Regeneron Exhibit 1190.001
`Regeneron v. Novartis
`IPR2021-00816
`
`MARKETING
`Jun 1, 2021 11:41am
`Novartis calls o 3 Beovu trials testing more
`frequent dosing on concerns of vision-
`threatening side eect
`By Angus Liu
`age-related macular degeneration
`drug safety
`VEGF
`Beovu
`Subscribe
`

`

`Regeneron Exhibit 1190.002
`Regeneron v. Novartis
`IPR2021-00816
`
`October 18-20, 2022
`Philadelphia , PA
`Novartis has terminated three clinical trials testing eye drug Beovu at an increased dosing frequency thanks to safety concerns. (Novartis)
`The vision-threatening safety risk from Novartis’ new VEGF inhibitor Beovu just got even clearer.
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`aecting the pharmaceutical industry moving forward.
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`Friday, Novartis said it had decided to nix three Beovu trials early after an interim analysis of the phase 3
`Merlin study found increased rates of inammation of the eyes in patients who got Beovu compared with
`those who received Regeneron and Bayer’s rival Eylea.
`The Merlin trial, as well as the Raptor and Raven studies, were testing Beovu given every four weeks. The
`drug currently carries an FDA label for dosing every eight to 12 weeks after three initial monthly loading
`doses.
`Novartis said it has communicated the data to health authorities and will seek an update to the Beovu label.
`It will also amend the protocols of other ongoing Beovu trials to remove the four-week dosing intervals for
`the maintenance phase.
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`Novartis launched the Merlin trial to see if the more frequent dosing could help age-related macular
`degeneration patients who still have unresolved retinal uid despite anti-VEGF therapy. On the ecacy
`front, 6 mg monthly Beovu matched up to 2 mg monthly Eylea in change in visual acuity after one year of
`treatment. The drug also bested Eylea on some anatomical secondary endpoints, Novartis said.
`

`

`Regeneron Exhibit 1190.003
`Regeneron v. Novartis
`IPR2021-00816
`
`g
`y
`y
`p
`,
`RELATED: 'Lightning struck': How a safety alert shifted doctor sentiment on Novartis' Beovu
`But Beovu doubled the rate of intraocular inammation compared with its rival, with 9.3% percent of
`patients suering the complication in the Beovu trial arm. That compared with 4.5% for Eylea. None of the
`Eylea patients developed reginal vasculitis or retinal vascular occlusion , while those side eects happened
`in 0.8% and 2% of Beovu patients, respectively. The problem could potentially damage a person’s vision.
`In Merlin , the rate of vision loss from any cause was 4.8% for Beovu patients and 1.7% for Eylea patients.
`“These data help inform our trials moving forward, so we can best determine how appropriate patients can
`benet most from this important medicine,” John Tsai, M.D., Novartis’ chief medical ocer, said in a
`statement.
`Shortly after Beovu’s launch in late 2019, the American Society of Retina Specialists raised the risk of the
`potential vision-damaging safety problem in a communication to its member doctors. Novartis later
`conrmed it through its own internal investigation.
`RELATED: Novartis' hot new eye drug Beovu tied to potential vision loss: experts
`The safety ag essentially deprived Beovu’s chance at challenging Eylea. Novartis previously had high
`hopes for the drug as it matched Eylea in best-corrected visual acuity and showed it could consistently dry
`retinal uid. Now, though , the drug has almost disappeared from Novartis’ public discussions about its
`nancial performance. And with the latest safety nding, Novartis will likely have a hard time restoring
`condence in Beovu.
`In the rst quarter, Beovu only pulled in $39 million in sales, a 44% decline over the prior year thanks to the
`safety scare and the pandemic’s constraint on the overall ophthalmology market. That’s compared with
`Eylea’s 15% U.S. sales boost during the same period to $1.35 billion. 
`The company has yet to identify the root cause behind Beovu’s safety problem.
`Pharma
`Marketing
`Novartis
`RESOURCE CENTER
`Report
`ASCO 2021 Highlights
`The ASCO Annual Meeting gathers oncology professionals from around the world to discuss the latest in cancer research and treatment. This year's event included more
`than 2,500 abstract presentations - and while each study is valuable, we want to share comments on a few topics of particular interest. Read more.
`Article
`Managing Clinical Trial Complexity
`The three factors driving up average study duration , and how to respond. Complexity isn't going anywhere, so instead of reducing these factors, let's make better ways to
`manage them  Learn more.
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`Regeneron Exhibit 1190.004
`Regeneron v. Novartis
`IPR2021-00816
`
`Article
`RBQM Is Our Future
`Let's talk about the future of clinical trials. There's no crystal ball, but we have plenty of data - and it shows the growing need for risk-based quality management (RBQM) in
`clinical research. Read more.
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`Regeneron Exhibit 1190.005
`Regeneron v. Novartis
`IPR2021-00816
`
`MARKETING
`Apr 4, 2022 11:02am
`Komodo and cancer charity map out dealing
`with the colorectal cancer
`By Sharon Klahr Coey
`Komodo Health
`colorectal cancer
`awareness campaigns
`Congress
`An jee Davis, The president of Fight CRC, in a #StrongArmSele. (Komodo Health)
`

