Covid-19 manufacturing roundup: AstraZeneca struggling to make planned vaccine deliveries to EU; J&J outlines plans to provide 100M doses of Covid vaccine in US as Pfizer, Moderna promise speedier delivery

February 23, 2021 04:18 PM ESTUpdated February 25, 01:32 PM

Manufacturing

Covid-19 manufacturing roundup: AstraZeneca struggling to make planned vaccine deliveries to EU; J&J outlines plans to provide 100M doses of Covid vaccine in US as Pfizer, Moderna promise speedier delivery

John Carroll

Editor & Founder

Amber Tong

Senior Editor

Nicole DeFeudis

Associate Editor

As J&J neared FDA approval for its Covid-19 vaccine in the US, with plans to start shipping doses quickly, Novavax and AstraZeneca are hustling along right behind in an attempt to get into the game in North America. But AstraZeneca continues to roil the waters in Europe, where countries have been sorely disappointed over shortfalls in vaccine delivery.

That all got a little worse this week after Reuters reported that AstraZeneca told EU officials it would deliver less than half of the supply promised for Q2. That report was followed up quickly by AstraZeneca, which said it was pulling out the stops to get the full delivery in place. The EU has been stung by AstraZeneca’s reported shortfall during Q1, with less than half of the 90 million doses that were initially planned now expected.

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March 6, 2021 07:36 AM EST

Weekly

The top 100 biopharma VCs, Bob Bradway places $2B bet in cancer, gene editing pioneer's new big idea, and more

Amber Tong

Senior Editor

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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

March 4, 2021 08:51 AM ESTUpdated March 6, 12:47 PM

Deals

UPDATED: Amgen snaps up cancer drug player Five Prime, adding PhIII-ready FGFR2b drug in $2B M&A play

John Carroll

Editor & Founder

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

March 4, 2021 06:57 AM ESTUpdated March 5, 12:48 AM

Discovery

In Focus

David Liu has a new big idea: proteome editing. It could one day shred tau, RAS and some of the worst disease-causing proteins

Jason Mast

Editor

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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March 3, 2021 08:33 AM EST

Deals

The 2021 top 100 biopharma investors: As the pandemic hit and IPOs boomed, VCs swung into action like never before

John Carroll

Editor & Founder

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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March 4, 2021 08:27 AM EST

Cell/Gene Tx

Manufacturing

In the latest big investment in gene therapy manufacturing, Biogen commits $200M to a major new facility in NC

John Carroll

Editor & Founder

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

March 2, 2021 05:17 PM ESTUpdated 05:34 PM

Manufacturing

With stars aligned and cash in reserve, Bob Nelsen's Resilience plans a makeover at 2 new facility additions to its drug manufacturing upstart

John Carroll

Editor & Founder

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

March 5, 2021 03:12 PM ESTUpdated 03:36 PM

Deals

Jazz CEO Bruce Cozadd campaigned for 6 months to buy GW Pharma. A 90% premium sealed the deal — along with $17.6M in ‘retention’ incentives

John Carroll

Editor & Founder

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

March 5, 2021 10:03 AM ESTUpdated 12:58 PM

Financing

UPDATED: Not 3 weeks after taking Humacyte public, Rajiv Shukla launches another blank check company

Max Gelman

Associate Editor

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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March 5, 2021 09:26 AM ESTUpdated 49 minutes ago

Manufacturing

Covid vaccine roundup: US vaccine supplies grow, but experts warn of potential hiccups in supply chain; Emergent touts growing Covid vaccine capacity

John Carroll

Editor & Founder

The Biden administration has been raising hopes in the US that there will be ample vaccine supplies to inoculate more than 250 million American adults by May. There have been new deals with Moderna and Pfizer to ramp up 400 million doses, to cover 200 million, with 100 million single-shot vaccines from J&J top finish the job.

But some experts are sounding a warning that there could be a lot more to this than simply signing contracts. Vaccine manufacturing is not an easy business.