Costs ris­ing, As­traZeneca switch­es con­trac­tors and once again de­lays sched­uled com­ple­tion of its trou­bled $650M-plus HQ project

De­sign of As­traZeneca’s Cam­bridge Bio­med­ical Cam­pus

Click on the im­age to see the full-sized ver­sion

Those ru­mors about big trou­ble for As­traZeneca’s $650 mil­lion (plus) HQ project proved to be en­tire­ly ac­cu­rate. To­day a spokesper­son for the phar­ma gi­ant tells me that they are switch­ing build­ing con­trac­tors and once again sig­nif­i­cant­ly de­lay­ing a planned move-in at the Cam­bridge, UK site. And the price tag for com­ple­tion is head­ed high­er.

Their state­ment in re­sponse to a query:

Yes, as the sci­en­tif­ic fit-out and com­mis­sion­ing phase of the build­ing takes shape, we are tran­si­tion­ing from Skan­s­ka to a com­pa­ny called Mace which has ex­per­tise in this next phase. As we be­gin this sci­en­tif­ic fit-out we will have more up­dates but, as of now, we’re look­ing at oc­cu­pa­tion in first half of 2020.

The pun­ish­ing set­back came af­ter a UK trade pub cit­ed Skan­s­ka’s trou­ble in get­ting the sprawl­ing head­quar­ters site com­plete — a full 5 years af­ter it was be­gun. The project — in­tend­ed to rep­re­sent As­traZeneca’s bold em­brace of new tech and its com­mit­ment to the UK’s bio­phar­ma hub — has be­come an ex­pen­sive al­ba­tross around CEO Pas­cal So­ri­ot’s neck as he push­es to turn around the com­pa­ny.

Orig­i­nal­ly the project was to be com­plet­ed in 2016, then 2017 and most re­cent­ly in the spring of 2019 as As­traZeneca in­tend­ed a stag­gered oc­cu­pa­tion for the lo­cal R&D work force, which has swelled in an­tic­i­pa­tion of the rib­bon-cut­ting cer­e­mo­ny. This new set of con­struc­tion goals will push the move-in to a full 7 years af­ter con­struc­tion was green-light­ed at As­traZeneca.

As the work slowed, it al­so be­came sig­nif­i­cant­ly more ex­pen­sive. Orig­i­nal­ly slat­ed to cost about $430 mil­lion, the com­pa­ny had to add $220 mil­lion more. Now it’s head­ed even high­er.

As­traZeneca de­clined to say what the new price tag on the build­ing is, but con­ced­ed that the es­ti­mate has now pushed past the $650 mil­lion mark.

(W)hat we can say is that our over­all in­vest­ment in our Cam­bridge HQ project will be high­er than ini­tial­ly com­mu­ni­cat­ed, now at over £500m. The in­creased in­vest­ment re­flects our com­mit­ment to Cam­bridge and the UK sci­ence-base, in par­tic­u­lar:

  • We have ac­cel­er­at­ed our tran­si­tion to the Cam­bridge area ahead of build­ing com­ple­tion and over 2,600 of our staff are al­ready here.
  • Part of our in­vest­ment in the new site is more state of the art equip­ment and tech­nolo­gies and we are in­vest­ing heav­i­ly in this space.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

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This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
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What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

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The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

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