Dermapharm Holding SE expands capacity to produce COVID-19 vaccine

 Dermapharm Holding SE expands capacity to produce COVID-19 vaccine and plans for vaccine manufacturing to contribute

high double-digit million EUR in sales in 2021 
Grünwald, February 12, 2021 - Dermapharm Holding SE ("Dermapharm"), a leading manufacturer of off-patent branded 
pharmaceuticals for selected therapeutic areas, expects the collaboration with BioNTech SE, Mainz, Germany, for the 
production of the Covid-19 vaccine Comirnaty^(R) to contribute a high double-digit million EUR amount to the consolidated 
sales of the Dermapharm Group in the full year 2021. This is the result of a current plan for vaccine production 
approved by the Dermapharm Management Board today. Among other things, it includes the establishment of additional 
production capacities at the Reinbek site, which are scheduled to go into operation in May 2021. 
In September 2020, Dermapharm signed a cooperation and supply agreement with BioNTech SE to support the production of 
the vaccine Comirnaty^(R). At the main production site at mibe GmbH Arzneimittel in Brehna, Dermapharm has expanded 
production and special storage capacities for the formulation as well as the aseptic filling, packaging (fill & finish) 
and storage of the vaccine. The vaccine has been produced in Brehna since the beginning of October 2020. 
Due to the high demand for the vaccine, additional production capacities are now being established at Allergopharma 
GmbH & Co. KG, a subsidiary of Dermapharm, at the Reinbek site. Initial personnel are already being recruited and 
employees are being trained in Brehna in order to be able to start vaccine production as soon as possible. 
"At Allergopharma, we have the necessary prerequisites and also the internal know-how to set up vaccine production at 
short notice. We will build up capacities in Reinbek that significantly exceed our production capacities in Brehna. We 
owe the short-term implementation in particular to the constructive cooperation with BioNTech, our suppliers and 
employees, and the responsible authorities," continues Dr. Feldmeier. "We are very proud and highly motivated to be 
able to make an important contribution to combating the pandemic with this partnership. Our high flexibility for the 
cooperation with BioNTech proves once again the necessity to maintain production capacities for pharmaceuticals at the 
location Germany / Europe." 

https://www.marketscreener.com/quote/stock/DERMAPHARM-HOLDING-SE-40718509/news/PRESS-RELEASE-Dermapharm-Holding-SE-expands-capacity-to-produce-COVID-19-vaccine-and-plans-for-vac-32427332/

Amazon sues New York attorney general to preempt a state COVID lawsuit

 

Amazon.com Inc on Friday sued New York's attorney general to stop the state from taking legal action over its early COVID-19 response, including its firing of activist Christian Smalls.

The retailer drew scrutiny 10 months ago when workers protested conditions at a Staten Island warehouse and it fired Smalls for violating a paid quarantine. Senators questioned Amazon about the incident, the city announced a probe, and State Attorney General Letitia James said the company may have violated the law.

In a complaint in Brooklyn federal court, Amazon accused James of overstepping bounds by legally threatening the company and demanding remedies like its surrender of profit. Federal labor and safety laws preempt those of the state, from which Amazon is seeking injunctive relief, its suit said.

Reuters was unable to immediately seek James' comment.

The atypical lawsuit shows how Amazon believes it was unfairly maligned despite the many COVID-19 precautions it implemented, most recently COVID-19 tests and plans for vaccine administration. It also demonstrates how the company will not back down from criticism of its workplace.

According to the lawsuit, Amazon passed with flying colors an unannounced city inspection of its Staten Island facility on March 30, the day of the protest. The warehouse's temperature checks, signage to encourage social distancing, and shift staggering showed safety complaints were "completely baseless," the lawsuit says the inspector found.

Amazon said demands by the attorney general's office (OAG) were "far more stringent than the standard adopted by the OAG when defending, in other litigation, the New York State Courts' reasonable but more limited safety response to COVID-19."

Amazon said the OAG assessed violations regardless of documentation the company provided, such as photographs of Smalls not social distancing. Smalls has said he would not stop protesting until Amazon protects staff, and in November he filed a class action suit seeking damages for Black and Hispanic workers he alleged Amazon put at risk.

More than 19,000 or 1.44% of Amazon's U.S. frontline employees contracted COVID-19 as of September, the company has said.

https://www.marketscreener.com/news/latest/Amazon-sues-New-York-attorney-general-to-preempt-a-state-COVID-lawsuit--32427214/

Diagnostic testing developer Talis Biomedical raises deal size by 15% ahead of $173M IPO

 Talis Biomedical, which is developing diagnostic tests for COVID-19 and other infectious diseases, raised the proposed deal size for its upcoming IPO on Thursday.

The Menlo Park, CA-based company now plans to raise $173 million by offering 11.5 million shares at a price range of $14 to $16. The company had previously filed to offer 10 million shares at the same range. At the revised deal size, Talis Biomedical will raise 15% more in proceeds than previously anticipated.

