`REGEN ERON®
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`August 13, 2019 at 7:00 AM EDT
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`FDA APPROVES EYLEA® (AFLIBERCEPT) INJECTION PREFILLED SYRINGE
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`TARRYTOWN, N.Y., Aug. 13, 2019 /PRNewswire/ -
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`EVLEA is the only anti•VEGF approved to treat four retinal conditions with a single dose strength pref1lled syringe
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`EYLEA is available in multiple dosing intervals, offering doctors flexibility to address patients' individual needs
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`fu)generon Pharmaceutjcals,.Jnc.. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration
`(FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the
`EYLEA® (aflibercept) Injection prefllled syringe. The 2 mg, single-dose, sterilized prefllled syringe provides physicians
`with a new way to administer EYLEA that requires fewer preparation steps compared to vials. Market supply of the
`EYLEA prefllled syringe is expected to be available to physicians and patients this year.
`
`"With eight pivotal Phase 3 trials and millions of injections used around the world, EYLEA sets a high bar for visual
`acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye
`diseases," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "This
`approval may help doctors more conveniently and efficiently deliver EYLEA to appropriate patients."
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`The sterilized prefllled syringe offers the same medicine as the currently available EYLEA, in an easier to use and
`administer presentation.
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`In the U.S., EYLEA is indicated to treat neovascular (wet) age-related macular degeneration (Wet AMO), macular
`edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).
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`About EVLEA® (afllbercept) Injection
`
`EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for
`the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through
`blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth
`factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its
`approved indications and is supported by a robust body of research that includes eight pivotal Phase 3 trials.
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`IMPORTANT SAFETY INFORMATION FOR EVLEA® (aflibercept) INJECTION
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`EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active
`intra ocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
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`lntravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal
`detachments. Proper aseptic injection technique must always be used when administering EYLEA.
`Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal
`detachment without delay and should be managed appropriately. lntraocular inflammation has been
`reported with the use of EYLEA.
`
`Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection,
`including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated
`intravitreal dosing with VEGF inhibitors. lntraocular pressure and the perfusion of the optic nerve head
`should be monitored and managed appropriately.
`
`There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF
`inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial Infarction, or
`vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in
`wet AMO studies during the first year was 1.8% (32 out of 1824) in the combined group of patients trp~•--t
`with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 we, BACK
`the incidence was 3.3% (60 out of 1824) In the EYLEA group compared with 3.2% (19 out of 595) in , TO TOP
`ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 5ttsJ
`in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) In the control
`group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of
`https://investor.regeneron.com/news-releases/news-release-details/fda-approves-eylear-aflibercept-injection-prefilled-syringe
`
`Novartis Exhibit 2270.001
`Regeneron v. Novartis, IPR2021-00816
`
`
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`patients treated with EYLEA compared with 4.2% {12 out of 287) in the control group. There were no
`reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO
`studies.
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`Serious adverse reactions related to the injection procedure have occurred in <0.1 % of intravitreal
`injections with EYLEA including endophthalmitis and retinal detachment.
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`The most common adverse reactions {;?5%) reported in patients receiving EYLEA were conjunctiva!
`hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure
`increased.
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`INDICATIONS
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`EYLEA® (aflibercept) Injection 2 mg {0.05 ml) is indicated for the treatment of patients with Neovascular {Wet) Age(cid:173)
`related Macular Degeneration {AMO), Macular Edema following Retinal Vein Occlusion {RVO), Diabetic Macular
`Edema {DME), and Diabetic Retinopathy (DR).
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`For more information, please see full Prescribing loformatjon.
`
`About Regeneron Pharmaceuticals, Inc.
`Regeneron {NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people
`with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and
`consistently translate science into medicine has led to seven FDA-approved treatments and numerous product
`candidates in development. all of which were homegrown in our laboratories. Our medicines and pipeline are
`designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic
`diseases, infectious diseases, pain and rare diseases.
`
`Regeneron is accelerating and improving the traditional drug development process through our proprietary
`VelociSuite® technologies, such as Veloclmmune® which produces optimized fully-human antibodies, and ambitious
`research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics
`sequencing efforts in the world.
`
`For additional information about the company, please visit ~generon com or follow @Regeneron on Twitter.
`
`Forward-Looking Statements and Use of Digital Media
`This press release includes forward-looking statements that involve risks and uncertainties relating to future events
`and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron• or the ·company"), and actual events or
`results may differ materially from these forward-looking statements. Words such as •anticipate: •expect,' "intend,'
`"plan: 'believe: "seek," "estimate: variations of such words, and similar expressions are intended to identify such
`forward-looking statements, although not all forward-looking statements contain these identifying words. These
`statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success
`and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now
`underway or planned, including without limitation EYLEA® (aflibercept) Injection; the availability and extent of
`reimbursement of the Company's products (such as EYLEA) from third-party payers, including private payer healthcare
`and insurance programs, health maintenance organizations, pharmacy benefit management companies, and
`government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers
`and new policies and procedures adopted by such payers; competing drugs and product candidates that may be
`superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success
`of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others
`and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates;
`unforeseen safety issues resulting from the administration of products and product candidates in patients, including
`serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials; the
`likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product
`candidates and new indications for marketed products; the extent to which the results from the research and
`development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to
`therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron's marketed products (such
`as EYLEA), research and clinical programs, and business, including those relating to patient privacy; determinations by
`regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to
`develop or commercialize Regeneron's products and product candidates; the ability of Regeneron to manufacture and
`manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, suppliers,
`or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and
`other steps related to Regeneron's products and product candidates; unanticipated expenses; the costs of developing,
`producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and
`changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration
`agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or '
`CK
`8
`respective affiliated companies, as applicable), to be cancelled or terminated without any further product suet ro\op ,
`risks associated with intellectual property of other parties and pending or future litigation relating thereto, inclu<.i .. . ,,
`without limitation the patent litigation and other related proceedings relating to EYLEA, Dupixent® (dupilumab) Injection,
`and Praluent® (alirocumab) Injection, the ultimate outcome of any such proceedings, and the impact any of the
`https://investor.regeneron.com/news-releases/news-release-details/fda-approves-eylear-aflibercept-injection-prefilled-syringe
`
`Novartis Exhibit 2270.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete
`description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange
`Commission, including its Form 10-K for the year ended December 31, 2018 and its Form 10-Q for the quarterly period
`ended June 30, 2019. Any forward-looking statements are made based on management's current beliefs and
`judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron
`does not undertake any obligation to update publicly any forward-looking statement, including without limitation any
`financial projection or guidance, whether as a result of new information, future events, or otherwise.
`
`Regeneron uses its media and investor relations website and social media outlets to publish important information
`about the Company, including information that may be deemed material to investors. Financial and other information
`about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website
`(ll1tp:llnewsroom regeneron com l and its Twitter feed (h!tp /!twitter comlregeJW:Qll).
`
`Regeneron Contacts:
`
`Media Relations
`Joseph Ricculli
`Tel:+1 {914)418-0405
`Joseph Bicculli@a:generon com
`
`Investor Relations
`Justin Holko
`Tel: +1 (914) 847-7786
`Justin Holko@J:egeneron com
`
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`SOURCE Regeneron Pharmaceuticals, Inc.
`
`https://investor.regeneron.com/news-releases/news-release-details/fda-approves-eylear-aflibercept-injection-prefilled-syringe
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`
`Novartis Exhibit 2270.003
`Regeneron v. Novartis, IPR2021-00816
`
`