Pharma group bets up to $1B-plus on the PhIII resurrection of a once dead-and-buried LDL drug

Lina Gugucheva, NewAmsterdam Pharma CBO

June 28, 2022 08:00 AM EDT

Pharma group bets up to $1B-plus on the PhIII resurrection of a once dead-and-buried LDL drug

John Carroll

Editor & Founder

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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Innovative MedTech Demands Specialist Clinical Trial Regulatory Affairs and Design

Tom Avery

Scientific and Medical Affairs Specialist, Medical Devices

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Ted Love, Global Blood Therapeutics CEO

August 8, 2022 07:34 AM EDTUpdated 11:57 AM

Deals

Updated: Pfizer scoops up Global Blood Therapeutics and its sickle cell therapies for $5.4B

Amber Tong

Senior Editor

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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August 8, 2022 07:54 PM EDT

R&D

BREAKING: Mathai Mammen makes an abrupt exit as head of the big R&D group at J&J

John Carroll

Editor & Founder

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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ENDPOINTS CAREERS

Chief Scientific Officer

Experimental Drug Development Centre

Singapore

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August 8, 2022 07:46 PM EDT

Pharma

Novavax shares shredded as Covid vaccine sales fall more than 90% in Q2

Nicole DeFeudis

Editor

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

August 5, 2022 12:02 PM EDTUpdated 12:55 PM

Deals

Breaking: Pfizer in hot pursuit of a $5B buyout of Global Blood Therapeutics — report

John Carroll

Editor & Founder

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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Anna Protopapas, Mersana CEO

August 8, 2022 04:02 PM EDTUpdated 04:14 PM

Deals

Pharma

In $1.36B biobuck deal with GSK, Mersana touts 'biggest preclinical ADC deal ever'

Kyle LaHucik

Associate Editor

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

August 8, 2022 02:58 PM EDT

Pharma

Despite falling Covid-19 sales, BioNTech maintains '22 sales guidance

Paul Schloesser

Associate Editor

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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ENDPOINTS CAREERS

Senior Project Manager

CAI

Boston, MA, USA

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

August 8, 2022 02:15 PM EDT

FDA+

Law

With drug pricing almost done, Congress looks to wrap up FDA user fee legislation

Zachary Brennan

Senior Editor

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

August 8, 2022 01:58 PM EDTUpdated 2 hours ago

Pharma

FDA+

AstraZeneca and Daiichi Sankyo sprint to market after FDA clears Enhertu in just two weeks

Nicole DeFeudis

Editor

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.