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Wednesday, July 28, 2021

Glaxo sees smaller 2021 profit fall after Q2 beat

 

GSK forecast a smaller drop in 2021 profit on Wednesday as the drugmaker beat second-quarter earnings expectations, buoyed by a recovery in routine visits to doctors as pandemic restrictions ease.

The British company, which is spinning off its consumer health arm to focus on improving its pharmaceuticals business, said it made adjusted earnings per share (EPS) of 28.1 pence in the three months to the end of June on sales of 8.1 billion pounds ($11.2 billion).

Analysts had on average expected adjusted EPS of 19.9 pence on turnover of 7.56 billion pounds, according to a company-compiled consensus https://www.gsk.com/en-gb/investors/analyst-consensus/analyst-consensus.

"We expect this positive momentum to continue through the second half of the year driving us towards the better end of our earnings guidance range for 2021, and meaningful performance improvement in 2022," CEO Emma Walmsley said in a statement.

The world's biggest vaccines maker by sales has forecast adjusted EPS will decline by a mid to high-single digit percentage this year.

GSK shares, which lost a quarter of their value in 2020, were up 1.4% to 1,419 pence at 1125 GMT.

Pressure to show sustainable growth has mounted on Walmsley after years of underperformance at the pharmaceuticals business. The company has also locked horns with activist investor Elliott over its future after the spin-off next year.

GSK said it made 258 million pounds of quarterly sales from its adjuvant used to boost the effectiveness of COVID-19 vaccines.

But it added that while immunisation campaigns were making progress, there remained uncertainty over the impact of the pandemic and sales of key shingles vaccine Shingrix were recovering more slowly than expected outside the United States.

As a result, it forecast revenues from vaccines over the full year would be broadly flat.

https://www.marketscreener.com/news/latest/GSK-sees-smaller-2021-profit-fall-after-Q2-beat--35986497/

Pfizer raises 2021 COVID-19 vaccine sales forecast to $33.5B

 

Pfizer Inc on Wednesday raised its full-year sales forecast for the COVID-19 vaccine it developed with Germany's BioNTech by 29% to $33.5 billion, as nations stock up on doses for the rest of the year.

The company also said it could apply for an emergency use authorization for a potential booster dose as early as August, reiterating that a third shot will likely be needed to enhance protection amid a resurgence in infections in many countries.

New early data showed that a third dose generated virus-neutralizing antibodies more than 5 times higher in younger people and more than 11 times higher in older people than from two doses, Pfizer said.

Pfizer shares were up 2% at $42.98 in morning trading.

The drugmaker, whose shot was authorized in the United States, Europe and other regions around the world in December of 2020, has won new orders as rivals such as AstraZeneca and Johnson & Johnson have faced manufacturing and safety hurdles.

Pfizer also competes with U.S. mRNA vaccine maker Moderna Inc, which has not been able to scale up production as quickly as its much larger rival.

"Worldwide demand for vaccines against the virus is expected to continue and the generally positive attitude towards Pfizer's vaccine ... puts the company in a strong position to benefit going forward," said uk.Investing.com analyst Samuel Indyk.

The updated sales forecast is based on signed deals for 2.1 billion doses. The forecast could be raised again if Pfizer signs additional contracts.

J&J last week estimated full-year COVID-19 vaccine sales of $2.5 billion, while Moderna has forecast $19.2 billion.

Pfizer said it has shipped 1 billion doses of the vaccine since December. The companies have a production target of around 3 billion doses this year.

The production ramp-up is subject to expansion at current facilities, adding new suppliers and contract manufacturers, the company said. Pfizer records most of the combined sales from the vaccine, and splits expenses and profit 50-50 with its German partner.

Pfizer and BioNTech plan next month to test a version of the vaccine specifically designed to take on the fast-spreading Delta variant, with the first batch already manufactured, Pfizer said. The more easily transmissible variant now accounts for more than 80% of new U.S. COVID-19 cases and has also become dominant in many other countries.

