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`Investor Update
`
`Basel, 22 March 2018
`
`FDA approves 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 1
`
`♦ Prefilled syringe options are now FDA-approved
`for all Lucentis indications
`
`Roche (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 new 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 affects nearly
`7.7 million people in the u.s.1.2 The Lucentis 0.3 mg PFS
`is now the first syringe prefilled with an anti-vascular
`
`ht1ps://www.roche.corrJinvestors/updates/inv-update-2018-03-22.htm
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`1/5
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`Novartis Exhibit 2264.001
`Regeneron v. Novartis, IPR2021-00816
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`

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`endothelial growth factor (VEGF) agent FDA-approved
`to treat both diabetic retinopathy and □ME.
`
`"Diabetic retinopathy is a serious condition that affects
`millions of people in the U.S.," said Sandra Horning,
`M.D., Chief Medical Officer 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(cid:173)
`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 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
`off 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 (AM D), macular
`edema following retinal vein occlusion (RVO) and
`myopic choroidal neovascularisation (mCNV).
`
`About Diabetic Retinopathy and Diabetic Macular
`Edema
`Diabetic retinopathy is the most common cause of
`vision loss in people with diabetes, which affects
`approximately 30 million people in the U.S.3 The longer a
`person has diabetes, especially if it is poorly controlled,
`
`https://www.roche.co1TV1nvestors/updates/inv-update-2018-03-22.htm
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`'215
`
`Novartis Exhibit 2264.002
`Regeneron v. Novartis, IPR2021-00816
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`

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`the higher the risk of developing diabetic retinopathy
`
`
`
`
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`and vision loss. Diabetic retinopathy occurs when blood
`
`
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`vessels in the retina become damaged. This can cause
`
`
`
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`vision loss or distortion when the abnormal vessels leak
`blood or fluid into the eye.1
`
`Diabetic macular edema (DME), which affects
`
`
`
`
`approximately 750,000 people in the U.S., is one of the
`
`
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`vision-threatening complications of diabetic retinopathy,
`
`in which chronic damage occurs to the fine blood
`
`
`
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`vessels of the retina, the light-sensitive tissue at the
`
`back of the eye necessary for good vision.
`5
`4,
`
`About Lucentis
`Lucentis is a vascular endothelial growth factor (VEGF)
`
`
`
`
`
`
`
`
`inhibitor designed to bind to and inhibit VEGF-A, a
`
`
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`protein that is believed to play a critical role in the
`
`
`
`formation of new blood vessels (angiogenesis) and the
`
`
`
`
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`hyperpermeability (leakiness) of the vessels.
`
`Lucentis is FDA-approved for the treatment of patients
`
`
`
`
`
`with neovascular (wet) age-related macular
`
`
`
`degeneration (AMO), macular edema following retinal
`
`
`
`vein occlusion (RVO), diabetic macular edema (DME),
`
`
`diabetic retinopathy (DR) and myopic choroidal
`
`neovascularisation (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.
`
`Outside the U.S., Lucentis is approved in more than 11 O
`
`
`
`
`
`
`countries to treat patients with neovascular (wet) AMO,
`
`
`for the treatment of DME, and due to macular edema
`
`
`
`secondary to both branch retinal vein occlusion (BRVO),
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`https://www.roche.com/investors/updates/inv-update-2018-03-22.htm
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`3/5
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`Novartis Exhibit 2264.003
`Regeneron v. Novartis, IPR2021-00816
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`central retinal vein occlusion (CRVO) and visual
`
`
`
`
`
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`impairment due to choroidal neovascularisation (CNV).
`
`About Roche in ophthalmology
`
`
`Roche is researching and developing new treatments
`
`for people living with a range of eye diseases that cause
`
`
`
`
`
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`significant visual impairment and blindness, including
`
`
`
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`neovascular age-related macular degeneration (AMO),
`
`
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`diabetic macular edema (DME), diabetic retinopathy
`
`
`(DR), geographic atrophy (GA) and other retinal
`
`
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`diseases. Roche is also investigating platforms for
`
`sustained ocular drug delivery. Additional focus includes
`
`
`
`
`
`
`
`using bispecific antibodies to simultaneously address
`
`multiple targets.
`
`About Roche
`Roche is a global pioneer in pharmaceuticals and
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`
`
`
`
`
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`diagnostics focused on advancing science to improve
`
`
`
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`people's lives. The combined strengths of
`
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`under one roof have pharmaceuticals and diagnostics
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`
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`made Roche the leader in personalised healthcare - a
`
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`strategy that aims to fit the right treatment to each
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`patient in the best way possible.
`
`Roche is the world's largest biotech company, with truly
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`
`
`
`
`
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`differentiated medicines in oncology, immunology,
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`
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`infectious diseases, ophthalmology and diseases of the
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`
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`central nervous system. Roche is also the world leader
`
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`in in vitro diagnostics and tissue-based cancer
`
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`diagnostics, and a frontrunner in diabetes management.
`
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`Founded in 1896, Roche continues to search for better
`
`
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`ways to prevent, diagnose and treat diseases and make
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`
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`a sustainable contribution to society. The company also
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`
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`aims to improve patient access to medical innovations
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`
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`by working with all relevant stakeholders. Thirty
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`https://www.roche.com/investors/updates/inv-update-2018-03-22.htm
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`4/5
`
`Novartis Exhibit 2264.004
`Regeneron v. Novartis, IPR2021-00816
`
`

