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`Genentech: Press Releases | Friday, Oct 14, 2016
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`South San Francisco, CA -- October 14, 2016 --
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`https://www.gene.com/media/press-releases/14640/2016-10-14/fda-approves-genentechs-lucentis-ranibiz
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`Novartis Exhibit 2116.001
`Regeneron v. Novartis, IPR2021-00816
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`We are actively responding to the global COVID-19 pandemic. For more, please
`visit our COVID-19 response
`page, or call 1-877-436-3683 . See the latest update on Actemra® (tocilizumab) supply here.
`Friday, Oct 14, 2016
`FDA Approves Genentech’s Lucentis (Ranibizumab Injection) Prefilled
`Syringe
`Lucentis prefilled syringe oers a ready-to-use option to deliver treatment with fewer
`steps
`First anti-VEGF prefilled syringe FDA-approved to treat people with wet age-related
`macular degeneration and people with macular edema after retinal vein occlusion
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`Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced
`that the U.S. Food and Drug Administration (FDA) approved the Lucentis (ranibizumab
`injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the
`Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular
`degeneration (AMD) and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is
`the first syringe prefilled with an anti VEGF medicine FDA approved to treat two eye conditions.
`“The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing
`commitment to people aected by vision-threatening eye diseases,” said Sandra Horning, M.D.,
`chief medical ocer and head of Global Product Development. “With the PFS, physicians will
`have a new option for administering Lucentis to the hundreds of thousands of people in the U.S.
`diagnosed with either wet AMD or macular edema after RVO.”
`The Lucentis PFS allows physicians to eliminate several steps in the preparation and
`administration process, including disinfecting the vial, attaching a filter needle, drawing the
`medicine from the vial using the needle, removing the filter needle from the syringe and replacing
`with an injection needle. With the Lucentis PFS, physicians attach the injection needle to the
`syringe and adjust the dose prior to administration.
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`The Lucentis 0.5 mg PFS is expected to be available in early 2017.
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Friday, Oct 14, 2016
`
`AboutRVO
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`About Lucentis
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`https://www.gene.com/media/press-releases/14640/2016-10-14/fda-approves-genentechs-lucentis-ranibiz
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`2/5
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`Novartis Exhibit 2116.002
`Regeneron v. Novartis, IPR2021-00816
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`Age-related macular degeneration (AMD) is a disease that impacts the part of the eye that
`provides sharp, central vision and is a leading cause of blindness in people age 60 and over.  Wet
`AMD is an advanced form of the disease that can cause rapid and severe vision
`loss.  Approximately 11 million people in the United States have some form of AMD and, of those,
`about 1.1 million have wet AMD.
`Wet AMD is caused by growth of abnormal blood vessels, also known as choroidal
`neovascularization (CNV) or ocular angiogenesis, under the macula. These vessels leak fluid and
`blood and cause scar tissue that destroys the central retina. This process results in a deterioration
`of sight over a period of months to years.
`Lucentis was approved to treat wet AMD in 2006.
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`RVO aects more than one million people in the U.S. and is the second most common cause of
`vision loss due to retinal vascular disease,
` which can develop over a long period of time or occur
`suddenly. It occurs when the normal blood flow through a retinal vein becomes blocked, causing
`swelling (edema) and hemorrhages in the retina, which may result in vision loss. Sudden blurring
`or vision loss in all or part of one eye is common with RVO, although loss of vision can develop
`over a long period of time. RVO typically aects patients who are more than 50 years old, and the
`incidence increases with age. People with a history of high blood pressure, hypertension, diabetes
`and atherosclerosis are at an increased risk for developing RVO.
`There are two main types of RVO: branch RVO, which aects an estimated 887,000 people, and
`central-RVO, which aects an estimated 265,000 people in the U.S. Branch-RVO, which is three
`times more common than central-RVO,  occurs when one of the smaller veins emptying into the
`main vein of the eye becomes blocked. Usually, the blockage occurs at the site where an artery
`and a vein cross, and aects only a portion of the retina. Central RVO, the less common form of
`RVO, occurs when the main vein of the eye (located at the optic nerve) becomes blocked.
`Lucentis was approved to treat macular edema after RVO in 2010.
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`Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit
`VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Friday, Oct 14, 2016
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`Lucentis Important Safety Information
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`https://www.gene.com/media/press-releases/14640/2016-10-14/fda-approves-genentechs-lucentis-ranibiz
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`3/5
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`Novartis Exhibit 2116.003
`Regeneron v. Novartis, IPR2021-00816
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`p y
`(angiogenesis) and the hyperpermeability (leakiness) of the vessels.