Pfizer raised its estimates for overall full-year profit, with strong sales of blood thinner Eliquis, which it shares with Bristol Myers Squibb, and cancer drug Ibrance.

The vaccine is helping drive a large part of the company's forecast, but Pfizer's base business is also growing, said Mizuho analyst Vamil Divan.

Pfizer now expects full-year adjusted profit of $3.95 to $4.05 per share, up from its prior forecast of $3.55 to $3.65.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Pfizer-raises-2021-COVID-19-vaccine-sales-forecast-to-33-5-billion-35985981/

Bluebird Bio, Resilience to Develop Next Gen Cell Therapies

 Resilience to acquire bluebird’s clinical and commercial suspension lentiviral vector manufacturing facility in North Carolina, retaining all current employees at the site

Alliance designed to foster best in class cell therapy product and manufacturing innovation through risk-sharing and royalty-based model

bluebird to receive $110M upfront, preferred LVV manufacturing access and significantly reduce operational expenses over coming years

https://finance.yahoo.com/news/bluebird-bio-resilience-announce-strategic-120000678.html

LivaNova Reports Second Quarter 2021 Results

 LivaNova PLC (NASDAQ: LIVN), a market-leading medical technology and innovation company, today reported results for the quarter ended June 30, 2021.

For the second quarter of 2021, worldwide sales from continuing operations were $264.5 million, an increase of 45.2 percent on a reported basis and 41.0 percent on a constant-currency1 basis, as compared to the same quarter of the previous year. Worldwide sales from continuing operations for the second quarter of 2021, excluding sales related to the Heart Valves business that was divested effective June 1 as part of the initial closing, were $249.8 million, an increase of 51.6 percent on a reported basis and 47.6 percent on a constant-currency1 basis, as compared to the same quarter of the previous year. On the basis of U.S. Generally Accepted Accounting Principles (GAAP), second quarter 2021 diluted loss per share from continuing operations was $1.13. Second quarter 2021 adjusted diluted earnings per share from continuing operations was $0.52.

"As we navigate shifting market dynamics resulting from the pandemic, we continue to gain momentum in Epilepsy sales growth across all regions," said Damien McDonald, Chief Executive Officer of LivaNova. "Procedure volumes in Neuromodulation continue to recover, especially replacement implant volumes. Across our businesses, certain countries in our Europe and Rest of World regions remain challenged by COVID-19. Looking ahead, we are focused on delivering critical medical devices and therapies to significant patient populations, while managing our core businesses to drive profitability and cash generation. We also remain committed to investing in our pipeline and taking the appropriate actions to position our business for long-term growth."

https://finance.yahoo.com/news/livanova-reports-second-quarter-2021-100000371.html

Tuesday, July 27, 2021

Modeling 'true prevalence' of COVID-19 throughout pandemic

 Government officials and policymakers have tried to use numbers to grasp COVID-19's impact. Figures like the number of hospitalizations or deaths reflect part of this burden. Each datapoint tells only part of the story. But no one figure describes the true pervasiveness of the novel coronavirus by revealing the number of people actually infected at a given time -- an important figure to help scientists understand if herd immunity can be reached, even with vaccinations.

Now, two University of Washington scientists have developed a statistical framework that incorporates key COVID-19 data -- such as case counts and deaths due to COVID-19 -- to model the true prevalence of this disease in the United States and individual states. Their approach, published the week of July 26 in the Proceedings of the National Academy of Sciences, projects that in the U.S. as many as 60% of COVID-19 cases went undetected as of March 7, 2021, the last date for which the dataset they employed is available.

This framework could help officials determine the true burden of disease in their region -- both diagnosed and undiagnosed -- and direct resources accordingly, said the researchers.

