Bristol-Myers Returns $475M IL-12 Oncology Asset To Dragonfly

 

• Bristol-Myers Squibb & Co 
  BMY+0.09%+ Free Alerts
   has returned the exclusive rights to Dragonfly Therapeutics' IL-12 oncology candidate.
• In 2020, BMS handed out $475 million in near-term and upfront payments deal to license the interleukin-12 (IL-12) immunotherapy program, dubbed DF6002. 
• The therapy is currently being assessed in a phase 1/2 trial in patients with various solid tumors as a monotherapy and combination with BMS' cancer blockbuster Opdivo (Nivolumab).
• According to the press release, BMS is still conducting clinical development for DF6002, but Dragonfly is set to take over in the coming weeks.
• Dragonfly now holds all the rights for the IL12 cytokine—the most advanced drug in Dragonfly's cytokine pipeline. 
• Last month, Bristol-Myers Squibb exercised its option to enter into an exclusive license for a sixth TriNKET Immunotherapy drug candidate with Dragonfly Therapeutics.
• The announcement marks the first TriNKET opt-in outside of oncology.
• Dragonfly will receive a $25 million payment and is eligible for potential future milestones and royalties on net sales.

https://www.benzinga.com/general/biotech/23/02/30735248/big-pharma-bristol-myers-returns-475m-il-12-oncology-asset-to-dragonfly

Personalis upped to Buy from Hold by Needham

 Target $8

https://finviz.com/quote.ashx?t=PSNL&ty=c&ta=1&p=d

Georgia lawmakers, advocacy groups push for repeal of certificate of need laws

 After recently rolling back certificate of need laws for hospital construction, lawmakers and advocacy groups are pushing for Georgia to totally repeal the certificate of need process and allow health systems to build new medical centers without proving that the community needs them, The Augusta Chronicle reported Feb. 6.

A conservative advocacy group, Americans for Prosperity, spent six figures on an advertisement campaign pushing for a repeal of certificate of need laws ahead of the Georgia General Assembly session. 

The group hopes that repealing the certificate of need process will allow health systems to build more hospitals.

Some healthcare leaders are concerned that repealing certificate of need laws will hurt rural healthcare providers.

"A lot of out-of-state private equity money wants to come in and repeal certificates of need so they can build new facilities," Monty Veazey, president and CEO of the Georgia Alliance of Community Hospitals, which represents the state's nonprofit hospitals, said. "[But] nobody's going to build a hospital in a rural area where they can't make any money."

https://www.beckershospitalreview.com/legal-regulatory-issues/georgia-lawmakers-advocacy-groups-push-for-repeal-of-certificate-of-need-laws.html

Activist investor rallies Bayer shareholders as pressure on CEO mounts

 Bayer investor Jeff Ubben has contacted fellow shareholders in the German group, investors and sources familiar with the matter told Reuters, in an apparent attempt to rally support for big changes at the drugs-to-pesticides company.

The campaign increases the pressure on non-executive Chairman Norbert Winkeljohann, who has faced calls from large shareholders for the swift replacement of Chief Executive Werner Baumann, who engineered Bayer's troubled Monsanto takeover.

The approaches come after Ubben's activist investment fund Inclusive Capital Partners said last month it had bought a 0.83% stake in Bayer.

Ubben told the Financial Times at the time he would prefer an external candidate to replace Baumann and that while a break-up of the group may not be necessary, it needs to be considered.

David Herro, deputy chairman of Harris Associates, told Reuters in brief emailed comments that Ubben had contacted him to discuss Bayer. He did not provide further details.

Ubben has also been in touch with a portfolio manager at a large German mutual funds firm, and proposed a meeting, according to a person familiar with the matter.

Another source said Ubben had reached out to a large number of institutional Bayer investors to get support for a campaign to quickly replace Baumann with a candidate from outside the company to revive the sagging share price.

The investors declined to be identified due to the sensitivity of the matter.

Ubben did not respond to requests for comment.

A spokesperson said Bayer was always open to a constructive dialogue with shareholders and declined to comment further.

Two large German mutual companies and major Bayer shareholders Union Investment and Deka have also said they would like a swift CEO changeover at the group, whose business spans drugs, consumer healthcare products, seeds and pesticides.

Investors who have publicly called for a swift CEO change hold at least a combined 6.7% in Bayer, according to Refinitiv data.

https://www.yahoo.com/now/activist-investor-rallies-bayer-shareholders-171747289.html

Kidney dialysis-related infection rates higher in U.S. minorities

 

Preventable bloodstream infections related to kidney failure treatment are more common in U.S. Blacks and Hispanics than in whites, according to a report from the Centers for Disease Control and Prevention (CDC) released on Monday.

