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. 1,2

"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 ffb.ca 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 150th 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 www.bayer.ca.

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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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1 CNIB website http://www.cnib.ca/en/your-eyes/eye-conditions/eye-connect/AMD/About/Pages/default.aspx last accessed October 16, 2013.
2 Foundation Fighting Blindness website http://www.ffb.ca/eye_conditions/amd_center/what_amd.html
last accessed October 25, 2013

SOURCE: Bayer Inc.

For further information:

Your Contact at Bayer:
Laura Burns, 416-240-5484
E-Mail: laura.burns@bayer.com


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