"There are all sorts of different data sources we can draw on to understand the COVID-19 pandemic -- the number of hospitalizations in a state, or the number of tests that come back positive. But each source of data has its own flaws that would give a biased picture of what's really going on," said senior author Adrian Raftery, a UW professor of sociology and of statistics. "What we wanted to do is to develop a framework that corrects the flaws in multiple data sources and draws on their strengths to give us an idea of COVID-19's prevalence in a region, a state or the country as a whole."

Data sources can be biased in different ways. For example, one widely cited COVID-19 statistic is the proportion of test results in a region or state that come back positive. But since access to tests, and a willingness to be tested, vary by location, that figure alone cannot provide a clear picture of COVID-19's prevalence, said Raftery.

Other statistical methods often try to correct the bias in one data source to model the true prevalence of disease in a region. For their approach, Raftery and lead author Nicholas Irons, a UW doctoral student in statistics, incorporated three factors: the number of confirmed COVID-19 cases, the number of deaths due to COVID-19 and the number of COVID-19 tests administered each day as reported by the COVID Tracking Project. In addition, they incorporated results from random COVID-19 testing of Indiana and Ohio residents as an "anchor" for their method.

The researchers used their framework to model COVID-19 prevalence in the U.S. and each of the states up through March 7, 2021. On that date, according to their framework, an estimated 19.7% of U.S. residents, or about 65 million people, had been infected. This indicates that the U.S. is unlikely to reach herd immunity without its ongoing vaccination campaign, Raftery and Irons said. In addition, the U.S. had an undercount factor of 2.3, the researchers found, which means that only about 1 in 2.3 COVID-19 cases were being confirmed through testing. Put another way, some 60% of cases were not counted at all.

This COVID-19 undercount rate also varied widely by state, and could have multiple causes, according to Irons.

"It can depend on the severity of the pandemic and the amount of testing in that state," said Irons. "If you have a state with severe pandemic but limited testing, the undercount can be very high, and you're missing the vast majority of infections that are occurring. Or, you could have a situation where testing is widespread and the pandemic is not as severe. There, the undercount rate would be lower."

In addition, the undercount factor fluctuated by state or region as the pandemic progressed due to differences in access to medical care among regions, changes in the availability of tests and other factors, Raftery said.

With the true prevalence of COVID-19, Raftery and Irons calculated other useful figures for states, such as the infection fatality rate, which is the percentage of infected people who had succumbed to COVID-19, as well as the cumulative incidence, which is the percentage of a state's population who have had COVID-19.

Ideally, regular random testing of individuals would show the level of infection in a state, region or even nationally, said Raftery. But in the COVID-19 pandemic, only Indiana and Ohio conducted random viral testing of residents, datasets that were critical in helping the researchers develop their framework. In the absence of widespread random testing, this new method could help officials assess the true burden of disease in this pandemic and the next one.

"We think this tool can make a difference by giving the people in charge a more accurate picture of how many people are infected, and what fraction of them are being missed by current testing and treatment efforts," said Raftery.

The research was funded by the National Institutes of Health.


Story Source:

Materials provided by University of Washington. Original written by James Urton. Note: Content may be edited for style and length.


Journal Reference:

  1. Nicholas J. Irons, Adrian E. Raftery. Estimating SARS-CoV-2 infections from deaths, confirmed cases, tests, and random surveysProceedings of the National Academy of Sciences, 2021; 118 (31): e2103272118 DOI: 10.1073/pnas.2103272118

New cell therapy approach shows potential against solid tumors with KRAS mutations

 A new technology for cellular immunotherapy developed by Abramson Cancer Center researchers at Penn Medicine showed promising anti-tumor activity in the lab against hard-to-treat cancers driven by the once-considered "undruggable" KRAS mutation, including lung, colorectal, and pancreatic.

The study, published online in Nature Communicationssuccessfully demonstrated using human cells that a T-cell receptor, or TCR, therapy could be designed to mobilize an immune system attack on mutated KRAS solid tumors and shrink them. The preclinical work has laid the groundwork for the first-in-human clinical trial now in the planning stages for the treatment of advanced pancreatic cancer in patients whose tumors harbor specific KRAS mutations and express a specific type of human leukocyte antigen, or HLA, the therapy is built to recognize.

