Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

BioNTech’s Shares Tumble — Again — Amid Continued COVID Vaccine Sales Slide

Fierce Pharma reported:

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billion euros ($5.4 billion) to 4 billion euros ($4.3 billion), it was a jolting indication of the plummeting demand for COVID-19 vaccines.

When BioNTech reported its fourth-quarter results Wednesday, it was another harsh reminder of the continuing trend. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

On a conference call, BioNTech execs said the company was surprised by the level of fourth-quarter inventory write-downs at its COVID-19 partner Pfizer. “The negative impact on our revenue for 2023 accumulated to a total of approximately 900 million euros,” BioNTech chief financial officer Jens Holstein said on the call.

Either way, it’s another indication that post-pandemic revenue for the COVID-19 vaccine sellers is not what they expected. In addition to BioNTech coming up short on its 2023 guidance, at this time last year, Pfizer projected sales of Comirnaty to reach $13.5 billion. They instead came to $11.2 billion.

Bayer Says 2024 Sales of Prostate Cancer Drug Above $1 Billion

Reuters reported:

Bayer (BAYGn.DE) on Thursday predicted at least $1 billion in 2024 sales for prostate cancer drug Nubeqa, which is playing a bigger role for the drugmaker’s growth prospects after the failure of a promising anti-blood-clotting therapy.

“Nubeqa … is set for continued growth in prostate cancer and is on track to reach blockbuster status this year – only five years after first indication launch,” it said in a statement. Blockbuster is an industry term for drugs with at least $1 billion in annual sales.

Bayer chalked up sales of Nubeqa, jointly developed with Finnish drugmaker Orion (ORNBV.HE) of 869 million euros ($948 million) last year and the company has previously projected annual peak sales potential of more than three billion euros.

Two Years Ago, We Had a Baby Formula Crisis. Let’s Hope Lawmakers Remember.

The Washington Post reported:

More than two years after safety concerns at a major infant formula manufacturing plant sparked a nationwide shortage, two Democratic lawmakers are introducing a bill aimed at creating a more competitive, stable market for this essential product.

The question now is whether the hundreds of lawmakers in both parties who declared the shortage a crisis in 2022 still remember the desperation parents felt then — and whether these representatives and senators can act on behalf of the babies who rely on formula now. The shortage was the result of a collision between the hyper-concentration of manufacturers in the formula industry and the need to regulate them carefully.

In 2022, just four companies made 97% of the infant formula sold in the United States — and one of those subsequently bought another’s U.S. operations. That makes it difficult for food safety regulators to come down hard without disrupting the supply chain. When Abbott Nutrition voluntarily shuttered its Sturgis, Mich., factory in early 2022 to address safety and sanitary concerns and recalled formula produced there, roughly 20% of formula production nationwide went offline.

Safety isn’t negotiable in infant formula: Babies have died after drinking formula containing the bacteria Cronobacter sakazakii. But the shortage had consequences, too. Pediatricians and parents struggled to source formulas for children with allergies and other metabolic conditions. Some infants even had to be hospitalized for lack of nourishment.

Nitazenes: The Opioids 500 Times Stronger Than Heroin

Deutsche Welle reported:

Just when communities were starting to understand the lethal effects of fentanyl and oxycodone abuse, yet another painkiller opioid emerged from the pharmaceutical archives as a deadly street drug.

Commonly known as nitazenes, 2-benzyl Benzimidazole opioids are said to be up to 500 times more potent than heroin, making people more prone to addiction.

Drug and health agencies in the U.K., elsewhere in Europe, and the U.S. are reporting a rise in the number of overdoses and fatalities linked to nitazenes.

A class of more than 20 synthetic chemical compounds, nitazenes were originally developed in the 1950s as opioid analgesics — painkillers. But they were never approved for use in human or veterinary medicine. Synthetic drugs like nitazenes and fentanyl are not grown naturally or cultivated in the environment like heroin or cannabis, but are manufactured artificially by humans using chemicals.

