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`Genentech: Press Releases | Wednesday, Mar 21, 2018
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`South San Francisco, CA -- March 21, 2018 --
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`https://www.gene.com/media/press-releases/14708/2018-03-21/fda-approves-genentechs-lucentis-ranibiz
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`Novartis Exhibit 2117.001
`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.
`Wednesday, Mar 21, 2018
`FDA Approves Genentech’s Lucentis (Ranibizumab Injection) 0.3 mg
`Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy
`First and only prefilled syringe treatment option FDA-approved to treat all forms of diabetic
`retinopathy in people with or without diabetic macular edema (DME)
`Diabetic retinopathy is the leading cause of blindness among adults aged 20-74 in the United
`States
`Prefilled syringe options are now FDA-approved for all Lucentis indications
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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) 0.3 mg prefilled syringe (PFS) as a n
`ew method of administering the medicine to treat
`all forms of diabetic retinopathy. In April 2017, Lucentis 0.3 mg became, and remains, the first and
`only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without
`diabetic macular edema (DME), a complication of the eye disease that causes swelling in the back
`of the eye. Diabetic retinopathy is the leading cause of blindness among working age adults and
`aects nearly 7.7 million people in the U.S.
` The Lucentis 0.3 mg PFS is now the first syringe
`prefilled with an anti-vascular endothelial growth factor (VEGF) agent FDA-approved to treat
`both diabetic retinopathy and DME.
`“Diabetic retinopathy is a serious condition that aects millions of people in the U.S.,” said
`Sandra Horning, M.D., chief medical ocer and head of Global Product Development. “Today’s
`approval of the Lucentis 0.3 mg prefilled syringe reinforces our commitment to advancing
`therapy for those impacted by this vision-threatening disease.”
`The Lucentis 0.3 mg PFS, which is made of borosilicate glass and is packaged in a single-use
`sterile, sealed tray, allows physicians to eliminate several steps in the preparation and
`administration process, including disinfecting the vial, attaching a filter needle, drawing the
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Wednesday, Mar 21, 2018
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`About Diabetic Retinopathy and Diabetic Macular Edema
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`About Lucentis
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`(ranibizumab injection)
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`https://www.gene.com/media/press-releases/14708/2018-03-21/fda-approves-genentechs-lucentis-ranibiz
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`Novartis Exhibit 2117.002
`Regeneron v. Novartis, IPR2021-00816
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`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 snap o the syringe cap, attach the
`injection needle to the syringe and adjust the dose prior to administration.
`The Lucentis 0.3 mg PFS is expected to be available in the second quarter of 2018.
`The Lucentis 0.5 mg PFS, FDA-approved in October 2016, is indicated for the treatment of
`neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein
`occlusion (RVO) and myopic choroidal neovascularization (mCNV).
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`Diabetic retinopathy is the most common cause of vision loss in people with diabetes, which
`aects approximately 30 million people in the U.S.
` The longer a person has diabetes, especially
`if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss.
`Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause
`vision loss or distortion when the abnormal vessels leak blood or fluid into the eye.
`Diabetic macular edema (DME), which aects approximately 750,000 people in the U.S., is one of
`the vision-threatening complications of diabetic retinopathy, in which chronic damage occurs to
`the fine blood vessels of the retina, the light sensitive tissue at the back of the eye necessary for
`good vision.
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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
`(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 following retinal vein occlusion (RVO), diabetic macular
`edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).
`Lucentis was developed by Genentech, a member of the Roche Group. The company retains
`commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the
`world.
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Wednesday, Mar 21, 2018
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`Lucentis Important Safety Information
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`Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
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`Patients may also report side effects to Genentech at (888) 835-2555.
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`https://www.gene.com/media/press-releases/14708/2018-03-21/fda-approves-genentechs-lucentis-ranibiz
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`3/5
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`Novartis Exhibit 2117.003
`Regeneron v. Novartis, IPR2021-00816
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`Outside the U.S., Lucentis is approved in more than 110 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), central retinal vein occlusion (CRVO) and visual impairment due to choroidal
`neovascularization (CNV).
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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.
`Lucentis is not for everyone. Some Lucentis patients have had detached retinas and serious eye
`infections. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision,
`call or visit your eye doctor right away.
`Some patients have had increased eye pressure before and within 1 hour of an injection. Your eye
`doctor should check your eye pressure and eye health before and after your Lucentis injection.
`Uncommonly, Lucentis patients have had serious, sometimes fatal, problems related to blood
`clots, such as heart attacks or strokes.
`Fatal events were seen more often in patients with DME and DR with Lucentis compared with
`patients who did not receive Lucentis. Although there were only few fatal events which included
`causes of death typical of patients with advanced diabetic complications, these events may be
`caused by Lucentis.
`Some Lucentis patients have serious side eects related to the injection. These include serious
`infections inside the eye, detached retinas, and cataracts. 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, anemia, nausea and cough.
`Lucentis is for prescription use only.
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`1/13/22, 2:25 PM
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`Genentech: Press Releases | Wednesday, Mar 21, 2018
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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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`About Genentech Access Solutions
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`About Genentech
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`https://www.gene.com/media/press-releases/14708/2018-03-21/fda-approves-genentechs-lucentis-ranibiz
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`4/5
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`Novartis Exhibit 2117.004
`Regeneron v. Novartis, IPR2021-00816
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`Genentech is researching and developing new treatments for people living with a range of eye
`diseases that cause significant visual impairment and blindness, including neovascular age-
`related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy
`(DR), geographic atrophy (GA) and other retinal diseases. The company is also investigating
`platforms for sustained ocular drug delivery.
`Genentech’s parent company, Roche, is investigating a bispecific antibody for the treatment of
`retinal eye diseases.
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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.
`
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`Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers,
`develops, manufactures and commercializes medicines to treat patients with serious and 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.
`U.S. Centers for Disease Control and Prevention. Common Eye Disorders: Diabetic Retinopathy.
`Available at https://www.cdc.gov/visionhealth/basics/ced/index.html. Accessed February 7, 2018.
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`1/13/22, 2:25 PM
`
`Genentech: Press Releases | Wednesday, Mar 21, 2018
`
`https://www.gene.com/media/press-releases/14708/2018-03-21/fda-approves-genentechs-lucentis-ranibiz
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`5/5
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`Novartis Exhibit 2117.005
`Regeneron v. Novartis, IPR2021-00816
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`Prevent Blindness America. Diabetic Retinopathy. Available at
`http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html.
`Accessed February 7, 2018.
`American Diabetes Association. Statistics About Diabetes. Available at
`http://www.diabetes.org/diabetes-basics/statistics/  Accessed February 7, 2018.
`Bressler NM, Varma R, Doan Q, et al. Underuse of the Health Care System by Persons With
`Diabetes Mellitus and Diabetic Macular Edema in the United States. JAMA Ophthalmology. 2014
`Feb;132(2):168-73.
`Bhagat N, Grigorian RA, Tutela A, et al. Diabetic macular edema: pathogenesis and treatment.
`Surv Ophthalmol. 2009;54(1):1-32.
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