Biden calls on employers to mandate vaccines despite Supreme Court ruling

 President Biden on Thursday appealed to states and companies to require people to get vaccinated against the coronavirus despite the Supreme Court blocking his vaccine-or-test mandate for large employers.

The Supreme Court on Thursday ruled 6-3 against the Occupational Safety and Health Administration's (OSHA) mandate, blocking it from taking effect while other legal challenges play out. The rule would require companies with at least 100 employees to require workers either provide proof of vaccination or provide weekly negative coronavirus test results and wear face coverings to work. 

“As a result of the Court’s decision, it is now up to States and individual employers to determine whether to make their workplaces as safe as possible for employees, and whether their businesses will be safe for consumers during this pandemic by requiring employees to take the simple and effective step of getting vaccinated,” the president said in a statement.

The president vowed to put pressure on companies to voluntarily create their own vaccine-or-test requirements.

He said the Supreme Court ruling “does not stop me from using my voice as President to advocate for employers to do the right thing to protect Americans’ health and economy.”

“I call on business leaders to immediately join those who have already stepped up – including one third of Fortune 100 companies – and institute vaccination requirements to protect their workers, customers, and communities,” Biden added in his statement. 

He called the OSHA mandate a commonsense requirement and a "modest burden" on workers. 

“I am disappointed that the Supreme Court has chosen to block common-sense life-saving requirements for employees at large businesses that were grounded squarely in both science and the law,” he said. “This emergency standard allowed employers to require vaccinations or to permit workers to refuse to be vaccinated, so long as they were tested once a week and wore a mask at work: a very modest burden.”

Labor Secretary Marty Walsh said in a statement in response to the ruling that “OSHA will be evaluating all options to ensure workers are protected from this deadly virus.”

He said he was also disappointed in the court’s decision, calling it a setback on health and safety for workers and said that OSHA stands by the standard as the “best way to protect the nation’s workforce.”

The Supreme Court also on Thursday ruled 5-4 to uphold a vaccine mandate for health providers at federally-funded facilities, a move that Biden said “will save lives.”

White House press secretary Jen Psaki on Thursday called the health providers ruling “good news” and news that “maybe isn’t getting enough attention.” 

“Requirements for health care workers to be vaccinated will save the lives of patients as well as the lives of doctors, nurses, and others who work in health care settings,” she said.

She also put the responsibility on employers when asked in the White House briefing about the Supreme Court’s decision. 

The decision “essentially means that in this pandemic, it is up to individual employers to determine whether their workplaces will be safe for employees and whether their businesses will be safe for consumer,” she said.

She pointed to the White House encouraging private companies to impose their own mandates again when asked if Biden will try a mandate again or accept what the Supreme Court decided.

Psaki cited polling that show 57 percent of Americans support vaccine requirements “because employees want to feel safe in the workplace, because they want to incentivize workers to come back to the workplace and because they’ve seen a large companies across the country implement this and see how effective this is.” 

When asked what kind of impact the Supreme Court decision will have on the administration’s efforts to combat COVID-19, Psaki said officials are encouraging people to get boosted.

She added that the administration will continue to work with employees and workers to “convey very clearly what the benefits of vaccine or testing requirements would be on workplaces.”

https://thehill.com/homenews/administration/589657-biden-calls-on-employers-to-do-the-right-thing-after-supreme-court

Supreme Court blocks Biden's vaccine-or-test mandate for employers

 The Supreme Court on Thursday temporarily blocked the Biden administration's vaccine-or-test mandate for large employers, but allowed a vaccine-only mandate for health providers at federally funded facilities.  

The high court ruled 6-3 against the Occupational Safety and Health Administration's (OSHA) employer mandate, blocking it from taking effect while other legal challenges play out.   

The court ruled 5-4 to keep the health care worker mandate, with Chief Justice Roberts and Justice Brett Kavanaugh joining the more liberal Justices Stephen Breyer, Sonia Sotomayor and Elena Kagan.  

The Biden administration has argued that both policies are necessary in order to get as many people vaccinated against COVID-19 as possible. President Biden has indicated he is running out of patience with Americans who refuse to get vaccinated against the coronavirus and that the rules were meant to force the issue in order to make workplaces safer. 

