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. 

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”