AbbVie Bolsters Neuro Platform with $1B Syndesi Buy

 AbbVie has bolstered its neuropsychiatric and neurodegenerative portfolio with the acquisition of Belgium-based Syndesi Therapeutics in a deal valued at up to $1 billion. 

With an upfront payment of $130 million, AbbVie gains Syndesi's portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. SV2A plays a central role in synaptic transmission, the communication between neurons in the brain. Improved regulation of SV2A could play a role in approaching treatment of Alzheimer’s disease, major depressive disorder and other disorders with cognitive impairment. 

Tom Hudson, AbbVie’s head of R&D and chief scientific officer, noted that there is a “major unmet need” for new therapeutics and treatments that can improve cognitive function in patients with hard-to-treat neurologic diseases. Through the acquisition of Syndesi, AbbVie hopes to advance the research of the first-in-class SDI-118 for the treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders, Hudson said in a statement. 

A small molecule, SDI-118, is currently in Phase Ib studies. In the study, the asset targets nerve terminals to enhance synaptic efficiency. In its announcement, AbbVie said that synaptic dysfunction is believed to be an underlying issue in cognitive impairment that is associated with multiple disorders.  

Last year, Syndesi initiated dosing in the proof-of-principle study about eight months after results from two small Phase I studies showed the drug was safe and well-tolerated in trial participants. The studies also included promising data in electroencephalogram (EEG) recordings of brain activity. 

Syndesi said SDI-118 produced a “unique profile of changes in quantitative EEG relative frequency power,” which was consistent with a novel mechanism of action. The company said that the data complemented the PET target engagement data that had previously been seen. 

Jonathan Savidge, chief executive officer of Syndesi, said the company has been impressed with AbbVie and its shared view of the potential of SDI-118 in a range of neurologic diseases. 

“I am delighted with the closing of this deal. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well-positioned to move into later stages of clinical development,” Savidge said in a statement. 

Under terms of the deal, AbbVie forked over $130 million. The remaining $870 million in the back-end heavy deal will be paid to Syndesi shareholders based on the achievement of certain established milestones.  

Backed by Novo Holdings, Syndesi launched in 2017 to develop novel SV2A modulators. In 2018, the company licensed SDI-118, which had been discovered by UCB Biopharma SRL, one of the organizations that helped launch Syndesi.  

For AbbVie, the acquisition of Syndesi is expected to complement its ongoing neurodegenerative disease collaboration with Mission Therapeutics. Last fall, the two companies nominated two deubiquitinating enzyme (DUB) targets to advance as potential therapies for Alzheimer’s and Parkinson’s.  

The company previously had an Alzheimer’s partnership with Voyager Therapeutics, but that partnership was dissolved in 2020. The two companies initially hooked up in 2018 in a tau and alpha-synuclein vectorized antibody collaboration with a goal to develop vectorized antibodies against the tau protein. 

https://www.biospace.com/article/abbvie-acquires-belgium-s-syndesi-therapeutics-and-its-neurodegenerative-disease-assets-/

RedHill Upamostat Shows 100% Efficacy In Non-Hospitalized COVID-19 Patients

 RedHill Biopharma Ltd 

RDHL -10.05%

 (Get Free Alerts for RDHL) has announced topline results from the Phase 2 part of the Phase 2/3 study of RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients.

• The study showed promising efficacy results delivering a 100% reduction in hospitalization due to COVID-19, with zero patients on RHB-107 hospitalized with COVID-19 compared to 15% on the placebo-controlled arm requiring hospitalization. 
• Furthermore, the study showed an 87.8% reduction in reported new severe COVID-19 symptoms, with only one patient on RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the placebo-controlled arm experiencing new COVID-19 related severe symptoms.
• The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107.
• RHB-107 is an orally-administered antiviral targeting human serine proteases that prepare the spike protein for viral entry into target cells. 

https://www.benzinga.com/general/biotech/22/03/25909080/redhill-biopharmas-upamostat-shows-100-efficacy-in-non-hospitalized-covid-19-patients

Kids With Cancer in Ukraine Take Shelter, Wait for Evacuation

 Young cancer patients in Ukraine's children's hospitals have taken shelter in hospital basements that are serving as temporary bomb shelters.

Amid the Russian invasion of Ukraine, doctors and nurses are trying to provide limited treatment when possible, though supplies of necessary food, water, and medications are dwindling, according to NBC News.

