Search This Blog

Thursday, October 20, 2022

Talaris reports patient death in Phase 3 trial

  Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today announced a status update on its Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients.

On October 18, 2022, the Company received a report of a patient death, which triggered a pre-specified, temporary stopping requirement and review by the FREEDOM-1 Data Monitoring Committee (DMC). After their review of this case, the DMC determined that trial enrollment and dosing may continue. The Company has reported this event and the DMC’s recommendation to the U.S. Food and Drug Administration (FDA).

https://finance.yahoo.com/news/talaris-therapeutics-provides-freedom-1-110000768.html

Aum Biosciences to Become a Public Company via Merger with Mountain Crest Acquisition

 

  • The transaction reflects a pre-money equity value of $400 million for AUM Biosciences

  • Transaction is expected to provide $69 million of gross proceeds (assuming no redemptions by Mountain Crest stockholders)

  • Broad pipeline of drug candidates across multiple oncology programs; two lead clinical-stage candidates addressing a combined market opportunity of $10+ billion in metastatic colorectal cancer, and TRK Fusion and mutation cancers

  • Mr. Vishal Doshi will continue to lead as the CEO of the publicly traded holding entity; a Mountain Crest representative will join the Board of Directors

  • Company to expand US operations and clinical programs

Irish & UK Families Spend A Third Of Their Income On Childcare

 The UK and Ireland have some of the highest childcare costs in the developed world.

As Statista's Anna Fleck details below, according to data from the OECD, the average working couple in Ireland and the UK spends about a third of their income on childminders and nurseries.

That’s around three times as much as parents in Luxembourg, Spain and Norway.

Infographic: UK Families Spend A Third Of Their Income On Childcare | Statista

You will find more infographics at Statista

Childcare costs in Cyprus and the Czech Republic are also steep, with families forced to spend on average at least 31 and 29 percent of their income respectively on full-time care for their children.

In the United States, costs are slightly lower (around a fifth of a couple’s wages).

It’s worth noting however, that in countries where benefit rules are not decided on a national level but rather by region or municipality, analysts have sourced data that refers to a “typical” case, for example in the capital.

This chart is based on the data of 40 year old couples that are earning an average, full-time wage, with two children aged 2 and 3.

It takes into consideration wages after childcare benefits have been deducted - whether those are childcare allowances, tax concessions, fee rebates and increases in other benefit entitlements.

As wages stagnate and the cost of living increases, the high prices of childcare are putting families under increased financial pressure.

https://www.zerohedge.com/personal-finance/irish-uk-families-spend-third-their-income-childcare

AlzeCure Presents New Data with Preventive Treatment Alzstatin at Alzheimer Conference

 AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) AlzeCure Pharma AB (publ) (FN STO:ALZCUR), a pharmaceutical company that develops a broad portfolio of small molecule drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer's disease and pain, today announced that an abstract with new preclinical Alzstatin data has been accepted for presentation at the annual Alzheimer conference CTAD, Clinical Trials in Alzheimer's Disease, which this year is being held in San Francisco on November 29 - December 2.

The abstract, titled AC-0027875, a novel gamma-secretase modulator for the treatment of Alzheimer's disease, will be presented at the international Alzheimer conference CTAD 2022 by Dr. Johan Sandin, CSO at AlzeCure. The other co-authors are Dr. Märta Dahlström, Dr. Maria Backlund, Veronica Lidell, Azita Rasti, Sanja Juric, Dr. Magnus Halldin, Director of Discovery DMPK & Safety assessment at AlzeCure, Dr. Pontus Forsell, Head of Discovery & Research at AlzeCure, and Dr. Gunnar Nordvall, Director of Medicinal Chemistry at AlzeCure.

The presentation includes new preclinical results with AlzeCure's compound AC-0027875, which is a new potent small molecule gamma-secretase modulator (GSM) and part of AlzeCure's research platform Alzstatin®. The substance exhibits potent effects on the production of toxic Aβ42 and reduces levels by over 50% in vivo. GSM's represents a promising class of Aβ42-lowering anti-amyloidogenic substances for the treatment of Alzheimer's disease. It exhibits several key properties that makes it suitable as a preventive or disease-modifying treatment for Alzheimer's disease.

