Flexion secures China deal for osteoarthritis drug; Struggling to find a buyer, Akorn throws in the towel

April 1, 2020 10:53 AM EDTUpdated 01:01 PM

Flexion secures China deal for osteoarthritis drug; Struggling to find a buyer, Akorn throws in the towel

Amber Tong

Senior Editor

→ Flexion may be hitting the brakes on clinical trials, including one for its osteoarthritis drug Zilretta, but that’s not stopping the biotech from plotting regulatory action in China. Hong Kong Tainuo has committed $10 million upfront to seize the development and commercialization rights to Zilretta, with plans to apply for a clinical trial in China by the end of the year. Flexion, which said it has 10 months of finished goods in the US and 12 months of active pharmaceutical ingredient available, will supply all products to the Chinese partner.

→ Struggling specialty generic maker Akorn has given up on finding a buyer, ending a sale process that it said was negatively impacted by the broader market uncertainties under the Covid-19 crisis. There are no bids on the table that would sufficiently pay off all its loans, the company said.

AUTHOR

Amber Tong

Senior Editor

amber@endpointsnews.com @AmberTongPW

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ZS Perspective: 3 Predictions on the Future of Cell & Gene Therapies

Ben Hohn

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

January 15, 2022 06:00 AM ESTUpdated 21 hours ago

Weekly

Latest news on Pfizer's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the numbers; Biogen's Aduhelm reckoning; The story of sotrovimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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January 14, 2022 04:29 PM ESTUpdated January 14, 07:04 PM

Pharma

FDA+

A $3B+ peak sales win? Pfizer thinks so, as FDA offers a tardy green light to its JAK1 drug abrocitinib

John Carroll

Editor & Founder

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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ENDPOINTS CAREERS

Director/Group Head of Platform Biology

Siduma Therapeutics, Inc.

New Haven, CT, USA

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

January 14, 2022 06:47 AM EST

FDA+

Rob Califf advances as Biden's FDA nominee, with a close committee vote

Zachary Brennan

Senior Editor

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

January 13, 2022 10:07 AM EST

Pharma

Biogen vows to fight CMS' draft coverage decision for Aduhelm before April finalization

Zachary Brennan

Senior Editor

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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January 13, 2022 07:02 AM EST

Outsourcing

FDA+

CRO owner pleads guilty to obstructing FDA investigation into falsified clinical trial data

Zachary Brennan

Senior Editor

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

January 13, 2022 06:56 AM ESTUpdated 10:56 AM

R&D

Cancer powerhouse AstraZeneca rolls the dice on a $75M cash bet on a buzzy upstart in the oncology field

John Carroll

Editor & Founder

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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Director-Regulatory

Icosavax, Inc.

Seattle, WA, USA

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January 12, 2022 10:25 AM EST

Pharma

‘Skinny labels’ on generics can save patients money, research shows, but recent court decisions cloud future

Zachary Brennan

Senior Editor

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

January 12, 2022 05:10 AM ESTUpdated 08:12 AM

Coronavirus

In Focus

How a tiny Swiss lab and two old blood samples created one of the only effective drugs against Omicron (and why we have so little of it)

Jason Mast

Editor

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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