How badly does Sanofi chief Paul Hudson want Principia? Enough to ink a $3.7B buyout deal, doubling down on MS

Sanofi CEO Paul Hudson

August 16, 2020 08:10 PM EDTUpdated 06:50 AM

How badly does Sanofi chief Paul Hudson want Principia? Enough to ink a $3.7B buyout deal, doubling down on MS

John Carroll

Editor & Founder

Sanofi CEO Paul Hudson has a home for a chunk of that Regeneron money sitting in the bank.

The pharma exec is shelling out $100 a share to take out Principia $PRNB — helmed by Martin Babler — and the MS drug that Hudson has been talking up for months as a breakthrough in the field. That’s a $3.7 billion deal.

Principia has a whole portfolio of BTK inhibitors in the pipeline, but it’s ‘168 that is the jewel in the crown for Hudson, a partnered drug which he is now doubling down on to help push the “ongoing R&D transformation” at Sanofi. Beyond MS the brain-penetrating drug has potential in other CNS diseases, offering a potential pipeline in a product.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

January 28, 2021 10:21 AM EST

Deals

Lilly attempts to revive an old idea for tackling pain, licensing PhI program from Japan’s Asahi Kasei Pharma

Max Gelman

Associate Editor

Eli Lilly is fronting some new cash in a space they’re quite familiar with.

The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.

Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.

Steve Harr (L) and Hans Bishop

January 28, 2021 10:07 AM EST

Financing

One of the most ambitious startup teams in biotech just outlined plans for a $400M IPO and a valuation of about $4B

John Carroll

Editor & Founder

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

January 28, 2021 08:26 AM ESTUpdated 09:14 AM

Deals

R&D

Top gene therapy deals, M&A pacts in 2020 highlight another big year in one of the hottest fields in biopharma

John Carroll

Editor & Founder

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

January 28, 2021 10:12 AM EST

Manufacturing

Thermo Fisher platform seeks to expedite donor cell cultivation for allogeneic cell therapies

Conner Mitchell

Associate Editor

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Dean Li, Merck

January 28, 2021 08:00 AM ESTUpdated 10:39 AM

Deals

Dean Li kicks off Merck's post-Roger Perlmutter era by teaming with Artiva and its off-the-shelf CAR-NK tech

Max Gelman

Associate Editor

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.

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.”

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 99,000+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Michael Kovac/Getty Images)

January 28, 2021 09:27 AM EST

R&D

ARCH announces largest fund yet, raising $1.85B to back mental health, cell and gene editing approaches

Jason Mast

Editor

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.