Stefan Oelrich (Bayer)

What can a 157-year-old phar­ma gi­ant bring to the ta­ble of cell and gene ther­a­pies? Quite a bit, Bay­er says

By now, Bay­er has sketched out in bold strokes some grand plans for cell and gene ther­a­py, ce­ment­ed by big-dol­lar ac­qui­si­tions of plat­form com­pa­nies.

But just how do you stitch to­geth­er a new unit burst­ing with the newest ideas with­in a sto­ried phar­ma?

Ste­fan Oel­rich, the head of Bay­er’s phar­ma di­vi­sion, briefly lift­ed the cur­tain and spot­light­ed three key fac­tors as he took the stage on a vir­tu­al me­dia day, flanked by Emile Nuwaysir and Sheila Mikhail, the chiefs of Blue­Rock and AskBio, who each in­tro­duced their work in a way you’d ex­pect from a biotech CEO.

The chem­i­cal ex­per­tise that the Ger­man be­he­moth has ac­crued over 157 years, for starters, isn’t just pro­pelling small mol­e­cule drug R&D. It’s giv­en them one of the biggest chem­i­cal li­braries in the pri­vate sec­tor, one that Oel­rich re­calls be­ing front and cen­ter in deal ne­go­ti­a­tions:

When we ac­quired AskBio, one of the first ques­tions that Jude Samul­s­ki asked me be­fore we closed is do I get ac­cess to your li­brary once this is done? And I said of course, you’re gonna be part of the fam­i­ly. He told me some­thing that I wasn’t aware of. When you’re a biotech com­pa­ny, like for ex­am­ple in gene aug­men­ta­tion. To de­vel­op your cap­sids, to get the ge­net­ic in­for­ma­tion in­to the tis­sue where it needs to get to, you ac­tu­al­ly need chem­istry. And we can pro­vide things to them that they’re not hav­ing ac­cess to to­day. So there’s even syn­er­gy be­tween the two. What we need to learn now is how we con­nect those and how we build an en­vi­ron­ment in which both tech­no­log­i­cal plat­forms can re­al­ly thrive. This is some­thing that we’re work­ing on.

It fits in­to the next piece — what BD chief Mar­i­anne De Backer calls “ag­ile deal­mak­ing” by her team.

Mar­i­anne De Backer

“To give you one ex­am­ple, we have ac­quired 2 com­pa­nies last year and from a non-bind­ing of­fer to sign­ing of the agree­ment took all of 6 weeks,” she said. “So the speed of our de­ci­sion mak­ing, the speed at which we can do this is ex­treme­ly, ex­treme­ly fast. I think we are one of the most com­pet­i­tive in the in­dus­try.”

The au­ton­o­my that Blue­Rock and AskBio now en­joy, they sug­gest, should be felt by every fu­ture cell and gene ther­a­py com­pa­ny that comes un­der their um­brel­la.

“How do we bring this to­geth­er with­out giv­ing up what made these com­pa­nies so suc­cess­ful in the first place, with­out los­ing a beat in their abil­i­ty to con­tin­ue to in­no­vate, with­out los­ing the abil­i­ty to re­main re­al­ly a very fast and nim­ble biotech or­ga­ni­za­tion?” Oel­rich mused. “And so we came up with our idea to ac­tu­al­ly or­ches­trate these com­pa­nies that we would ac­quire in an arm’s length fash­ion.”

Those pro­grams won’t be con­tribut­ing to the bot­tom line any time soon. In the next three to four years, Bay­er is count­ing on more tra­di­tion­al drugs to be the next block­buster prod­ucts.

There’s daro­lu­tamide, the prostate can­cer drug it’s de­vel­op­ing with Ori­on; finerenone, the treat­ment for chron­ic kid­ney dis­ease that’s just scored pri­or­i­ty re­view at the FDA; the heart fail­ure drug veri­ciguat, be­ing co-de­vel­oped with Mer­ck; or even BAY-342, the newest Phase III prod­uct for symp­toms of menopause that ar­rived via the buy­out of KaNDy Ther­a­peu­tics.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.

Northway Biotech's new manufacturing facility in Greater Boston

North­way Biotech sets up shop in Boston hub, look­ing to court more cus­tomers with bi­o­log­ics-fo­cused plant

Getting a foot in the door in Boston’s bustling biopharma hub is a rite of passage for many companies, but it comes with a steep price tag. Lithuanian CDMO Northway — now with a new moniker — will set up a new plant in close proximity, and it’s hoping its biologics focus will find a willing customer base.

Northway Biotech (formerly Northway Biotechpharma) on Wednesday held a virtual grand opening ceremony for its $40 million Waltham, MA facility — a 30,000 square-foot cGMP manufacturing and process development plant that will widely expand on the company’s previous capabilities.

News brief­ing: Five pub­lic biotechs, over 2 days, raise $883M from fresh of­fer­ings; Bel­gian biotech ex­pands Se­ries B fund­ing

The wave of biotech IPOs we’ve been seeing in the last few days underscores that the public markets remain one of the key channels for fresh investments in drug R&D. And that trend was in full view this week as a slate of biotechs nailed down hundreds of millions of dollars in fresh funds.

One of the big winners of the week is Editas $EDIT, which nailed $231 million to back its pioneering work on a gene editing platform. The biotech sold 3.5 million shares at $66 each.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,200+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.