Use of neck veins for administration of hemodialysis was the most important risk factor, but not the only one, researchers said in the CDC's Morbidity and Mortality Weekly Report.

Using data from multiple national databases collected between 2017 and 2020, they estimated that potentially deadly Staphylococcus (or S.) aureus bloodstream infections occurred in 4,751 of every 100,000 Black patients receiving hemodialysis and 4,500 of every 100,000 Hispanic patients compared with 3,866 of every 100,000 white late-stage kidney disease patients receiving these treatments.

Roughly 40% of the infections were resistant to treatment with the antibiotic methicillin, the report found.

Patients whose kidney function falls below a certain level require a dialysis machine periodically to do the organs' work of cleansing the blood.

The most significant risk factor for the serious and potentially deadly infection was administration of dialysis though a large "central vein" catheter in the neck.

Use of a central venous catheter for hemodialysis conferred a six-times-higher risk for S. aureus bloodstream infection compared to use of a port in the arm known as a fistula, the researchers found.

The highest use of central venous catheters was seen in Black patients ages 18 to 49.

Ideally, as kidney function deteriorates and patients get closer to needing dialysis, doctors recommend a surgical procedure to create the fistula, with an artery connected to a vein.

Without the fistula, dialysis must be administered via a catheter in a large central vein in the neck, which is associated with higher rates of complications, including infections, and should only be used temporarily.

Even after accounting for use of these catheters, the risk of S. aureus bloodstream infections was still higher in Hispanics than in whites.

"Central venous catheter use was the most important risk factor but didn't entirely explain the higher risk in Hispanic patients," said study leader Dr. Shannon Novosad, team lead for Dialysis Safety in CDC's Division of Healthcare Quality Promotion.

There were also more S. aureus bloodstream infections in areas with higher poverty, crowding, and lower education levels.

"Overall these are complex relationships that deserve additional study," Novosad said.

Her team called for research to help minimize central venous catheters use, address possible barriers to use of safer routes for hemodialysis access, and improve education of patients and healthcare providers.

"We need to focus interventions that we know work to prevent infections, specifically in these (high-risk) groups," Novosad said.

https://www.marketscreener.com/news/latest/Kidney-dialysis-related-infection-rates-higher-in-U-S-minorities-report--42912256/

U.S. plans to stop buying Covid shots for the public this fall

 The U.S. will stop buying Covid shots at a reduced price for the entire country and shift vaccine distribution to the private market as soon as early fall, shifting the cost to U.S. insurers and uninsured Americans who stand to lose access to the free vaccines.

Dr. Ashish Jha, the White House Covid response coordinator, said in an an interview with UCSF Department of Medicine on Thursday that the shift to a private market will happen over the summer or early fall, though no exact date has been set.

A senior official with the Health and Human Services Department told CNBC the fall would be a natural time to transition to a private market, particularly if the Food and Drug Administration selects a new Covid strain for the vaccines and asks the manufacturers to produce updated shots ahead of the respiratory virus season.

For the past two years, the U.S. has bought the vaccines directly from Pfizer and Moderna at an average price of about $21 per dose, according to the Kaiser Family Foundation.

The federal government has required pharmacies, doctor’s offices and hospitals to provide these shots for free to everyone regardless of their insurance status.

If you have health insurance

When the federal Covid vaccination program ends, the shots will remain free for people who have health insurance due to requirements under the Affordable Care Act.

But uninsured adults may have to pay for their immunizations when Pfizer and Moderna start selling the shots on the private market and the current federal stockpile runs out. There is a federal program to provide free vaccines to children whose families or caretakers can’t afford the shots.

Jha said on Tuesday the planned switch is not tied to the end of the Covid public health emergency in May.

“The end of the PHE does NOT mean people will suddenly not be able to get the vaccines and treatments they need,” Jha wrote in a Twitter thread on Tuesday.

When the federal government no longer buys vaccines at a discount for the entire nation, individual health-care providers will purchase the shots from the vaccine makers at a higher price.

Moderna CEO Stephane Bancel told CNBC last month that the company is preparing to sell the vaccines on the private market as early as this fall. Pfizer CEO Albert Bourla told investors during the company’s earnings call this week that he is preparing for the vaccines to go commercial in the second half of the year.

Pfizer and Moderna have said they are considering hiking the price of the vaccines to somewhere around $110 to $130 per dose once the U.S. government pulls out of the vaccine program.

