Vertex poised for shopping spree, still unclear just what

 After setting the tone at JP Morgan for a busy year of dealmaking, Reshma Kewalramani and her Vertex crew are giving slightly more shape to the pipeline they want to build with $6.7 billion in cash — but leaving much to be speculated.

Through it all, the freshman CEO says, Vertex will remain “a company that is about specialty markets” — and emphatically not a rare disease player.

Geoff Porges at SVB Leerink, though, sees the drive to introduce new drugs to the pipeline more driven by necessity than anything else. The company, according to him, is avoiding key questions while exposing “inconsistencies between their portfolio and their strategy.”

(T)he company’s success is catching up with them, in terms of the burden of having to diversify their business and add to their pipeline,” he wrote in a note. “Notwithstanding the company’s catchphrases of ‘cracking the biology’ and ‘pouring on the chemistry’, their most advanced program is CTX-001 which is an allogeneic stem therapy treatment for sickle cell disease and beta thalassemia. Another of their handful of clinical programs is their pancreatic islet cell transplant therapy for type I diabetes (entering clinic 1H 21).”

Rather than specifics, she offered some “color and texture” behind capital allocation: Compared to three years ago, Vertex molecules are in patients across six disease areas (up from just two, cystic fibrosis and pain) and revenue has grown from a little north of $2 billion to more than $6 billion.

As she suggested at JPM, it all backs up a search for mid-to late-stage assets alongside new tools:

I want to be very clear that the strategy is exactly the same what I outlined previously. And if I just focus in on the assets that fit our R&D strategy, we are now able to look at, for example, Phase 2 assets, assets that might be in Phase 3, and those are assets that we’re going to look at. We’re also going to continue to look at tools for our toolkit. I’m not looking at — I have no preconceived notions about the timing of a transaction and I have no preconceived notions about the dollar amount of a transaction. It has to fit our R&D strategy. It has to be transformative. We have to be able to add value. And, when we find that asset, and we have the patience and the judgment to be very thoughtful about that, we’re going to be ready to evaluate.

The execs also dodged a question on whether there is any platform tech that they don’t already have but would be interested in.

They have already dipped their toes into some of the hottest pools, including gene therapy, gene editing, mRNA, protein degradation and small molecule approaches for drugging RNA. “And you will continue to see us do deals and partnerships where there’s a particular technology that opens up a target that we think has transformational potential, and we’ll continue to do those as time goes on,” was as far as R&D chief David Altshuler was willing to go.

For now, at least.

https://endpts.com/vertex-is-poised-for-a-shopping-spree-but-its-still-unclear-just-what-might-go-into-their-basket-and-at-least-one-analyst-is-getting-impatient/

Genesis HealthCare Resident, Staff COVID-19 Vaccine Acceptance Rates

 Genesis HealthCare, (“Genesis” or “Company”) (NYSE: GEN), one of the largest post-acute care providers in the United States, announced today that 84% of its skilled nursing residents and 61% of skilled nursing staff members have been vaccinated, each receiving their first dose of the COVID-19 vaccine, through January 29, 2021. Staff vaccine acceptance rates far exceed the national average, and resident acceptance rates at Genesis skilled nursing centers were also above the national average, based on vaccine administration data in an analysis published by the Centers for Disease Control and Prevention (CDC).

On February 1, 2021, the CDC announced that “among 11,460 SNFs with at least one vaccination clinic conducted during the first month of the CDC Pharmacy Partnership for Long-Term Care Program, a median of 77.8% of residents and 37.5% of staff members received ≥1 vaccine dose through the program.”

“I am so extraordinarily proud of the progress our centers have made vaccinating both residents and staff,” states Dr. Richard Feifer, Chief Medical Officer of Genesis. “Our leadership team, clinicians, physicians and advanced practice providers have been working around the clock to educate patients, residents, staff and families about the importance of being vaccinated, and to answer every point of hesitancy or concern with a combination of compassion and factual information. These acceptance rates are a testament to the hard work and dedication our leadership and center staff have shown throughout this entire pandemic. We are not done yet, and continue our work to increase vaccination rates even higher.”

As of January 21, 2021, 100% of Genesis skilled nursing facilities received dose one of the vaccine, primarily utilizing CVS Health, our primary partner through the Pharmacy Partnership for Long Term Care program. Genesis facilities were among the first to begin vaccinations in nursing homes, beginning on December 17, 2020. After the first clinic, the pharmacists return three to four weeks later to administer the second booster shots for those who received the vaccine in round one, and will also vaccinate anyone not included in round one. The pharmacists will then return for a third time, three to four weeks after round two, to administer the final booster shots. Genesis skilled nursing facilities are approximately 67% through their second clinics.

https://www.streetinsider.com/Globe+Newswire/Genesis+HealthCare+Announces+Resident+and+Staff+COVID-19+Vaccine+Acceptance+Rates/17905589.html

COVID-19 lockdowns temporarily raised global temperatures

 The lockdowns and reduced societal activity related to the COVID-19 pandemic affected emissions of pollutants in ways that slightly warmed the planet for several months last year, according to new research led by the National Center for Atmospheric Research (NCAR).

