Eylea keeps its lead in the reti­nal space as physi­cians re­main hes­i­tant on Roche's Susvi­mo — re­port

Roche trum­pet­ed a “ma­jor ad­vance­ment” in the reti­nal space with the ap­proval of its eye drug Susvi­mo last Oc­to­ber, tout­ing it as a more man­age­able op­tion for pa­tients with wet age-re­lat­ed mac­u­lar de­gen­er­a­tion. How­ev­er, safe­ty con­cerns leave some physi­cians hes­i­tant.

While most oph­thal­mol­o­gists have heard of Susvi­mo — 86%, ac­cord­ing to the lat­est Spher­ix sur­vey of 76 doc­tors — on­ly one in ten be­lieve the ben­e­fits com­plete­ly out­weigh the risks. And a ma­jor­i­ty of the re­spon­dents said they’d turn to Re­gen­eron’s Eylea as a safer and more ac­ces­si­ble op­tion.

Susvi­mo snagged an FDA win back in Oc­to­ber, just a month af­ter reg­u­la­tors cleared the first biosim­i­lar to Roche’s block­buster Lu­cen­tis. Un­like Lu­cen­tis’ month­ly in­jec­tions — or Eylea’s 8- to 12-week in­jec­tions — the Susvi­mo im­plant is in­sert­ed in the eye dur­ing a one-time out­pa­tient pro­ce­dure, and on­ly needs to be re­filled every six months.

“With Susvi­mo, my pa­tients now have an op­tion that can help them main­tain their vi­sion as well as an­ti-VEGF in­jec­tions, but on a more man­age­able twice-year­ly treat­ment sched­ule,” said Carl Regillo, an in­ves­ti­ga­tor on the Phase III Susvi­mo study.

Oph­thal­mol­o­gists ac­knowl­edged this ben­e­fit, with a third of them call­ing the drug a “sub­stan­tial ad­vance to the mar­ket.” And two-fifths of doc­tors who pre­scribed Susvi­mo cit­ed a de­creased treat­ment bur­den as their main rea­son. But Roche still has a lot of work to do be­fore it catch­es up to Eylea — if it ever does.

Eylea has dom­i­nat­ed the di­a­bet­ic mac­u­lar ede­ma and wet age-re­lat­ed mac­u­lar de­gen­er­a­tion mar­kets for near­ly a decade — and physi­cians sus­pect it will con­tin­ue to beat out Lu­cen­tis, Susvi­mo and Roche’s oth­er eye con­tender Vabysmo over the next six months. On­ly two of five physi­cians said they plan on pre­scrib­ing Susvi­mo for the first time in the next six months, while an­oth­er quar­ter of physi­cians said they ex­pect to wait sev­en months to a year.

Of those hes­i­tant to pre­scribe Susvi­mo, most cit­ed safe­ty and tol­er­a­bil­i­ty con­cerns, fol­lowed by re­im­burse­ment un­cer­tain­ty.

In the Phase III Arch­way tri­al, Susvi­mo was as­so­ci­at­ed with a three-fold high­er rate of en­doph­thalmi­tis, or se­vere in­flam­ma­tion of the tis­sues in­side the eye, com­pared to pa­tients re­ceiv­ing month­ly Lu­cen­tis in­jec­tions. The most com­mon side ef­fects were con­junc­ti­val he­m­or­rhage, con­junc­ti­val hy­per­emia, iri­tis and eye pain, Roche re­port­ed last year.

Roche read out long-term da­ta for Susvi­mo back in Feb­ru­ary, re­port­ing that 95% of pa­tients were able to main­tain a six-month treat­ment sched­ule. At two years, the most com­mon side ef­fects of “spe­cial in­ter­est” were cataract, con­junc­ti­val bleb and vit­re­ous haem­or­rhage, Roche said.

Susvi­mo raked in just un­der $1 mil­lion (CHF 1 mil­lion) last quar­ter, ac­cord­ing to Roche. Mean­while, Eylea saw $1.5 bil­lion in sales, a 13% boost over the first quar­ter of last year.

Don’t count Susvi­mo out just yet. Al­most half of the pa­tients who switched to Susvi­mo were pre­vi­ous­ly treat­ed with Eylea, ac­cord­ing to Spher­ix. And of the doc­tors who pre­scribed it, none re­port­ed dis­sat­is­fac­tion. Near­ly two-fifths re­port­ed “ex­treme sat­is­fac­tion,” while the rest said they were mod­er­ate­ly sat­is­fied.

Cor­rec­tion: Eylea’s dos­ing sched­ule is 8-12 weeks, not months. 

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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As­traZeneca gives up on late-stage IL-23 drug due to tri­al de­lays, com­pet­i­tive land­scape

AstraZeneca is shelving an IL-23 antibody that’s been through a winding journey around pharma — including stops at Amgen and Allergan — and putting an end to Phase II and III trials testing the drug for inflammatory bowel disease.

“The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve,” a press release reads.

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