Quebecers suffering from wet Age-Related Macular Degeneration first with government coverage

Quebec lists Eylea^® as new drug to treat wet Age-Related Macular Degeneration patients

MONTREAL, April 24, 2014 /CNW/ - Bayer Inc. commends the Government of Quebec's priority review and subsequent listing for Eylea^® (aflibercept) under the provincial drug benefit plan as a treatment for wet Age-Related Macular Degeneration (wet AMD). Quebec is the first province in Canada to cover this drug which will provide a savings to the drug plan with a new treatment option for patients.

After the initial one injection per month for three months, the dosing of Eylea^® is administered every month for the first three months and subsequently every two months thereafter.

"We are excited that patients in Quebec will now have an additional option for treatment of their wet AMD, particularly since its use can reduce the number of required injections," says Andre Lavoie, General Manager, Quebec Association of Macular Degeneration. "We believe that the addition of Eylea to the treatment options will support improved quality of life for wet AMD patients."

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 result in a loss of central 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.^1,2,3

''Eylea is an important new option for patients with wet AMD, as it has been shown in clinical trials, to be equally effective, even if administered less frequently than other treatments,'' says Retina Specialist Dr. Pierre Labelle. ''This is a significant improvement for patients and their families."

Eylea^® was approved by Health Canada in late 2013 and has been available to patients across Canada since January 2014. Bayer Inc. is currently undertaking efforts to rapidly gain reimbursement in all provinces across the country.

The Health Canada approval of Eylea^® was 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 acuity 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.

About VEGF and Eylea^® (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^® 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. Eylea^® 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, Canada, 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 AQDM
The Association québécoise de la dégénérescence maculaire is a non-profit organization whose mission is to support the independence and maintaining or improving the quality of life of people with macular degeneration. In 2011 the organization also added the right to free health care as part of its mission. The Association refers individuals with AMD to existing medical, technological and social resources. It also informs patients about prevention methods and treatment as well as global research efforts. The AQDM's goal is also to educate the general public, health care practitioners and government bodies about the disease.

For more information on AMD, call 1 866-867-9389 or visit www.aqdm.org

About Bayer in Canada
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate headquarters for the Canadian operations.  Founded in 1863, 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 2013, Bayer had sales of $1.6 billion and invested $61 million in research and development in Canada. Globally, Bayer AG had sales of €40.2 billion and invested €3.2 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.

1	CNIB website http://www.cnib.ca/en/your-eyes/eye-conditions/eye-connect/AMD/About/Pages/default.aspx last accessed April 10, 2014.
2	Foundation Fighting Blindness website http://www.ffb.ca/eye_conditions/amd_center/what_amd.html last accessed April 10, 2014.
3	Canadian Ophthalmalogical Society website http://www.cos-sco.ca/vision-health-information/conditions-disorders-treatments/retinal-diseases/amd/ last accessed April 10, 2014.

SOURCE: Bayer HealthCare

Communications Contacts: Liana Del Medico, Bayer Inc., 416-248-3017, [email protected]; David Airdrie, Hill and Knowlton, 416-413-4745, [email protected]