Af­ter build­ing ex­pec­ta­tions, the UK’s life sci­ences plan falls short of the hype

Mer­ck’s re­cent an­nounce­ment of a new re­search cen­ter in Lon­don like­ly whet­ted the UK life sci­ences sec­tor’s ap­petite for even big­ger news from the gov­ern­ment’s new in­dus­try plan, out to­day. But de­spite a con­sid­er­able amount of loy­al cheer­ing about post-Brex­it prepa­ra­tions, it doesn’t amount to near­ly enough to tip the eco­nom­ic scales in bio­phar­ma’s fa­vor.

And to be fair, what kind of of­fi­cial eco­nom­ic de­vel­op­ment plan, salt­ed with cor­po­rate projects, can do that, any­way?

Af­ter hear­ing some heat­ed ru­mors of a ma­jor fund com­ing in on a bil­lion-dol­lar biotech start­up plan, the gov­ern­ment’s out­line in­cludes a com­mit­ment from Ap­ple Tree Part­ners to launch a new com­pa­ny. Good news from an ac­tive firm with $1.6 bil­lion un­der man­age­ment, but not earth shak­ing. There is a round of com­mit­ments from the big lo­cal play­ers — GSK and As­traZeneca — to back the lo­cal play­ers. GSK has al­so come up with a £40 mil­lion com­mit­ment to ex­pand se­quenc­ing plans at the UK Biobank from the 50,000 an­nounced ear­li­er in the year to 500,000.

That won’t hurt.

Pas­cal So­ri­ot

As­traZeneca is al­ready do­ing its bit with a ma­jor in­vest­ment in a new re­search cen­ter and head­quar­ters in Cam­bridge, an­nounced soon af­ter Pas­cal So­ri­ot took the helm. And the UK gov­ern­ment hap­pi­ly threw that in­to the pot, with­out men­tion­ing how far be­hind sched­ule it is, along with every oth­er up­beat an­nounce­ment made in the field in the last few years.

J&J and Ox­ford will col­lab­o­rate on new clin­i­cal tri­al plat­form mod­els, look­ing to si­mul­ta­ne­ous­ly study var­i­ous neu­ro­science drugs. That’s in­trigu­ing, pos­si­bly point­ing to de­vel­op­ment mod­els that may well at­tract var­i­ous bio­phar­ma com­pa­nies look­ing for a more ef­fi­cient way to study high-risk pro­grams. I’ll be cu­ri­ous to see how that may in­flu­ence sim­i­lar ef­forts around the world.

But the gov­ern­ment plan — which in­cludes added fi­nan­cial sup­port from tax­pay­ers — falls short of the high ex­pec­ta­tions cre­at­ed in re­cent weeks. State, fed­er­al and lo­cal plans in the US of­ten start with the same hoopla, and al­so pre­fer to claim every shred of pos­i­tive news as ev­i­dence of its cer­tain suc­cess while leav­ing out any hard re­al­i­ties.

It’s tax poli­cies and reg­u­la­to­ry re­spon­sive­ness, though, that lay the ground­work for life sci­ences growth — the rest is up to the com­pa­nies and the en­tre­pre­neurs.

The UK has a lot go­ing for it, with two ma­jor phar­ma com­pa­nies, a world-class sci­en­tif­ic com­mu­ni­ty based in stel­lar in­sti­tu­tions and a small but en­thu­si­as­tic biotech group still in need of more fi­nan­cial sup­port from pri­vate in­vestors skilled at com­pa­ny cre­ation and tal­ent build­ing.

They’ll all be get­ting some ad­di­tion­al help, but all the hard work re­mains. So ac­tu­al­ly not much has changed.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

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The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better,

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

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Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

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In a paper published in the Lancet, the biotech reported that their adenovirus-based vaccine was “tolerable and immunogenic at 28 days post-vaccination” among the 195 volunteers enrolled in the trial. In addition to antibody responses, T cell responses were also observed.

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Julie Grant, Day One CEO

A new biotech from a long­time de­vel­op­er wants to bring the tar­get­ed can­cer rev­o­lu­tion to the kids left be­hind

Daphne Haas-Kogan was treating and studying children’s brain tumors at the University of California San-Francisco, when she got a call that shook her. The pharma company whose drug she had been prepping for a trial had decided, despite all preclinical evidence, to not run any trials on kids, only adults. Haas-Kogan’s patients would not get the therapy.

“Ultimately the company had to make a decision for what trials they would support,” Haas-Kogan said. “I can still recall my blood pressure rising as I found out.”

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