CVS to buy Signify Health in $8 billion deal

 

CVS Health Corp on Monday agreed to buy home healthcare services company Signify Health for about $8 billion in cash, a move that will enable one of the largest U.S. healthcare companies to provide further care management to patients in their homes.

Healthcare companies like CVS have been expanding beyond managing health and pharmacy benefits with acquisitions of doctors groups and surgical centers in recent years.

"We've been very clear about what we were looking for in expanding our health services, either be it primary care, provider enablement or in the home, and Signify Health clearly checks off two boxes: into the home and provider enablement," CVS CEO Karen Lynch said in an interview.

Signify Health brings CVS, which runs pharmacies, pharmacy benefits and the Aetna insurance plans, a network of 10,000 clinicians who provide home-based assessments of patient health and social needs.

CVS expects the deal to close in the first half of 2023 and said that it expects the acquisition to be "meaningfully" accretive to earnings.

CVS said it would pay $30.50 per share for the company, or about $7.6 billion in equity as well as about $400 million in equity appreciation rights.

Lynch said the companies would work with regulators who review deals for any antitrust issues.

"We are not competitors. We don't have any overlapping functions," Lynch said.

Large mergers and acquisitions have come under intense antitrust scrutiny and lowering healthcare costs has been an important strategic mission for the Biden Administration.

SIGNIFY HEALTH

Signify Health serves two groups of customers: about 50 U.S. health insurance plans including CVS' Aetna division and rivals such as UnitedHealth Group Inc and groups of providers. UnitedHealth and Amazon Inc. are among companies that were interested in Signify, a source familiar with the discussions previously told Reuters.

Signify mostly serves the companies and providers associated with Medicare Advantage health plans, in which private insurers provide government-paid health benefits to people aged 65 and older. It also services Medicaid plans for people with low incomes.

The company said it expects to service 2.5 million people through annual in-person and virtual health assessments. The visits combine with technology and analytics to coordinate follow up care and social services with the goal of improving health of underserved populations and lowering health costs, Signify said.

Signify Health CEO Kyle Armbrester, who will remain as the head of the division, said the company plans to expand to commercial health plans.

The company, which went public in early 2021, has struggled since its stock market launch and had announced a restructuring earlier this summer. Talks of the sale process were first reported in August.

CVS said in a statement that the company is "increasingly confident" it can achieve its long-term earnings goals. As outlined in December of 2021, that includes high single-digit year-over year growth in 2023 and low double-digit year-over-year growth in 2024.

New Mountain Capital, which owns 60% of Signify Health, said that it planned to vote for the deal. CVS and Signify Health said both boards of directors had approved the deals.

CVS was advised by Bank of America's BofA Securities and Signify Health by Goldman Sachs and Deutsche Bank.

https://www.marketscreener.com/quote/stock/DEUTSCHE-BANK-AG-56358396/news/CVS-to-buy-Signify-Health-in-8-billion-deal-41698744/

Dying of a disease I never knew existed

 By this time next year, if the medical forecasts are correct, I will probably be dead, another casualty of a fatal illness that most people have never heard of: idiopathic pulmonary fibrosis (IPF).

This condition has been described by Michael J. Stephen in his 2021 book “Breath Taking” as the “most frustrating and disheartening of all the diseases in pulmonary medicine.” Over a frighteningly short time (the median age of survival after diagnosis is three years), patients with IPF will become increasingly short of breath as the lungs no longer perform their vital function of oxygenating the blood. The alveoli — the sac-like pockets where this process takes place — will fill with mucus and harden until, in Stephen’s disturbing phrase, the lungs “turn to stone.”

Almost as shocking as the rapid progression of the disease is its obscurity. Roughly 40,000 people die from it every year in the United States, 5,000 more than die from prostate cancer and only slightly fewer than die from breast cancer. Stephen estimates that as many as 200,000 Americans struggle annually to survive with idiopathic pulmonary fibrosis.

Yet, as he notes, there are no TV ad campaigns, road races, color-coded ribbons, or ice-bucket challenges to raise awareness and fundraise for a cure.

When I was told two years ago that I had IPF, I had never heard of it, nor had any of my friends. My main worry at the time was colon cancer. In November 2019, it took doctors five hours of surgery to remove a sizable tumor from my large intestine. The cancer had also tainted more than half a dozen lymph nodes.

Luckily, the disease had not spread to other parts of my body, so in the nomenclature of cancer I was categorized as stage 3: a seriously ill but treatable patient. I underwent 12 sessions of chemotherapy at the start of 2020, after which a colonoscopy and blood tests found no traces of cancer.