"These children suffer more because they need to stay alive to fight with the cancer — and this fight cannot wait," Lesia Lysytsia, a doctor at Okhmatdyt, the country's largest children's hospital in Kyiv, told the news station.

Some kids only have access to a basic form of chemotherapy right now, while other treatments have been interrupted. Doctors have expressed concerns about relapses if the interruption of treatment continues for an extended  period.

At Kyiv Regional Oncology Center, some kids' blood counts grew so low, and supplies became so sparse, that doctors started blood transfusions from parents to their kids, NBC News reported.

"Our patients, they will die," Lysytsia said. "We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren't diagnosed of disease in time, how many patients died because they didn't receive treatment. It's an epic amount of people."

Hospital staff members want to evacuate the families, but it can be a difficult process, NBC News reported. They don't know how long the travel will take, what medical supplies are needed, or what obstacles they could face on the road.

"Patients and their parents ask me if it's safe, and I say, 'I don't know,'" Lysytsia said. "I don't even know if it's safe to go outside. It's possible they go out near the hospital and they'll be attacked."

For now, medical professionals across Ukraine have been discussing ways to move patients with the most severe cancer and other medically vulnerable residents in Kyiv to medical centers in Lviv and western Ukraine, where supplies are better and conditions are safer. From there, some of the sickest children could be transported to Poland, where officials have promised medical care.

On Monday, 14 children in Kyiv were put on a bus to Lviv, which is typically a 3- or 4-hour trip, NBC News reported. But after 8 hours of winding routes and checkpoints, they likely had 5  more hours to go. The group will be joined in Lviv by another bus of 20 children, and police will escort both across the border.

"We will do everything that is important for our patients," Lysytsia said. "And we will stay until the end."

SOURCE:

NBC News: "Kids with cancer in Ukraine shelter in hospital basements, hoping to evacuate."

https://www.medscape.com/viewarticle/969414

Russian-backed investment fund tied to influential U.S. corporate consulting firm Teneo

 

• LetterOne has multiple links to Teneo, which was founded by two Democratic consultants who worked for former Presidents Bill Clinton, Barack Obama and former Secretary of State Hillary Clinton.
• Under the contract, which was viewed by CNBC, LetterOne was on track to pay Teneo more than $3.6 million since September 2020. The discovery of these ties comes as Russia is getting hit with sanctions from around the world following their initial invasion of Ukraine.
• The Department of Justice’s FARA Unit, which monitors U.S. lobbying and consulting work for foreign representatives, said it believes the contract between Teneo and LetterOne “remains active.”
• An investment fund backed by Russian oligarchs sanctioned by the European Union following the invasion of Ukraine has ties to Teneo, an influential corporate-advisory firm based in the United States.

The public relations and strategy giant was hired in 2020 by LetterOne, a private equity firm based out of Luxembourg that counts sanctioned billionaires Mikhail Fridman, who is a native of Ukraine, and Petr Aven among its cofounders. The contract, which was viewed by CNBC, appears to have paid Teneo more than $3.6 million to line up interviews and consult on media strategy in the U.S.

LetterOne was founded by Fridman, Aven, Alexei Kuzmichev, Andrei Kosogov and German Khan — all of whom are some of the wealthiest business leaders with interests in Russia. All five founders have been on LetterOne’s board, with Fridman as the chairman, according to data from PitchBook reviewed by CNBC. The executives launched the firm in 2013 after establishing Alfa Group, one of the largest conglomerates in Russia.

Fridman and Aven have been sanctioned by the EU, and accused of having ties to Russian President Vladimir Putin, claims that were denied in an emailed statement to CNBC. The statement did not answer any of CNBC’s questions on LetterOne’s work with Teneo or how the investment fund is planning to move ahead now that two of its founders have been sanctioned. Fridman’s bank, Alfa Bank, has also been sanctioned by the United States. He’s called for an end to the Russian invasion of Ukraine.

After CNBC asked a LetterOne representative on Monday about their business, including their relationship with Teneo, several pages of their website, including the “our people” section, appear to have been wiped as of Tuesday morning. An error message now appears on that section which listed the founders and executives at the firm. The LetterOne board section is still active, but it no longer shows Fridman and Aven as members of the board.

Joshua Hardie, a spokesman for LetterOne, said Fridman and Aven resigned from the board on Tuesday. CNBC first contacted the private equity firm on Monday.

