Monday,Apr 17, 2017
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`FDA Approves Genentech’s Lucentis (RanibizumabInjection) for Diabetic
`Retinopathy, the Leading Cause of Blindness Among Working Age Adultsin
`the United States
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`¢ First and only medicine FDA-approvedtotreat all forms of diabetic retinopathy
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`¢ Granted Priority Review Designation by the FDA based on analysis of results froma
`National Institutes of Health (NIH)-funded collaborative group study
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`South San Francisco, CA -- April 17, 2017 --
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`Genentech, a memberof the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced
`that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumabinjection)
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`0.3 mg for the monthly treatmentofall forms of diabetic retinopathy. The most commoncause of
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`vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among
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`adults aged 20 to 741 andaffects nearly 7.7 million people in the U.S. With this approval,
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`Lucentis becomes thefirst and only FDA-approved medicine to treat diabetic retinopathy in
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`people whohave been diagnosed either with or without diabetic macular edema (DME), a
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`complication of diabetic retinopathy that causes swelling in the back of the eye. In February 2015,
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`Lucentis received FDA approval for the treatmentof diabetic retinopathy in people with DME
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`based on data from the pivotal RIDE and RISE PhaseIII clinical trials.
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`The FDAgranted Lucentis Priority Review for the treatmentof diabetic retinopathy without DME
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`based on an analysis of the Diabetic Retinopathy Clinical Research Network’s (DRCR.net)
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`Protocol S study. This NIH-funded study compared Lucentis treatment to panretinal laser
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`treatment in diabetic retinopathy patients both with and without DME.In the analysis that
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`supported this approval, patients with and without DME in the Lucentis group experienced
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`improvementsin the severity of their retinopathy. Adverse events were consistent with those
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`seen in previous studies.
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`“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the U.S.
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`betweenthe ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat
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`retinopathy in people with and without DME,” said Sandra Horning, M.D., chief medicalofficer
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`head of Global Product Development. “In multiple clinical studies, Lucentis demonstrated a
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`IPR2023-00884
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`Regeneron Pharmaceuticals, Inc. Exhibit2110
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`significant improvementof patients’ diabetic retinopathy, andit is the first and only anti-VEGF
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`therapy approvedto treat all forms of diabetic retinopathy.”
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`Priority Review Designation is granted to medicines that the FDA has determined to have the
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`potential to provide significant improvementsin the safety and effectiveness of the treatmentof
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`a serious disease. The FDA previously granted Lucentis Breakthrough Therapy Designation for
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`diabetic retinopathy in 2014 based on the pivotal RIDE and RISE PhaseIII clinical trials.
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`Breakthrough designation is intended to expedite the development and review of medicines with
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`early evidence of potential clinical benenfit in serious diseases and to help ensurethat patients
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`receive access to medicines as soon as possible.
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`Diabetes affects more than 29 million people in the U.S.* The longera person hasdiabetes,
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`especially if it is poorly controlled, the higherthe risk of developing diabetic retinopathy and
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`vision loss. Diabetic retinopathy occurs when bloodvessels in the retina become damaged. This
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`can causevision loss or distortion when the abnormal vessels leak bloodorfluid into the eye.*
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`AboutProtocol S
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`The Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study was a
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`randomized, active-controlled study comparing Lucentis to a type of laser therapy called
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`panretinal or scatter photocoagulation (PRP) in 305 patients with proliferative diabetic
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`retinopathy, including those with and without diabetic macular edema (DME). In the Lucentis
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`group, patients received a baseline 0.5 mgintravitreal injection followed by three monthly
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`intravitreal injections, after which treatment was guided by pre-specified re-treatmentcriteria.
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`In the analysis that supported the approval, 37.8 percent (n=56/148) of patients in the Lucentis
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`group without baseline DME had a two-step or better improvementin their diabetic retinopathy
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`and 28.4 percent (n=42/148) had a three-step or better improvementat twoyears, according to
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`the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-
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`DRSS). In Lucentis-treated patients with baseline DME, 58.5 percent (n=24/41) had a two-step or
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`better improvementin their diabetic retinopathy and 31.7 percent (n=13/41) had a three-step or
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`better improvementat two years. Adverse events were similar to those seen in other Lucentis
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`trials.
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`The DRCR.net is funded by the National Eye Institute, part of the National Institutes of Health.
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`DRCR.netis a collaborative network dedicated to facilitating multicenter clinical research of
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`nt
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`IPR2023-00884
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`Regeneron Pharmaceuticals, Inc. Exhibit2110
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`diabetic retinopathy, DME andassociated conditions, and supportsthe identification, design and
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`implementation of multicenter clinical research initiatives focused on diabetes-induced retinal
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`disorders. The DRCR.net was formed in September 2002 and currently includes over 115
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`participating sites with over 400 physicians throughout the U.S. The Protocol S study was
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`supported, in part, by Genentechaspart of the company’s ongoing commitmentto supporting
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`independentresearch and collaboration to advancescience.