The company's testing platform, called Talis One, is being developed as a sample-to-answer, cloud-enabled molecular diagnostic platform. It is developing Talis One tests for respiratory infections, infections related to women’s health, and sexually transmitted infections. Talis submitted a request for an Emergency Use Authorization to the FDA for its Talis One platform with COVID-19 molecular diagnostic assay in January 2021. It plans to initiate a clinical trial to support clearance of a 510(k) pre-market notification of its Talis One instrument with a test for chlamydia and gonorrhea in mid-2021, with the pre-market notification following in the 1H22.

Talis Biomedical was founded in 2010 and booked $12 million in sales for the 12 months ended September 30, 2020. It plans to list on the Nasdaq under the symbol TLIS. J.P. Morgan, BofA Securities and Piper Sandler are the joint bookrunners on the deal. It is expected to price during the week of February 8, 2021.

Relevant Profile: TLIS

https://www.renaissancecapital.com/IPO-Center/News/77543/Diagnostic-testing-developer-Talis-Biomedical-raises-deal-size-by-15-ahead-

CureVac Initiates Rolling Submission in Europe for COVID-19 Vax

 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company's mRNA-based COVID-19 vaccine candidate, currently in late-stage clinical testing. The process was initiated when the first data package consisting of CVnCoV pre-clinical data was submitted to EMA and passed the technical validation.

"We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19," said Dr. Lidia Oostvogels, Vice President Area Head Infectious Diseases at CureVac. "Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease."

The rolling submission represents a time-optimized route to provide and review all necessary data needed for a potential market authorization during a public health emergency. Over the course of the rolling submission process, EMA will assess CVnCoV's compliance with standards for vaccine efficacy, safety, and pharmaceutical quality on the basis of individually submitted data packages as a prerequisite for a formal market authorization application.

https://finance.yahoo.com/news/curevac-initiates-rolling-submission-european-103000670.html

Pandemic habits could cut rise in US health spending over 2 decades: Deloitte

 

• The growing shift from reactive to preventive healthcare could rapidly decelerate health spending over the next two decades, according to a new report from Deloitte, running counter to much more dire predictions made before COVID-19.
• Previous CMS analyses estimate health spending will grow by 5.3% per year through 2028, which — if extrapolated out — means health spend will snowball to about a fourth of the gross domestic product by 2040. But Deloitte's predictive modeling based on the rise of digital health products and more consumer engagement in their health post-pandemic instead predicts health spending will reach $8.3 trillion by 2040, making up a much-lower 18.4% of the GDP.
• That's a difference of $3.5 trillion freed up that can be reinvested back in patient care, infrastructure or other needs, the consultancy said.
• In 2019, U.S. health spending reached $3.8 trillion, almost 18% of the GDP, according to CMS. Prior to the coronavirus pandemic, the agency forecast health spending would reach almost $6.2 trillion by 2028, a sharp increase which, if the rate of change holds, means U.S. health spending could reach a whopping $11.8 trillion by 2040.

That's 26.1% of the entire GDP.

But that estimate aired before COVID-19. The pandemic, which has killed more than 460,000 people in the U.S. to date, has exposed numerous flaws in the healthcare system, well known for its focus on treatment of existing diseases rather than prevention.

However, some experts believe COVID-19 could be good for the healthcare system in the long run by showing the necessity of proactive care and driving the adoption of health tech, among other changes

Roughly 80% of health spending in 2019 went toward treatment. But by 2040, Deloitte projects 60% of spending will shift toward wellness maintenance and preventive care instead, as companies invest in data to generate predictive health insights and tools nudging consumers to take best actions for their health.

Adoption of such tools has already exponentially accelerated due to COVID-19, but the growing emphasis on preventive care means startups and existing players alike will begin hyper-focusing on early engagement with consumers and using sensors to continuously monitor health, Deloitte said. Additionally, the rise of retail clinics, inexpensive urgent care facilities and virtual care means it's easier for patients to meet with providers, significantly reducing traditional barriers to access like cost and physical distance.

These shifts would lead to less waste in the system, which previous research suggests makes up a fourth of all health spend.

Deloitte's models show spending in these wellness areas will eclipse treatment-related spend by 2033. By 2040, the consultancy predicts spending on wellness to make up 11.3% of the GDP, with spending on treatment and diagnostics to make up the remaining 7.1%.

By that time, the health system could look radically different. The industry could see a sea change in how healthcare is financed, along with the end of traditional care settings like the general hospital and a slowdown in mass-produced biopharmaceutical products, Deloitte predicts.

Standalone hospitals have suffered, long before COVID-19, from shrinking volume due to the rise of home- and community-based care, a trend exacerbated by the pandemic. That's likely to accelerate in the next few decades, with patients needing care increasingly receiving it in highly specialized settings outside of the acute care hospital, researchers predicted.

