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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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