"We've shown that targeting mutant KRAS immunologically is feasible and potentially generalizable for a group of patients with lung, colorectal and pancreatic tumors," said senior author Beatriz M. Carreno, PhD, an associate professor of Pathology and Laboratory Medicine in the Perelman School of Medicine at the University of Pennsylvania and a member of the Center for Cellular Immunotherapies, the Abramson Cancer Center, and Parker Institute for Cancer Immunotherapy at Penn. "We look forward to taking this research to the next level and closer to clinical study."

KRAS mutations are among the most prevalent mutations observed in cancers and have been shown to drive tumor development and growth. Only recently have targeted therapies been shown to successfully treat a specific KRAS mutation found most commonly in lung cancer; however, no treatments currently exist for the majority of other KRAS mutations more prevalent in other tumor types. Immunological targeting of mutant KRAS represents an alternative treatment approach but has been less studied and understood.

Using a multiomics approach, the Penn team identified specific neoantigens associated with mutations at the G12 site on the KRAS gene. Neoantigens are protein fragments that form on the cancer cell surface when certain mutations occur in tumor DNA. More than 75 percent of the alterations in the KRAS protein occur at G12, making it an ideal site to target with therapies.

Armed with this knowledge, the researchers tested a TCR therapy directed toward specific KRAS G12 mutations present in conjunction with particular HLA types highly prevalent among patients. They showed in a mouse tumor model that it was effective at attacking and eliminating tumor cells. HLAs are an important part of the immune system because they encode cell surface molecules that present specific neoantigens to the T-cell receptors on T cells.

In other words, HLAs are key genetic codes needed for these engineered T cells to find and attack tumors.

The research further supports the use of neoantigens for targeting tumor cells, for both cellular therapy and cancer vaccines, which have been underway at Penn Medicine and elsewhere.

Importantly, the neoantigen and HLA information from this latest study is being used to develop TCR therapies to treat solid tumors, as well as new cancer vaccines. Based off these latest findings, the team initiated a vaccine clinical trial led by Mark O'Hara, MD, an assistant professor of Hematology-Oncology at Penn and co-author on the study, in pancreatic cancer targeting mutated KRAS.

The first clinical trial for the TCR therapy is projected to launch as soon as 2022, depending on regulatory approval, at Penn's Abramson Cancer Center for patients with advanced pancreatic cancer who have both the KRAS mutation and specific HLA types identified in this latest study -- which could represent up to 10 percent of patients with pancreatic cancer. The study opens the door, however, to expand the patient population as researchers continue to discover more about the neoantigens derived from regions of the KRAS gene and other mutated oncogenes implicated in driving cancer.

"We provide evidence that this oncogenic protein is a very promising clinical target of immune-based therapies," said lead author Adham Bear, MD, PhD, an instructor in the division of Hematology-Oncology at Penn and member of the Parker Institute for Cancer Immunotherapy at Penn. "The goal, now that we have identified these neoantigens and T cell receptors, is to translate these findings and apply them to develop new therapies at Penn."

The study was supported by the National Institutes of Health (R01 CA204261, P30 CA016520, CA196539 and CA232568), The Stand Up to Cancer/Lustgarten Foundation Pancreatic Cancer Collective, the Penn Institute for Immunology, and the Parker Institute for Cancer Immunotherapy.


Story Source:

Materials provided by University of Pennsylvania School of MedicineNote: Content may be edited for style and length.