The employer policy would have required companies with at least 100 workers to mandate all employees be vaccinated or provide weekly negative coronavirus test results and wear face coverings to work on-site.  

The White House said the order covered about 17 million health care workers, while the requirement on large companies would have covered more than 80 million employees, about two-thirds of the American workforce. 

While lower courts were split, the conservative Supreme Court majority ruled the employer vaccine-or-test mandate was an overreach. The justices said the challengers, a coalition of businesses and 27 Republican-led states, were likely to succeed on the merits.  

“The Secretary has ordered 84 million Americans to either obtain a COVID–19 vaccine or undergo weekly medical testing at their own expense,” the justices wrote. “It is instead a significant encroachment into the Lives—and health—of a vast number of employees. ... There can be little doubt that OSHA’s mandate qualifies as an exercise of such authority.”

At the heart of the challenges was OSHA's authority to issue emergency temporary standards, which bypass the normal regulatory process and take effect immediately if the Labor secretary deems that employees are "exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful."  

The majority said OSHA’s standards are meant to regulate workplaces only, and COVID-19 is a public health issue, not just a workplace one. 

“Although COVID-19 is a risk that occurs in many workplaces, it is not an occupational hazard in most. COVID–19 can and does spread at home, in schools, during sporting events, and everywhere else that people gather,” the justices wrote.  

Breyer, in a dissenting opinion joined by Sotomayor and Kagan, blasted the conservative majority for stepping “outside of its competence and without legal basis” to stymie the administration's pandemic mitigation effort. 

The liberal justices argued that the 1970 law that established OSHA clearly authorized the agency’s move. Drawing​ on the statute’s language, they wrote that the virus poses a “grave danger” to employees and that because the disease spreads in shared indoor spaces, “it presents heightened dangers in most workplaces.” 

“It is perverse, given these circumstances, to read the Act’s grant of emergency powers in the way the majority does — as constraining OSHA from addressing one of the gravest workplace hazards in the agency’s history,” Breyer wrote. 

“The Standard protects untold numbers of employees from a danger especially prevalent in workplace conditions,” he continued. “It lies at the core of OSHA’s authority. It is part of what the agency was built for.” 

In a separate unsigned ruling, the court let stand a vaccine mandate for employees at health care facilities that receive federal funding. Four of the court’s more conservative justices dissented. 

The policy, issued by the Department of Health and Human Services (HHS), mandates vaccines for the roughly 17 million health workers at hospitals across the country that receive funding through Medicare and Medicaid. It provides for narrow exemptions on religious and medical grounds. 

The practical effect of the ruling was to reinstate the federal health worker vaccine mandate in roughly half the country, where lower federal courts had blocked it while a challenge by separate groups of GOP-led states plays out.   

The majority ruled that the vaccine requirement fell squarely within the HHS secretary’s authority, as delegated by Congress.  

“Congress has authorized the Secretary to impose conditions on the receipt of Medicaid and Medicare funds that ‘the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services,’” the court wrote, citing a federal statute.

The secretary’s determination that a COVID–19 vaccine mandate would "substantially reduce the likelihood that healthcare workers will contract the virus and transmit it to their patients” thus “fits neatly within the language of the statute,” they wrote.  

Justices Clarence Thomas and Samuel Alito wrote separate dissenting opinions. Thomas and Alito were joined by fellow conservative Justices Neil Gorsuch and Amy Coney Barrett in dissent.

In their opinions, both Thomas and Alito said they would have denied the Biden administration’s request, making clear their view the government failed to establish that it has adequate legal justification for the mandate.  

Alito also faulted the administration for bypassing normal rulemaking procedures, which require a weighing of public reaction and other procedural safeguards.  

“Today’s decision will ripple through administrative agencies’ future decisionmaking. The Executive Branch already touches nearly every aspect of Americans’ lives,” Alito wrote. “In concluding that CMS had good cause to avoid notice-and-comment rulemaking, the Court shifts the presumption against compliance with procedural strictures from the unelected agency to the people they regulate.”

https://thehill.com/policy/healthcare/589633-supreme-court-blocks-bidens-vaccine-or-test-mandate-for-employers

Parkinson's Progression Slower With Sustained Physical Activity

 People with early Parkinson's disease who exercised regularly over 5 years performed better on cognitive testing and had slower disease progression in several domains, an observational cohort study showed.

