Media / Press Releases
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`Friday, Oct 14, 2016
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`FDA Approves Genentech’s Lucentis’ (RanibizumabInjection) Prefilled
`Syringe
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`e Lucentis prefilled syringe offers a ready-to-use option to deliver treatment with fewer
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`steps
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`e First anti-VEGF prefilled syringe FDA-approved to treat people with wet age-related
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`macular degeneration and people with macular edemaafter retinal vein occlusion
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`South San Francisco, CA -- October 14, 2016--
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`Genentech, a memberof the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),today
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`announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis®
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`(ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering
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`the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people
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`with wet age-related macular degeneration (AMD) and macular edema after retinal vein
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`occlusion (RVO). The Lucentis PFSis the first syringe prefilled with an anti-VEGF
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`medicine FDA-approvedto treat two eve conditions.
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`“The FDA approval of the Lucentis prefilled syringe marks a newmilestone in our ongoing
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`commitment to people affected by vision-threatening eye diseases,” said Sandra Horning,
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`M.D., chief medical officer and head of Global Product Development. “With the PFS,
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`physicians will have a newoption for administering Lucentis to the hundreds of thousands
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`of people in the U.S. diagnosed with either wet AMD or macular edema after RVO.”
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`The Lucentis PFS allows physicians to eliminate several steps in the preparation and
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`administration process, including disinfecting the vial, attaching a filter needle, drawing
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`the medicine from thevial using the needle, removing the filter needle from the syringe
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`and replacing with an injection needle. With the Lucentis PFS, physicians attach the
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`injection needle to the syringe and adjust the dose prior to administration.
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`The Lucentis 0.5 mg PFSis expected to be available in early 2017.
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`About Wet AMD
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`Age-related macular degeneration (AMD) is a disease that impacts the part of the eye that
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`provides sharp, central vision andis a leading cause of blindness in people age 60 and
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`over.! Wet AMDis an advanced form ofthe disease that can cause rapid and severe vision
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`loss. Approximately 11 million people in the United States have some form ofAMD and,of
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`those, about 1.1 million have wet AMD.3+
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`Wet AMDis caused by growth of abnormal blood vessels, also known as choroidal
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`neovascularization (CNV) or ocular angiogenesis, under the macula. These vessels leak
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`fluid and blood and cause scar tissue that destroys the central retina. This process results in
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`Novartis Exhibit 2041.001
`Regeneron v. Novartis, IPR2020-01318
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`Novartis Exhibit 2041.001
`Regeneron v. Novartis, IPR2020-01318
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`

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`a deterioration of sight over a period ofmonths to years.
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`Lucentis was approved to treat wet AMD in 2006.
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`About RVO
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`RVO affects more than one million people in the U.S.andis the second-most common
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`cause of vision loss due to retinal vascular disease,® which can develop over a long period
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`of time or occur suddenly. It occurs when the normal blood flowthrough a retinal vein
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`becomes blocked, causing swelling (edema) and hemorrhages in the retina, which may
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`result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with
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`RVO, although loss of vision can develop over a long period of time. RVO typically affects
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`patients who are more than 50 vears old, and the incidence increases with age. People with
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`a history of high blood pressure, hypertension, diabetes and atherosclerosis are at an
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`increased risk for developing RVO.
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`There are two main types of RVO: branch-RVO,which affects an estimated 887,000
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`people, and central-RVO, which affects an estimated 265,000 people in the U.S. Branch-
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`RVO, which is three times more common than central-RVO,’ occurs when one of the
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`smaller veins emptying into the main vein of the eve becomes blocked. Usually, the
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`blockage occurs at the site where an artery and a vein cross, and affects only a portion of
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`the retina. Central-RVO, the less common form of RVO, occurs when the main vein of the
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`eye (located at the optic nerve) becomes blocked.
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`Lucentis was approved to treat macular edema after RVO in 2010.
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`About Lucentis
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`Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and
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`inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new
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`blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
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`Lucentis is FDA-approved for the treatment of patients with wet age-related macular
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`degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular
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`edema (DME) anddiabetic retinopathy (DR) in people with DME.Lucentis safety and
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`efficacy has been studied in more than 9,000 patients, across eight pivotal and 23 clinical
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`trials.
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`Lucentis was developed by Genentech. The company retains commercial rights in the U.S.
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`and Novartis has exclusive commercial rights for the rest of the world.
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`Outside the U.S., Lucentis is approved in more than 100 countries to treat patients with
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`wet AMD,for the treatment of DME, and due to macular edema secondary to both branch
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`retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
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`Lucentis Important Safety Information
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`Patients should not use Lucentis if they have an infection in or around the eye or are
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`allergic to Lucentis or any of its ingredients. Lucentis is a prescription medication given by
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`injection into the eye andit has side effects. Some Lucentis patients have had detached
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`retinas and serious infections inside the eve.
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`Novartis Exhibit 2041.002
`Regeneron v. Novartis, IPR2020-01318
`
`Novartis Exhibit 2041.002
`Regeneron v. Novartis, IPR2020-01318
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`

