Beovu® (brolucizumab injection)
`now publicly reimbursed in Ontario
`and New Brunswick for the
`treatment of neovascular (wet) age-
`related macular degeneration Français
`
`NEWS PROVIDED BY
`Novartis Pharmaceuticals Canada Inc.
`
`Dec 17, 2021, 07:00 ET
`
`Beovu is an anti-VEGF that offers the option for eligible patients to start on a three-
`®
`month dosing interval immediately after the loading phase with no compromise in
`efcacy.
`1,2
`While wet age-related macular degeneration (AMD) represents 10 to 20 per cent of all
`AMD cases, it is the most severe form of AMD and is responsible for 90 per cent of vision
`loss associated with this disease.
`3
`
`DORVAL, QC, Dec. 17, 2021 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to
`announce that Beovu (brolucizumab injection) is now listed on the Ontario Drug Benet
`Pr
`®
`Formulary and the New Brunswick Drug Plan for the treatment of neovascular (wet) age-
`related macular degeneration (AMD) for eligible patients.
`
`"We would like to thank the Governments of Ontario and New Brunswick for their leadership in
`making Beovu  accessible for eligible patients and remain committed to working
`®
`collaboratively with the remaining provinces to ensure patients across the country can benet
`from this therapy. Access to this next generation wet AMD treatment will make a difference to
`
`
`Regeneron Exhibit 1181.001
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`the vision health of Canadians and represents another step towards Novartis' goal of
`eradicating preventable blindness," said Andrea Marazzi, Country Pharma Organization Head,
`Novartis Pharmaceuticals Canada Inc.
`
`Affecting more than 2.5 million Canadians, AMD is a chronic disease of the retina that causes
`progressive loss of central vision and is the leading cause of vision loss in people over the age of
`50.
` There are two types of AMD – dry and wet.
`In wet AMD, new blood vessels grow under
`4,5,6
`4 
`the macula and leak uid into the eye causing scarring of the macula. Left untreated, wet AMD
`7 
`can lead to profound, rapid, and permanent loss of sight.
`Vision loss has a signicant impact
`4,8,9 
`on people's quality of life and mental health – their autonomy is lost, they can't drive, read or
`see the faces of their loved ones, often leading them to experience feelings of social isolation
`and depression.
` 
`9,10
`
`"Given wet AMD can be aggressive in its progression and has no cure, it can have a devastating
`impact on patients and their vision if patients don't adhere to the regular treatment that is
`required," said Dr. Peter Kertes, MD, ophthalmologist and retinal specialist, Sunnybrook
`Hospital, Toronto. "As someone who knows how important extended treatment intervals can
`be for patients, I welcome the news that Beovu is now publicly funded in these provinces,
`®
`providing a new treatment option for wet AMD."
`
`Anti-vascular endothelial growth factor (anti-VEGF) therapy is widely regarded as the standard
`of care for patients with wet AMD. Approved by Health Canada in March 2020, Beovu  is an
`11 
`®
`anti-VEGF that offers the option for eligible patients to start on a three-month dosing interval
`immediately after the rst three doses (loading phase).
` 
`1,2
`
`"Regular treatment is key to preserving sight and maintaining the independence of people
`living with wet AMD," said Doug Earle, president and CEO, Fighting Blindness Canada. "It may
`be challenging to keep up with frequent appointments, especially for those living in remote or
`isolated communities, or requiring mobility assistance. These issues have further been
`exacerbated by COVID-19. The Governments of Ontario and New Brunswick's decision to add
`Beovu to their provincial formularies offers the opportunity to reduce the burden of frequent
`®
`injections and will be meaningful to provide treatment options for people living with wet AMD
`and their loved ones." 
`
`
`
`Regeneron Exhibit 1181.002
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`About Beovu (brolucizumab injection)
`®
`Beovu (brolucizumab injection) is a humanized vascular endothelial growth factor (VEGF)
`®
`inhibitor that binds to VEGF-A isoforms, thereby preventing binding of VEGF-A to its receptors
`VEGFR-1 and VEGFR-2. By inhibiting VEGF-A binding, Beovu suppresses endothelial cell
`®
`proliferation in vitro and reduces neovascularization of vascular permeability.
`1 
`
`Beovu  received Health Canada approval on March 12, 2020 for the treatment of neovascular
`®
`(wet) age-related macular degeneration (AMD) based on ndings from the pivotal HAWK and
`HARRIER Phase III studies.
`1 
`
`The full prescribing information for Beovu can be found at: www.novartis.ca.
