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In just two short years, BioNTech will have more than doubled the size of its workforce at the German biologics facility it bought from Novartis at the height of the pandemic.
BioNTech is hiking the headcount at its Marburg, Germany, vaccine plant by 50%, the company confirmed via email Wednesday. Since it picked up the site from Novartis in 2020, BioNTech has added about 200 employees. Now, it's planning to recruit an additional 250 staffers before the year is out, a company spokesperson said.
At the same time, the German mRNA specialist is socking some €50 million (about $56.4 million) into the site. It’s planning to add additional office space there as it weighs options for future growth, BNN Bloomberg reports.
The site came equipped with about 300 workers at the time it was purchased.
The Marburg facility already ranks among the biggest mRNA vaccine factories in the world, and it's helped supply more than 1.2 billion doses of Pfizer and BioNTech's COVID-19 vaccine, Comirnaty, BNN pointed out. For 2022, the partners are aiming to produce a staggering 4 billion COVID-19 vaccine doses across their global manufacturing sites. That could include a mix of their current vaccine formula, plus a potential new omicron-specific shot, if one is needed, BioPharma Reporter noted earlier this week.
BioNTech isn't just sticking to pandemic products in Marburg, either. The company has telegraphed plans to work on other mRNA vaccines there once they're approved, such as the shots it's developing with Pfizer for flu and shingles, plus its solo mRNA vaccine efforts in malaria, tuberculosis and herpes, BNN said. The company has also said it plans to work on antibodies and cell and gene therapies for cancer and infectious diseases at the facility.
BioNTech bought the Marburg site from Novartis back in 2020, right around the time it and Pfizer were starting to rack up sizable supply deals for their shot. At the time, the German company said the site could have annual capacity of up to 750 million COVID-19 mRNA vaccine doses. It’s since dialed up that capacity estimate to 1 billion doses per year.
BioNTech added in September of 2020 that the site would be used to handle the first three steps of manufacturing for its mRNA shot: mRNA production, drug substance purification and concentration, and formulation.
BioNTech kicked off messenger RNA production in Marburg last February. The European Medicines Agency gave the site a thumbs up to start making and supplying partners with vaccine drug products from Marburg in March.
Pfizer and BioNTech’s shot has quickly risen through the ranks as the world’s top-selling drug. Together with Pfizer’s oral antiviral Paxlovid, Pfizer and BioNTech’s vaccine could generate combined peak sales of between $50 billion and $60 billion, Cantor Fitzgerald’s Louise Chen wrote in a note to clients last month. Working solo, the vaccine could reach $25 billion in 2027 sales, the analyst predicted at the time.
During its third-quarter earnings presentation, Pfizer projected about $29 billion in 2022 COVID-19 vaccine revenues.
“We’ll continue to update the numbers for 2022 based on the contracts that we’ve signed,” Pfizer CFO Frank D’Amelio said on a call with investors.
Early data from a trial evaluating Cue Biopharma Inc's (NASDAQ: CUE) CUE-101 combined with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) demonstrated that two out of four patients in dose-escalation cohorts had partial responses.
The other two patients are showing reductions in target lesions.
CUE-101, which targets IL-2, is under development as a potential third-line treatment for HPV+ recurrent/metastatic head and neck squamous cell carcinoma.
CUE-101 + pembrolizumab combination therapy is under examination as a front-line treatment.
Updated data on the dose-expansion CUE-101 as a monotherapy trial showed a 50% clinical benefit rate.
The Company plans to file an Investigational New Drug (IND) application for CUE-102, another candidate from IL-2 based CUE-100 series, in Q1 of 2022.
In January, the Company received a $3 million milestone payment from LG Chem Life Sciences under an agreement for CUE-102.
Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, received a grant award from the Bill & Melinda Gates Foundation ('Gates Foundation') to evaluate the application of Aridis' inhaled formulation technology to deliver cost-effective monoclonal antibodies (mAbs) against influenza and SARS-CoV2 to people in low- and middle-income countries.