`

`Regeneron Exhibit 1190.006
`Regeneron v. Novartis
`IPR2021-00816
`
`The less people want to talk about a subject the more the industry has to push to get the word and
`information out. For colorectal cancer awareness month , Komodo Health , working with Fight Colorectal
`Cancer (Fight CRC), is the latest pharma to emphasize the importance of managing the second most deadly
`form of cancer, with the introduction of the Fight CRC Provider Finder.
`The Provider Finder, which can be found on Fight CRC’s website, is a digital resource to help nd the best
`HCPs in the U.S. throughout all stages of the disease.  The user can choose providers based on location ,
`expertise, and if they are involved with clinical trials and use biomarkers.
`“The healthcare systems are very complicated,” Usha Periyanayagam , MD, MPH, head of clinical product
`and RWE, Komodo Health said. “It's really hard to nd the right doctor to reach out at the right time to get
`the right answers. So the question becomes how do I do that?”
`Periyanayagam also spoke about Komodo’s work at the Call-on Congress event which took place in
`Washington , D.C. on March , 17. The event included virtual meetings with members of Congress urging them
`to focus on dealing with the disease which is on track to be the leading cause of cancer deaths for people
`under 50.
`Fight CRC created United in Blue, “the rst-ever installation on the National Mall to spotlight colorectal
`cancer as a national priority and raise awareness that we need to ght for more.” It featured 27,400 blue
`ags on the Mall representing the people under the age of 50 estimated to be diagnosed with colorectal
`cancer by 2030. 
`The eort is supported by a strong mix of media including Fight CRC’s #StrongArmSele. All the work has
`been promoted over a variety of social media channels including Twitter, LinkedIn, Youtube, Facebook and
`Instagram.
`According to Fight CRC, at the height of the pandemic colonoscopy screenings and biopsies fell by 90%. So
`this year’s colorectal cancer month has seen a lot of initiatives by a lot of dierent organizations to try and
`counteract the damage the pandemic has wrought when it comes to the disease. In May, the U.S. Preventive
`Services Task Force lowered the colorectal cancer screening rate from 50 to 45, making 45 million
`Americans eligible to be checked for the potentially life-threatening disease.
`RELATED
`Exact Sciences enlists Katie Couric for new commercial to promote Cologuard, colorectal cancer
`screening
`Pharma
`Marketing
`RELATED ARTICLES
`

