Is Roche's pRED fi­nal­ly ready to step out from be­hind Genen­tech for its close­up? Prob­a­bly not

John Reed
Bioreg­num
The view from John Car­roll

It’s been close to 5 years since John Reed jumped from San­ford-Burn­ham to be­come the head of Roche’s Basel-based pRED or­ga­ni­za­tion. And on­ly now is the big drug re­search group he leads get­ting a close­up af­ter years spent watch­ing his col­leagues at gRED — Genen­tech — steal the show with a string of block­buster hits.

The old pRED was shred­ded when Roche an­nounced in the sum­mer of 2012 that it would shut­ter its big R&D cam­pus in Nut­ley, NJ and move a group of sur­vivors in­to Man­hat­tan. The re­or­ga­ni­za­tion, like any such R&D or­ga­ni­za­tion, Reed told me in 2013, was pure “poi­son” for the group, vow­ing to stick with a re­search strat­e­gy and avoid any more such trau­mat­ic dis­rup­tions.

There was one key suc­cess, with Gazy­va, but that hasn’t per­formed spec­tac­u­lar­ly well so far on the mar­ket­ing side of things. And some of the drugs that Reed men­tioned to me back in 2013 — like RG7116 and emac­tuzum­ab — ap­pear to have ei­ther been lost along the way or still face a long clin­i­cal path. And even in­side Roche there ap­pears to have been some grow­ing frus­tra­tions.

Sev­erin Schwan

Roche CEO Sev­erin Schwan, though, is now ready to em­brace the long over­shad­owed pRED, tap­ping some mid-stage pro­grams as top prospects. Here’s what he had to tell Reuters:

“In pRED, some ex­cit­ing op­por­tu­ni­ties are now com­ing through af­ter a time when many things did not work. It goes in waves. You can’t pro­gram to have a cer­tain num­ber of mol­e­cules com­ing through the pipeline every year in each unit.”

An­oth­er ex­ec put it this way: “Thank God. It took a while, but pRED is fi­nal­ly start­ing to de­liv­er.”

So what’s in the spot­light?

A bis­pe­cif­ic called CEA-TCB that en­gages T cells for an at­tack on can­cer cells, a fol­low-up drug for Lu­cen­tis, ida­sunut­lin for AML and an autism drug.

It’s un­usu­al for any gi­ant phar­ma com­pa­ny like Roche to tout mid-stage pro­grams, which have a high mor­tal­i­ty rate, es­pe­cial­ly as mar­ket­ing chal­lenges can now just as eas­i­ly kill off a pro­gram just as sure­ly as bad da­ta ever could. But then it’s al­so ex­tra­or­di­nar­i­ly un­usu­al for a com­pa­ny like Roche to suc­cess­ful­ly ac­quire Genen­tech with­out killing the in­no­v­a­tive spir­it that drove a leg­endary string of new can­cer drugs in­to ex­is­tence.

The gen­er­al con­sen­sus at the time was that the but­toned down Basel crew would de­stroy the col­or­ful cul­ture at Genen­tech, elim­i­nat­ing its abil­i­ty to stay on the cut­ting edge of drug re­search. In­stead, even as top ex­ecs moved on to oth­er things, flow­er­ing Bay Area star­tups, the Bay Area com­pa­ny con­tin­ued to thrive.

Reed and pRED, both of which have main­tained a very low pro­file in re­cent years, still have a long way to go be­fore prov­ing whether Roche can cre­ate the same spir­it in the large­ly Eu­ro­pean or­ga­ni­za­tion.

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.

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.”

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.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.