If you’re uninsured

“If you’re uninsured, then you might be faced with the full cost,” said Cynthia Cox, an expert on the Affordable Care Act at the Kaiser Family Foundation.

But the U.S. still has a substantial stockpile of free vaccines left. The Biden administration ordered 171 million omicron boosters last year. About 51 million boosters have been administered so far, according to the Centers for Disease Control and Prevention.

The uninsured will continue to have access to these 120 million doses for free, but it’s unclear how long the supply will last.

“With the supply we have of vaccines and antivirals, we don’t think we’re going to be in a state of precipitous transition to drop this on market partners,” the HHS official said.

Although the vaccine makers are preparing to sell shots on the private market later this year, it’s possible that the federal stockpile of free shots could last longer than that because booster uptake has been low, Cox said.

“Everyone in the U.S. regardless of their citizenship status or their insurance status is able to get a free vaccine as long as this federal stockpile lasts,” Cox said.

Sen. Bernie Sanders, I-Vt., slammed the vaccine price hike in a letter to Moderna’s CEO last month. Sanders, who chairs the Senate health committee, said the price hike would cost taxpayers billions via its impact on Medicaid and Medicare’s budgets.

“Perhaps most significantly, the quadrupling of prices will make the vaccine unavailable for millions of uninsured and underinsured Americans who will not be able to afford it,” Sanders said. “How many of these Americans will die from Covid-19 as a result of limited access to these lifesaving vaccines?”

Jha said this week that the Biden administration is committed to helping the uninsured access Covid shots and treatments.

“We are creating a whole separate set of efforts for the uninsured because the uninsured, of course, will not be able to get vaccines for free and treatments for free under the regular insurance system by definition,” Jha said Thursday. “We are working on a plan on that.”

The HHS official said one tool the federal government plans to use is a program called Section 317 that provides funding to procure and administer shots to uninsured adults at no cost.

ACA requirements

But for the overwhelming majority of people with private insurance, the Affordable Care Act will cover the cost of the vaccines. Under the ACA, private health insurance is required to cover all immunizations recommended by the CDC at no cost to the consumer.

Medicare would cover the shots for seniors, who are the most vulnerable to the virus, and lower-income people could get the vaccine through Medicaid.

There may be a small number of legacy private health insurance plans from before the ACA that are not required to cover Covid vaccines, Cox said. The HHS official said most of those plans will likely pay for the shots.

In addition, some short-term insurance policies might not pay for the vaccines, Cox said. These plans were expanded during the Trump administration and aren’t required to comply with the ACA.

The ACA also allows private insurance to limit vaccine coverage to in-network providers, Cox said. People who have grown accustomed to getting vaccinated at any pharmacy during the pandemic might have to go to a specific drugstore in the future to get a free shot, she said.

Consumers could also see their health insurance premiums increase if Pfizer and Moderna hike the price of the shots, Cox said.

Paxlovid may not be free

Some patients, depending on their insurance policy, will also probably have to pay for Pfizer’s antiviral pill Paxlovid in the future. Unlike preventive services such as vaccines, the ACA does not require insurance to cover treatments.

Bourla told market analysts this week that Pfizer expects to start selling Paxlovid through the private market at commercial prices in the second half of 2023.

Pfizer has not announced how much the antiviral will cost once it goes commercial. The federal government is paying about $530 for a five-day treatment course. It’s unclear how much patients will have to pay out of pocket and how much of the price insurance will cover.

Dawn O’Connell, who heads the federal office responsible for the U.S. stockpile, said last August that the Health and Human Services Department expected to run out of Paxlovid by mid-2023.

Jha said on Tuesday that there are still millions of doses of Paxlovid and omicron boosters in the U.S. stockpile. “They will continue to be available for free to all Americans who need them,” Jha said of the remaining federal supply.

https://www.cnbc.com/2023/02/04/us-plans-to-stop-buying-covid-shots-in-the-fall-what-that-means.html

Ketamine Clinics Are Jumping Ahead of the Evidence

 Almost a quarter of U.S. adults

opens in a new tab or window suffered from a mental illness in 2021, yet less than half of them received treatment. This has incredible impactsopens in a new tab or window on individuals, families, the economy, and public health, and it is of utmost importance to address these untreated mental health needs. Understandably, innovation is important as people are often looking for creative solutions to treat their mental health concerns. Partially as a result, there has been a proliferation of "edgier" approaches, such as boutique ketamine infusion clinics and at-home psilocybin therapies, which are not yet FDA approved for psychiatric indications or may not be supported by rigorous research.