`

`Regeneron Exhibit 1190.007
`Regeneron v. Novartis
`IPR2021-00816
`
`MARKETING
`Apr 4, 2022 07:45am
`Merck, nearing completion of
`$1B Gardasil manufacturing
`push, eyes 2023 to double
`production —again
`Apr 4, 2022 09:45am
`Sano launches DE&I board
`with outside advisors, the rst
`of its kind in pharma
`Apr 4, 2022 09:22am
`Meeting the cold chain
`challenges of remote locations
`Apr 4, 2022 08:00am
`Preparing manufacturers for a
`changing copay landscape
`Apr 4, 2022 08:00am
`Novo Nordisk, trying to switch patients to
`Rybelsus, launches new TV ad
`By Ben Adams
`Rybelsus
`Novo Nordisk
`Diabetes
`Ozempic (semaglutide)
`Novo has so far spent $4.2 million on the "Down with Rybelsus" ad in March. (Novo Nordisk)
`

`

`Regeneron Exhibit 1190.008
`Regeneron v. Novartis
`IPR2021-00816
`
`Down with Rybelsus! No, this isn’t a line from "1984," but rather the new message from Novo Nordisk for its
`rst Rybelsus ad of 2022.
`One of the biggest issues facing new medicines like Rybelsus, which was approved by the FDA in 2020 to
`help lower blood sugar levels in Type 2 diabetes patients, is that doctors often don’t like to switch their
`patients to new meds.
`This new ad appears to be zeroing in on that issue. Several Type 2 diabetes patients talk about their sugar
`levels—measured as A1C—and how they needed to be lower. We cut in the rst scene to a doctor saying his
`patient’s sugar levels “are down , thanks to Rybelsus.”
`With a very upbeat jingle—“A1C, down with Rybelsus”—the middle of the TV spot gets to the meat of the
`message. “Once-daily Rybelsus showed in a clinical trial that it signicantly lowered A1C better than a
`leading branded pill,” the narrator says.
`Pharma companies don’t typically target competitors in their ads or directly state that patients should
`switch to their drugs, but Novo is letting viewers connect the dots to come to that conclusion.
`The switching-focused ad also dovetails with a comments from Novo’s CEO Lars Fruergaard Jørgensen , who
`said in a recent interview with Fierce Pharma that doctors were generally “hesitant about changing
`prescriptions” for stable diabetes patients. It looks as if the marketing department has made that issue front
`and center of this new ad campaign.  
`Rybelsus’ launch , like a lot of new rollouts, has suered from the COVID environment, but its sales still
`jumped 168% in 2021 compared to 2020, bringing home 4.8 billion Danish krone ($720 million)—and it
`could breach blockbuster status this year.
`The latest ad also sees Novo switch it up from the animation-led ads it originally aired for the drug, the rst
`one forced from live to animation as COVID restrictions interfered with live lming.
`The older animated ads had predominately focused on "waking up possible’"or certain variations of that
`theme, which plugged the drug’s ability to help people lose weight and live their lives to the fullest.
`Novo has so far spent $4.2 million on the Down with Rybelsus ad in March , according to the real-time ad
`trackers at iSpot.tv.
`Rybelsus racked up pharma's second-largest drug ad spend in 2021, coming in second to Sano and
`Regeneron’s Dupixent, with Novo spending $307 million on all ad campaigns for the med in its rst full
`commercial year, massively up from the $103 million it spent in 2020.
`It does sit within a big eld of new competing Type 2 diabetes drugs, including Eli Lilly’s in jected Trulicity
`and its Boehringer-partnered Jardiance, as well as J&J’s Invokana.
`But Rybelsus also a unique selling point, being the only GLP-1 diabetes medicine sold as an oral therapy,
`and therefore easier to administer for patients.
`RELATED
`Novo's Rybelsus launch is on the up-and-up after taking pandemic hit: execs
`RELATED
`Novo Nordisk debuts animated Rybelsus ad after COVID-19 nixed lm shoot
`

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`Regeneron Exhibit 1190.009
`Regeneron v. Novartis
`IPR2021-00816
`
`Marketing
`diabetes drugs
`TV ads
`RELATED ARTICLES
`In major shake-up, Novartis
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`Regeneron Exhibit 1190.010
`Regeneron v. Novartis
`IPR2021-00816
`
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`Regeneron Exhibit 1190.011
`Regeneron v. Novartis
`IPR2021-00816
`
`