Similarly, as more health data is collected, biopharma companies will be able to produce more tailored therapies for individual patients by analyzing their unique needs and conditions in new ways. COVID-19 forced researchers to more heavily rely on digital technology for clinical trails, and that growing reliance, along with streamlined regulatory processes, resulted in diagnostic tests, therapies and multiple vaccines hitting the market at a record clip. In the next 20 years, that pace could continue or even exponentially accelerate, Deloitte said.

And, as the adoption of technology and devices increases, industry could also see a change in how healthcare is paid for. Diseases could be detected sooner and treated (or prevented altogether) before they become more severe. If this lowering level of health risk occurs, consumers could seek out more targeted insurance plans, as opposed to the sweeping coverage designed as an umbrella for broad populations that exists today, researchers found.

Deloitte researchers analyzed National Healthcare Expenditure Accounts data along with other spending and current trends to model potential shifts in the health landscape, including the effects of rising data sharing and interoperability, the push for equitable health access, consumerism and behavior change and the rising pace of scientific breakthroughs.

https://www.healthcaredive.com/news/pandemic-habits-could-cause-us-health-spending-to-decelerate-over-2-decades/594682/

Molina expects utilization to remain depressed in 2021

 

• Molina's net income fell sharply in the fourth quarter as the insurer was forced to refund rates to some of its state partners as COVID-19 continues to depress normal care utilization, CEO Joe Zubretsky told investors Thursday.
• Although utilization remained curtailed, COVID-19 costs were higher in the fourth quarter than any other quarter in 2020, Zubretsky said. As such, Molina's medical care ratio for the quarter increased to 90.8% from 86% the prior-year period.
• Still, Molina remained in the black for the full year of 2020. Looking ahead, the company expects utilization to improve, though does not expect it to rebound entirely. At the same time, the company expects direct COVID-19 costs to come in lower than last year.
• The pandemic took a bite out of Molina's net income in the fourth quarter as the company reported that figure fell to $34 million from $168 million in Q4 2019.

The biggest contributor to the impact on the bottom line was Medicaid refunds to states, including California, Michigan and Ohio. States have clawed back some of the money they pay insurers like Molina as members continue to defer care, which is a benefit to insurers as they then pay out less.

Molina painted a clearer picture of this scenario during Thursday's conference call with investors.

For the full year, Molina estimated that medical cost suppression amounted to $620 million while direct COVID-19 costs amounted to $200 million. In other words, curbed utilization continued to outweigh direct COVID-19 costs, resulting in a $420 million benefit from the pandemic, which the company characterized as a surplus.

But states took back a total of $565 million through rate refunds. Overall, the net impact of COVID-19 was a $180 million hit to Molina for 2020 when factoring in other costs.

Looking ahead, executives seemed cautiously optimistic for 2021 but noted headwinds from the pandemic will persist. While the forecast reflects future growth, Zubretsky said, "it is a constrained picture" of the company's potential earnings.

Some of those headwinds include Medicare risk scores that don't fully capture the acuity of their Medicare members. As seniors put off care in 2020, companies like Molina were unable to capture diagnosis codes to help them determine how sick members are and the ultimate risk they pose.

Still, there are some bright spots. As the public health emergency is likely to be continued throughout the remainder of the year, it means that redeterminations will remain halted, or, in other words, Medicaid members will not be kicked off coverage.

This was a boon for Molina in 2020, as it allowed them to pick up a significant number of new members. Overall, it was a major catalyst for Medicaid membership growth in 2020, Zubretsky said.

Molina expects care utilization to improve this year but not fully return to normal. Instead, it expects utilization suppression to be about one third of 2020 levels.

Molina, which solely focuses its portfolio on government sponsored and marketplace plans, said it expects to pick up as many as 30,000 additional members during the Affordable Care Act special enrollment period.

Opening up a special enrollment period was one of the first moves made by the new administration in the White House. Zubretsky seems enthused by the recent moves through executive orders and the unfolding bill developments in Congress that are looking to raise premium subsidies on the exchanges.

Those early actions "just couldn't be better for government sponsored managed care, and we're pleased to see that progress already being made," Zubretsky said.

https://www.healthcaredive.com/news/molina-expects-utilization-to-remain-depressed-in-2021/594895/

Cuomo aide admits they hid nursing home data so feds wouldn’t find out

 Governor Cuomo’s top aide privately apologized to Democratic lawmakers for withholding the state’s nursing-home death toll from COVID-19 — telling them “we froze” out of fear the true numbers would “be used against us” by federal prosecutors, The Post has learned.