Regular overall physical activity levels over time were significantly associated with slower deterioration of postural instability and gait scores (β _interaction =-0.10), activities of daily living scores (β _interaction =0.08), and processing speed scores (β _interaction =0.05), reported Kazuto Tsukita, MD, of Kyoto University in Japan, and colleagues.

Moderate-to-vigorous exercise was linked with slower decline in postural and gait stability, while work-related physical activity was tied to slower deterioration in processing speed, they wrote in Neurology. Baseline activity level, however, was not tied to Parkinson's progression.

"We found that to slow progression of the disease, it was more important for people with Parkinson's to maintain an exercise program than it was to be active at the beginning of the disease," Tsukita said in a statement.

"Although medications can provide people with Parkinson's some symptom relief, they haven't been shown to slow the progression of the disease," Tsukita added. "We found that regular physical activity, including household tasks and moderate exercise, may actually improve the course of the disease over the long run."

The findings extend the evidence that activity and exercise improve outcomes and delay disability in Parkinson's, noted Lisa Shulman, MD, of University of Maryland School of Medicine in Baltimore, who wasn't involved with the research.

"An intriguing remaining question is about the mechanism," Shulman told MedPage Today. "Are these benefits in Parkinson's disease related to improvement in various components including endurance, strength, and mobility, or is there a more fundamental effect on the neural extrapyramidal pathways?"

Tsukita and colleagues looked at 237 people with early-stage Parkinson's and a median age of 63 from the Parkinson's Progression Markers Initiative (PPMI), an international longitudinal natural history study. Participants were followed for a median of 5 years.

The PPMI study included longitudinal and comprehensive evaluations of motor function and cognitive function, as well as regular physical activity levels assessed by the Physical Activity Scale for the Elderly (PASE), a self-reported questionnaire measuring time and intensity of leisure, household, and occupational activities. Processing speed was measured with the Symbol Digit Modalities Test.

Participants who engaged in 4 or more hours a week of moderate to vigorous exercise had slower instability and gait decline over 5 years, the researchers found. Those who participated in at least 15.5 hours a week of paid or volunteer work that included physical activity had better processing speed scores over time.

"We believe that our findings have important implications for daily clinical practice and future clinical trials," Tsukita and colleagues observed. "They highlight the importance of supporting patients with Parkinson's disease in daily clinical practice to enable them to maintain their physical activity levels."

"To maintain high physical activity levels for Parkinson's disease patients, it is essential that they themselves are convinced of the benefits of high physical activity levels," the researchers pointed out.

The findings also may guide future randomized controlled trials to demonstrate the disease-modifying effects of exercise in Parkinson's, they added.

The study is observational and causal relationships could not be assessed, Tsukita and colleagues acknowledged. In addition, regular physical activity was quantified using data from the self-reported PASE questionnaire.

Disclosures

Tsukita had no disclosures. Co-authors disclosed relationships with Takeda, Boehringer Ingelheim, Dainippon Sumitomo, Kyowa-Kirin, Eisai, Otsuka, Novartis, Sanofi, Kan Institute, Nihon Medi-physics, Astellas, Abbvie, Mylan, JBO, Sanwa Kagaku, FP Pharma, Tsumura, Kissei, Chugai, and Biogen.

Primary Source

Neurology

Source Reference: Tsukita K, et al "Long-term effect of regular physical activity and exercise habits in patients with early Parkinson disease" Neurology 2022; DOI: 10.1212/WNL.0000000000013218.

https://www.medpagetoday.com/neurology/parkinsonsdisease/96651

Which COVID Outpatient Therapy Should Clinicians Reach For?

 Due to the Omicron variant and the short supply of COVID therapeutics, NIH recommends certain therapies over others for patients at high risk of progressing to severe COVID, said federal officials on a call with clinicians Wednesday.