Journal Reference:

  1. Adham S. Bear, Tatiana Blanchard, Joseph Cesare, Michael J. Ford, Lee P. Richman, Chong Xu, Miren L. Baroja, Sarah McCuaig, Christina Costeas, Khatuna Gabunia, John Scholler, Avery D. Posey, Mark H. O’Hara, Anze Smole, Daniel J. Powell, Benjamin A. Garcia, Robert H. Vonderheide, Gerald P. Linette, Beatriz M. Carreno. Biochemical and functional characterization of mutant KRAS epitopes validates this oncoprotein for immunological targetingNature Communications, 2021; 12 (1) DOI: 10.1038/s41467-021-24562-2

Global dementia cases forecasted to triple by 2050

 Positive trends in global education access are expected to decrease dementia prevalence worldwide by 6.2 million cases by the year 2050. Meanwhile, anticipated trends in smoking, high body mass index and high blood sugar are predicted to increase prevalence by nearly the same number: 6.8 million cases. Both according to new global prevalence data reported at the Alzheimer's Association International Conference® (AAIC®) 2021 in Denver and virtually.

With these forecasts incorporated, researchers with the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine reported at AAIC 2021 that they estimate the number of people with dementia will nearly triple to more than 152 million by 2050. The highest increase in prevalence is projected to be in eastern sub-Saharan Africa, North Africa and the Middle East.

"Improvements in lifestyle in adults in developed countries and other places -- including increasing access to education and greater attention to heart health issues -- have reduced incidence in recent years, but total numbers with dementia are still going up because of the aging of the population," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer. "In addition, obesity, diabetes and sedentary lifestyles in younger people are rising quickly, and these are risk factors for dementia."

The U.S. National Institute on Aging estimates people over the age of 65 will make up 16% of the world's population by 2050 -- up from 8% in 2010.

Also reported at AAIC 2021 were two other prevalence/incidence studies. Key findings include:

  • Each year, an estimated 10 in every 100,000 individuals develop dementia with early onset (prior to age 65). This corresponds to 350,000 new cases of early onset dementia per year, globally.
  • From 1999 to 2019, the U.S. mortality rate from Alzheimer's in the overall population significantly increased from 16 to 30 deaths per 100,000, an 88% increase.
  • Among all areas of the U.S., mortality rates for Alzheimer's were highest in rural areas in the East South Central region of the U.S., where the death rate from Alzheimer's is 274 per 100,000 in those over 65.

Global Prevalence of Dementia Expected to Grow Rapidly through 2050

To more accurately forecast global dementia prevalence and produce country-level estimates, Emma Nichols, MPH, a researcher with the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine, and colleagues leveraged data from 1999 to 2019 from the Global Burden of Disease (GBD) study, a comprehensive set of estimates of health trends worldwide. This study also aimed to improve on prior forecasts by incorporating information on trends in dementia risk factors.

Nichols and team found dementia would increase from an estimated 57.4 (50.4 to 65.1) million cases globally in 2019 to an estimated 152.8 (130.8 to 175.6) million cases in 2050. The highest increases were observed in eastern sub-Saharan Africa, North Africa and the Middle East. Their analysis suggested that projected increases in cases could largely be attributed to population growth and aging, although the relative importance of these two factors varied by world region.

What's more, Nichols and team forecasted dementia prevalence attributable to smoking, high body mass index (BMI) and high fasting plasma glucose using the expected relationship between these risk factors and dementia prevalence. They found an increase of 6.8 million dementia cases globally between 2019 and 2050 due specifically to expected changes in these risk factors. Separately and conversely, the researchers found that expected changes in education levels will lead to a decline in dementia prevalence of 6.2 million individuals globally between 2019 and 2050. Taken together, these opposing trends come close to balancing each other out.

"These estimates will allow policymakers and decision makers to better understand the expected increases in the number of individuals with dementia as well as the drivers of these increases in a given geographical setting," Nichols said. "The large anticipated increase in the number of individuals with dementia emphasizes the vital need for research focused on the discovery of disease-modifying treatments and effective low-cost interventions for the prevention or delay of dementia onset."

Recently published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, Nichols and team used the same data set to estimate that Alzheimer's mortality rates increased by 38.0% between 1990 and 2019.