The counterintuitive finding highlights the influence of airborne particles, or aerosols, that block incoming sunlight. When emissions of aerosols dropped last spring, more of the Sun's warmth reached the planet, especially in heavily industrialized nations, such as the United States and Russia, that normally pump high amounts of aerosols into the atmosphere.

"There was a big decline in emissions from the most polluting industries, and that had immediate, short-term effects on temperatures," said NCAR scientist Andrew Gettelman, the study's lead author. "Pollution cools the planet, so it makes sense that pollution reductions would warm the planet."

Temperatures over parts of Earth's land surface last spring were about 0.2-0.5 degrees Fahrenheit (0.1-0.3 degrees Celsius) warmer than would have been expected with prevailing weather conditions, the study found. The effect was most pronounced in regions that normally are associated with substantial emissions of aerosols, with the warming reaching about 0.7 degrees F (0.37 C) over much of the United States and Russia.

The new study highlights the complex and often conflicting influences of different types of emissions from power plants, motor vehicles, industrial facilities, and other sources. While aerosols tend to brighten clouds and reflect heat from the Sun back into space, carbon dioxide and other greenhouse gases have the opposite effect, trapping heat near the planet's surface and elevating temperatures.

Despite the short-term warming effects, Gettelman emphasized that the long-term impact of the pandemic may be to slightly slow climate change because of reduced emissions of carbon dioxide, which lingers in the atmosphere for decades and has a more gradual influence on climate. In contrast, aerosols - the focus of the new study - have a more immediate impact that fades away within a few years.

The study was published in Geophysical Research Letters. It was funded in part by the National Science Foundation, NCAR's sponsor. In addition to NCAR scientists, the study was co-authored by scientists at Oxford University, Imperial College, and the University of Leeds.

Teasing out the impacts

Although scientists have long been able to quantify the warming impacts of carbon dioxide, the climatic influence of various types of aerosols - including sulfates, nitrates, black carbon, and dust - has been more difficult to pin down. One of the major challenges for projecting the extent of future climate change is estimating the extent to which society will continue to emit aerosols in the future and the influence of the different types of aerosols on clouds and temperature.

To conduct the research, Gettelman and his co-authors used two of the world's leading climate models: the NCAR-based Community Earth System Model and a model known as ECHAM-HAMMOZ, which was developed by a consortium of European nations. They ran simulations on both models, adjusting emissions of aerosols and incorporating actual meteorological conditions in 2020, such as winds.

This approach enabled them to identify the impact of reduced emissions on temperature changes that were too small to tease out in actual observations, where they could be obscured by the variability in atmospheric conditions.

The results showed that the warming effect was strongest in the mid and upper latitudes of the Northern Hemisphere. The effect was mixed in the tropics and comparatively minor in much of the Southern Hemisphere, where aerosol emissions are not as pervasive.

Gettelman said the study will help scientists better understand the influence of various types of aerosols in different atmospheric conditions, helping to inform efforts to minimize climate change. Although the research illustrates how aerosols counter the warming influence of greenhouse gases, he emphasized that emitting more of them into the lower atmosphere is not a viable strategy for slowing climate change.

"Aerosol emissions have major health ramifications," he said. "Saying we should pollute is not practical."

###

About the article

Title: "Climate Impacts of COVID-19 Induced Emission Changes"
Authors: A. Gettelman, R. Lamboll, C. G. Bardeen, P. M. Forster, D. Watson-Parris
Journal: Geophysical Research Letters

This material is based upon work supported by the National Center for Atmospheric Research, a major facility sponsored by the National Science Foundation and managed by the University Corporation for Atmospheric Research. Any opinions, findings and conclusions or recommendations expressed in this material do not necessarily reflect the views of the National Science Foundation.

https://www.eurekalert.org/pub_releases/2021-02/ncfa-clt020221.php

Age groups that sustain resurging COVID-19 epidemics in US

 As of October 2020, individuals aged 20-49 were the only groups sustaining COVID-19 transmission with reproduction numbers well above 1 in the US, according to the latest publication in Science today by the Imperial College COVID-19 Response team.

Following initial declines, numbers of COVID-19 cases started to rise again halfway through 2020 in the United States and Europe. In September the team published report 32, using age-specific mobility data from across the United states and linking these to age-specific COVID-19 mortality. Their findings pointed out that targeting interventions to adults aged 20-49 could facilitate safe reopening of schools and kindergartens.

The peer reviewed publication in Science today includes new data up to October 2020. The updated analysis of aggregated age-specific mobility data from more than 10 million individuals in the US, shows that 65 of 100 COVID-19 infections still originated from individuals aged 20-49 in the US.