In order of preference, clinicians should use the oral antiviral nirmatrelvir-ritonavir (Paxlovid), the monoclonal antibody sotrovimab, the IV antiviral remdesivir (Veklury) and finally, the oral antiviral molnupiravir, said Alice Pau, PharmD, of the NIH COVID-19 Treatment Guidelines panel.

While the drugs were ranked from 1 to 4, she noted that nirmatrelvir-ritonavir, sotrovimab, and IV remdesivir three times a day all had similar clinical efficacy, with a relative risk reduction of 88%, 85%, and 87% in hospitalizations and deaths, respectively, versus placebo. However, molnupiravir, with its 30% efficacy, should be used only if the other three choices are not available, Pau noted.

She cited the sweeping changes made to the NIH guidelines for COVID therapies at the end of December, namely due to the fact that bamlanivimab + etesevimab and casirivimab + imdevimab are no longer recommended for outpatients, as the agents have not shown in vitro efficacy against the Omicron variant.

Pau said that while the clinical efficacy of the agents was the most important factor in the panel's recommendations, the logistics of delivering the drugs (taken orally vs IV infusion), duration, populations of interest, and the drug interaction potential also played a role in the panel's reasoning.

For example, she said that nirmatrelvir-ritonavir, sotrovimab, and remdesivir are all authorized or approved for ages 12 and up, while molnupiravir is authorized only for adults ages 18 and up.

Supply of therapeutics has been a problem, although Colin Shepard, MD, CDC liaison to the Office of the Assistant Secretary for Preparedness and Response, said that this week, the federal government provided 100,000 courses of nirmatrelvir-ritonavir, and 400,000 of molnupiravir.

"Given the limited drug supplies, the highest priority should be given to patients with the highest risk of progression to severe disease," Pau said.

She reviewed the patient groups where the drugs can be administered, in order of who might receive the most benefit:

• Immunocompromised people who don't mount a good response to vaccines, unvaccinated adults over age 75, or unvaccinated adults over age 65 with clinical risk factors

• Unvaccinated people under age 65 without risk factors

• Vaccinated adults over age 75 or vaccinated adults over age 65 with risk factors

• Vaccinated adults over age 65 without risk factors or vaccinated adults under age 65 with risk factors

Clinicians were the most interested in nirmatrelvir-ritonavir -- namely that because it contains a course of the protease inhibitor ritonavir, it could lead to the development of HIV resistance. FDA staff noted that patients with HIV who are not on treatment and do not have an undetectable viral load should consult with their healthcare provider when taking nirmatrelvir-ritonavir.

Pau also said the most important step in prescribing nirmatrelvir-ritonavir is determining if there will be any drug/drug interactions, specifically with ritonavir and the patient's current medications. She added that because it is a 5-day course, it's "different than taking the drug chronically."

"Get that list of medications the patient is on, look through them, and see if there's any potential interaction," she noted.

CDC staff also confirmed that there are no data yet on whether patients on antivirals can discontinue isolation sooner, as there has been little research on the effect of antivirals on SARS-CoV-2 transmission.

https://www.medpagetoday.com/infectiousdisease/covid19/96655

MS Risk Skyrockets After Epstein-Barr Virus, but Not Other Infections

 Risk of multiple sclerosis (MS) increased 32-fold after infection with Epstein-Barr virus (EBV) but was unchanged after other viral infections, a longitudinal analysis showed.

Data from more than 10 million U.S. military recruits monitored over a 20-year period -- 955 of whom were diagnosed with incident MS during their service -- showed that MS had a hazard ratio of 32.4 (95% CI 4.3-245.3, P<0.001) with EBV seroconversion compared with persistent EBV seronegativity, reported Alberto Ascherio, MD, DrPH, of the Harvard T.H. Chan School of Public Health, and co-authors in Science.

The findings point to MS as a complication of EBV infection, the researchers noted. "The hypothesis that EBV causes MS has been investigated by our group and others for several years, but this is the first study providing compelling evidence of causality," Ascherio said in a statement.

"This is a big step because it suggests that most MS cases could be prevented by stopping EBV infection, and that targeting EBV could lead to the discovery of a cure for MS," he added.