Johnson & Johnson Accuses Former Employee of Taking Thousands of Files to New Role at Pfizer

Fierce Pharma reported:

As two of the world’s largest pharmaceutical companies, Johnson & Johnson and Pfizer have long been rivals in various therapeutic areas. That made for an intriguing backdrop when a J&J employee changed sides and allegedly brought thousands of confidential strategy-related files with him.

The drugmaker has sued its former employee Andrew Brackbill in New Jersey federal court, claiming he “clandestinely and maliciously” downloaded more than a thousand sensitive strategy-related files onto external hard drives three weeks prior to his resignation, Stat News first reported.

To make matters worse, Brackbill then accessed the J&J information while on the clock in his new position at Pfizer, J&J alleged.

In an industry so rife with competition, such accusations are not uncommon. In October, Novartis accused one of its former staffers of transferring some 10,000 files to his personal email about a month before he left the company to eventually start at Takeda in a “similar” role, the company argued in its complaint.

Moderna COVID Vaccine Tech Patents Must Face Validity Review

Bloomberg Law reported:

BioNTech SE and Pfizer Inc. convinced a U.S. Patent and Trademark Office administrative tribunal to review the validity of two Moderna Inc. patents related to producing mRNA vaccines like those for COVID-19.

BioNTech and Pfizer sufficiently demonstrated that the agency overlooked relevant previous inventions when granting Moderna’s U.S. Patent Nos. 10,702,600 and 10,933,127 covering betacoronavirus mRNA vaccines, according to two Patent Trial and Appeal Board decisions made public Tuesday.

Moderna accused BioNTech and Pfizer in August 2022 of infringing the technology to develop their monovalent COVID-19 vaccines in a U.S. District Court for the District of Massachusetts lawsuit.

Novo Is Building a Really Big Computer

STAT News reported:

The Novo Nordisk Foundation, whose controlling stake in the maker of Wegovy has made it the wealthiest charitable foundation in the world, is getting into AI.

Specifically, it’s putting up about $90 million to construct Gefion, a Danish supercomputer running on hardware and software from the trillion-dollar tech firm Nvidia. The idea is to put “extreme AI computing power” to the task of “drug discovery, disease diagnosis, and treatment,” Novo Nordisk Foundation CEO Mads Krogsgaard Thomsen said in a statement.

Gefion, once it comes online later this year, will be made available to Danish researchers in the public and private sectors, with any resulting revenue invested back into the project.

RSV: Pediatricians Call on Government to Expedite Infant Vaccination Program

The BMJ reported:

The Royal College of Paediatrics and Child Health has called on the U.K. government not to wait until after the upcoming general election to approve an infant immunization program against the respiratory syncytial virus (RSV) so that babies can be protected next winter.

In June 2023 the Joint Committee on Vaccinations and Immunisations (JCVI) recommended developing an RSV immunization program for infants and for older adults.1 It issued a fuller statement reiterating the advice in September 2023.2 But the government has yet to make a final decision on rolling out an RSV immunization program.

A letter signed by more than 2000 pediatricians and healthcare professionals says that the sooner a full RSV vaccination program is implemented the more effective it will be and that it “could save child health services reaching breaking point.”

GSK to Cap Out-of-Pocket Inhaler Costs in U.S.

Reuters reported:

British pharmaceutical giant GSK (GSK.L) said on Wednesday it would cap out-of-pocket costs for all its inhaled asthma and chronic lung disease medicines at $35 per month for eligible patients in the United States, following similar moves by two of its rivals. GSK said the decision will take effect by Jan. 1, 2025.

The cost cap would apply to all of its asthma and chronic obstructive pulmonary disease (COPD) medicines, including Advair Diskus, Advair HFA, and Trelegy Ellipta, and would apply to patients whose monthly costs currently exceed $35.

U.S. lawmakers in January had criticized the top four inhaler manufacturers — AstraZeneca, Boehringer, Teva Pharmaceuticals (TEVA.TA) and GSK — over high prices, and launched an investigation to look into the prices at which these were sold in the U.S. versus other countries.

The lawmakers claimed in the letter sent to the four companies in January that GSK’s Advair HFA costs $319 in the United States but $26 in the United Kingdom.