Though emails to Teneo were not returned, Kathleen Lacey, a company senior managing director who was listed in a document as working the LetterOne account, told CNBC in a brief phone call on Monday that LetterOne was no longer one of her clients and she believed her firm wasn’t representing it anymore.

The Department of Justice’s FARA Unit, which monitors U.S. lobbying and consulting work for foreign representatives, told CNBC on Tuesday that it believes the contract between Teneo and LetterOne “remains active.”

LetterOne has multiple links to Teneo, which was founded by two Democratic consultants who worked for former Presidents Bill Clinton, Barack Obama and former Secretary of State Hillary Clinton. The private equity firm has been involved in almost a dozen deals estimated to be worth over $1 billion, according to PitchBook. Uber, for example, saw a $200 million investment from LetterOne in 2016.

Teneo has since grown into a consulting giant, with past clients including Dow Chemical and Coca-Cola. Foreign clients have included Neom, a company backed the juggernaut Public Investment Fund with the goal of creating a megacity in Saudi Arabia, and a foundation led by an Emirati princess.

Their listed senior advisors is a who’s who of political and business leaders including former Republican House Speaker Paul Ryan, former IBM CEO Ginni Rometty, former Dow Chemical CEO Andrew Liveris and Harvey Pitt, a former chairman of the Securities and Exchange Commission.

Doug Band, who was once one of Bill Clinton’s closest aides, founded Teneo with Declan Kelly and Paul Keary. Kelly worked as the special envoy to Northern Ireland in the Obama administration and helped Hillary Clinton run for president in 2008. Band and Kelly have since left the firm, with the latter resigning from being Teneo’s CEO after reports of him drunk and acting inappropriately at an event organized by the Global Citizen nonprofit. Keary became the CEO after Kelly’s resignation.

A contract between Teneo and LetterOne reviewed by CNBC shows that the consulting firm was hired in 2020 for a retainer of $150,000 per month to advise the fund on their media strategy. Teneo, according to the contract, was expected to “provide strategic counsel and stakeholder engagement advice to the company and its board members (including, without limitation, scheduling media interviews, assisting with media briefings, coordinating stakeholder engagements and related activities).”

Under the contract, LetterOne was on track to pay Teneo more than $3.6 million since September 2020. There were at least four Teneo representatives who worked the account, according to other documents filed to the DOJ.

Further documents show that through last year, Teneo took credit for trying to set up interviews for LetterOne leaders with producers and television anchors, including those at CNBC, Bloomberg and Fox Business. A document shows that a Bloomberg representative was contacted almost a dozen times to see whether LetterOne could sponsor one of their Bloomberg Invest events.

There are other ties between Teneo and LetterOne.

LetterOne’s nonexecutive chairman is Evan Davies, a British businessman who was once the U.K. minister of state for trade, investment and small business. He’s also a senior advisor at Teneo.

VEON, a telecommunications company operating in Russia and Ukraine is listed on LetterOne’s website as one of its active investments. Ursula Burns was chairman of the VEON board for almost three years before stepping down in 2020. She later became the chairwoman of Teneo.

Meanwhile, VEON announced on Tuesday that Mikhail Fridman resigned from their board.

https://www.cnbc.com/2022/03/01/russian-backed-investment-fund-tied-to-influential-us-corporate-consulting-firm.html

Doctors Shelter in Place at Ukrainian Heart Hospital

 As Russian troops occupy the space just a few kilometers away from his hospital, Borys Todurov, MD, director of the Heart Institute of the Ministry of Health of Ukraine in Kyiv, has remained focused on supporting the patients -- and staff -- who have taken shelter at the facility.

Missiles, tanks, and cannons deployed by the Russian military have destroyed parts of Kyiv, creating major obstacles for transportation to and from healthcare facilities throughout the city. Patients and staff at the Heart Institute have remained in place since the start of the invasion, since it's unsafe for people to enter or leave hospital grounds. Most of the patients, staff, and family members at the facility have stayed in the basement -- where they have been since Russia threatened to bomb Kyiv.

"The Heart Institute is totally blocked," Todurov told MedPage Today through a translator. Nurses and doctors at the hospital have worked for several days straight, he said, completing their shifts without any staff changes.

Some of the staff have gathered their family members to take shelter in the basement at the Heart Institute, including Todurov's children, grandchildren, and pregnant daughter-in-law. But other doctors and nurses are completely disconnected from their families, unsure of where they are or how to contact them. "Our nurses, our doctors are worried about their families," Todurov said. "It is very critical."