"We are gratified to receive support from the Bill & Melinda Gates Foundation, which underscores the importance of applying advanced inhalation technology to combat infection and transmission of respiratory viruses such as COVID-19 and influenza," said Vu Truong, Ph.D. CEO of Aridis. "The combination of dose sparing achieved by inhaled delivery and algae sourced mAbs has the potential to dramatically reduce the cost of antiviral treatment and expand the access of mAbs worldwide," said Truong.
Calls are mounting among industry and legislators for a federal investigation into potential price gouging by nurse staffing agencies that have found their services in high demand throughout the COVID-19 pandemic.
Tuesday, a bipartisan group of almost 200 lawmakers penned a letter to White House COVID-19 Response Team Coordinator Jeffrey Zients asking the official “to enlist one or more” federal agencies to open an investigation into potential anti-competitive activity or violation of consumer protection laws.
The group, headed by Representatives Peter Welch, D-Vermont, and Morgan Griffith, R-Virginia, said it has heard of agencies charging “two, three or more” times their pandemic rates while pocketing 40% or more of what hospitals are paying out.
“We have heard the amounts charged to hospitals rose precipitously as the newest wave of the COVID-19 crisis swept the nation and the agencies seemingly seized the opportunity to increase their bottom line,” the lawmakers wrote. “Hospitals have no choice but to pay these exorbitant rates because of the dire workforce needs facing hospitals around the country.”
Tuesday’s letter comes roughly two months after four senators and congress members made a similar request of the White House’s pandemic lead.
In that letter, Senator Mark Kelly, D-Arizona, Senator Bill Cassidy, M.D., R-Louisiana, Representative Doris Matsui, D-California, and Representative David McKinley, R-West Virginia, pushed for federal agencies to look into nurse staffing agencies’ ownership structures and the community impact of increased prices alongside potential price gouging.
“This model is unsustainable for many health systems,” the four wrote in November. “As the pandemic continues and we enter flu season, we request you enlist one or more of the federal agencies with competition and consumer protection authority to investigate this conduct.”
Lawmakers' latest call to action landed alongside a renewed push for investigative action out of the American Hospital Association (AHA), which had raised similar concerns to the Federal Trade Commission (FTC) as far back as February 2021.
In a Tuesday morning press call, AHA President and CEO Rick Pollack cited the same pricing behaviors highlighted by the legislators and noted that his organization has yet to hear back from the FTC on its early 2021 request.
Melinda Hatton, general counsel to the AHA, added that the organization believes it has seen some agencies make similar rate adjustments “in lock-step” throughout the nation. She also said that certain staffing agencies have demonstrated “some proclivity for anticompetitive behavior” and referenced ongoing Department of Justice lawsuits reviewing no-poach agreements allegedly intended to suppress workers’ wages.
“There were a number of investigations by the administration on price gouging throughout the pandemic on various supplies,” she said Tuesday morning. “I think you could argue this is even a more important resource than some of the areas they investigated and certainly one that’s ripe for some kind of federal scrutiny.”
Hatton declined to mention any of the potentially offending staffing agencies by name.
Mass General Brigham's high prices and excessive spending have led Massachusetts regulators to require the Boston-based system to develop and implement a “performance improvement plan” to contain healthcare costs within its organization and, by extension, the state.
Following a unanimous vote by the Massachusetts Health Policy Commission (HPC)’s board, MGB will have 45 days to propose a plan that identifies the causes of its spending growth, outlines a savings goal and lists specific steps the system will take to reach that goal, according to the commission.
Should the proposal be approved, MGB will have 180 days to implement the plan and report its outcome to the commission. The regulator’s board can assess a fine of up to $500,000 for noncompliance.
