Bayer receives approval for Eylea® as new drug to treat wet Age-Related Macular Degeneration Patients in Canada

Bayer receives approval for Eylea® as new drug to treat wet Age-Related 
Macular Degeneration Patients in Canada 
Eylea® (aflibercept, solution for intravitreal injection) offers new hope for 
patients suffering from wet age-related macular degeneration 
TORONTO, Nov. 12, 2013 /CNW/ - Bayer Inc. announced today that it has received 
approval from Health Canada for Eylea(®) (aflibercept, solution for 
intravitreal injection) for the treatment of patients with neovascular (wet) 
age-related macular degeneration (wet AMD). 
AMD is a progressive eye disease that affects a person's central vision and is 
a leading cause of vision loss in Canadians over age 50. There are two forms 
of AMD - wet and dry. Wet AMD is the most severe form of the disease, and can 
cause a sudden loss of vision within weeks or months. Living with AMD can be 
extremely difficult - patients may no longer be able to read, drive or see the 
faces of family and friends. Without treatment, AMD can lead to blindness.( 
"The approval of Eylea in Canada is great news for the increasing number of 
patients suffering from wet AMD, a sight-threatening eye condition," said Dr. 
David T. Wong, MD, FRCSC Associate Professor of Ophthalmology and Vision 
Sciences,St. Michael's Hospital, University of Toronto. "The dosing of Eylea 
every two months has the potential to significantly reduce the burden for 
patients living with this devastating disease by giving them more time to do 
the things they like to do." 
"The approval of Eylea in Canada means that patients with wet AMD will have 
more treatment options to help them to continue to live fulfilling lives," 
said Sharon Colle, President & CEO of the Foundation Fighting Blindness. "The 
potential for less frequent office visits with this new treatment will mean a 
lot to patients and their families." 
The Health Canada approval of Eylea(®) is based on the results of two Phase 
III clinical studies (VIEW 1 and VIEW 2) which demonstrated that aflibercept 
injection dosed every 8 weeks, following 3 initial monthly injections, was 
non-inferior to ranibizumab injection dosed every 4 weeks. This was measured 
by the primary endpoint of proportion of subjects who maintained vision (i.e. 
loss of fewer than 15 letters of best-corrected visual accuity compared to 
baseline) at week 52. The most common adverse reactions (frequency of 5.0% or 
more) reported in patients receiving aflibercept injection were conjunctival 
hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and 
increased intraocular pressure. 
Bayer Inc. plans to launch Eylea(®) in January 2014, and has initiated 
efforts to gain early and rapid reimbursement for this new product. 
About VEGF and VEGF Trap-Eye (aflibercept, solution for intravitreal injection)
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in 
the body. Its normal role in a healthy organism is to trigger formation of new 
blood vessels (angiogenesis) supporting the growth of the body's tissues and 
organs. It is also associated with the growth of abnormal new blood vessels in 
the eye, which exhibit abnormal increased permeability that leads to edema. 
Scarring and loss of fine-resolution central vision often results. 
Eylea(®), also known as VEGF Trap-Eye, is a recombinant fusion protein, 
consisting of portions of human VEGF receptors 1 and 2 extracellular domains 
fused to the Fc portion of human IgG1 and formulated as an iso-osmotic 
solution for intravitreal administration. VEGF Trap-Eye acts as a soluble 
decoy receptor that binds VEGF-A and placental growth factor (PlGF) and 
thereby can inhibit the binding and activation of their cognate VEGF receptors. 
Eylea(®) is already approved in the United States, Europe, Japan, Australia, 
and many other countries for use in wet AMD and in the U.S., Europe, and 
several countries in South America for the treatment of macular edema 
following CRVO. 
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the 
global development of Eylea(®). Regeneron maintains exclusive rights to 
Eylea(®) in the United States. Bayer HealthCare has licensed the exclusive 
marketing rights outside the United States, where the companies share equally 
the profits from sales of Eylea(®), except in Japan where Regeneron receives 
a royalty on net sales. 
About Wet AMD
Age-related macular degeneration (AMD) is a leading cause of acquired 
blindness. Macular degeneration is diagnosed as either dry (non-exudative) or 
wet (exudative). In wet AMD, new blood vessels grow beneath the retina and 
leak blood and fluid. This leakage causes disruption and dysfunction of the 
retina creating blind spots in central vision, and it can account for 
blindness in wet AMD patients. 
About The Foundation Fighting Blindness
The Foundation Fighting Blindness is Canada's largest charity for sight-saving 
research and has contributed over $24 million to find the causes, treatments 
and cures for retinitis pigmentosa, macular degeneration and related blinding 
eye diseases. You'll see: results thanks to Foundation-funded discoveries, 
made possible by its generous donors. The Foundation is also known by its 
signature events: Comic Vision, Cycle for Sight, Ride for Sight, and Vision 
Quest. Visit or call 1.800.461.3331 for the latest in vision research. 
About Bayer in Canada
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate headquarters 
for the Canadian operations. Celebrating its 150(th) anniversary, Bayer AG 
is an international research-based group with core businesses in healthcare, 
crop science and innovative materials committed to creating a better life for 
all through science. 
In Canada, Bayer operates its healthcare business - Pharmaceuticals, Consumer 
Care, Diabetes Care, Animal Health and Radiology & Interventional - from its 
headquarters in Toronto, ON, and Bayer CropScience Inc. operates out of its 
head office in Calgary, AB. Together with its material science business, Bayer 
improves the quality of life for Canadians through products that fight 
disease, protect crops and animals, and provide high-performance materials for 
numerous daily life uses. 
With more than 1,300 employees across the country, in 2012, Bayer had sales of 
$1.6 billion and invested $55.9 million in research and development in Canada. 
Globally, Bayer AG had sales of €39.8 billion and invested €3 billion in 
research and development. 
For more information about Bayer, please visit 
Forward-Looking Statements 
This release may contain forward-looking statements based on current 
assumptions and forecasts made by Bayer Group or subgroup management. Various 
known and unknown risks, uncertainties and other factors could lead to 
material differences between the actual future results, financial situation, 
development or performance of the company and the estimates given here. These 
factors include those discussed in Bayer's public reports which are available 
on the Bayer website at The company assumes no liability 
whatsoever to update these forward-looking statements or to conform them to 
future events or developments. 
(1) CNIB website
ult.aspx last accessed October 16, 2013.
(2) Foundation Fighting Blindness website
last accessed October 25, 2013

SOURCE  Bayer Inc. 
Your Contact at Bayer: Laura Burns, 416-240-5484 
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CO: Bayer Inc.
ST: Ontario
-0- Nov/12/2013 11:59 GMT