"AC-0027875 rapidly reaches the brain in relevant concentrations and greatly reduces the amount of toxic Aβ42. The mechanism of Alzstatin lends itself particularly well to early, preventive treatment, and these promising data demonstrate the potent effects of our substances," said Johan Sandin, CSO at AlzeCure Pharma.

"The goal of Alzstatin is to be able to offer a preventive and disease-modifying treatment against Alzheimer's in tablet form, and with these new data and the increased interest in the field, I look positively on the continued development work and outlicensing discussions," said Martin Jönsson, CEO of AlzeCure Pharma.

The abstract and poster will be available on AlzeCure's website after the presentation (https://www.alzecurepharma.se/en/presentations-and-interviews/).

https://www.biospace.com/article/releases/alzecure-presents-new-data-with-its-preventive-treatment-alzstatin-at-the-alzheimer-conference-ctad/

Prime Medicine Announces Pricing of Upsized IPO

 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the pricing of its upsized initial public offering of 10,294,118 shares of its common stock at a price to the public of $17.00 per share. All of the shares are being offered by Prime Medicine. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Prime Medicine, are expected to be $175.0 million. In addition, the underwriters have a 30-day option to purchase up to 1,544,117 additional shares of common stock at the initial public offering price less underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Market on October 20, 2022 under the ticker symbol “PRME.” The offering is expected to close on October 24, 2022, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Goldman Sachs & Co. LLC, Morgan Stanley and Jefferies are acting as joint book-running managers for the offering.

https://www.businesswire.com/news/home/20221019006202/en/Prime-Medicine-Announces-Pricing-of-Upsized-Initial-Public-Offering

Shifting coverage for COVID-19 tests, treatments to commercial insurers will be complex

 Finding a way to protect the uninsured and creating incentives for the private sector to continue producing cutting-edge treatments, vaccines and tests—that ideally would find limited use—comprise two of the challenges facing the U.S. in the near future.

Speaking at a Health Wonk Shop webinar hosted by the Kaiser Family Foundation titled “The Commercialization of COVID,” Dawn O’Connell, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services (HHS), said the transition will be a complicated one.

The tests, treatments and vaccines will move to the private sector on different timelines, depending on regulatory status. For instance, “Medicare and Medicaid cover things differently if they’re approved versus whether they’re under emergency use authorization,” O’Connell said.

Joining O’Connell in the discussion were Jen Kates, KFF’s senior vice president and director of global health and HIV policy, and Rena Conti, an assistant professor in the department of markets, public policy and law at Boston University. Larry Levitt, KFF’s executive vice president for health policy, hosted the discussion.

Guaranteeing there will be a market for what the private industry produces to counter future pathogenic threats will be critical, said Levitt.

“The government was essentially guaranteeing a market for tests, for treatments, for vaccines,” Levitt said. “We need to think about making sure that those countermeasures are available in a timely way and in adequate supply.”

Kates agreed, saying that “innovators really do need to understand that there is a market for their products. And even if we see this pandemic kind of receding into the background for ourselves, that doesn’t mean that there isn’t worldwide demand for both preventives and also therapeutics. But also, there will be another pandemic. Making sure that there’s a robust investment by the private sector in such medical countermeasures is critical to moving forward.”

Conti said that those with public or private insurance will still have access to free vaccines for COVID-19 after the government stops giving them out. “There is a supply issue … if manufacturers aren’t making enough. But at least from a coverage perspective, vaccines should be mostly taken care of.”

Uninsured children will have coverage under the Vaccines for Children Program, but, “if you’re an uninsured adult, you’re kind of out of luck.”

Tests and treatments will be a different story, said Conti. “A lot of people are going to face cost sharing. If you have public or private insurance, you’ll still get them but there will likely be cost sharing in your future. And in some cases, you might not even get coverage for it even if you have insurance. Some insurers probably won’t cover it and don’t have to.”

O’Connell said that the government is “learning as we go” about how to shift costs to private industry. She cited Eli Lilly, which manufactures bebtelovimab, the only monoclonal antibody that’s effective against omicron. The company has supplied hundreds of thousands of doses of the drug to the government.

