Roche touts less oner­ous sched­ule for its in-the-eye in­jec­tion faricimab, hop­ing to sweet­en the sales pitch over Eylea

Re­gen­eron has made its name on the back of wet AMD drug Eylea, but the block­buster’s dos­ing sched­ule of in­to-the-eye shots every eight weeks is no cake­walk for pa­tients. Roche, look­ing to take the fight to Eylea with faricimab, thinks it has a lighter sched­ule that could help sway physi­cians.

Rough­ly half of pa­tients across four Phase III tri­als el­i­gi­ble for ex­tend­ed dos­ing of faricimab were able to be treat­ed every four months af­ter one year, sub­sidiary Genen­tech an­nounced Fri­day, and near­ly 75% could take the ex­per­i­men­tal drug every three months. Roche has al­ready prepped a hefty da­ta pack­age for its hope­ful Eylea com­peti­tor, re­leas­ing trick­ling da­ta from four Phase III tri­als over the last few months in di­a­bet­ic mac­u­lar ede­ma and wet AMD.

Levi Gar­raway

“These pos­i­tive re­sults show the po­ten­tial for faricimab as the first new type of med­i­cine in 15 years for peo­ple with neo­vas­cu­lar age-re­lat­ed mac­u­lar de­gen­er­a­tion and in close to a decade in di­a­bet­ic mac­u­lar ede­ma,” Roche CMO Levi Gar­raway said in a state­ment.

Two of the tri­als eval­u­at­ed faricimab in DME and two stud­ied it in wet AMD. Ex­tend­ing the dosage pe­ri­ods and mea­sur­ing the pro­por­tion of peo­ple able to do so was a key sec­ondary end­point, Roche said.

The DME stud­ies showed 52.8% and 51% of pa­tients, re­spec­tive­ly, achieved four-month dos­ing at one year. On top of that, an­oth­er 21% and 20.1% in each study were able to be dosed every three months.

Then, in wet AMD, the stud­ies reg­is­tered a re­spec­tive 45.7% and 44.9% of pa­tients who re­ceived four-month dos­ing reg­i­mens. An­oth­er 34% and 32.9% of in­di­vid­u­als man­aged three months be­tween dos­es.

Each of the four stud­ies saw about 300 pa­tients ran­dom­ized in­to the drug arms, and Fri­day’s da­ta come from a to­tal of 1,225 in­di­vid­u­als across all four groups.

Roche is ex­pect­ed to present full da­ta from all four tri­als this week­end, where an­a­lysts ex­pect sig­nif­i­cant warn­ing signs for Eylea’s dom­i­nance. The faricimab pro­gram has al­ready demon­strat­ed non-in­fe­ri­or­i­ty in both dis­eases, and cou­pled with the ex­tend­ed time be­tween dos­es, the can­di­date has emerged as the “top com­pet­i­tive threat” to the Re­gen­eron fran­chise, Cowen’s Yaron Wer­ber wrote ear­li­er this week.

Faricimab is the first bis­pe­cif­ic an­ti­body for AMD, tar­get­ing two path­ways — an­giopoi­etin-2 and vas­cu­lar en­dothe­lial growth fac­tor-A. The treat­ment, like Eylea, is in­ject­ed di­rect­ly in­to the eye and de­signed to pre­vent in­flam­ma­tion and blood ves­sels from leak­ing. Longer time be­tween dos­es is cen­tral to Roche’s pitch, giv­en the in­her­ent dis­com­fort in re­ceiv­ing any sort of eye in­jectable.

Roche hasn’t spec­i­fied when it’s sub­mit­ting the da­ta to reg­u­la­tors, but Wer­ber pre­dicts it could make it to the mar­ket some­time in 2022. Faricimab isn’t the on­ly po­ten­tial Eylea com­peti­tor, how­ev­er, with Cheng­du Kang­hong’s Con­ber­cept and Ko­di­ak’s KSI-301 al­so mak­ing moves. But it’s still too ear­ly to say how much im­pact that pro­gram could have, he wrote.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Mod­er­na's Stéphane Ban­cel plans to dou­ble down on vac­cine pro­duc­tion, new vari­ants as mR­NA rules in pan­dem­ic fight

Stéphane Bancel thought he’d be sleeping more by now.

The 48-year-old Moderna CEO figured that by 2021 he’d have his vaccine through the clinic, authorized, and in mass production — that the hard part would be over. Instead, he’s still working Saturdays and Sundays, talking with his lab and manufacturing teams and fielding calls with two to three world leaders a day to answer their concerns about supply and emerging new variants.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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