Agios pivots away from oncology, auctioning off cancer pipeline for $2B and shifting the spotlight in restructuring

Jackie Fouse, Agios

December 21, 2020 07:00 AM ESTUpdated 08:43 AM

Agios pivots away from oncology, auctioning off cancer pipeline for $2B and shifting the spotlight in restructuring

John Carroll

Editor & Founder

Agios made its name as a cancer drug developer under the legendary founder David Schenkein, who took the company from a famously blank sheet of paper to commercialization before he stepped aside a couple of years ago and handed the reins to Celgene vet Jackie Fouse. But now Fouse, who’s had to contend with some setbacks along the way, has a whole new future in mind.

And it doesn’t have anything to do with cancer.

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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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Amit Munshi, Arena

March 2, 2021 05:44 PM EST

R&D

One of Arena's top drugs flops in a PhIIb study for IBS pain. But researchers tease out a possible path forward as CEO explores 'strategic options'

John Carroll

Editor & Founder

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

March 2, 2021 09:20 AM ESTUpdated 09:42 AM

Deals

AbbVie tees up a biotech buyout after sizing up their Parkinson's drug spun out of Kevan Shokat's lab

John Carroll

Editor & Founder

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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March 1, 2021 05:22 PM ESTUpdated 12 hours ago

Pharma

Regulatory

UPDATED: Merck pulls Keytruda in SCLC after accelerated nod. Is the FDA getting tough on drugmakers that don't hit their marks?

Kyle Blankenship

Managing Editor

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

March 1, 2021 06:29 AM ESTUpdated 06:41 AM

Pharma

Pascal Soriot cashes in AstraZeneca’s chips on Moderna for $1.2B cash injection

Amber Tong

Senior Editor

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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March 2, 2021 09:45 AM EST

Coronavirus

Manufacturing

After bailing on Covid-19 vaccines, Merck will team up with J&J to produce its shot as part of unusual Big Pharma pact

Kyle Blankenship

Managing Editor

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Paul Sekhri

March 2, 2021 08:00 AM ESTUpdated 09:10 AM

Financing

R&D

The next big biotech superstar? Paul Sekhri has some thoughts on that

Jason Mast

Editor

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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David Chang, WuXi AppTec

March 2, 2021 07:30 AM EST

Deals

A 'love story': WuXi AppTec wraps UK-based CRO into its cell and gene therapy unit

Nicole DeFeudis

Associate Editor

When WuXi AppTec, one of China’s largest contract research organizations, started working with UK-based Oxgene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Oxgene, a roughly decade-old CRO focused on scalable gene therapy tech, began licensing some of their plasmid work to WuXi just over a year ago. And when that pilot went well, WuXi expressed interest in investing, Oxgene CEO Ryan Cawood said.

March 2, 2021 07:24 AM EST

Regulatory

FibroGen shares skid lower as a surprise adcomm raises risks on roxa OK

Amber Tong

Senior Editor

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.