That was the good news. The bad news was that the potent drugs administered to me during those six months — drugs that are likely responsible for my good news — can have a rare but documented side effect.

I wasn’t aware of this possibility until a visit with my oncologist at the end of my regimen. During what I expected to be a congratulatory meeting at the finish line, he pointed to a CT scan of my chest and said it showed signs of scarring, or “glassy lung.” (In radiological photographs, damaged lung tissue can present as white dots or opaque space, indicating that the alveoli are blocked.) He recommended that I see a pulmonologist.

I wasn’t too concerned. The words “glassy lung” had a pleasing sound. I imagined that, like bronchitis, it would clear up after a dose of antibiotics. The notion that scarring of the lungs could be a symptom of something deadly didn’t occur to me. This wasn’t, after all, cancer.

Medical researchers have known about pulmonary fibrosis since the 19th century, but little has been done to ameliorate its symptoms, much less to pinpoint its origins. No one seems sure of its causes. My case is called idiopathic because doctors can’t be certain that chemotherapy was the trigger.

Nothing has so far been discovered that will substantially extend life. Two drugs, Ofev and Esbriet, were approved by the Food and Drug Administration in 2014 because they were found to slow the rapidity of lung deterioration. I take two Ofev capsules twice a day. A vial of 60 pills costs upwards of $10,000, a burden relieved by a medical foundation grant.

I have no idea whether the pills are effective or not. My doctors seem just as uncertain. The only guarantee is that idiopathic pulmonary fibrosis has no cure and cannot be stopped. It is, to quote my first pulmonologist, “irremediable.”

The symptoms struck me without warning. In May 2021 I was playing two sets of doubles tennis three times a week. Two months later I couldn’t swing a racket without feeling winded. I was prescribed a steroid inhaler and large doses of prednisone, and they seemed to alleviate my breathlessness for a few weeks — until they didn’t.

Our house on Long Island today is crisscrossed with long, thin plastic tubes connecting me via cannulae to respirators that can produce up to 10 liters of oxygen a minute. I am hooked up to one or the other of these two machines, set at six liters, every hour of every day. When I go out, I carry a portable respirator that is less powerful but allows me some measure of free movement. I try not to travel far. Being away from my machines for too long taxes my oxygen level. If I go to museums — part of my job as an arts critic is reviewing exhibitions — I need to be pushed in a transport chair. Propelling myself in a wheelchair is too exhausting. My sole encounter with Covid-19 was mild. A more severe one could finish me off.

I am 69, and my only hope of living into my mid-70s is a lung transplant, an operation currently prohibited for patients like me: In U.S. hospitals where the procedure is done — there are about 65 of them and counting — a patient must be cancer-free for five years to qualify. Even if by some miracle I were to live another three years, I would then have to wait a minimum of two years to receive one lung, three years for two lungs. At the end of that period, I would be 75, past the cutoff date when lung transplants are authorized. Checkmate.

I wish I could say that the realization of the brief time I have left has altered my procrastinating habits and that I have begun to behave like those characters in Russian literature who felt liberated when infected by tuberculosis. So far, though, that hasn’t happened. I have made no progress on my long-delayed book about photography and violence; documentary film projects that were slated to begin are no closer to fruition. Thinking about anything except my day-to-day health and how to improve it is a struggle.

I don’t know whether to be grimly amused or enraged by the irony that the chemotherapy drugs designed to save my life may be what will kill me.

The discouraging lack of progress in finding a cure for such an ancient disease may explain the relative silence about IPF. Journalists throng to report on any illness when science advances understanding of it, and there hasn’t been a lot of promising news to report on this front. The prospects for treating, say, lung or prostate cancer are far more optimistic. It can’t be easy for doctors to uplift the spirits of their patients knowing that so little can be done to keep them alive. Ofev will only slow the steady pace of the inevitable — the petrification of my lungs.

If idiopathic pulmonary fibrosis is, as Stephen writes, “the big mystery in all of pulmonary medicine, a disease so cryptic it seems almost impenetrable,” one would hope that more hospitals were now trying to crack the code. This is a disease that badly needs a respected public figure to advocate for more research funding. The powerful tools of the medical-industrial complex can’t be trained on solving the riddle of IPF until more people learn that it exists.

Richard B. Woodward is an arts critic in New York. This article was originally published in the Ideas section of The Boston Sunday Globe.

https://www.statnews.com/2022/09/05/dying-of-idiopathic-pulmonary-fibrosis-a-disease-i-never-knew-existed/

Study raises concerns about the effectiveness of the monkeypox vaccine

 A new study is raising concerns about the effectiveness of the monkeypox vaccine being used in the United States and other parts of the world.

