality risk among individuals with advanced AMD Greater need for assistance with daily living activities v
11、s older adults without AMD,1. Brody et al. Ophthalmology. 2001;108:1893. 2. Williams et al. Arch Ophthalmol. 1998;116:514.,AMD Decreases Quality of Life,Both intermediate and advanced AMD negatively impact quality of life,Berdeaux et al. Am J Ophthalmol. 2005;139:271. Clemons et al. Arch Ophthalmol.
12、 2003;121:211.,Mental health Role difficulties Dependency Peripheral vision,General vision Near activities Distance vision Driving,Chronic renal failure on home dialysis,Perfect health with perfect vision Death,Congestive heart failure,Cataract,Symptomatic HIV or AIDS,Complete blindness,Mean value,0
13、,0.20,0.40,0.60,0.80,1.00,Quality of Life Ratings for Chronic Diseases,Scores ranged from 1 (perfect health with perfect vision) to 0 (death). Submacular Surgery Trials Research Group. Arch Ophthalmol. 2004;122:1856.,1 0,0.77,0.68,0.54,0.65,0.33,Status,Score,Subfoveal Choroidal Neovascularization (C
14、NV):,Evolution of Therapy for Neovascular AMD,Improve vision,Halt progression,PDT = photodynamic therapy,1980,2000,2006,Like laser therapies, seek to obliterate the blood vessels, but these approaches have been described as being “like using a blowtorch to stop weeds”, according to retinal specialis
15、t Dr. Anne Fung of San Francisco,Chase M (2007) Genentechs Big Drug For Eyes Faces a Rival. The Wall Street Journal,There are many different growth factors for many different types of tissues. Some help build bone, others nerves, skin,red blood cells, and so on. One class of growth factors called va
16、scular endothelial growth factors, or VEGFs, triggers new blood vessel growth. This process is called angiogenesis.,In the mid-1990s, the discovery of specific growth factors in the body that stimulated angiogenesis lead scientists to hypothesize that blocking these same growth factors might stop cancer from growing. One of these scientists was Dr.Napoleone Ferrara.(Napolon Bonaparte),Ferrara is a legend at Genentech, itself a legend in t
