In quick start to new year’s M&A, Arvelle Therapeutics hands reins to Angelini as it nears EU approval for cenobamate

Mark Altmeyer, Arvelle

January 4, 2021 08:32 AM ESTUpdated 09:10 AM

In quick start to new year's M&A, Arvelle Therapeutics hands reins to Angelini as it nears EU approval for cenobamate

Kyle Blankenship

Senior Editor

With a team of Axovant veterans leading the way, CNS startup Arvelle Therapeutics is nearing approval for licensed epilepsy med cenobamate in the EU after snagging an FDA approval in late 2019. Looking to take its first med to market, Arvelle has agreed to hand the reins to Italy’s Angelini Pharma in the first big biopharma buyout of 2021.

Angelini will pay $610 million post-approval with $350 million in sales milestones to acquire Switzerland’s Arvelle, a team helmed by three veterans from the Vivek Ramaswamy outfit that expects an EU nod for cenobamate this year, the companies said Monday.

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Data Literacy: The Foundation for Modern Trial Execution

Kristin Mauri

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

January 27, 2021 10:11 AM EST

R&D

Pfizer's big blockbuster Xeljanz flunks its post-marketing safety study, renewing harsh questions for JAK class

Jason Mast

Editor

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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January 27, 2021 07:02 AM ESTUpdated 11:05 AM

Coronavirus

Covid-19 roundup: EU and AstraZeneca trade blows over slowdowns; Unusual unions pop up to test antibodies, vaccines

Amber Tong

Senior Editor

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

January 25, 2021 04:54 PM ESTUpdated January 26, 07:11 PM

In Focus

After 3 deaths rock the field, gene therapy researchers contemplate AAV's future

Jason Mast

Editor

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

January 26, 2021 04:55 PM ESTUpdated 05:23 PM

R&D

Agios scores its second positive round of data for its lead pipeline drug — but that won't answer the stubborn questions that surround this program

John Carroll

Editor & Founder

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

January 26, 2021 07:35 AM ESTUpdated 07:48 AM

R&D

Coronavirus

Regeneron touts positive preliminary impact of its Covid antibody cocktail, preventing symptomatic infections in high-risk group

John Carroll

Editor & Founder

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Pascal Soriot, AP

January 27, 2021 09:21 AM EST

Bioregnum

AstraZeneca CEO Pascal Soriot severs an unusual board connection, steering clear of conflicts while retaining important alliances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Jim Tananbaum, Foresite

January 27, 2021 07:08 AM ESTUpdated 11:04 AM

Deals

Foresite returns to the SPAC well, as investors wonder how long the run can last

Jason Mast

Editor

Six months after launching his first biotech SPAC, Foresite’s Jim Tananbaum has started a second. On Tuesday, the longtime life science investor filed to raise $100 million by selling 10 million shares of the blank check company FS development II.

It’s a quick return to Wall Street for Foresite, although other firms have moved quicker. Perceptive Advisors raised a $130 million SPAC in June and were back before the end of July to raise another $125 million. By that point, the firm was evidently nearing a deal for the June SPAC, which would announce a half-billion-dollar merger with Cerevel Therapeutics on July 30.

January 27, 2021 04:02 AM EST

R&D

AI

AstraZeneca scores new goal on the pipeline front, adding its first AI-generated target to the portfolio

Max Gelman

Associate Editor

As more and more biopharmas develop artificial intelligence platforms, the drug discovery process is being reshaped to fit new goals on cutting down the prodigious amount of time, energy and money that go into a drug program. Now one of the most ambitious players in the drive to improve on ROI, AstraZeneca, is marking a milestone on that front by adding the first target generated by AI to its portfolio.