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. 

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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