`Lucentis is FDA-approved for the treatment of patients with wet age-related macular
`degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema
`(DME) and diabetic retinopathy (DR) in people with DME. Lucentis safety and ecacy has been
`studied in more than 9,000 patients, across eight pivotal and 23 clinical trials.
`Lucentis was developed by Genentech. The company retains commercial rights in the U.S. and
`Novartis has exclusive commercial rights for the rest of the world.
`Outside the U.S., Lucentis is approved in more than 100 countries to treat patients with wet
`AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein
`occlusion (BRVO) and central retinal vein occlusion (CRVO).
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`Patients should not use Lucentis if they have an infection in or around the eye or are allergic to
`Lucentis or any of its ingredients. Lucentis is a prescription medication given by injection into the
`eye and it has side eects. Some Lucentis patients have had detached retinas and serious
`infections inside the eye.
`Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to blood
`clots, such as heart attacks or strokes.
`Some patients have had increased eye pressure before and within one hour of an injection.
`Serious side eects include inflammation inside the eye and, rarely, problems related to the
`injection procedure such as cataracts. These side eects can make vision worse.
`The most common eye-related side eects are increased redness in the white of the eye, eye pain,
`small specks in vision and increased eye pressure. The most common non-eye-related side eects
`are nose and throat infections, headache, lung/airway infections, and nausea.
`If the eye becomes red, sensitive to light, or painful, or if there is a change in vision, patients
`should call or visit an eye doctor right away.
`Lucentis is for prescription use only.
`Patients may report side eects to the FDA at (800) FDA-1088 or
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Friday, Oct 14, 2016
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`About Genentech in Ophthalmology
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`About Genentech Access Solutions
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`About Genentech
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`https://www.gene.com/media/press-releases/14640/2016-10-14/fda-approves-genentechs-lucentis-ranibiz
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`4/5
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`Novartis Exhibit 2116.004
`Regeneron v. Novartis, IPR2021-00816
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`Patients may report side eects to the FDA at (800) FDA-1088 or
`http://www.fda.gov/medwatch. Patients may also report side eects to Genentech at (888) 835-
`2555.
`For additional safety information, please see Lucentis full prescribing information, available here:
`http://www.gene.com/download/pdf/lucentis_prescribing.pdf
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`Genentech’s vision for ophthalmology is to bring innovative therapeutics to people with eye
`diseases. Currently, the company is investigating platforms for sustained drug delivery and is
`conducting Phase III clinical trials for people with geographic atrophy (GA), an advanced form of
`AMD and giant cell arteritis, a form of vasculitis that can lead to blindness. Additional focus
`includes using bispecific antibodies to simultaneously address multiple targets.
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`Access Solutions is part of Genentech’s commitment to helping people access the Genentech
`medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists
`at Access Solutions is dedicated to helping people navigate the access and reimbursement
`process, and to providing assistance to eligible patients in the United States who are uninsured or
`cannot aord the out of pocket costs for their medicine. To date, the team has helped more than
`1.4 million patients access the medicines they need. Please contact Access Solutions (866)
`4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.
`
`Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops,
`manufactures and commercializes medicines to treat patients with serious or life-threatening
`medical conditions. The company, a member of the Roche Group, has headquarters in South San
`Francisco, California. For additional information about the company, please
`visit http://www.gene.com.
` Macular Degeneration Partnership. What is Macular Degeneration? Available at:
`http://www.amd.org/what-is-amd.html. Accessed June 17, 2016.
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Friday, Oct 14, 2016
`
`https://www.gene.com/media/press-releases/14640/2016-10-14/fda-approves-genentechs-lucentis-ranibiz
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`5/5
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`Novartis Exhibit 2116.005
`Regeneron v. Novartis, IPR2021-00816
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`Macular Degeneration Partnership. Wet AMD. Available at: http://www.amd.org/what-is-
`macular-degeneration/wet-amd/. Accessed June 17, 2016.
` BrightFocus Foundation. Macular Degeneration: Essential Facts. Available at:
`http://www.brightfocus.org/macular/news/macular essential facts. Accessed June 29, 2016
` American Academy of Ophthalmology. What Is Macular Degeneration? Available at:
`http://www.aao.org/eye-health/diseases/amd-macular-degeneration. Accessed July 08, 2016.
` Genentech data on file (Based on population-based studies/the Beaver Dam Eye Study 2000
`and 2008 and the United States Census).
` Rehak J, Rehak M. Branch retinal vein occlusion: pathogenesis, visual prognosis, and treatment
`modalities.
`Curr Eye Res. 2008;33:111-131.
` Hamid S et al. Etiology and Management of Branch Retinal Vein Occlusion. World Applied
`Sciences Journal 6(1):94 99, 2009.
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