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`About Lucentis
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`Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to andinhibit
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`VEGF-A,a protein thatis believed to playacritical role in the formation of new blood vessels
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`(angiogenesis) and the hyperpermeability (leakiness) of the vessels.
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`Lucentis is FDA-approved for the treatmentof patients with wet age-related macular
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`degeneration (AMD), macular edemaafter retinal vein occlusion (RVO), diabetic macular edema
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`(DME), diabetic retinopathy and myopic choroidal neovascularization (mCNV).
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`Lucentis was developed by Genentech, a memberof the Roche Group. The companyretains
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`commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the
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`world.
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`Outside the U.S., Lucentis is approved in more than 110 countries to treat patients with wet AMD,
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`for the treatment of DME,and due to macular edema secondaryto both branchretinal vein
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`occlusion (BRVO), central retinal vein occlusion (CRVO)and visual impairment due to choroidal
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`neovascularization (CNV).
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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 orareallergic to
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`Lucentis or any of its ingredients. Lucentis is a prescription medication given by injection into the
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`eye andit has side effects. Some Lucentis patients have had detached retinas and serious
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`infections inside the eye. If the eye becomesred, sensitive to light, or painful, or if there is a
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`changein vision, patients should call or visit an eye doctor right away.
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`Somepatients have had increased eye pressure before and within one hour of an injection.
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`IPR2023-00884
`Samsung etal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2110
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`Uncommonly, Lucentis patients have had serious, sometimesfatal problemsrelated to blood
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`clots, such as heart attacks or strokes. Fatal events were seen more often in patients with diabetic
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`macular edema and diabetic retinopathy with Lucentis compared with patients who did not
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`receive Lucentis.
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`Seriousside effects include inflammation inside the eye and,rarely, problemsrelated to the
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`injection proceduresuchascataracts. These side effects can makevision worse.
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`The most commoneye-relatedside effects are increased rednessin the white ofthe eye, eye pain,
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`small specks in vision and increased eye pressure. The most common non-eye-related side effects
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`are nose and throat infections, headache, lung/airway infections, and nausea.
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`Patients may report side effects to the FDA at (800) FDA-1088or
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`http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-
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`2555.
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`For additional safety information, please see Lucentis full Prescribing Information, available here:
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`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 ophthalmologyis to bring innovative therapeutics to people with eye
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`diseases. Currently, the company is conducting PhaseIII clinical trials for people with geographic
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`atrophy (GA), an advanced form of AMD,as well as investigating platforms for sustained ocular
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`drug delivery and a treatmentfor giantcell arteritis, a form of vasculitis that can lead to
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`blindness. Additional focus includes using bispecific antibodies to simultaneously address
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`multiple targets for patients with AMD anddiabetic eye disease.
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`About Genentech Access Solutions
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`Access Solutions is part of Genentech’s commitmentto helping people access the Genentech
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`medicines they are prescribed,regardless of their ability to pay. The team of in-house specialists
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`at Access Solutionsis dedicated to helping people navigate the access and reimbursement
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`process, and to providing assistance to eligible patients in the United States who are uninsured or
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`cannotafford the out-of-pocketcosts for their medicine. To date, the team has helped more than
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`IPR2023-00884
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`Regeneron Pharmaceuticals, Inc. Exhibit2110
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`1.4 million patients access the medicines they need. Please contact Access Solutions (866)
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`4ACCESS/(866) 422-2377or visit http://www.Genentech-Access.com for more information.
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`About Genentech
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`Founded41 years ago, Genentechis a leading biotechnology company that discovers, develops,
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`manufactures and commercializes medicines to treat patients with serious or life-threatening
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`medical conditions. The company, a memberof the Roche Group, has headquarters in South San
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`Francisco, California. For additional information about the company, please visit
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`http://www.gene.com.
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`1 U.S. Centers for Disease Control and Prevention. CommonEyeDisorders: Diabetic Retinopathy.
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`Available at https://www.cdc.gov/visionhealth/basics/ced/index.html. Accessed March7, 2017.
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`2 Prevent Blindness America. Diabetic Retinopathy. Available at
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`http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html.
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`Accessed March 7, 2017.
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`3 American Diabetes Association. Statistics About Diabetes. Available at
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`http://www.diabetes.org/diabetes-basics/statistics/. Accessed March7, 2017.
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`IPR2023-00884
`Samsung etal. v. Regeneron
`Regeneron Pharmaceuticals, Inc. Exhibit2110
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