“Mass General Brigham has a spending problem,” Stuart Altman, chair of the HPC, said in a statement. “Its spending performance and plan for new expansions at their flagship hospitals and into the Boston suburbs raise significant concerns, as documented by the HPC today. In fact, continuing in this manner is likely to impact the state’s ability to meet its spending benchmark and could do serious harm to the structure of the state’s delivery system.”
The HPC decided to issue its first-ever performance improvement plan after an examination of MGB’s spending from 2014 to 2019, according to the commission.
The review found that MGB has more cumulative commercial spending growth above annual spending benchmarks (a cutoff set by the HPC under state law) than any other provider organization, totaling $293 million in excess of the benchmarks over six years.
MGB’s hospital and physician prices are also higher than “nearly” every other provider in the state, the commission found, while simultaneously controlling the largest amount of market share and “consistently” posting strong financial performances.
The HPC’s review found that price and mix were bigger drivers of spending growth than utilization increases. Additionally, despite providing numerous high acuity services, the HPC found that the organization’s case mix index “is not significantly higher” than other providers in the state with lower prices.
The HPC said it was unconvinced that ongoing cost-control strategies shared by MGB have sufficiently reduced the system’s commercial spending growth.
MGB contested the HPC’s findings on its case mix, saying in a statement that the commission’s review was “selective” in its use of medical expense metrics that “ignore” the complex patients seen at MGB’s academic health centers.
“The HPC’s refusal to acknowledge the acuity of our patients in its judgment of health care spending is short-sighted and unfair, especially to patients,” the organization said in a statement. “While we strongly disagree with the HPC’s decision, we are committed to working alongside them to address the challenge of healthcare costs in Massachusetts while continuing our efforts to overcome the multiple crises brought by the pandemic.”
Alongside the performance improvement plan, the HPC also weighed in on MGB’s plans to expand and renovate two of its major Boston hospitals and open new ambulatory sites elsewhere in the state.
The commission found that these projects would “likely” increase healthcare spending by tens of millions, drive a “substantial” amount of patient volume and revenue away from other lower-cost providers and negatively impact healthcare access, equity and market function.
MGB’s expansion plan has taken flak over the past year, with several local providers, chambers of commerce, health equity organizations and others mounting a resistance to the $2 billion road map. An independent cost analysis conducted by a third party and released in December, however, concluded that the expansion plans fall in line with Massachusetts’ cost containment requirements.
https://www.fiercehealthcare.com/hospitals/mass-general-brigham-mgb-massachusetts-cost-spending
The Biden administration reportedly shifted almost $7 billion in pandemic relief funding for providers to purchases of COVID-19 vaccines and therapeutics, according to a Stat report citing an internal document.
A Department of Health and Human Services (HHS) spokesperson told the publication that repurposing money from the Provider Relief Fund was appropriate because the vaccines and therapeutics that were purchased were given to providers for free.
“All Provider Relief Fund dollars have been used for Provider Relief Fund purposes,” the spokesperson told Stat.
Combining this with the Trump administration decision to divert $10 billion from the $178 billion fund for its Operation Warp Speed would mean that nearly a tenth of the money carved out by Congress in the CARES Act was not allocated for direct payments to hospitals and practices.
Fierce Healthcare has reached out to HHS to confirm the reporting.
The news comes as provider organizations are pleading to Congress to write additional relief money into next month’s potential omnibus spending bill, noting that none of the original $178 billion designated through the CARES Act addresses pandemic expenses incurred after March 2021.
“While this fund has been a lifeline for some healthcare providers, no distributions have been made or announced for expenses related to the delta or omicron surges … despite decreases in deaths, hospitalizations and cases,” American Hospital Association President and CEO Rick Pollack said during a Tuesday morning press call.
Further, the Biden administration is still working to hand out the last of the initial pot, having announced just this week the distribution of $2 billion to 7,600 providers and another $6 billion or so to go in the fourth phase of the relief program.
Stat also reported that the Biden administration is looking to redirect an additional $1 billion from Congress-provided COVID-19 testing funding to more vaccine and therapeutics purchases.