The work, which has not yet been peer-reviewed, found that two doses of the vaccine induced relatively low levels of neutralizing antibodies against the monkeypox virus, and those antibodies had poor neutralizing capacity.

The researchers noted the so-called correlates of protection — what is needed, in terms of immune system weaponry, to be protected against monkeypox — are not known. Still, the evidence of low levels of neutralizing antibodies raises questions about how much protection is generated by two doses of the vaccine, marketed as Jynneos in the U.S. and made by the Danish manufacturer Bavarian Nordic.

“At this moment it is unclear what the relatively low [monkeypox virus] neutralizing titers mean for protection against disease and transmissibility,” the researchers, from Erasmus Medical Center in Rotterdam, the Netherlands, wrote.

But one of the senior authors of the paper said what is clear is that people being administered this vaccine ought to be cautious about assuming they are protected against infection.

“The expectation is not that this will provide sterilizing immunity,” said Marion Koopmans, who heads Erasmus’ department of viroscience, referring to the type of immunity that will block infection.

Koopmans added that controlling the outbreak will require a suite of transmission-reducing tools, including isolation of cases, tracing and quarantining of contacts, and vaccination of people who have been exposed to the virus or are at high risk of exposure.

Inger Damon, who heads the division of high-consequence pathogens and pathology at the Centers of Disease Control and Prevention, said that studying how much protection the vaccine offers is critical, especially given that many of the people contracting it may be becoming infected via exposure of mucus membranes to infectious lesions. Mucus membranes are more delicate than skin, potentially allowing a larger dose of virus to infect an exposed individual.

“I think this is something that we have to very carefully follow, and we need to really be very forthright in helping the community who is at risk to understand what the limitations of our knowledge is,” Damon told STAT earlier this week in an interview.

On Friday, she said Koopmans had shared the data in the study with the CDC before it was posted online.

“Foundational to all of this will be to understand the progression of disease and the immune response to disease with the different routes of infection that we believe we are seeing,” Damon said in an email. “This is complicated, and will require concerted, coordinated, and collaborative efforts to find the right solutions to stop the spread of disease. Good health communications, and effective harm reduction messages are going to be integral.”

The Erasmus study suggests, among other things, that a one-dose regimen seems to be inadequate to induce protection.

“The second vaccination is important for reaching detectable antibody levels, as individuals in a single-shot regimen hardly developed antibody responses four and eight weeks after vaccination,” the researchers wrote.

The study also casts a shadow over the recent decision by the U.S. government and others to stretch vaccine supplies by giving people one-fifth of a regular dose — and to do so by intradermal (into the skin) rather than subcutaneous (under the skin) injection. Intradermal administration, which requires smaller doses to be protective, has been shown to be effective in other disease outbreaks with other types of vaccine.

The decision to use this dose-sparing approach — which allows up to five people to be vaccinated with the amount of vaccine normally used for one — was largely based on a small study that compared immune responses generated by two fractional doses given intradermally to two full doses given subcutaneously. They were deemed to be comparable.

But Koopmans and her colleagues saw another result in an earlier Erasmus study that tested fractional doses of a bird flu vaccine using the same vaccine backbone as the Bavarian Nordic product.

Jynneos uses a modified vaccinia virus — called MVA, the same attenuated virus formerly used to vaccinate against the now-eradicated smallpox — to teach the immune system to be on guard for monkeypox, a related virus.

The same MVA backbone was used in an experimental vaccine to protect against H5N1 bird flu. There, the two fractional doses generated lower amounts of antibodies than the full doses did, the researchers reported.

“This same trial indicates that dose-sparing … has a negative effect on the serological outcome of vaccination,” they wrote.

It should be noted that in that trial, the fractional doses were administered by intramuscular injections, not intradermal. Koopmans said the group is planning to test whether intradermal vaccine administration would improve results, once it has been cleared to conduct the study.

Asked if she thought public health authorities should rethink giving fractional doses of monkeypox vaccine, she wrote: “I think it requires testing.”

So does Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. Osterholm thought the move to fractional dosing was made too quickly, based on too little data.

“I realize in a public health crisis, sometimes you have to make decisions with imperfect information,” he said after reading the Erasmus study. “But this is the kind of data that I think everyone needs to take a step back now and say: What does this mean for what we’re doing right now?”

“They don’t have a lot of other tools,” he acknowledged. “But at the same time, if the tool you’re using isn’t adequate to do the job, then you have to consider that. Do we need to go back to full dose?”