Across the US as a whole, the mobility trends indicate substantial initial declines in venue visits (such as visit by an individual to locations like supermarkets and restaurants) followed by a subsequent rebound for all age groups. In contrast with the large fluctuations in the share of age groups among reported COVID-19 cases, the study describes the share of age groups among the observed COVID-19 deaths remarkably constant.

The researchers find that in locations where novel highly-transmissible SARS-CoV-2 lineages have not yet established, additional interventions among adults aged 20-49, such as mass vaccination with transmission-blocking vaccines, could bring resurgent COVID-19 epidemics under control and avert deaths.

The work is presented in the latest report from Imperial's Department of Mathematics and the WHO Collaborating Centre for Infectious Disease Modelling within the MRC Centre for Global Infectious Disease Analysis, Abdul Latif Jameel Institute for Disease and Emergency Analytics (J-IDEA), Imperial College London.

Since the emergence of the new coronavirus (COVID-19) in December 2019, the Imperial College COVID-19 Response Team has adopted a policy of immediately sharing research findings on the developing pandemic.

Dr. Samir Bhatt, from Imperial College London, said, "This work is a big step in understanding how age affects the dynamics of COVID-19 epidemics. We would like thank in particular all epidemiologists at state Departments of Health who work tirelessly to update data on the evolving COVID19 epidemics. Without this effort, this study would not have been possible."

Dr. Melodie Monod, from Imperial College London, said, "We find adults aged 20-49 are a main driver of the COVID-19 epidemic in the United State and are the only age groups contributing disproportionally to onward spread, relative to their population size. While children and teens contribute more to COVID19 spread since school closure mandates have been lifted in fall 2020, we find these dynamics have not changed substantially since school re-opening."

Dr. Oliver Ratmann, from Imperial College London, concluded, "We believe this study is important because we demonstrate that adults aged 20-49 are the only age groups that have consistently sustained COVID-19 spread across the US, despite large variations in the scale and timing of local epidemics. Thus—at least where highly transmissible variants have not established—additional interventions targeting the 20-49 age group could bring resurgent epidemics under control and avert deaths."

More information: "Age groups that sustain resurging COVID-19 epidemics in the United States," Science (2021). science.sciencemag.org/cgi/doi … 1126/science.abe8372

https://medicalxpress.com/news/2021-02-age-groups-sustain-resurging-covid-.html

FDA to streamline approval for vax updated to protect against virus variants

 Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said the agency is working to streamline the process for authorizing COVID-19 vaccines after they have been updated to protect against new variants of the novel coronavirus, according to The Hill.

During a Jan. 29 webinar hosted by the American Medical Association, Dr. Marks said the agency would work to "get these variants covered as quickly as possible."

Dr. Marks also said updated COVID-19 vaccines would not have to complete another phase 3 trial to ensure efficacy. Rather, they will be required to go through "some small clinical trials" to ensure they incite an immune response and protect against both the new variants and earlier versions of the novel coronavirus.

Experts have not reached a consensus on whether updated vaccines are necessary, but the possibility is being pursued, as B.1.351, the variant first identified in South Africa, has shown it diminishes the effects of COVID-19 vaccines to varying extents.

Vaccines using the mRNA platform, like the ones developed by Moderna and Pfizer, are relatively easy to update for protection against new virus variants. However, experts recommend as many people as possible be vaccinated with current vaccines to slow the spread of the virus, which continues to spread and mutate.

https://www.beckershospitalreview.com/pharmacy/fda-to-streamline-process-to-approve-vaccines-updated-for-protection-against-virus-variants.html

US COVID-19 testing is 'problematic' : Gottlieb

 Former FDA Commissioner Scott Gottlieb, MD, told CNBC Feb. 2 that the country's COVID-19 testing system is "discontinuous" and "problematic" and that he doesn't expect any large-scale improvements until fall. 

"You don’t have an efficiently run system because no one really built this rationally," Dr. Gottlieb said. 

He said that the U.S. has reached a point where we can do "a tremendous amount of testing," and that on some days more than 2 million new tests are conducted. But, "We need to be able to do 3, 4 million tests a day and get back a result back within 24 hours or else ... it’s useless. A PCR-based result that takes more than a day or two isn’t useful," he said, according to CNBC. 

A big issue is that because of the way the system is currently organized, test samples aren't getting to labs that have the capacity to quickly run the tests and return the results to patients in a timely manner, Dr. Gottlieb told CNBC. 

Dr. Gottlieb said there will still be a need for COVID-19 testing in the fall, even though many Americans will likely be vaccinated like then. 

“We need to build this out for the fall when testing volumes are going to come up again, and we’re going to be pressed again," he told CNBC. 

https://www.beckershospitalreview.com/supply-chain/us-covid-19-testing-is-problematic-former-fda-chief-says.html

Vertex target cut by Wainwright

 To $275 from $315; retains Buy.

https://finviz.com/quote.ashx?t=VRTX