GE Healthcare to become standalone company after conglomerate completes 3-way split

 After years of speculation and false starts, General Electric is officially spinning off its healthcare business into an independent company.

GE Healthcare, already a clearly defined division under the GE umbrella, is slated to become a standalone public company in early 2023, after the completion of its tax-free spinoff from the nearly 130-year-old industrial giant. GE said it expects to retain a stake of just under 20% in the resulting company.

The healthcare company is set to be led by Peter Arduini, who was tapped earlier this year to take on the role of CEO and president of GE’s healthcare division at the start of 2022.

Alongside that split, GE will combine its renewable energy, power and digital divisions into a single business and then, in early 2024, conduct a second spinoff, releasing that energy-focused entity as another public company.

The remainder will become GE Aviation, led by the conglomerate’s current CEO, H. Lawrence Culp. Culp will also serve as non-executive chairman of the new GE Healthcare after it leaves the nest.

The shake-up is expected to set GE back by about $2 billion in one-time separation, transition and operational costs, plus tax fees of less than half a billion dollars, depending on the specifics of the transactions.

“By creating three industry-leading, global public companies, each can benefit from greater focus, tailored capital allocation and strategic flexibility to drive long-term growth and value for customers, investors and employees,” Culp said in a statement. “We are putting our technology expertise, leadership and global reach to work to better serve our customers.”

This isn’t the first time that GE has considered pushing its healthcare division out of the nest. It last announced plans to do so in June 2018, when the hypothetical spinoff company was valued at up to $70 billion. Though GE was said to have filed for a confidential IPO in December of that year, the divorce plans were dashed when the company opted instead to simply sell off its biopharma manufacturing business to Danaher in a $21.4 billion deal, which was relaunched as Cytiva.

Even as GE has found itself struggling to stay afloat and shedding many of its assets, GE Healthcare has remained relatively stable and focused on growth in recent years. On its own, the healthcare division comprised $18 billion of the entire company’s nearly $80 billion in total global revenue for 2020. Those earnings were driven largely by sales of respiratory devices and imaging and ultrasound machines.

GE Healthcare has continued to focus the bulk of its attention in those areas. In September, for example, it dropped almost $1.5 billion on BK Medical, which develops imaging support technology for use in the operating room. Prior to that, in May, the company scooped up France’s Zionexa and its molecular imaging agent, which was recently approved by the FDA to help diagnose breast cancer.

Those acquisitions build on GE’s homegrown efforts to expand its imaging portfolio. In back-to-back debuts earlier this year, it began rolling out first a new wireless ultrasound device that’s small enough to fit in a clinician’s pocket, then another point-of-care ultrasound, this one powered by artificial intelligence and specifically designed to be used in COVID-19 wards.

https://www.fiercebiotech.com/medtech/ge-healthcare-to-become-standalone-public-company-after-ge-completes-three-way-split

Takeda-backed Poseida puts off-the-shelf CAR-T in its basket, puts autologous therapy back on shelf

 The future of BCMA cell therapy is allogenic, it seems, as Poseida has decided to back away from work on its autologous candidate.

Autologous chimeric antigen receptor (CAR) T cells, i.e., ones derived from the patient, have no doubt helped changed the face of how we treat certain blood cancers, but a new wind is blowing and caused Poseida a casualty in its pipeline.

The biotech, just last month tapped by Takeda in a major $3.6 billion (largely backloaded biobucks) pact, said it is ditching work on its autologous P-BCMA-101 program in order to focus on its allogenic therapy, known as P-BCMA-ALLO, currently in phase 1 for multiple myeloma.

So-called “off-the-shelf” therapies—allogeneic CAR T cells from donors—often trump autologous approaches, because you can freeze samples and have them on demand, reducing time and costs. This shift has been happening across the industry, and it's now catching up with Poseida.

But there are considerable safety risks in this approach, namely life-threatening graft-versus-host disease, and they may also be rapidly eliminated by the host immune system. Reducing this risk will become the next big priority.

But the risk appears worth taking. In its third-quarter financials reported Tuesday evening, the San Diego biotech said: “The IND clearance [in August] and the start-up of the phase 1 clinical trial mark the beginning of the Company's strategic shift toward focusing on P-BCMA-ALLO1 rather than the autologous P-BCMA-101 program.

“While data in the autologous trial showed meaningful responses and a favorable safety profile, the company's strategic focus has long been on allogeneic CAR-T therapies, leveraging the learnings of the autologous CAR-T program to provide benefits beyond those of autologous CAR-T, including a more desirable off-the-shelf product profile for future commercialization while maintaining the tolerability advantage of our autologous product candidate.”

It added that P-BCMA-ALLO1 has the potential to deliver up to hundreds of doses per manufacturing run, “thereby dramatically reducing both clinical trial costs and ultimately commercial product cost compared to the autologous P-BCMA-101 program.”

https://www.fiercebiotech.com/biotech/takeda-backed-poseida-puts-off-shelf-car-t-its-basket-places-autologous-therapy-back-shelf

AstraZeneca, FibroGen hope to keep their roxadustat dream alive with new FDA meet

 After an FDA cold shoulder, FibroGen and partner AstraZeneca still aim to pave a way to market for anemia therapy roxadustat—even if it means conducting another clinical trial. The two companies are now betting the drug’s U.S. future on an upcoming meeting with the FDA.

