Media 1’ Press Releases
`
`Friday, Oct 14, 2016
`
`FDA Approves Genentech's Lucentis” (Ranibizumab Injection} Prefilled
`Synnge
`
`I Lucentis prefilled syringe offers a ready-to-use option to deliver treatment 1with fewer
`
`steps
`
`I 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
`
`South San Francisco, CA -- October 14, 2016 --
`
`Genentecb, a member of the Roche Group (SIX: R0, ROG; DTCQX: RHHBY), today
`
`announced that the U.S. Food and Drug Administration [FDA] approved the LucentisI
`
`(rambizumab 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 (MD) and macular edema after refinal vein
`
`occlusion (RVO). The Lucenu's PFS is the first syringe prefilled with an anti—VEGF
`
`
`
`medicine FDA—approved to treat two eye conditions.
`
`“The FDA approval of the Lucean prefilled syringe marks a new milestone in our ongoing
`
`commitm-t to people affected by vision—threatening eye diseases,” said Sandra Homing,
`
`M.D., chief medical officer and head of Global Product Development. n""‘lu'li'ith the PFS,
`
`physicians will have a new option for administering Lucentis to the hundreds of thousands
`
`of people in the US. diagnosed with either wet MD or macular edema after RVD.”
`
`The Lucenfis PFS allows physicians to eliminate several steps in the preparaiion and
`
`administraiion process, including disinfeciing 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 administraiion.
`
`The Lucentis 0.5 mg PFS is expected to be available in early 2017.
`
`About Wet AMD
`
`Age—related macular degenerafion (Ah-[ID] 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
`
`oven:l Wet AMD is an advanced form of the disease that can cause rapid and severe vision
`
`loss.2 Approximately 11 million people in the United States have some form ofAMD and, of
`
`those, about 1.1 million have wet 131MB?-4
`
`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 fissue that destroys the coliral retina. This process results in
`
`
`
`Novartis Exhibit 2041.001
`
`Regeneron V. Novartis, IPR2020-013 18
`
`Novartis Exhibit 2041.001
`Regeneron v. Novartis, IPR2020-01318
`
`

`

`a deterioration of sight over a period of months to years.
`
`Lucenu's was approved to treat wet AMD in 2006.
`
`About RVO
`
`RVO affects more than one million people in the U.S.5 and is the second—most common
`
`cause of vision loss due to retinal vascular disease,a 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 refina, 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 1ime. RVO typically affects
`
`pan'ents 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 affects an esu'mated 887,000
`
`people, and oentral—RVO, which affects an estimated 265,000 people in the U.S.5 Branch—
`
`RVO, which is three 1imes more common than central—EVE); 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 affects 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.
`
`Lucenn's was approved to treat macular edema after RVO in 2010.
`
`About Lucentis
`
`Lucenn's 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 forman'on of new
`
`blood vessels (angiogenesis) and the hyperpermeability flealriness) of the vessels.
`
`Lucenn's is FDA—approved for the treatment of patients with wet age—related macular
`
`degeneration LAMB}, macular edema after retinal vein occlusion (RVO), diabetic macular
`
`edema [DME] and diabetic retinopathy [DR] in people with DME. Luceniis safety and
`
`efficacy has been studied in more than 9,000 pafients, across eight pivotal and 23 clinical
`
`trials.
`
`Lucenn's 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
`
`refinal vein occlusion (BRVO) and central retinal vein occlusion [CRVOL
`
`Lueenfis Inlportant Safety Information [sing
`
`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 effects. Some Lucenfis paiients have had detached
`
`refinas and serious infecn'ons inside the eye.
`
`
`
`
`
`Novartis Exhibit 2041.002
`
`Regeneron V. Novartis, IPR2020-013 18
`
`Novartis Exhibit 2041.002
`Regeneron v. Novartis, IPR2020-01318
`
`

