BioReg­num: An­oth­er great rea­son emerges for As­traZeneca to tar­get new biotech deals

Bioreg­num
The view from End­points

The pres­sure on As­traZeneca CEO Pas­cal So­ri­ot to get its glob­al R&D op­er­a­tion to per­form while ex­e­cut­ing new deals just soared. The phar­ma gi­ant has lost a bid to keep cheap gener­ic ver­sions of Crestor off the mar­ket. That drug earned some $5 bil­lion of the $23 bil­lion it made last year.

To put this in­to a per­spec­tive that must be in­creas­ing­ly un­com­fort­able at the phar­ma gi­ant, As­traZeneca will soon have a new, block­buster-sized hole to fill as in­vestors con­tin­ue to in­sist that the com­pa­ny keep its promise to hit $45 bil­lion in sales in just sev­en more years.

It’s no won­der that As­traZeneca has been ru­mored to be lurk­ing near the bar­gain­ing ta­ble for the Medi­va­tion buy­out. An es­tab­lished drug plus a promis­ing late-stage PARP in­hibitor could be just what the doc­tor or­dered. And if an­oth­er com­pa­ny like Sanofi wins the bid­ding war, As­traZeneca is go­ing to be forced to find oth­er drugs to help with its am­bi­tious mis­sion.

The com­pa­ny’s lawyers had kept peo­ple guess­ing about the out­come un­til late yes­ter­day, when a fed­er­al judge ruled against As­traZeneca’s bid to use a re­cent ap­proval to use a high dose of the drug for rare cas­es of ho­mozy­gous fa­mil­ial hy­per­c­ho­les­terolemia in chil­dren. The lawyers tried to ar­gue that FDA la­bel­ing rules on pe­di­atric drugs should keep the gener­ic off the ta­ble.

The judge, though, wasn’t in­ter­est­ed in pro­tect­ing the mega-fran­chise at the pub­lic’s ex­pense and re­ject­ed the re­quest for a tem­po­rary re­strain­ing or­der. Sen­a­tors Su­san Collins and Claire Mc­Caskill weren’t amused, ei­ther. They not­ed in a let­ter to So­ri­ot that the ap­proval they based their chal­lenge on rest­ed on 300 pa­tients, rais­ing con­cerns about the mil­lions who would ben­e­fit from a cheap copy­cat.

Cut off from the le­gal gam­bit, So­ri­ot will be forced to fo­cus on deals, as it’s un­like­ly the pipeline will get him to where he needs to be.

As­traZeneca—the world’s 7th largest drug de­vel­op­er by R&D bud­get—won big with its re­cent ap­proval for Tagris­so. But with its check­point in­hibitor rel­e­gat­ed to a late fourth-place fin­ish, it will need a lot of help to come even close to the fin­ish line it set for it­self as Pfiz­er looked to buy the com­pa­ny.

Any biotech com­pa­ny that sees them com­ing won’t over­look that sim­ple fact. As­traZeneca will need to pay a pre­mi­um for sheer need­i­ness.

In the mean­time, As­traZeneca may al­so feel pres­sure to shed more R&D jobs. The com­pa­ny con­firmed last week that it was cut­ting back at Med­Im­mune, even as it fo­cused more on im­muno-on­col­o­gy. Now comes con­fir­ma­tion of some small but note­wor­thy cut­backs in Boston as well.

Any­one not work­ing on a pri­or­i­ty project—par­tic­u­lar­ly in can­cer—may be feel­ing par­tic­u­lar­ly vul­ner­a­ble right now. – John Car­roll, fol­low me @John­Cendpts

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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