FibroGen and AZ have scheduled a meeting with the FDA to discuss a potential path forward for roxadustat in anemia of chronic kidney disease, FibroGen CEO Enrique Conterno told investors on a conference call Tuesday.

“The question is really, how can we ensure that we can conduct a trial that meets the complete response letter for us to be able to have commercial access in the U.S. in anemia of CKD,” Conterno said. The company aims to run the trial “in an expeditious manner,” he added.

As the partners navigate that process, FibroGen has started cutting expenses to focus on roxadustat and pancreatic cancer candidate pamrevlumab. The California biotech plans to reduce its projected spending by about $100 million a year for the next three years, Conterno said. It will also remove about 100 U.S. positions, of which 30% are existing jobs.

In August, the FDA turned down roxadustat’s application in anemia for kidney disease patients following negative opinions from an external advisory committee and a rough FDA internal review. Previously, industry watchers thought roxa could become the first drug in the oral HIF-PHI class to reach the U.S. market. Analysts had pegged blockbuster expectations to roxa based on the notion that it could offer safety benefits over traditional erythropoietin therapies.

But the agency rejected roxa in both dialysis- and nondialysis-dependent patients after linking it with an increased risk of blood clots, serious infections, seizures and other metabolic and gastrointestinal side effects. Given the obvious defeat from roxa’s existing trials, a separate study seems inevitable if FibroGen and AZ still intend to pursue an FDA approval.

The most concerning safety signal flagged by the FDA centers on roxa’s heart safety profile, including an elevated risk of a composite marker of major adverse cardiovascular events. Both the FDA and FibroGen have hypothesized that the problem might stem from a fast hemoglobin overshoot seen with roxa. But as experts on the advisory committee pointed out in rejecting FibroGen’s proposal of a different dosing strategy, it’s only a theory without a clinical trial to back it up.

“That's something we're clearly going to explore with the FDA,” Mark Eisner, FibroGen’s chief medical officer, said of the dose adjustment plan during this week's call. FibroGen still intends to eventually get a label that covers both dialysis and nondialysis patients, he added.

Roxa has scored approvals in China, Japan and most recently Europe as Evrenzo. In the third quarter, roxa sales in China reached $57.8 million, FibroGen said.

After the FDA rebuff, analysts speculated that AZ might walk away from the partnership. But CEO Conterno said the AZ relationship is “healthy” as the two try to “have an aligned path forward.”

Whether AZ will keep its toe in roxa is likely dependent on the outcome of the FDA meeting, SVB Leerink analyst Geoffrey Porges wrote in a Wednesday note to investors. The size, duration and cost of the required trial or trials, the potential breadth of the drug's label and the estimated timing of an approval relative to competitors are possible determinants, Porges added.

GlaxoSmithKline’s daprodustat, approved in Japan under the brand Duvroq, seems to have the best profile in the HIF-PHI class. Detailed data unveiled last week showed that the GSK med matched up to erythropoiesis-stimulating agents in terms of heart safety in both dialysis and nondialysis patients. By contrast, Akebia Therapeutics’ vadadustat missed its MACE goal in the nondialysis population.

https://www.fiercepharma.com/marketing/astrazeneca-fibrogen-keep-roxadustat-s-anemia-dream-alive-new-fda-meeting

Moderna, U.S. clash in patent dispute over origins of COVID-19 vaccine

 The public/private partnership between the U.S. government and Moderna to quickly develop a COVID-19 vaccine has been lauded as a feel-good success story—and a blueprint for future health crises.

But less than a year after Moderna gained FDA authorization for its vaccine, its marriage with the feds is on the rocks. The company has done little appease the Biden administration’s call to make the vaccine available to poor countries, and now a much bigger battle over patent rights is brewing, The New York Times reports.

The issue surrounds a July filing by Moderna with the U.S. Patent and Trademark Office which claims that it invented the vaccine. Meanwhile, the NIH says that three of its scientists created key elements of the shot. 

The squabble has been ongoing for more than a year, the Times reports. The consumer rights advocacy group Public Citizen has helped bring the dispute from behind closed doors after reviewing patent documents. Without a resolution between the parties, the battle could be headed for court.

At the outset of the pandemic, the government provided funds to several companies—including $1.4 billion to Moderna—to develop COVID-19 vaccines. Assisting in the effort was the NIH and scientists from its Vaccine Research Center—John Mascola, M.D., Barney Graham, M.D., and Kizzmekia Corbett, M.D.

But in a patent document, Moderna claims that it has “reached the good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the present application.”

In the application, Moderna includes the names of several employees who are credited with the invention.