At the Heart Institute in Kyiv, nurses take a short break in the basement. Photo by the Heart Institute.

Nearly all of the patients, including children, have also been moved to the basement for their protection. However, Todurov said in a video on Sunday (which was translated for MedPage Today) that not all of the patients, including five who were intubated, could be moved underground.

As of Sunday, the Heart Institute had 98 admitted patients, 28 of whom are in the ICU, Todurov said. Prior to the invasion, the hospital might have as many as 170 admitted patients. But because transportation is inaccessible, hospital admissions have come to a halt.

"We cannot admit people with active coronary disease," Todurov said, because there are no ambulances, no other ground transportation, and it is not safe to move around the city. The facility has not yet admitted any patients wounded from the war, but Todurov said that they are ready to do so.

Todurov said he doesn't anticipate being able to restock medications or other medical supplies once they exhaust their short-term supply. He is particularly concerned for patients who have kidney issues, because they may not be able to continue their dialysis treatments if the hospital does not get access to supplies.

Neighbors and volunteers are making food deliveries to the hospital to sustain patients, healthcare workers, and their families. "We are trying our best to keep everyone happy and healthy," Todurov said. "It's very important to listen, to talk and to give hope to people and to say that it will pass," Todurov said. "We will be happy."

"This is our reality," he added. "It's very hard, but at the same time, people in Ukraine have never been so united to fight for freedom."

https://www.medpagetoday.com/special-reports/exclusives/97417

Medicare Cuts Threaten Specialty Practices Nationwide

 The COVID-19 pandemic has brought to the forefront inequities and vulnerabilities that have always existed in our healthcare system. Yet, as the pandemic persists, policies that further limit access to care for underserved populations continue to be pushed forward.

For about a year now, providers have been ringing alarm bells about devastating cuts to Medicare funding for specialty care services directed by CMS. The 2022 Medicare Physician Fee Schedule final rule issued in November proposes reimbursement cuts of 20% that will harm a large variety of office-based specialists treating cancer, vascular and heart disease, dialysis patients, and more. The cuts will force free-standing medical clinics to close their doors, reducing treatment options for patients and, in many cases, leaving hospital-based care as the only option, despite the already existing strain on hospital resources.

Some claim the clinical labor pricing updates in the 2022 Physician Fee Schedule will help address workforce shortages among nurses and other clinical staff. However, this is based on the false assertion that staff won't get pay raises in 2022 if clinical labor pricing isn't updated. Salary data from the last 20 years shows that Medicare's clinical labor pricing doesn't dictate what doctors actually pay staff.

Further, proponents of the clinical labor cuts acknowledge that Medicare's budget neutrality requirements will lead to payment reductions for many procedures, but they don't address how the specialty practices performing those procedures will make up for lost revenue. By ignoring the dire consequences for specialty practices, they're leaving an essential sector of the healthcare system out of the equation. With the clinical labor pricing in effect, specialty clinical staff won't be getting raises -- they'll be losing their jobs as centers inevitably close.

With hospitals across the country overwhelmed, this is a particularly grim time to force the closures of specialty practices that provide a measure of relief to both the patient as well as these overburdened hospitals. Patients who are grappling with serious illness will have to face the added health risk of seeking treatment in a hospital setting.

In the long-term, these slashes in funding will accelerate the consolidation of our healthcare system, which limits patient choice and drives up costs for everyone. Large hospital systems are already devouring physician networks and office-based specialists in an effort to grab a larger portion of the pie. The CMS-directed cuts will only serve to help these organizations gain more market share and further drive down competition, which will lead to increased healthcare costs. Small, office-based healthcare providers cannot stay in business without reasonable reimbursement rates from the federal government.

Many of the illnesses treated by specialty clinics disproportionally affect underserved populations already struggling to access care. To be clear, these funding cuts will likely lead to worse health outcomes for Black, Hispanic, and Native Americans -- exacerbating existing inequities. Easily accessible outpatient care centers in underserved communities could be shuttered permanently.

Fortunately, Congress has the opportunity to prevent these serious adverse outcomes by reversing the cuts in the upcoming omnibus appropriations legislation. Many lawmakers are sounding the alarms right alongside healthcare providers and patient advocates. In a 2021 letter to CMS, 75 lawmakers in the House of Representatives -- led by Reps. Bobby Rush (D-Ill.) and Gus Bilirakis (R-Fla.) -- highlighted the troubling impacts that the cuts would have on the U.S. healthcare system.

