MACUGEN(TM) represents a substantial improvement in the treatment of age-related macular degeneration19 March 2006
Pfizer Canada Inc. announced today that MACUGEN(TM) (pegaptanib sodium injection) has now been recognized by the Human Drug Advisory Panel (HDAP) New Medicine Review as providing a substantial improvement in the treatment of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). As indicated in the Health Canada's Notice of Decision, before MACUGEN, there were no approved treatment options in Canada for 70 to 80 per cent of patients with AMD who have minimally classic occult lesions. The HDAP is a governmental agency, part of the Patented Medicine Prices Review Board (PMPRB).
MACUGEN is the only approved and effective treatment that helps preserve vision in patients with wet (neovascular) age-related macular degeneration (AMD) regardless of lesion subtype. It was approved by Health Canada in May, 2005, following a Priority Review due to the unmet medical need for new therapies to treat wet AMD, the most common cause of severe vision loss in Canadians older than 50 years of age.
Wet AMD is a fast, progressive disease that leads to irreversible vision loss and can severely compromise a person's ability to function independently. The disease affects a very small and specialized area in the centre of the retina, the macula, which is responsible for fine, detailed central visual tasks. Without treatment, AMD can take away central vision and lead to blindness.
"The favorable safety and efficacy profile demonstrated by MACUGEN in clinical studies reflects the benefits that this drug can provide to patients with all subtypes of neovascular AMD who have been waiting for a treatment option to help preserve their vision by stopping the progression of the disease," declared Dr. Alan F. Cruess, retina specialist and Head of the Department of Ophthalmology, Dalhousie University, Nova Scotia. "The fact that we can treat a greater spectrum of patients with MACUGEN, combined with the relative ease of administration and medically manageable side effects, is an important advancement."
In Canada, it is estimated that more than 100,000 people suffer from wet AMD. Each year it is estimated that more than 20,000 new cases of wet AMD are reported, with the incidence likely to increase significantly with a growing aged population.
"The problem of age related macular degeneration (AMD) will be a growing one for the aging populations of Canada and the industrial world," said Steve Winyard, Chairman of the AMD Alliance International. "AMD can rob someone of their sight within as little as three months and must be recognized as an important medical and societal priority. There are an estimated 500,000 new cases of wet AMD worldwide each year, so a range of safe and effective treatment options is critically important to preventing needless blindness."
MACUGEN PROVEN SAFE AND EFFECTIVE
MACUGEN (pegaptanib sodium injection) is indicated for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration and was specifically developed for that indication. The goal of therapy with MACUGEN is to help slow the progression of the disease and preserve vision. MACUGEN is a medicine that is injected into the eye by an ophthalmologist every six weeks. It is delivered by injection so it can reach the back of the eye where it is needed. Since its introduction on the market, MACUGEN has been used with approximately 50,000 patients worldwide, for a total of 160,000 injections.
MACUGEN is a selective vascular endothelial growth factor inhibitor, commonly referred to as a VEGF inhibitor. VEGF is a protein which acts as a signal triggering the abnormal blood vessel growth and leakage that is the hallmark of neovascular AMD.
MACUGEN was developed in collaboration with Eyetech Pharmaceutical (which was acquired by OSI Pharmaceuticals in 2005), a New York- based biopharmaceutical company specializing in the discovery, development and commercialization of novel ophthalmology therapeutics and devices. Pfizer and Eyetech co-promote MACUGEN in the United States. Eyetech Pharmaceuticals has granted Pfizer the exclusive right to develop and commercialize the product outside the United States.
ABOUT PFIZER CANADA INC.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals, as well as many of the world's best-known over-the-counter healthcare products. Pfizer Inc invests more than US$7 billion annually in R&D in a wide range of therapeutic areas, including arthritis, cardiovascular disease, endocrinology, infectious disease, neurological disease, oncology and ophthalmology. Pfizer Canada is one of the top 15 investors in Canadian research and development, investing more than $190 million in 2005. Pfizer Canada employs more than 2,000 people across the country. Canadian headquarters of Pfizer Global Pharmaceuticals is in Kirkland, Quebec.
For further information: please contact: Sabrina Tremblay, Pfizer Canada Inc., Cell.: (514) 346-1032; Josée Béliveau/Daphne Weatherby, Edelman, (514) 844-6665, ext. 241/225
Source: newswire
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