Osterholm and others expressed concern that people getting the vaccine will conclude they have a level of protection that they may not have.

https://www.statnews.com/2022/09/02/study-raises-concerns-about-the-effectiveness-of-the-monkeypox-vaccine/

Robert W. Baird Lowers Veeva Systems (NYSE:VEEV) Price Target to $250.00

 Veeva Systems (NYSE:VEEV – Get Rating) had its price objective cut by stock analysts at Robert W. Baird from $267.00 to $250.00 in a note issued to investors on Thursday, The Fly reports. The brokerage presently has an “outperform” rating on the technology company’s stock. Robert W. Baird’s price target would suggest a potential upside of 47.08% from the stock’s previous close.

https://www.defenseworld.net/2022/09/03/robert-w-baird-lowers-veeva-systems-nyseveev-price-target-to-250-00.html

Sanofi sees EU regulatory decision on its COVID booster in weeks

 The European Union's drugs regulator may be a few weeks from deciding whether to approve the experimental COVID-19 vaccine developed by French drugmaker Sanofi and its British partner GSK, a Sanofi executive said on Monday.

The companies' bivalent vaccine targets the Beta variant as well as the original Wuhan strain of the virus. Trial results also showed the shot confers protection against the Omicron variant currently widespread in Europe.

Thomas Triomphe, Sanofi's executive vice-president for vaccines, told a hearing in the European Parliament that he believed the European Medicines Agency (EMA) would decide on the possible approval of the vaccine in a few weeks.

The EMA was not immediately available to comment.

Sanofi and GSK, two of the world's biggest vaccine makers, are hoping to gain a foothold in the market for variant-focused COVID shots, after falling behind competitors including Moderna , AstraZeneca and Pfizer-BioNTech , in the original race to contain the pandemic.

Triomphe said manufacturing of the vaccine had already started, and deliveries to EU countries could begin immediately after approval by the EMA, which is currently reviewing the shot.

The vaccine could be used as a booster for people who had received any other COVID-19 vaccine, Triomphe said.

The EU secured up to 300 million doses of the Sanofi-GSK vaccine at the early stages of the pandemic in 2020, but the companies' difficulties in developing the vaccine pushed them behind other manufacturers.

Triomphe said Sanofi was in talks with the EU to allow the shipment of its vaccine to poorer nations after purchase by EU governments. 

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-sees-EU-regulatory-decision-on-its-COVID-booster-in-weeks-41697848/

Illumina in talks with EU regulators to divest Grail

 

U.S. life sciences company Illumina is in talks with EU antitrust regulators to divest Grail ahead of an EU veto next week on its $7.1 billion acquisition of the biotechnology company, people familiar with the matter said.

The European Commission is set to block the deal because remedies offered by Illumina do not fully address the EU competition enforcer's concerns, other sources told Reuters last month.

Illumina completed its takeover of Grail in August last year without waiting for the EU green light, and was subsequently ordered by the EU watchdog to keep Grail separate and install independent managers to run the company until a regulatory decision on the deal.

https://www.marketscreener.com/quote/stock/ILLUMINA-INC-9659/news/Exclusive-Illumina-in-talks-with-EU-regulators-to-divest-Grail-sources-41697599/

Fountainvest, TPG, Warburg among bidders for Carlyle's Ambio stake

 

Private equity firms Fountainvest Capital Partners, TPG and Warburg Pincus are among final-round bidders for Carlyle Group's stake in AmbioPharm Inc, people with knowledge of the transaction told Reuters.

Carlyle, which is targeting a valuation of $1 billion for Ambio in a sale, is expecting binding bids in the coming days, said three of the people. A deal could be reached by end-September at the earliest, said one of them.

Carlyle, Fountainvest, TPG and Warburg all declined to comment. The sources declined to be identified as the information is confidential.

Investment bank Jefferies has been hired by Carlyle to run the sale, Reuters has previously reported. The bank did not immediately comment.

Carlyle bought a significant minority stake in Ambio, a peptide active pharmaceutical ingredient contract development and manufacturing organisation, from specialist healthcare fund MVM Partners in 2018 for an undisclosed amount. Its current ownership level in Ambio could not be determined.

Founded in 2007 by scientist and entrepreneur Chris Bai, Ambio is headquartered in South Carolina, United States and also has peptide manufacturing and purification facilities in Shanghai, China.

The firm provides services for drugs approved by the U.S. Food and Drug Administration, the European Medicines Agency and the China National Medical Products Administration and has a pipeline of pre-clinical and clinical programmes.

https://www.marketscreener.com/quote/stock/THE-CARLYLE-GROUP-INC-10531255/news/Fountainvest-TPG-Warburg-among-bidders-for-Carlyle-s-Ambio-stake-sources-41695311/