`®
`
`About Novartis in Ophthalmology
`At Novartis, our mission is to discover new ways to improve and extend people's lives. In
`ophthalmology, we develop and deliver life-changing medicines and therapies for diseases and
`conditions from front to back of the eye, enabled by data and transformative technologies. Our
`ophthalmic solutions reach more than 150 million people per year, from premature infants to
`the elderly. 
`
`About Novartis Pharmaceuticals Canada Inc.
`Novartis Pharmaceuticals Canada Inc., a leader in the healthcare eld, is committed to the
`discovery, development and marketing of innovative products to improve the well-being of all
`Canadians. In 2020, the company invested $45 million in research and development in Canada.
`Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000
`people in Canada and is an afliate of Novartis AG, which provides innovative healthcare
`solutions that address the evolving needs of patients and societies. The company prides itself
`on its commitment to diversity and to nurturing an inclusive and inspiring environment.
`Novartis is recognized as a Great Place to Work , ranked among the Top 50 Best Workplaces™
`®
`in the country and is proudly named on the 2021 Best Workplaces™ for Women in Canada and
`Best Workplace™ for Mental Wellness lists. For further information, please consult
`www.novartis.ca.   
`
`
`
`Regeneron Exhibit 1181.003
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`About Novartis 
`Novartis is reimagining medicine to improve and extend people's lives. As a leading global
`medicines company, we use innovative science and digital technologies to create
`transformative treatments in areas of great medical need. In our quest to nd new medicines,
`we consistently rank among the world's top companies investing in research and development.
`Novartis products reach more than 800 million people globally and we are nding innovative
`ways to expand access to our latest treatments. About 110,000 people of more than 140
`nationalities work at Novartis around the world. Find out more at www.novartis.com.
`
`Beovu is a registered trademark.
`
`References
`_________________________
`Beovu Product Monograph. November 23, 2021. Available at: www.novartis.ca/beovumonograph. Accessed on December 2, 2021.
`1.
`®
`American Academy of Ophthalmology. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular
`2.
`Age-Related Macular Degeneration. Available at: https://www.aaojournal.org/article/S0161-6420(18)33018-5/fulltext. Accessed on December 2, 2021.
` Institut national d'excellence en santé et en services sociaux. Efficacité et innocuité de la monothérapie antiangiogénique dans le traitement de la
`3
`dégénérescence maculaire liée à l'âge. Available at:
`https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/DMLA/Note_informative_DMLA.pdf. Accessed on December 2, 2021.
` Medscape. Age-Related Macular Degeneration. Available at: https://www.medscape.com/viewarticle/848348_print. Accessed on December 2, 2021.
` Fighting Blindness Canada. AMD Survey. Available at: https://www.fightingblindness.ca/amdsurvey/. Accessed on December 2, 2021.
` Canadian Council of the Blind. The Cost of Vision Loss and Blindness in Canada. Available at: https://www.fightingblindness.ca/wp-
`content/uploads/2021/05/Deloitte-Final-Acc-of-VL-and-Blindness-in-Canada-May-2021.pdf. Accessed on December 2, 2021.
` American Academy of Ophthalmology. What is Macular Degeneration? Available at: https://www.aao.org/eye-health/diseases/amd-macular-degeneration.
`7
`Accessed on December 2, 2021.
` Fighting Blindness Canada. Age Related Macular Degeneration. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/age-related-
`8
`macular-degeneration/. Accessed on December 2, 2021.
` Wykoff CC et al. Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration. J Manag Care Spec
`9
`Pharm. 2018 Feb. Available at: https://pubmed.ncbi.nlm.nih.gov/29383980/. Accessed on December 2, 2021.
` American Macular Degeneration Foundation. Depression in Age-related Macular Degeneration. Available at: https://www.macular.org/depression-amd-
`10
`arnold-wyse-md. Accessed on December 2, 2021.
` CADTH Therapeutic Report. Anti-Vascular Endothelial Growth Factor Drugs for the Treatment of Retinal Conditions Recommendations Report. 2016.
`11
`Available at: https://www.cadth.ca/sites/default/files/pdf/TR0009_Anti-VEGFs_Recs_Report.pdf. Accessed on December 2, 2021.
`
`4 5 6
`
`SOURCE Novartis Pharmaceuticals Canada Inc.
`
`For further information: Novartis Media Relations, Katia Kononova, Novartis Pharmaceuticals
`Communications, + 1 514 633 7873, E-mail: camlph.communications@novartis.com
`
`
`
`Regeneron Exhibit 1181.004
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`Related Links
`http://www.novartis.ca
`
`
`
`Regeneron Exhibit 1181.005
`Regeneron v. Novartis
`IPR2021-00816
`
`