Beovu, Novartis | FiercePharma
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`O
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`O
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`Special Reports
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`Beovu, Novartis
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`by Noah Higgins-Dunn |@®ct 25, 2021 3:00am
`
`——ae
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`
`ie | oc 0078.0827-61
`i:
`*,4
`4 Beovu.
`(brolucizumab-dbll)
`Injection
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`Guests
`0.05 mL
`Se émg/ Ra
`Far sara!
`ei
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`i) NOVARTIS
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`Beovuhas generated a mere $87 million in sales so far this year, a 16% decline compared with the same period a year prior.
`
`(Novartis)
`
`
`Mylan v. Regeneron
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`Drug name: Beovu
`Company: Novartis
`Page 1 ot08
`
`Exhibit 2192
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`https://www fiercepharma.com/special-report/beovu-novartis-top-10-drug-launch-disasters[ 12/30/2021 6:43:13 PM]
`
`IPR2021-00881
`U.S. Pat. 9,254,338
`Exhibit 2192
`
`,
`
`;
`
`Exhibit 2192
`Page 01 of 04
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`Beovu, Novartis | FiercePharma
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`Firs approval: October 2019, U.S. FDA
`Indication: Wet age-related macular degeneration (AMD)
`Pas sales esimate: $4.38 billion by 2021
`2020 sales: $190 million
`
`When Novartis’ wet age-related macular degeneration (AMD) med Beovu crossed the FDA’s fnish line, it seemed to pose a
`formidable threat to Regeneron’s megablockbuser Eylea and Roche’s Lucentis. But its foes had one card left to play: Beovu
`carried greater safety risks. And that hampered its highly anticipated rollout.
`
`Market watchers held high expectations for Beovu when it scored the agency’s go-ahead in October 2019. The drug was
`priced on par with its rivals and could be used to treat AMD patients on a longer quarterly or every-other-month basis.
`
`At the time, Wall Street analyss expected Novartis’ new eye med to top the market by 2026, earning roughly $4.38 billion by
`the end of 2021, according to consensus esimates. Novartis execs talked up the less-frequent dosing schedule, encouraging
`patients to spend more time focusing “on what's important in their lives."
`
`RELATED: Novartis takes on Regeneron, Roche blockbusers with Beovu approval
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`But convenience has proven to be a less-than-enticing sales pitch. Beovu has generated a mere $87 million in sales so far
`this year, a 16% decline compared with the same period a year prior.
`
`When Beovu frs entered the scene, Novartis touted head-to-head data showing it could topple market giant Eylea on some
`metrics. Eylea has been a massive hit for Regeneron, ranking among the world’s bes-selling drugs las year.
`
`In two late-sage clinical trials, Beovu matched Eylea on efcacy, as measured by bes-corrected visual acuity. Beovu even
`beat out the anti-VEGF med at reducing retinal fuid and central subfeld thickness, a measure of abnormal fuid accumulation
`and edema that can result in vision loss.
`
`Meanwhile, Roche’s Lucentis has faced copycat competition in the U.S. and Europe following a key patent expiration. Those
`biosimilars, notably one from Samsung Bioepis that scored an FDA nod jus weeks ago, are set to chip away at the entire
`AMD market. Still, Beovu had an impressive enough resume to spell blockbuser sales, analyss fgured.
`
`But Beovu had a chink in its armor from the get-go. SVB Leerink analyss speculated that Regeneron could take advantage of
`Beovu’s “higher safety liabilities,” namely that in late-sage trials, Beovu patients were four times as likely to report intraocular
`infammation than were those on Eylea.
`
`Turns out, that’s exactly what happened. The American Society of Retina Specialiss (ASRS) issued a warning in February
`2020 pinning Beovu to cases of retinal vasculitis, or eye infammation. Eleven of the 14 cases of ASRS detected at the time
`were serious enough to raise the risk of vision loss.
`
`RELATED: Novartis' hot new eye drug Beovu tied to potential vision loss: experts
`
`Novartis later confrmed that Beovu carries greater risks of side efects and asked the FDA for a label update. RBC Capital
`Markets analys Kennen MacKay at that time suspected that a revision would end up with a black box warning, which would
`relegate Beovu “to niche corners” of the ophthalmology market.
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`https://www fiercepharma.com/special-report/beovu-novartis-top-10-drug-launch-disasters[12/30/2021 6:43:13 PM]
`
`Exhibit 2192
`Page 02 of 04
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`

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`Beovu, Novartis | FiercePharma
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`The COVID-19 pandemic shutdowns swept in shortly after, posing a particularly bleak challenge to Novartis given that
`physicians were advised to monitor patients following their Beovu injections. As Bernsein analys Ronny Gal put it, that meant
`"adoption of Beovu has been essentially sopped," according to the BioPharma Dive report.
`
`That gave Regeneron and its partner Bayer the opportunity to tout Eylea’s own safety data and an extended dosing schedule
`that allows the product to be adminisered every 4, 8 or 12 weeks. In 2020, Eylea sales grew 7% year over year to $8.36
`billion.
`
`As for Beovu, its safety troubles have only grown worse. In June, Novartis called of three trials tesing a four-week dosing of
`the VEGF inhibitor after one of them turned up higher rates of eye infammation compared with Eylea. The company sill
`hasn’t identifed the root cause of the issue.
`
`Editor's Note: A previous version of the article misakenly sated that Novartis had asked the FDA to include a black box
`warning on Beovu. The company has asked for a label update.
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`https://www fiercepharma.com/special-report/beovu-novartis-top-10-drug-launch-disasters[12/30/2021 6:43:13 PM]
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`Exhibit 2192
`Page 03 of 04
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`Exhibit 2192
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`Page 04 of 04
`https://wwwfiercepharma.com/special-report/beovu-novartis-top-10-drug-launch-disasters[ 12/30/2021 6:43:13 PM]
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`Exhibit 2192
`Page 04 of 04
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