As headlines and industries tout these approaches (without qualifying the need for use in protocolized ways with medical supervision), the general consumer may seek those treatments to find relief. But to keep patients safe and to effectively treat them, we can't let industry get ahead of the science, research, and guidelines, whether it be with ketamine or any other similar substance.

With respect to ketamine, clinics are advertising the treatment of many mental health disorders -- and it's becoming increasingly popular. However, the protocols and approaches used by many clinics are not in national practice guidelines, or in some cases not well researched. Ketamine is only FDA approvedopens in a new tab or window as esketamine spray (Spravatoopens in a new tab or window) for medical use under supervision of a trained prescriber, and only for treatment resistant, severe unipolar major depression without psychotic features. Often, what is being administered in private clinics is not isolated ketamine and is not the nasal spray. In some cases, a psychiatrist or a physician isn't supervising, and it is not always being given for true treatment-resistant depression. Rather, the medication is being administered off-label. While this is common practice in medicine, it's generally after more research is available -- which we don't have yet on ketamine. A 2017 consensus statementopens in a new tab or window from the American Psychiatric Association provides an excellent summary and guidance on off-label use of ketamine given the state of the research to that point. At that time, only 147 cases were available.

Ketamine is also not without risks. Even esketamine spray, which has been studied and FDA approved, has boxed warnings with risks that include sedation, dissociation, and abuse or misuse, and is subject to strict controls on dispensing and administration under a risk evaluation and mitigation strategy (REMS) program. Physicians need to be trained in REMS, can only dispense esketamine spray in a healthcare setting, and are required to monitor patients for 2 hours after dispensation.

If individuals attempt to use these substances on their own or in less structured clinics they risk acute adverse effects, for example a "bad trip," reckless behavior, worsening of psychiatric symptoms, panic, confusion, rapid heart rate, and possible interactions with other medications. There are also longer-term adverse effects of regular hallucinogen use such as persistent psychosisopens in a new tab or window, ketamine associated cystitis or bladder issuesopens in a new tab or window, or even developing a hallucinogen use disorder (addiction). Especially with off label use, the FDA has issued an alertopens in a new tab or window about risks of compounded ketamine nasal sprays made by pharmacies (this is not the FDA approved esketamine, but ketamine). The alert cites cases of people experiencing side effects such as delusion, dissociation, visual hallucination, and panic attacks, as well as abuse and misuse.

Some clinics may not screen patients for risk of adverse effects or whether they meet criteria for use (especially since there is little criteria for use). Furthermore, they may be offering these drugs for diagnoses other than depression, and they may not have psychiatric professionals available on staff. Some are using ketamine off label for other indications

opens in a new tab or window, such as pain, obsessive compulsive disorder, anxietyopens in a new tab or window, and even substance use disorders. These clinics are often appealing, offering a fast treatment for long-time suffering. People with depression or other diagnoses may sink a lot of money into the treatments (as often these clinics do not take insurance) with false hopes of finding relief.

I am hopeful for the potential of new therapies in mental health. Some hallucinogens are approved for researchopens in a new tab or window via the FDA breakthrough therapy designation, such as MDMA (3,4-methylenedioxymethamphetamine) and psilocybin for post-traumatic stress disorder, but the therapeutic indications are narrow and with highly structured protocols and expert healthcare providers.

On the other hand, decades of research offer evidence-based ways of treating common mental health diagnoses, such as depression and anxiety. These include well established psychotherapy approaches

opens in a new tab or window such as cognitive behavioral therapy, medicationsopens in a new tab or window such as antidepressants, and combinations of those approaches. Unfortunately, people are often not aware of these proven treatments or may not have given these treatments a sufficient trial. My concern is that people with mental health or substance use disorders will spend their time, money, and energy trying treatments that are not as well proven, or worse, may be harmful.

While I am hopeful about the potential for new treatments for mental health, I am wary of clinics that offer ketamine or other substances outside of their approved/recommended uses, especially without a psychiatrist involved. We need to follow the science and clinical guidelines properly to realize the benefit of these potential therapeutics safely. We must encourage our patients -- as well as friends or family -- who are struggling with mental health symptoms to seek help from evidence-based sources, such as their primary care physicians, therapists, psychiatrists, and health plans.

Smita Das, MD, PhD, MPH,opens in a new tab or window is chair of the Council on Addiction Psychiatry at the American Psychiatric Association. She is also a clinical associate professor of psychiatry and behavioral sciences at the Stanford University School of Medicine.

https://www.medpagetoday.com/opinion/second-opinions/102956