`

`Uncommonly, Lucentis patients have had serious, sometimes fatal problems related to
`
`blood c1013, such as heart attacks or strokes.
`
`Some pafients have had increased eye pressure before and within one hour of an injection.
`
`Serious side effects include inflammation inside the eye and, rarely, problems related to the
`
`injection procedure such as cataracts. These side effects can make vision worse.
`
`The most common eye—related side effects 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 effects are nose and throat infections, headache, lungjainvay infections, and nausea.
`
`If the eye becomes red, sensi1ive to light, or painful, or if there is a change in vision,
`
`patients should call or visit an eye doctor right away.
`
`Lucen1is is for prescription use only.
`
`Patients may report side effects to the FDA at (800) FDA—1088 or
`
`http:ffwwwfda.govjmedu-‘atch. Patients may also report side effects to Genentech at [883)
`
`E535—2555-
`
`For additional safety information, please see Lucentis full prescribing information,
`
`available here: htm: fjmngenenomf dovmloadfpdf/lucentisi rescribing.pdf
`
`About Genentech in Opbtllabnology
`
`
`
`Genentech’s vision for ophthalmology is to bring innovafiye therapeutics to people with eye
`
`diseases. Currently, the company is invesu'gating platforms for sustained drug delivery and
`
`is conducting Phase 11] clinical trials for people with geographic atrophy (GA), an advanced
`
`form ofAMD and giant cell arteritis, a form of vasculitis that can lead to blindness.
`
`Additional focus includes using bispecific antibodies to simultaneously address mul1ip1e
`
`targets.
`
`About Genentech Access Solutions
`
`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 afford the out—of—pocket costs for their medicine. To date, the
`
`team has helped more than 1.4 million patien1s access the medicines they need. Please
`
`contact Access Solutions [866) 4ACCESSfI1866] 422—2377 or visit http:j,-’u1m-:Genentech—
`
`Accesscom for more information.
`
`About Genentech
`
`Founded 40 years ago, Genentech is a leading biotechnology company that discovers,
`
`develops, manufactures and comrnercializes 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 httpjfmflvgenecom.
`
`
`
`Novartis Exhibit 2041.003
`
`Regeneron V. Novartis, IPR2020-013 18
`
`Novartis Exhibit 2041.003
`Regeneron v. Novartis, IPR2020-01318
`
`

`

`1 Macular Degeneran'on Partnership. 1What is Macular Degeneration? Available at:
`
`http:,fl-“www.alnd.orgf'what—is—amdhmil. Accessed June 17, 2016.
`
`2 Macular Degeneration Partnership. Wet AMD. Available at: http:,fi-‘wmv.a1nd.org;"what—
`
`is—n1acular—degenerationf'wet—amdf. Accessed June 1?, 2016.
`
`3 BrightFocus Foundaiion. Macular Degeneration: Essenu'al Facts. Available at:
`
`httpg.’from-1131ightfocus.orgf'rnacularfnewsfmacul ar—essential-facts. Accessed June 29,
`
`2016
`
`4 American Academy of Ophthalmology. What Is Macular Degeneraiion? Available at:
`
`httpg.’Awninaaocrgfeye -he althfdiseasesfalnd-nlacular—degeneration. Accessed July 08,
`
`2016.
`
`5 Genentech data on file [Based on populaiion—based studies{the Beaver Dam Eye Study
`
`2000 and 2008 and the United States Census).
`
`6 Rehak J, Rehak M. Branch refinal vein occlusion: pathogenesis, visual prognosis, and
`
`treatment modalifiesflm‘r Eye Res. 2008;33:111—131.
`
`7 Hamid S et a1. Etiology and Management of Branch Retinal 1Vein Occlusion. World
`
`Applied Sciences Journal 6(1):94—99, 2009.
`
`
`
`Novartis Exhibit 2041.004
`
`Regeneron V. Novartis, IPR2020-013 18
`
`Novartis Exhibit 2041.004
`Regeneron v. Novartis, IPR2020-01318
`
`