Multiple strands of evidence indicate the association of EBV infection with MS is causal, noted Gavin Giovannoni, MBBCh, PhD, an academic neurologist at Queen Mary University of London in England, who wasn't involved with the research.

"Now Alberto Ascherio and colleagues show in a large cohort study of young adults in the U.S. military that the risk of multiple sclerosis increased 32-fold after infection with EBV, which was unchanged after infection with other viruses, including cytomegalovirus, a closely related herpesvirus with similar patterns of transmission," Giovannoni told MedPage Today.

"In a new and exciting finding, blood neurofilament light chain levels, a marker of neurodegeneration, were seen to increase in study subjects, but only after EBV infection indicating presymptomatic MS disease onset," he added. "These findings strengthen the causal link between EBV and MS and make a compelling case for an MS prevention study using an EBV vaccine. They also support ongoing trials targeting EBV as a therapeutic strategy to treat MS."

Prior research has found increased serum antibodies to EBV in 99.5% of MS patients and 94% of healthy individuals, observed William Robinson, MD, PhD, and Lawrence Steinman, MD, both of Stanford University, in an accompanying editorial.

"Nearly everyone is infected with EBV, but only a small fraction develop MS," Robinson and Steinman wrote. "Thus, other factors, such as genetic susceptibility, are important in MS pathogenesis."

Mechanisms linking EBV and MS remain elusive, the editorialists pointed out. Molecular mimicry is a possibility, as is EBV transformation of B cells. "In addition, EBV might mediate bystander damage to the axon and its surrounding sheath, or defective clearance of infected B cells," they wrote. "CD8+ T cells specific for EBV lytic proteins are present in MS brain lesions, and a persistent EBV infection in the CNS [central nervous system] might stimulate CD8+ T cell responses that mediate CNS injury."

In their study, Ascherio and colleagues analyzed serum samples taken biennially by the Department of Defense. They determined EBV status at the time of the first sample and the relationship between EBV infection and MS onset during the period of active duty.

Samples came from a racially diverse U.S. military population from 1993 to 2013. Most participants were under 20 at the time of their first blood collection. No participants had an MS diagnosis at baseline. Those who developed MS had symptom onset a median of 5 years after their first EBV-positive sample.

Each incident MS case was matched with two controls without MS of the same age, sex, race or ethnicity, and branch of military service. In total, 801 MS cases and 1,566 controls had samples available to assess EBV status over time.

EBV seropositivity was nearly ubiquitous at the time MS developed; only one of 801 MS cases was EBV seronegative at the time of MS onset.

Levels of serum neurofilament light, an axonal injury biomarker that's not disease-specific, rose after EBV infection in people who were EBV-negative at baseline and went on to develop MS. "There were no signs of neuroaxonal degeneration before EBV seroconversion in individuals who later developed MS, indicating that EBV infection preceded not only symptom onset but also the time of the first detectable pathological mechanisms underlying MS," Ascherio and co-authors wrote.

To assess predispositions to both infections and MS, the researchers also measured antibodies against cytomegalovirus (CMV), a herpesvirus that, like EBV, is transmitted through saliva. Among people who were CMV-negative at baseline, CMV seroconversion occurred at a similar rate in those who later developed MS and those who didn't.

"To explain a 32-fold increase in MS risk, any confounder would have to confer a >60-fold increase in risk of EBV seroconversion and a >60-fold risk of MS," Ascherio and co-authors noted.

"None of the known or suspected risk factors for MS has such strong associations," they added. "The next strongest known risk factor for MS, homozygosity for the HLA-DR15 allele, which confers a threefold increase in MS risk, is not associated with EBV positivity and thus cannot explain the EBV-MS association."

Currently, there's no way to effectively prevent or treat EBV infection, but vaccines against EBV are actively being studied. Last week, Moderna dosed the first participant in the Eclipse clinical trial of its mRNA EBV vaccine candidate. The phase I study will enroll approximately 270 people from around 15 U.S. centers.

Disclosures

This work was supported by the National Institute of Neurological Disorders and Stroke, National Multiple Sclerosis Society, German Research Foundation, and NIH Directors Early Independence Award.