“We give a lot of credit to Eli Lilly for stepping up and being able to do that,” O’Connell said. “And we’ve been working with them to learn some lessons about what that was like to be able to continue to provide accessibility as they think about how they will continue to provide this product to the uninsured moving forward. We’re learning as we go, and in very active and collaborative conversations.”

All the experts enthusiastically praised the role played by the Biomedical Advanced Research and Development Authority (BARDA) during the pandemic. BARDA is an arm of the Administration for Strategic Preparedness and Response in the HHS.

Through BARDA, the “government created incentive to be able to bring some of the smaller biotech companies forward to innovate against some of our more challenging threats across the biological, chemical and radiological landscape that we’re currently facing,” O’Connell said. “BARDA gets to play a role in continuing to do the innovation in the COVID space and keep companies invested while it looks and returns to its regular portfolio of those chemical, radiological, biological and other threats.”

Conti said, “I totally agree. Make sure that people appreciate the role that BARDA played. They were both identifying companies that had standard capacity to make existing products that needed to be on the ground. And to help people in the emergency, they were also identifying innovators who are willing to innovate in a very time-constrained situation. And incredibly, they were investing in manufacturing at risk for products that hadn’t even been authorized or approved, not just for the U.S. population, but also frankly, for the worldwide benefit.”

https://www.fiercehealthcare.com/providers/experts-kaiser-family-foundation-webinar-discuss-shifting-covid-coverage-health-insurers

Plan sponsors' satisfaction with PBMs is declining

 Satisfaction with pharmacy benefit managers is on the decline, particularly among health plans, a new survey shows.

Pharmaceutical Strategies Group, a consulting firm, surveyed 236 benefits leaders who represented plan sponsors totaling 76 million lives in May and June of this year. Respondents were asked to rate satisfaction on a 10-point scale, with overall satisfaction with PBMs earning a 7.8 score, down from an 8.2 in 2021.

The average score on whether a respondent would recommend their PBM landed at 7.6, down from 8.1, and likelihood to renew without gathering other proposals was down to 7.4 from 7.6 last year, according to the survey.

Satisfaction among employers was 8.1 out of 10 on average, the survey found, but 6.9 out of 10 among health plans. Health plans were also less likely to recommend a PBM compared to employers.

"Employer respondents perceived better alignment between their PBM’s incentives and their organization’s goals, thought of their PBM as more of a proactive partner in managing their drug spend, were more satisfied with the transparency of their PBM, and were more likely to renew their contract with their PBM without issuing a competitive RFP," the authors wrote.

For example, employers gave PBMs a score of 4.3 on satisfaction with the delivery of promised services, while health plan leaders instead gave a 3.6 average score.

What is behind the decline in scores? The survey points to a number of factors. For one, plan sponsors are very concerned about drug trend, which is rising for many. Plus, while PBMs did secure some positive press during the COVID-19 pandemic as vaccines and therapies were distributed, most of the news about them more recently has been negative, including the announcement that the Federal Trade Commission would investigate the business practices of the largest companies in the market.

The survey also identified where plan sponsors are the least satisfied with their current PBM, marking areas of improvement for these companies. Areas with the lowest satisfaction among plan sponsors include a PBMs' willingness to integrate with other pharmacy solutions, customizability, management of drug trend and contract and service flexibility, according to the survey.

Plan sponsors also reported lower satisfaction with the product differentiation in the market as well as PBMs' clinical outcomes reporting.

The most used programs offered by PBMs are utilization management, used by 82% of plan sponsors, and formulary exclusions, used by 72%. However, just 8% had used gene therapy financial protections and 15% tapped into alternative funding programs, which indicate PBMs could do more to make plan sponsors aware of such offerings, and communicate the benefits clearly.

In addition, the survey digs into data for individual PBMs, including overall satisfaction with five of the largest companies. Express Scripts, a subsidiary of Cigna, and Optum Rx, a subsidiary of UnitedHealth Group, each earned a 7.9 score out of 10, the highest. CVS Health's Caremark earned a 7.7, Prime Therapeutics a 7 and MedImpact a 6.5.

https://www.fiercehealthcare.com/payers/plan-sponsors-satisfaction-pbms-declining-new-survey-shows-heres-why