With a make-or-break PhIII readout looming, a struggling Concert offloads a 'portfolio' of drugs – Endpoints News

A one-time high-flying biotech which once had big plans for its platform tech is jettisoning a “portfolio” of pipeline drugs as it hunkers down for a make-or-break attempt to compete with two pharma giants in what looks to be an intensely competitive alopecia field.
In a brief statement out on Friday, a tiny outfit called Terran Biosciences put out word that it has snapped up a group of CNS drugs from Concert Pharmaceuticals, which axed its mid-stage schizophrenia drug a little more than a year ago after a crushing Phase II failure. There’s no word on which drugs are involved and not a peep about the dollars involved.
Pursuing a goal to become “an industry leader in neuropsychiatry,” little Terran noted:
These deuterated compounds represent next-generation therapeutics with applications across several different psychiatric and neurological conditions.
Not much is known about Terran, with little more than a title page online and a press release that talks about its late-stage work on drugs, including psychedelics, which have been gaining favor in the last couple of years.
Concert’s stock price $CNCE has been sliding steadily downward for the past 3 years, losing 90% of its value since an early 2018 peak and leaving the biotech staring down a Q2 deadline for reading out its first Phase III data for the alopecia areata drug CTP-543. A second Phase III is in the works to unveil in Q3, as Concert waits to see if it can compete with two of the most commercially powerful operations in Big Pharma.
For analysts cheerleading the company, failure here is not a pleasant option. Mizuho’s Vamil Divan recently noted hopefully:
Should CTP-543 deliver Phase III efficacy and safety close to what it did in Phase II, we believe there will be significant patient and physician interest in the product, even with competing JAK inhibitors from Lilly and Pfizer likely also entering that market.
For now, Concert’s team under CEO Roger Tung usually gets only side notes about their chances in treating an autoimmune condition that causes severe hair loss. Pfizer’s JAK inhibitor ritlecitinib performed well against placebo, setting up a showdown with Eli Lilly and Incyte, which have produced their own positive data on baricitinib. The JAKs, though, have their own set of safety issues to contend with.
Concert’s CTP-543 does have boasting rights to a breakthrough therapy designation, but they also have an ongoing patent dispute in the works with Incyte, which Divan says could trigger a deal requiring the smaller biotech to pay royalties.
Right now, all of Concert’s eggs are in one basket, with a market cap of $97 million that would constitute a rounding error at either Pfizer or Eli Lilly.
One of Sanofi’s top late-stage prospects has failed its first major test in breast cancer, dimming blockbuster hopes even as the French drugmaker doubles down on oncology.
Sanofi had touted amcenestrant as a “potentially transformative” product. In the AMEERA-3 trial, though, it did not meet the primary endpoint of improving progression-free survival over endocrine treatment of physician’s choice.
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A new seven-figure ad campaign takes aim – again – at Medicare’s pending coverage decision on Alzheimer’s disease anti-amyloid drugs.
UsAgainstAlzheimer’s launched the $1 million-plus national effort Sunday, including a TV ad that ran across the the day’s morning talk news shows. The group is the latest to push back on the Centers for Medicare and Medicaid Services’ proposed decision to only cover Biogen and Eisais’s Aduhelm and other potential anti-beta amyloid drugs for patients in clinical trials. CMS’ final decision is set for release on April 11.
Four companies that allegedly helped fuel the opioid epidemic recently agreed to pay about $26 billion to settle thousands of related lawsuits, but they also may use certain tax benefits for their settlement expenses, House Oversight Committee Chair Carolyn Maloney and colleagues recently wrote to Attorney General Merrick Garland and Treasury Secretary Janet Yellen.
Last March, the Oversight leaders questioned the companies — Cardinal Health, McKesson, AmerisourceBergen, and Johnson & Johnson — on reported plans to use a tax provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act to increase deductions for settlement costs related to their role in fueling the US opioid crisis.
Following the Federal Trade Commission’s decision last month to not investigate pharma middlemen, or pharmacy benefit managers, Iowa Republican Sen. Chuck Grassley sent a letter last week to FTC chair Lina Khan, urging the commission to find common ground and closely examine how the PBM industry affects patients’ out-of-pocket expenses.
The call from Grassley comes as Khan urged her fellow commissioners to advance a “long overdue” inquiry into PBMs, as the commission has “a real moral imperative to act.” PBMs have long been critiqued as driving up patients’ expenses at the pharmacy counter, and for using tactics to drive people away from community pharmacies to their chain pharmacies.
BridgeBio Pharma was in need of some good news. It got some from its Phase II trial of a drug for limb-girdle muscular dystrophy type 2i, and will now talk to drug regulators to talk about potential paths to approval.
The biopharma is presenting the results at this week’s Muscular Dystrophy Association Annual Meeting in Nashville. BridgeBio believes that the results show that BBP-418, also known as ribitol, can increase glycosylation of αDG and drive functional improvements and reduce CK, which is a key marker of muscle breakdown. It’s big news for a disease in which there are no approved treatment options.
Nektar could not hold up to Bristol Myers’ blockbuster Opdivo in a Phase III melanoma study, as the combo therapy went 0-for-3 on major markers, leading the CEO to suggest layoffs could be on the way.
The pair had been aiming to combine Opdivo with Nektar’s experimental drug ​​bempegaldesleukin, or bempeg for short, in metastatic melanoma. It’s an indication that made the PD-(L)1 class famous, as it was where Opdivo and rival Keytruda were first evaluated and nabbed their initial approvals before each becoming megablockbusters.
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Merck’s new Covid-19 pill molnupiravir barely cleared an FDA advisory committee vote (13-10) on the way to its EUA.
And although the FDA and NIH said that the Ridgeback-partnered pill should only be used as a last resort due to concerns with its mechanism of action, the Wall Street Journal reported Monday that more than 74,700 prescriptions for the Merck-Ridgeback pill were filled through Feb. 25, according to IQVIA, while there were more than 79,150 prescriptions filled for the more effective Paxlovid.
AstraZeneca will have to sit outside the ring of a hotly contested respiratory fight for now.
Despite what the pharma giant described as positive Phase III data, the FDA has rejected its sBLA for Fasenra in patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The complete response letter “requested additional clinical data,” according to AstraZeneca.
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When MorphoSys swooped in with a $1.7 billion deal to buy Constellation Pharmaceuticals last year, then CEO Jigar Raythatha paid tribute to the nearly 200 staffers who had been working on everything from discovery through late-stage work. Today, though, the German company said the only thing it wants to keep in the deal is in the clinic, and it’s exporting that work to Europe after shuttering everything else.
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