Ascherio declared no competing interests. Co-authors reported relationships with Analysis Group, Bristol Myers Squibb, Verily Life Sciences, Merck-Serono, Novartis, Genzyme, Swiss MS Society, Swiss National Research Foundation, Progressive MS Alliance, Bayer, Biogen, Octave Bioscience, Roche, Sanofi, ImmuneID, Detect, Quantum-SI, TSCAN Therapeutics, MAZE Therapeutics, Mirimus, and Homology Medicines.

Robinson is a co-inventor on a patent application filed by Stanford University that includes antibodies to EBV.

Primary Source

Science

Source Reference: Bjornevik K, et al "Longitudinal analysis reveals high prevalence of Epstein-Barr virus associated with multiple sclerosis" Science 2022; DOI: 10.1126/science.abj8222.

Secondary Source

Science

Source Reference: Robinson WH, Steinman L "Epstein-Barr virus and multiple sclerosis" Science 2022; DOI: 10.1126/science.abm7930.

https://www.medpagetoday.com/neurology/multiplesclerosis/96656

JPM22, Day 4: Vertex aims to be cystic fibrosis leader into the 2030s; Gritstone hopes for new cancer biomarker; Galapagos' rebound year

 We're into the final scheduled day of the annual J.P. Morgan Healthcare Conference.

After a slate of research collaborations defined the first days of the conference, there's still plenty of action to come as companies make their final pitches to their peers, investors and industry-watchers, and look to set the stage for the year ahead.

UPDATED: Thursday 12:49 p.m. ET

Galapagos thinks 2022 will be a rebound year, with potential acquisitions and new leadership in the mix. The biopharma went south last year when it canned a phase 3 asset, ziritaxestat, and ran into speed bumps with its JAK inhibitor, filgotinib, as the FDA tightened its stance on the drug class.

In his final presentation as CEO, Onno van de Stolpe said the company expects to announce a new CEO “in weeks rather than months.” The new leader “has a fantastic legacy,” he said during the annual J.P. Morgan Healthcare Conference on Thursday morning. And, to bolster its later-stage pipeline, Galapagos’ business development team has a “massive” effort in the works to in-license or acquire an “attractive molecule,” the outgoing CEO said.

Thursday 9:49 a.m. ET

Gritstone bio has taken its individualized neoantigen vaccine into a phase 2/3 trial that could support FDA approval in colorectal cancer. Discussing the news at JPM, Gritstone CEO Andrew Allen highlighted the data that supported the progress, revealing that all patients who were alive as of the earlier August cutoff were still alive as of last week. Gritstone has seen the best responses in patients who have a molecular response, as shown by decreased circulating tumor DNA (ctDNA), and expects regulators to ultimately start accepting the biomarker as evidence of efficacy.

“As we get more and more validation data, I think then we’ll start to see regulatory acceptance of ctDNA as a surrogate for efficacy and the basis for approval. We're not there yet. FDA obviously is accepting ctDNA for patient selection, but not yet as a basis for approval. I do believe that's a matter of time, however,” Allen said.

Thursday 8:45 a.m. ET

Vertex Pharmaceuticals thinks it’ll be the leader in cystic fibrosis (CF) “well beyond” this decade and into the 2030s, said President and CEO Reshma Kewalramani at JPM Monday. The reason is threefold, the CEO said: 25,000 patients who are eligible for treatment haven’t received it yet; the drugmaker is in the early launch stage in newly reimbursed countries like the Netherlands and awaits reimbursement in regions like Belgium and Australia; and Vertex aims to reach younger patients, including 2- to 5-year-olds down the road. Aside from its approved drugs, Vertex aims to treat CF with a triple combo that is in phase 3 and is working on an mRNA-based treatment, which hasn’t entered the clinic yet.