Patient access to appropriate care, hard-earned progress toward health equity, and even our capacity to fight the pandemic are at risk. There is only one ethical course of action: I respectfully encourage our representatives in Congress to act to prevent the weakening of our already strained healthcare system by providing relief for office-based specialty care and working on fundamental reform of the Physician Fee Schedule.

Mark Garcia, MD, is CMO for American Vascular Associates and the Health Policy Advisor for United Specialists for Patient Access.

https://www.medpagetoday.com/opinion/second-opinions/97414

White House Plans to Add to Mental Health Workforce, Better Enforce Parity Laws

 Increasing the mental health workforce and improving parity in mental health coverage are among the mental health issues President Biden plans to address in Tuesday night's State of the Union speech.

"Our country faces an unprecedented mental health crisis for people of all ages, one which COVID has exacerbated but which predates the current challenges," a senior administration official said on a Tuesday morning phone call with reporters. "Two out of five adults today report symptoms of anxiety or depression and children face especially acute challenges as COVID has disrupted routines and relationships ... The president will announce a mental health strategy that marks a major transformation in how mental health is understood, perceived, accessed, treated, and integrated in and out of healthcare settings."

The senior administration official outlined the administration's three-pronged strategy to improve Americans' mental health -- a strategy the president will discuss in the State of the Union speech:

• Increase the mental health workforce. "We do not have enough providers or system capacity to meet Americans' needs," the official said. "One-third of Americans live in areas without adequate behavioral health providers, and our crisis response infrastructure is frayed. We must begin with a major new investment in building our mental health and substance use disorder workforce." According to a White House fact sheet, Biden's fiscal year 2023 budget proposal "will invest $700 million in programs – like the National Health Service Corps, the Behavioral Health Workforce Education and Training Program, and the Minority Fellowship Program – that provide training, access to scholarships, and loan repayment to mental health and substance use disorder clinicians committed to practicing in rural and other underserved communities." The official said that the budget "will also propose a transformational expansion of certified community behavioral health centers and community mental health centers to build new capacity." In addition, the new "988" mental health hotline also will launch this summer, giving Americans an easier way to connect to support and resources, the official noted.

• Improve access to care. "Fewer than half of Americans with mental health needs receive treatment," the official said. "Costs and stigma are too often a barrier and care can be inconvenient or confusing to access." The administration is taking steps to more diligently enforce the Mental Health Parity and Addiction Equity Act of 2008, signed into law by President George W. Bush, which requires insurers to offer mental health benefits that are on a par with their physical health benefits. "That standard is too often ignored and this administration is taking important steps to enforce the law," the official said. Biden also will ask Congress to modernize mental health laws "so that all insurance plans are required ... to provide an adequate network of providers for those services." The president also will ask Congress to expand telehealth access and allow for telehealth delivery across state lines, and the Department of Health and Human Services (HHS) "will also build new, easy-to-access, user-friendly online Treatment Locator tools," the official said.

• Foster more supportive environments. This includes social media content aimed at children, the official said. "The president will call for action to address social media's mental health harms, especially for young people ... And we must strengthen privacy and advertising protections for kids on the Internet." To help set up students for success, "the president will call on Americans nationwide to take on roles as tutors and mentors to help our students recover."
• Regarding the parity provisions, the official said in response to a question from MedPage Today that the Biden administration hopes to both enforce existing law and to write new rules. The official noted that the departments of Labor, Treasury, and HHS recently issued a report that found "widespread failures by plans to comply with requirements related to documenting how they are setting their mental health coverage limits, and restrictive coverage that is oftentimes in violation of the law. The departments are committed to continuing those vigorous enforcement activities, and pursuing companies and plans that are not adequately covering the services" to make sure they comply.

The departments also are planning to begin rulemaking around parity later this year, the official added. And "moving beyond the existing parity requirements, we believe that all types of insurance coverage, including employer health plans, should be required to cover a robust package of behavioral health services ... and that part of that package of services should include access to three behavioral health visits with with no cost-sharing, so people have a way to walk in the front door of the behavioral health system without costs serving as a barrier." The new rules also should include network adequacy requirements, the official said.

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/97442