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

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

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

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.