Beyond the lung and digestive disorder, Vertex is also working on Type 1 diabetes. One patient, who has had diabetes for decades, was able to produce insulin after receiving Vertex’s cell therapy, dubbed VX880, the company said in October. Now, Vertex said the patient has seen a 92% reduction in daily insulin use as of Day 150, and the safety profile remains unchanged, Kewalramani said.

https://www.fiercebiotech.com/biotech/jpm22-day-4-vertex-aims-to-be-cystic-fibrosis-leader-into-2030s

JPM22, Day 3: Perrigo part of a new landscape; Legend, J&J prep for cilta-cel launch

 It’s day three of the 40th annual J.P. Morgan Healthcare Conference. We’ve already heard about Amgen’s biosimilar ambitions and Gilead Sciences’ long-term HIV strategy, but there’s still plenty of action to come. Be sure to check in throughout the day to get the skinny on all the biggest happenings from the virtual conference.

For instance, today we're hearing about Eli Lilly's plans for its forthcoming diabetes med tirzepatide, Ipsen's dealmaking plans and Bausch Health's progress toward its three-way split.

To look back at Fierce Pharma’s coverage from Day 2, click here. For Day 1, click here. And check out Fierce Biotech’s Day 2 coverage here.

UPDATED: Wednesday, Jan. 12 at 6:55 p.m. ET

The three things that matter in contract manufacturing? Capacity, capacity and capacity. That was a major theme during Samsung Biologics’ presentation, and—recalling that location is important, too—the CDMO touched on expansion opportunities beyond its home base in Korea.

Last year the company achieved all four goals it laid out at 2021’s JPM conference, CEO John Rim said Wednesday. The company hastened the build out of Plant 4, its “Super Plant” in Incheon, South Korea, by six months. Samsung also maximized the use of its factories, branched out into mRNA and cemented its spot near the head of the biosimilar pack, Rim said.

Samsung’s Super Plant will boast a whopping 620,000 liters of capacity when it becomes fully operational, which is expected in the second quarter of next year. An initial 60,000 liters will be available in the fourth quarter of 2022, Rim said. Separately, the company is homing in on a deal for another, larger campus in Korea.

The company has already grown from South Korea to San Francisco, and is “continuing to look at the United States for expansion at this time,” Rim said. Samsung is also eyeing Europe for expansion opportunities.

UPDATED: Wednesday, Jan. 12 at 5:48 p.m. ET

Three years ago, when Perrigo began its transformation into a consumer self-care company, its CEO Murray Kessler often found himself having to spell out what that meant.

“Folks were like, ‘Explain to me what that is. What is self-care?’" Kessler said on Wednesday. “Here we are a few years later and not only are we a top player in consumer self-care, but there’s a new industry, a dedicated and focused industry that is formed.”

With Johnson & Johnson spinning out a new publicly traded company to handle its consumer health business, mirroring similar moves by Merck, Sanofi, GlaxoSmithKline and Pfizer, there has become more awareness of this sector in a short time.

There’s also an understanding that these businesses can operate more efficiently by themselves. In this new environment, Perrigo is a “top seven player,” on a net sales basis, Kessler points out.

“This is exciting to us because with this focus of these companies will come many opportunities in new products,” Kessler said.

UPDATED: Wednesday, Jan. 12 at 5:28 p.m. ET

After a false start in Europe, bluebird bio is eager to push its trio of gene therapies out of the nest in the U.S., CEO Andrew Obenshain said. First up is the beta-thalassemia therapy beti-cel, which the FDA is expected to rule on in May. Next comes eli-cel in cerebral adrenoleukodystrophy, with a regulatory verdict slated for June. Finally, by the first quarter of next year, bluebird plans to submit lovo-cel for sickle cell disease, where the company foresees blockbuster potential.

All told, there are upward of 22,000 U.S. patients that bluebird could reach with its gene therapy trio. The company will start by targeting roughly 1,500 people with beta-thalassemia to lay the groundwork for subsequent product debuts. To prepare for that launch, bluebird is building treatment centers, dispensing gene therapy education, rolling out a patient support program and talking coverage with payers, Obenshain said.

The plan, then, is to use that beta thalassemia bedrock in pursuit of some 20,000 severe patients with sickle cell disease in 2023. While beta thalassemia and sickle cell are two “very different diseases,” there’s significant prescriber overlap, and 100% of bluebird’s beta thalassemia treatment centers are expected to become sickle cell treatment centers, too, Obenshain said.

