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`COMMENT July 1, 2020
`
`updated 01 Dec 2021 12:34pm
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`The dominance of Eylea is expected to persist in the foreseeable future
`
`By GlobalData Healthcare
`
`Regeneron Exhibit 1246.001
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`The urgency of treating retinal diseases is underscored by the fact that without pharmacotherapeutic intervention, most patients will rapidly lose vision. Credit: Shutterstock
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`Bayer/Regeneron’s Eylea (aibercept) is a fusion protein that is used to treat retinal diseases such as wet age-
`related macular degeneration (wAMD), proliferative diabetic retinopathy (PDR), and diabetic macular edema
`(DME). These diseases are frequently exacerbated by choroidal neovascularisation, a process in which new blood
`vessels grow from over-expression of pro-angiogenic proteins such as vascular endothelial growth factor (VEGF)
`and platelet-derived growth factor (PDGF).
`
`Roche/Genentech also has a portfolio of anti-VEGF products that are used to treat ophthalmic indications. These
`are the monoclonal antibodies Lucentis (ranibizumab) and Avastin (bevacizumab). Although Eylea and Lucentis
`are thought to have similar safety and efcacy proles, Eylea is injected into patients’ eyes between 6–8 times per
`year, while Lucentis is administered on a monthly basis. This reduction in the frequency of administration is an
`important benet because patients with retinal diseases such as wAMD and PDR are likely to have mobility issues
`and live with comorbidities such as cardiovascular disease, neuropathy, or nephropathy.
`
`The urgency of treating retinal diseases is underscored by the fact that without pharmacotherapeutic intervention,
`most patients will rapidly lose vision. Loss of central vision can prevent people from performing daily activities
`such as reading, writing, and driving. The fact that many diabetic patients are in the workforce makes diabetic
`retinopathy a major concern. Early intervention is associated with positive outcomes and improvements in
`patients’ quality of life.
`
`Regeneron Exhibit 1246.002
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`Other favourable aspects of treatment with Eylea include the well-established notion that Eylea is an effective
`medicine. This is evidenced by the fact that Eylea has met efcacy endpoints in over 200 clinical trials and has
`been seen to resolve subretinal uid, a major component of vision-threatening diabetic retinopathy and DME.
`
`According to a survey of ophthalmologists from three geographic regions, the US, Europe (France, Germany, Italy,
`Spain, and the UK), and Asia-Pacic (Japan, China, and Australia), the majority of physicians from all regions
`expect the number of patients treated with Eylea to increase over the next two years.
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`Figure 1: Physicians’ Perspectives on How the Prescription Rate of Eylea Will Change Between 2019 and 2022
`
`Source: GlobalData; Ophthalmologists surveyed for GlobalData’s Diabetic Retinopathy: Global Drug Forecast and
`Market Analysis to 2029 report, July 2020           
`
`More than half (68%) of doctors in the Asia-Pacic region expect Eylea to be prescribed to more patients between
`2019 and 2022.  No doctors in this region thought that the prescription rate of Eylea would decrease. This may be
`because safe and effective longer-acting anti-VEGF therapies are not expected to launch in the Asia-Pacic region
`until 2024. The majority (60%) of aibercept biosimilars in development in the Asia-Pacic region are in early-
`stage development. Early-stage development in this context refers to products at the Discovery or Preclinical
`stages. Because aibercept biosimilars are unlikely to launch in this region within the next two years, the sales
`erosion that would be expected with their launch is delayed, leaving sales of Eylea unscathed for the foreseeable
`future.  The majority (60%) of ophthalmologists in the US also expect to prescribe Eylea to more patients over the
`next two years. The lower annual cost of therapy (ACOT) of Eylea compared to Lucentis in the US makes this drug a
`cost-effective and practical choice for patients who cannot or choose not to receive monthly injections of Lucentis.
`
`While drug developers continue to spearhead innovation in the retinopathy market, the dominance of Eylea is
`expected to persist for the foreseeable future. Globally, Eylea generated $8.1B in 2019. Sales are expected to reach
`$8.4B in 2022, increasing at a compound annual growth rate (CAGR) of 1%.
`
`Regeneron Exhibit 1246.003
`Regeneron v. Novartis
`IPR2021-00816
`
`

`

`Poll
`
`What do you think is the biggest advantage
`associated with implementing electronic
`healthcare records (EHRs) in healthcare settings?
`
`Improved quality of care
`
`Increased security of data storage
`
`Interoperability (e.g., possibility to share data with other institutions)
`
`Accessibility (24/7)
`
`Patient empowerment through access to their EHRs
`
`Costs reduction (e.g., through decreased paperwork)
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`Regeneron Exhibit 1246.004
`Regeneron v. Novartis
`IPR2021-00816
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`Regeneron v. Novartis
`IPR2021-00816
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`Regeneron Exhibit 1246.006
`Regeneron v. Novartis
`IPR2021-00816
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