Media
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`Press Releases
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`Friday, Oct 14, 2016
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`FDA Approves Genentech's Lucentis® (Ranibizumab Injection) Prefilled
`Syringe
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`• Lucentis prefilled syringe offers a ready-to-use option to deliver treatment with fewer
`steps
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`• First anti-VEGF prefilled syringe FDA-approved to t reat people with wet age-related
`macular degeneration and people with macular edema after retinal vein occlusion
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`South San Francisco, CA -- Octob er 14, 2016 --
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`Genentech, a member of 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 apprO\·ed to treat people
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`with wet age-related macular degeneration (A.\1D) and macular edema after retinal vein
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`occlusion (RVO). The Lucentis PFS is the first syringe prefilled ";th an anti-VEGF
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`medicine FDA-approved to treat two eye conditions.
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`"The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing
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`commitment to people affected by ,.,;sjon-threatening eye diseases," said Sandra Horning,
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`M.D., chief medical officer and head of Global Product Development. "With the PFS,
`physicians \\Ul have a new option for administering Lucentis to the hundreds of thousands
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`of people in the U.S. diagnosed w;th either wet • .\.\1D or macular edema after RVO. »
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`The Lucentis PFS allows physicians to eliminate several steps in the preparation and
`administration process, including disinfecting the vial, attaching a filter needle, drawing
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`the medicine from the vial 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 PFS is expected to be available in early 2017.
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`About WetAMD
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`Age-related macular degeneration (MID) is a disease that impacts the part of the eye that
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`pro'l.;des sharp, central vision and is a leading cause of blindness in people age 60 and
`o,·er.1 Wet AlvID is an advanced form of the disease that can cause rapid and severe v;sion
`loss. 2 Approxinlately 11 million people in the United States have some form of M ·ID and, of
`those, about 1.1 million have wet M1D.3•4
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`Wet AMD is caused by growth of abnormal blood vessels, also known as clioroidal
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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 2015.001
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`a deterioration of sight over a period of months to years.
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`Lucentis was approved to treat wet AMD in 2006.
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`AboutRVO
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`RVO affects more than one million people in the U.S.5 and is the second-most common
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`cause of vision Joss due to retinal vascular disease, 6 which can develop over a Jong period
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`of time or occur suddenly. It occurs when the normal blood flow through 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 Joss. Sudden blurring or vision Joss in all or part of one eye is common with
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`RVO, although Joss of vision can develop over a Jong period of time. RVO typically affects
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`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
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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
`people, and central-RVO, which affects an estimated 265,000 people in the U.S.5 Branch(cid:173)
`RVO, which is three times more common than central-RV0,7 occurs when one of the
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`smaller veins emptying into the main vein of the eye 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 Jess 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 "ascular 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 "ith wet age-related macular
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`degeneration (Al\ID), macular edema after retinal vein occlusion (RVO), diabetic macular
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`edema (DME) and diabetic retinopathy (DR) in people "ith D1IE. 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 \\ith
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`wet AMO, 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 \'ein occlusion (CRVO).
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`Lucentis Important Safety Information ;}ri
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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 gi\·en by
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`injection into the eye and it has side effects. Some Lucentis patients have had detached
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`retinas and serious infections inside the eye.
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`Novartis Exhibit 2015.002
`Regeneron v. Novartis, IPR2021-00816
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`l,;ncommonly, Lucentis patients have had serious, sometimes fatal problems related to
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`blood clots, such as h eart attacks or strokes.
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`Some patients have had increased eye pressure before and within one hour of 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 ,ision worse.
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`The most common eye-related side effects are increased redness in the white of the eye, eye
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`pain, small specks in \'ision and increased eye pressure. The most common non-eye-related
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`side effects are nose and throat infections, headach e, lung/ainvay infections, and nausea.
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`If the eye becomes red, sensitive to light, or painful, or if there is a change in ,ision,
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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:// v;ww.fda.go\'/medwatch. Patients may also report side effects to Genentech at (888)
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`835-2555.
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`For additional safety information, please see Lucentis full prescribing information,
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`available here: http:// www.gene.com/ download/ pdf/lucentis_prescnbing.pdf
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`About Genentech in Ophthalmology
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`
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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 AJVID 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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`About Genentech Access Solutions
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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(cid:173)
`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 afford 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
`contact Access Solutions (866) 4ACCESS/ (866) 422-2377 or visit http://www.Genentech(cid:173)
`Access.com for more information.
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`About Genentech
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`Founded 40 years ago, Genentech is a leading biotechnology company that discovers,
`develops, manufactures and commercializes medicines to treat patients with serious or life(cid:173)
`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
`company, please visit http://www.gene.com.
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`Novartis Exhibit 2015.003
`Regeneron v. Novartis, IPR2021-00816
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`1 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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`2 Macular Degeneration Partnership. Wet AMD. Available at: http://www.amd.org/ what(cid:173)
`is-macular-degeneration/ wet-amd/ . Accessed June 17, 2016.
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`3 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 and the United States Census).
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`6 Rehak J, Rehak M. Branch retinal vein occlusion: pathogenesis, visual prognosis, and
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`treatment modalities.Curr Eye Res. 2008;33:111-131.
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`7 Hamid Set al. Etiology and Management of Branch Retinal Vein Occlusion. World
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`Applied Sciences Journal 6(1):94-99, 2009.
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`Novartis Exhibit 2015.004
`Regeneron v. Novartis, IPR2021-00816
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