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`Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to
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`blood clots, such as heart attacks or strokes.
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`Some patients have had increased eve pressure before and within one hourof an injection.
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`Serious side effects include inflammation inside the eye and, rarely, problems related to the
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`injection procedure such as cataracts. These side effects can make vision worse.
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`The most common eye-related side effects are increased redness in the white of the eye, eve
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`pain, small specks in vision and increased eve pressure. The most common non-eye-related
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`side effects are nose and throat infections, headache, lung/airway infections, and nausea.
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`Tf the eye becomes red, sensitive to light, or painful, or if there is a change in vision,
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`patients should call or visit an eye doctor right away.
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`Lucentis is for prescription use only.
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`Patients may report side effects to the FDA at (800) FDA-1088 or
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`http: //www.ida.gov/medwatch. Patients may also report side effects to Genentech at (888)
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`835-2555-
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`Foradditional safety information, please see Lucentis full prescribing information,
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`available here: http://www.gene.com/download/pdf/lucentis_prescribing.pdf
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`About Genentech in Ophthalmology
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`Genentech’s vision for ophthalmology is to bring innovative therapeutics to people with eye
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`diseases. Currently, the companyis investigating platforms for sustained drug delivery and
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`is conducting PhaseIII clinical trials for people with geographic atrophy (GA), an advanced
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`form ofAMD andgiantcell arteritis, a form of vasculitis that can lead to blindness.
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`Additional focus includes using bispecific antibodies to simultaneously address multiple
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`targets.
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`About Genentech Access Solutions
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`Access Solutionsis part of Genentech’s commitment to helping people access the
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`Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-
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`house specialists at Access Solutions is dedicated to helping people navigate the access and
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`reimbursement process, and to providing assistance to eligible patients in the United States
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`who are uninsured or cannotafford the out-of-pocket costs for their medicine. To date, the
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`team has helped more than 1.4 million patients access the medicines they need. Please
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`contact Access Solutions (866) 4ACCESS/(866) 429-2377 orvisit http://www.Genentech-
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`Access.com for more information.
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`About Genentech
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`Founded 40 years ago, Genentech is a leading biotechnology companythat discovers,
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`develops, manufactures and commercializes medicines to treat patients with serious orlife-
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`threatening medical conditions. The company, a member of the Roche Group, has
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`headquarters in South San Francisco, California. For additional information about the
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`company, please visit http://www.gene.com.
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`Novartis Exhibit 2041.003
`Regeneron v. Novartis, IPR2020-01318
`
`Novartis Exhibit 2041.003
`Regeneron v. Novartis, IPR2020-01318
`
`

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`! Macular Degeneration Partnership. What is Macular Degeneration? Available at:
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`http://www.amd.org/what-is-amd.html. Accessed June 17, 2016.
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`? Macular Degeneration Partnership. Wet AMD.Available at: http: //www.amd.org/what-
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`is-macular-degeneration/'wet-amd,'. Accessed June 17, 2016.
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`? BrightFocus Foundation. Macular Degeneration: Essential Facts. Available at:
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`http://www.brightfocus.org/macular/news/macular-essential-facts. Accessed June 29,
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`2016
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`4 American Academy of Ophthalmology. What Is Macular Degeneration? Available at:
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`http: //www.aao.org/eye-health/diseases/amd-macular-degeneration. Accessed July 08,
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`2016.
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`5 Genentech data on file (Based on population-based studies/the Beaver Dam Eye Study
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`2000 and 2008 andthe United States Census).
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`® Rehak J, Rehak M. Branch retinal vein occlusion: pathogenesis, visual prognosis, and
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`treatment modalities.Curr Eye Res. 2008;39:111-131.
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`7 Hamid S et al. Etiology and Managementof Branch Retinal Vein Occlusion. World
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`Applied Sciences Journal 6(1):94-99, 2000.
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`Novartis Exhibit 2041.004
`Regeneron v. Novartis, IPR2020-01318
`
`Novartis Exhibit 2041.004
`Regeneron v. Novartis, IPR2020-01318
`
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