UPDATED: Wednesday, Jan. 12 at 3:01 p.m. ET

Legend Biotech is prepping its Johnson & Johnson-partnered, “paradigm shifting” CAR-T multiple myeloma treatment cilta-cel for launch with a global manufacturing operation, which CEO Ying Huang, Ph.D., hopes will avoid the supply challenges suffered by companies that have come before them in cell therapy.

Cilta-cel is ready to go as soon as the FDA gives its OK, which is expected in February. Thousands of staff and a global manufacturing operation built out with partner J&J are standing by to roll out the blood cancer CAR-T therapy, Huang said at the annual J.P. Morgan Healthcare Conference. The company is is determined not to have the same supply challenges as Bristol Myers, Novartis, Gilead Sciences and others in the field. Story

UPDATED: Wednesday, Jan. 12 at 12:45 p.m. ET

Bausch Health has done the legwork necessary to split into three companies, CEO Joe Papa said on Wednesday. As previously announced, Bausch will separate from its medical aesthetics sector as Solta and its eye health business as Bausch & Lomb. When the market conditions dictate, Papa said, Bausch will file with the SEC to take those companies public.

“We can do them in either order,” said Papa, who declined to say which would go first. “We want to make sure we do what’s right for each of those businesses respectively.”

A major goal of the initiative is to reduce the debt the company incurred during its troubled era when it was known as Valeant Pharmaceuticals. Since Papa took over as CEO in 2016, the company has reduced its debt by $10 billion, but there’s still $20 billion to go.

Proceeds from the IPOs will help draw down the debt, Papa said. Nothing is written in stone however. The company has done $4 billion worth of divestment under Papa and could do the more if the right deal comes along.

“We’re looking at all the things public companies have to do to be successful,” Papa said. “We’re always open to options that will create shareholder value, which may include divestitures that add an appropriate premium price.”

UPDATED: Wednesday, Jan. 12 at 9 a.m. ET

Ipsen is targeting €3 billion in dealmaking firepower by 2024, Craig Marks, the company’s vice president of investor relations said during JPM. The number could grow further as the French pharma is in the process of a strategic review of its consumer health unit, which could reportedly be valued at $500 million in the case of a potential sale.

Buying or in-licensing external innovations is a key strategy of Ipsen. The company is Exelixis’ ex-U.S. partner for Cabometyx, which expects phase 3 readout for a combination with Roche’s PD-L1 inhibitor Tecentriq in second-line non-small cell lung cancer in the second half of 2022.

Last year, Ipsen completed seven transactions across oncology, rare disease and neuroscience, including paying  €120 million upfront for global rights to Genfit’s phase 3 asset elafibranor for primary biliary cholangitis.

Moving forward, Ipsen will continue to look for deals across the development stages, including for programs with unblinded phase 3 data or even marketed products, in those three therapeutic areas, Marks said. The company is also looking to beef up its U.S. presence through dealmaking.

UPDATED: Wednesday, Jan. 12 at 8:15 a.m. ET

Could Eli Lilly divide upcoming diabetes hopeful tirzepatide into multiple brands? It’s possible, Lilly CEO David Ricks hinted at the 2022 J.P. Morgan Healthcare Conference. The move wouldn’t be unprecedented: Lilly’s Danish rival Novo Nordisk already splits its injectable GLP-1 med semaglutide into two separate brands: Ozempic for diabetes and Wegovy for obesity. “We’re having those discussions,” Ricks said when asked about a two-brand strategy, adding that he sees pros and cons "on all sides."

The strategy made sense in the past because there was “a pretty different market for those obesity treatments than diabetes,” Ricks said. Previously, payers have been more willing to pay for diabetes drugs at a price point they wouldn’t approach for obesity. Ricks, for his part, sees payers becoming “much more interested in treating obesity,” which in turn could help lower the risks of cardiovascular disease, diabetes, joint problems and a plethora of other complications. Story

https://www.fiercepharma.com/pharma/jpm22-day-3-eli-lilly-weighs-dual-branding-for-diabetes-hopeful-tirzepatide