Of the four patents filed by Moderna and reviewed by Public Citizen, only one cites the contributions of the NIH. Public Citizen is urging the NIH to take up the cause of its scientists.

The advocacy group saw the patent fight coming. Last December, Peter Maybarduk, Access to Medicines Director at Public Citizen, dubbed it the “People’s vaccine.”

“It’s not merely Moderna’s vaccine,” Maybarduk told Forbes. “Federal scientists helped invent it and taxpayers are funding its development. We all have played a role. It should belong to humanity.”

Much is at stake in the patent fight. With rights to the vaccine, the government could license it to other companies to ensure broader access and recoup some of the funding it provided.

It is not the only patent battle in which Moderna is engaged. Last month, Bloomberg revealed that Moderna is seeking to invalidate two patents owned by Arbutus Biopharma. The move is a preemptive strike against the Pennsylvania company, which may be in position to sue Moderna for infringement of its drug-delivery technology, according to the news service.

The patent concerns come amid other troubles for Moderna. Last week, in reporting third quarter earnings, the company slashed its previous estimate of 2021 COVID-19 vaccine revenue from $20 billion to between $15 billion to $18 billion. The company said that international shipping delays have become more of a hinderance as Moderna tries to deliver the shot to more countries.

Over the last week, Moderna stock price has fallen by more than 30%.  

https://www.fiercepharma.com/pharma/moderna-u-s-clash-patent-dispute-over-development-covid-19-vaccine-report

Alcon Swung to 3Q Net Profit on Higher Sales

 Swiss eye-care company Alcon Inc. on Wednesday posted a swing to profit for the third quarter on higher sales.

The company said net profit was $2 million, up from a net loss of $147 million a year earlier, on sales that grew to $2.08 billion from $1.82 billion.

Operating income was $20 million, compared with an operating loss of $129 million a year earlier, Alcon said.

The company said that its Surgical and Vision Care franchises benefited from improvements in the eye-care market, among other factors, and that was led by continued strength in the U.S. Internationally, recovery from the pandemic took place at varied paces, according to Alcon.

https://www.marketscreener.com/quote/stock/ALCON-INC-56976364/news/Alcon-Swung-to-3Q-Net-Profit-on-Higher-Sales-36965235/

Yumanity Shares Drop After Results for Parkinson's Treatment Trial

 Yumanity Therapeutics Inc. shares fell 29% to $6.05 after the company reported that its lead product candidate, YTX-7739 achieved its primary endpoints in a Phase 1b clinical trial in patients with mild-to-moderate Parkinson's disease.

Yumanity said YTX-7739 was generally well tolerated, and results were consistent with earlier studies in healthy volunteers and preclinical models. YTX-7739 was shown to inhibit its primary target, stearoyl-CoA desaturase, an enzyme whose inhibition has been closely linked to neuronal survival and improved motor function in a Parkinson's disease model, the company said.

The company said that after 28 days of dosing there were no statistically significant differences in clinical assessments or most exploratory biomarkers. Quantitative electroencephalogram assessments of the effect of YTX-7739 on brain activity were completed in a subset of eight patients and demonstrated a statistically significant change compared to baseline, suggestive of a potential improvement in synaptic function.

The company said it expects to further validate the role of the diagnostic marker in future clinical studies.

https://www.marketscreener.com/quote/stock/YUMANITY-THERAPEUTICS-IN-117003859/news/Yumanity-Therapeutics-Shares-Drop-29-After-Results-for-Parkinson-s-Treatment-Trial-36974156/

Laffer warns of developing inflation pattern similar to '70s

 Former Reagan Economist Art Laffer warns of similarities between today's current inflation surge and patterns seen in the 1970s, arguing "it doesn't look good" for the Biden administration.

ART LAFFER: I don't know what this administration is doing to tame it [inflation]. Whatever they do is way beyond my ken, just for the record. But what you're seeing here in these prices - and let me say, if I can, a wholesale prices, producer prices index tends to be highly volatile over the years and only when we're coming into serious periods of inflation, long-term inflation, does the consumer price index tend to go along with a wholesale price index or the producer price index. That is exactly what you're seeing right here. 

This is the type of pattern that we saw in the 1970s, up until about 1981-82. That's the pattern. Since then, we have not had that pattern develop at all. Interest rates have been low. Inflation has been low. All of that, that appears to be changing dramatically. The consumer price index is following the producer price index way up. And both of those are very bad signs for inflation going forward. And I don't think Janet Yellen knows what to do. I don't think she can do anything. I think she'll try to do something very dramatic, but it doesn't look good for this administration on inflation. 

WATCH THE FULL INTERVIEW BELOW:

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Art Laffer on surging inflation: Fed does not have an answer

Former Reagan Economist Art Laffer discusses the administration's handling of inflation, Biden's Build Back Better agenda, unemployment in the U.S. and the ongoing economic recovery.

https://www.foxbusiness.com/economy/laffer-warns-of-developing-inflation-pattern-similar-to-the-1970s-it-doesnt-look-good-for-biden-he-says