The stunning admission of a cover-up was made by Secretary to the Governor Melissa DeRosa during a video conference call with state Democratic leaders in which she said the Cuomo administration had rebuffed a legislative request for the tally in August because “right around the same time, [then-President Donald Trump] turns this into a giant political football,” according to an audio recording of the two-hour-plus meeting.

“He starts tweeting that we killed everyone in nursing homes,” DeRosa said. “He starts going after [New Jersey Gov. Phil] Murphy, starts going after [California Gov. Gavin] Newsom, starts going after [Michigan Gov.] Gretchen Whitmer.”

In addition to attacking Cuomo’s fellow Democratic governors, DeRosa said, Trump “directs the Department of Justice to do an investigation into us.”

“And basically, we froze,” she told the lawmakers on the call.

“Because then we were in a position where we weren’t sure if what we were going to give to the Department of Justice, or what we give to you guys, what we start saying, was going to be used against us while we weren’t sure if there was going to be an investigation.”

DeRosa added: “That played a very large role into this.”

After dropping the bombshell, DeRosa asked for “a little bit of appreciation of the context” and offered what appears to be the Cuomo administration’s first apology for its handling of nursing homes amid the pandemic.

But instead of a mea culpa to the grieving family members of more than 13,000 dead seniors or the critics who say the Health Department spread COVID-19 in the care facilities with a March 25 state Health Department directive that nursing homes admit infected patients, DeRosa tried to make amends with the fellow Democrats for the political inconvenience it caused them.

“So we do apologize,” she said. “I do understand the position that you were put in. I know that it is not fair. It was not our intention to put you in that political position with the Republicans.”

Assembly Health Committee Chairman Richard Gottfried (D-Manhattan) immediately rejected DeRosa’s expression of remorse, according to the recording.

“I don’t have enough time today to explain all the reasons why I don’t give that any credit at all,” said Gottfried, one of the lawmakers who demanded the death-toll data in August.

State Senate Aging Committee Chairwoman Rachel May (D-Syracuse) — who was battered during her re-election bid last year over the issue of nursing-home deaths — also ripped into DeRosa, saying her former opponent had launched another broadside earlier in the day.

“And the issue for me, the biggest issue of all is feeling like I needed to defend — or at least not attack — an administration that was appearing to be covering something up,” she said.

“And in a, in a pandemic, when you want the public to trust the public-health officials, and there is this clear feeling that they’re not coming, being forthcoming with you, that is really hard and it remains difficult.”

Assemblyman Ron Kim (D-Queens), who took part in the call, told The Post on Thursday that DeRosa’s remarks sounded “like they admitted that they were trying to dodge having any incriminating evidence that might put the administration or the [Health Department] in further trouble with the Department of Justice.”

“That’s how I understand their reasoning of why they were unable to share, in real time, the data,” Kim said.

“They had to first make sure that the state was protected against federal investigation.”

Kim, whose uncle is presumed to have died of COVID-19 in a nursing home in April, also said he wasn’t satisfied with DeRosa’s apology.

“It’s not enough how contrite they are with us,” he said. “They need to show that to the public and the families — and they haven’t done that.”

In addition to stonewalling lawmakers on the the total number of nursing home residents killed by COVID-19, Cuomo’s administration also refused requests from the news media — including The Post — and fought a Freedom of Information lawsuit filed by the Empire Center on Public Policy.

Instead, it only disclosed data on the numbers of residents who died in their nursing homes.

But after Attorney General Letitia James last month released a damning report that estimated the deaths of nursing-home residents in hospitals would boost the grim tally by more than 50 percent, Health Commissioner Howard Zucker finally released figures showing the combined total was 12,743 as of Jan. 19.

Just a day earlier, the DOH was only publicly acknowledging 8,711 deaths in nursing homes.

In a Wednesday letter to lawmakers, Zucker said the total number of nursing home residents killed by COVID-19 had increased to 13,297 That number jumps to 15,049 when assisted living/adult care facilities are factored in.

The controversy generated by James’ report led to an infamous news conference at which Cuomo callously dismissed the matter of where nursing home fatalities actually took place.

“Who cares [if they] died in the hospital, died in a nursing home? They died,” he said.

During Wednesday’s conference call, DeRosa said it appeared the DOJ was no longer focused on New York’s nursing home deaths.

“All signs point to they are not looking at this, they’ve dropped it,” she said.

“They never formally opened an investigation. They sent a letter asking a number of questions and then we satisfied those questions and it appears that they’re gone.”

In a prepared statement, Cuomo spokesman Rich Azzopardi said, “We explained that the Trump administration was in the midst of a politically motivated effort to blame democratic states for COVID deaths and that we were cooperating with Federal document productions and that was the priority and now that it is over we can address the state legislature.”

“That said, we were working simultaneously to complete the audit of information they were asking for,” he added.

The DOJ declined to comment.

https://nypost.com/2021/02/11/cuomo-aide-admits-they-hid-nursing-home-data-from-feds/