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`medicines developed by Roche are included in the
`
`
`
`
`World Health Organization Model Lists of Essential
`
`
`Medicines, among them life-saving antibiotics,
`
`
`antimalarials and cancer medicines. Roche has been
`
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`recognised as the Group Leader in sustainability within
`
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`the Pharmaceuticals, Biotechnology & Life Sciences
`
`Industry nine years in a row by the Dow Jones
`(DJSI).
`
`Sustainability Indices
`The Roche Group, headquartered in Basel, Switzerland,
`
`
`
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`is active in over 100 countries and in 2017 employed
`
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`about 94,000 people worldwide. In 2017, Roche invested
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`CHF 10.4 billion in R&D and posted sales of CHF 53.3
`
`
`
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`billion. Genentech, in the United States, is a wholly
`
`owned member of the Roche Group. Roche is the
`
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`majority shareholder in Chugai Pharmaceutical, Japan.
`
`
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`For more information, please visit> www.roche.com.
`
`
`
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`All trademarks used or mentioned in this release are protected by law.
`
`References
`
`1. U.S. Centers for Disease Control and Prevention. Common Eye Disorders:
`
`
`
`
`
`
`
`Diabetic Retinopathy. Available at[§]
`
`
`February 7, 2018.
`
`https://www.cdc.gov/visionhealth/basics/ced/index.html. Accessed
`
`2. Prevent Blindness America. Diabetic Retinopathy. Available at[§]
`
`
`
`
`
`
`http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy­
`
`
`
`definition.html. Accessed February 7, 2018.
`
`3. American Diabetes Association. Statistics About Diabetes. Available at[§]
`
`
`
`
`
`
`
`
`
`http://www.diabetes.org/diabetes-basics/statistics/. Accessed February 7,
`2018.
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`Care Systemof the Health 4. Bressler NM, Varma R, Doan Q, et al. Underuse
`
`
`
`
`
`
`
`
`by Persons With Diabetes Mellitus and Diabetic Macular Edema in the
`
`
`
`United States. JAMA Ophthalmology. 2014 Feb;132(2):168-73.
`
`macular edema:5. Bhagat N, Grigorian RA, Tutela A, et al. Diabetic
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`
`
`
`
`
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`pathogenesis and treatment. Surv Ophthalmol. 2009;54(1):1-32.
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`© 2022 F. Hoffmann-La Roche Ltd 14.01.2022
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`https://www.roche.com/investors/updates/inv-update-2018-03-22.htm
`
`5/5
`
`Novartis Exhibit 2264.005
`Regeneron v. Novartis, IPR2021-00816
`
`