"Without effective treatments to stop, slow or prevent Alzheimer's and all dementia, this number will grow beyond 2050 and continue to impact individuals, caregivers, health systems and governments globally," Carrillo said. "In addition to therapeutics, it's critical to uncover culturally-tailored interventions that reduce dementia risk through lifestyle factors like education, diet and exercise."

The Alzheimer's Association U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a two-year clinical trial to evaluate whether lifestyle interventions that simultaneously target many risk factors protect cognitive function in older adults who are at increased risk for cognitive decline.

Incidence Estimates for Younger Onset Dementia Suggest 350,000 New Cases per Year

Data on younger-onset dementia (YOD), a form of dementia where the onset of symptoms happens before age 65, is extremely limited. To better understand the incidence of YOD, Stevie Hendriks, M.Sc., student at Maastricht University in the Netherlands, and colleagues conducted a systematic literature review of all studies published during the past 30 years that reported figures on how many people developed dementia before the age of 65.

Hendriks and team found that, overall, the global incidence rate was 10 new cases each year per 100,000 persons. They also found incidence increases with age. This suggests that around 350,000 people worldwide develop younger-onset dementia every year. Incidence rates for men and women were similar, and were highest for Alzheimer's disease, followed by vascular dementia and frontotemporal dementia.

"Our findings should raise awareness in healthcare professionals, researchers and policy makers because they show that a significant number of people are newly affected by young-onset dementia every year," Hendriks said. "This shows the need for investment in tailored healthcare for this special patient group and more research into how we can best support but also prevent and treat young-onset dementia."

"People living with younger-onset Alzheimer's face unique challenges when it comes to diagnosis, family, work, finances, future care and -- with the recent FDA action -- possible treatment options. But support and information is available," said Kristen Clifford, Alzheimer's Association chief program officer. "And you have the power to make a new plan and determine how you choose to live your best life with the disease."

Rural Areas of American South Experience Disproportionate Burden of Alzheimer's Mortality

Even though average lifespan has been steadily increasing over the past several decades in the U.S., there is an increasing divergence in mortality rates among urban and rural populations. This discrepancy is likely the result of many health disparities experienced by rural residents compared to their urban counterparts, including lower socio-economic status, higher levels of chronic disease, limited availability of internet services, and less access to health services including primary care.

To specifically understand geographic variations in Alzheimer's disease mortality, Ambar Kulshreshtha, M.D., Ph.D., from Emory University, and colleagues used data from the National Center for Health Statistics to examine trends in Alzheimer's death rates between 1999 and 2019 by urbanization levels.

Kulshreshtha and team found that, from 1999 to 2019, the mortality rate from Alzheimer's in the overall population significantly increased from 16 to 30 deaths per 100,000, an 88% increase. Rural areas across the United States were shown to have higher mortality rates from Alzheimer's compared to urban areas. Those rates were highest in rural areas in the East South Central region at 274 per 100,000 in those 65 years and older, more than three times that of urban areas in the mid-Atlantic region in which mortality rates were the lowest.

"Our work shows that there is an increasing discrepancy in Alzheimer's mortality between urban and rural areas. This discrepancy could be related to, or might be the result of, other urban-rural health disparities, including access to primary care and other health services, socio-economic level, time to diagnosis, and the rising proportion of older Americans living in these areas," Kulshreshtha said. "Identifying and understanding the reasons for these health disparities is critical for allocating key social and public health resources appropriately."

This study was partially funded by the Alzheimer's Association.


Story Source:

Materials provided by Alzheimer's AssociationNote: Content may be edited for style and length.


Journal Reference:

  1. Emma Nichols, Theo Vos. Estimating the global mortality from Alzheimer’s disease and other dementias: A new method and results from the Global Burden of Disease study 2019Alzheimer's & Dementia, 2020; 16 (S10) DOI: 10.1002/alz.042236