As­traZeneca R&D leader Pan­ga­los warns of a post-Brex­it UK re­search re­treat with­out re­im­burse­ment re­form

As­traZeneca’s in­flu­en­tial R&D leader Mene Pan­ga­los has blast­ed the UK gov­ern­ment’s drug watch­dog NICE for keep­ing the price of new drugs at low lev­els, say­ing that reg­u­la­tors are threat­en­ing the in­dus­try’s sub­stan­tial R&D pres­ence in the coun­try in a post-Brex­it world.

Mene Pan­ga­los

“To con­tin­ue to get the re­search and in­vest­ment here, you have to pay for the drugs,” Pan­ga­los told The Tele­graph in an in­ter­view. “Re­search and adop­tion of clin­i­cal in­no­va­tion go hand in hand and the Gov­ern­ment has to be pre­pared to pay for treat­ments that work.”

World-class aca­d­e­m­ic re­search in the UK’s Gold­en Tri­an­gle or Lon­don, Ox­ford and Cam­bridge com­bined with an at­trac­tive tax en­vi­ron­ment has played to the coun­try’s ad­van­tage so far, he adds, but Brex­it could change that equa­tion with­out a bet­ter ap­proach to re­im­burse­ment that rec­og­nizes the val­ue of new meds.

Added Pan­ga­los:

The UK is not a big enough mar­ket to be a pri­or­i­ty. As a drugs mar­ket it is more im­por­tant for us to launch in France, Ger­many and Swe­den than in the UK be­cause they adopt and pay for the drugs. The UK is a chal­lenge now but with­out the EU the UK will get left be­hind if it doesn’t start to change the way it re­im­burs­es drugs.

As­traZeneca $AZN has re­lied heav­i­ly on its pres­ence in the UK to weath­er a va­ri­ety of storms in re­cent years. CEO Pas­cal So­ri­ot raised the prospect of an R&D Ar­maged­don if Pfiz­er —  known for its will­ing­ness to pil­lage re­search as a way to pay for M&A — was al­lowed to fol­low through on its pro­posed takeover. And ear­ly on So­ri­ot hit hard on the com­pa­ny’s base in the UK with his com­mit­ment to build a half-bil­lion dol­lar HQ and re­search hub in Cam­bridge as he set out to re­or­ga­nize the com­pa­ny’s hap­less R&D op­er­a­tions four years ago.

He’s had mixed suc­cess on that score so far, gain­ing a cou­ple of sig­nif­i­cant ad­vances in on­col­o­gy with new drugs like Lyn­parza and Tagris­so. The phar­ma gi­ant al­so has a late-stage check­point in­hibitor in a slate of com­bi­na­tion stud­ies, though one pro­gram for head and neck can­cer was placed on a par­tial hold due to safe­ty fears. A string of oth­er set­backs have al­so tak­en a toll.

It’s not un­com­mon for drug com­pa­nies to ham­mer British reg­u­la­tors for the way NICE man­ages drug costs to their dis­ad­van­tage. But it is rare for a se­nior re­search ex­ec like Pan­ga­los to spear­head a di­rect as­sault like this by threat­en­ing the coun­try’s Achilles heel: hit­ting on re­search em­ploy­ment, which dis­tin­guish­es the coun­try from much of the rest of Eu­rope. That sig­nals their be­lief that the UK gov­ern­ment is feel­ing par­tic­u­lar­ly vul­ner­a­ble in the wake of the stun­ning Brex­it vote, and may fi­nal­ly be will­ing to do more to cater to Big Phar­ma now.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.