Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen’s COVID-19 vaccine candidate

Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses.

“The COVID-19 pandemic continues to threaten communities worldwide and we have a responsibility to ensure access to our COVID-19 vaccine as soon as we can. We appreciate the Commission’s and the Member States’ support for our COVID-19 vaccine candidate and development efforts,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.

This contract follows the conclusion of exploratory talks with the EC. The Company is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators.

Separate to the agreement with the EC, as part of the Company’s larger commitment to respond to the COVID-19 pandemic, Johnson & Johnson has also announced plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower income countries, with delivery beginning mid next year following approval or authorization from regulators. Recognizing the unique global demand for COVID-19 vaccines, we are working tirelessly to further expand the number of available doses.

Johnson & Johnson is developing and testing Janssen’s COVID-19 vaccine candidate in accordance with its usual rigorous ethical standards of safety and sound scientific principles. The Company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) that started in September. A second Phase 3 study with a two-dose regimen is planned to start later this year. The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.

Janssen’s investigational COVID-19 vaccine leverages Janssen’s AdVac® technology. The same technology was used to develop Janssen’s EC-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates. To date, more than 100,000 individuals have been vaccinated with a Janssen AdVac®-based vaccine. Based on our understanding of the stability of our vaccines, we anticipate our COVID-19 vaccine candidate to be compatible with standard distribution channels without the need for new distribution infrastructure.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

About the Janssen Pharmaceutical Companies

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

AstraZeneca puts a time limit on its COVID-19 ‘no-profit’ pledge: report

As more than a half-dozen pharma companies race to develop vaccines to fight COVID-19, AstraZeneca has stood out for its pledge that it won’t try to profit off its shot until after the pandemic ends. Now, the company may be walking back that vow a bit. AstraZeneca could declare the pandemic over as early as July 2021, according to a memo of understanding obtained by the Financial Times between the company and a Brazilian manufacturer. The pandemic period might be extended if AstraZeneca determines it’s not over, the memo said.

How will AstraZeneca make that determination? The company isn’t long on details. It will “seek expert guidance, including from global organizations,” a company spokesperson said.

The spokesperson did not confirm the existence of the memo, but said in a statement that the company’s approach is to treat the COVID-19 vaccine “as a response to a global public health emergency, not a commercial opportunity.”

In July, AstraZeneca told Fierce Pharma it would price the vaccine “to support broad and equitable access around the world,” and the company’s executive vice president of biopharmaceuticals R&D, Mene Pangalos, said in a prepared statement that under supply agreements formed at that time the company would derive no profit. That statement was prepared for a congressional hearing.

Johnson & Johnson, which is also working on a COVID-19 vaccine, has joined AstraZeneca in the no-profit pledge, but other companies haven’t been so enthusiastic about the prospect of not making a return on their investments in helping end the pandemic.

Pfizer CEO Albert Bourla, for example, said in July that the notion of vaccine developers forgoing profits on COVID-19 vaccines was “very fanatic and radical,” and the company expects to make a “marginal” profit on its vaccine.

AstraZeneca, which is developing its COVID-19 vaccine with the University of Oxford, has been locking up supply deals to meet what it expects to be a demand for 3 billion doses. Most recently, it formed a $60 million, three-year deal with Oxford Biomedica to reserve vaccine manufacturing space at three sites. Oxford Biomedica nabbed U.K. approval for a fourth vaccine manufacturing site earlier this week.

The creation of multiple supply chains for the COVID-19 vaccine will “ensure access is timely, broad and equitable for high and low income countries alike,” the spokesperson said.

AstraZeneca’s COVID-19 vaccine effort has been anything but smooth, however. The clinical trial of the vaccine was paused over safety concerns stemming from the British study, in which one patient suffered spinal cord damage. British regulators quickly resumed the trial there, but it’s still on hold in the U.S. as the National Institutes of Health completes an investigation.

Scientists look to ease ear-drop dosing with one-time, temp-stable hydrogel for swimmer’s ear

The market is swimming with ear infection drugs, but keeping up with frequent ear-drop doses can be a metaphorical headache—and a literal earache. But a group of scientists at the University of Montana have developed a temperature-stable, single-dose option, and they have new preclinical data to back it up. Plenty of existing antibiotics can treat acute otitis externa—also known as swimmer’s ear—but patients typically have to take ear drops multiple times a day for several weeks. A single-application gel taken at home could improve adherence, potentially curb bacterial drug resistance and expand access to those living in remote areas, the researchers figure.

Led by Monica Serban, Ph.D., the team developed two separate hydrogel delivery systems and tested them in a cell and mouse study published in the journal ACS Biomaterials Science & Engineering.

Both systems combine activated tetraethyl orthosilicate with different large molecules to create a hydrogel, which remains in a liquid state inside a syringe, but quickly forms a gel upon entering the ear, allowing for sustained drug release.

The team paired those hydrogel systems, stable from about 39 degrees to 104 degrees Fahrenheit, with the antibiotic ciprofloxacin, which itself doesn’t require refrigeration.

In cell cultures, the drug-infused hydrogels managed to wipe out the bacteria Pseudomonas aeruginosa and Staphylococcus aureus—the two major culprits behind swimmer’s ear—at doses 100 times lower than those used in most ear drops, the team said.

The gels also proved safe when tested on models of human skin and dissipated within 10 days in mouse ears. They had no significant impact on the mice’s hearing compared to standard ear drops, the team added.

Serban’s lab recently snared a $1.45 million award from the National Institute of Health for its ear infection efforts, which will allow the team to run further tests on shelf life and stability, ABC Fox Montana reported. If all goes to plan, the product could hit shelves in about two years, the team figures.

Meanwhile, the FDA in 2018 greenlighted Otonomy’s ciprofloxacin otic suspension, sold as Otiprio, as the first single-dose antibacterial approved to treat swimmer’s ear.

The drug, first cleared in 2015 to treat young children undergoing tympanostomy tube placement surgery, eliminates outer ear infections after a single dose, but Otiprio must be refrigerated and prepared before use. A medical professional must also administer the drug in the clinic—factors Serban’s team hope to overcome with its room temperature-stable delivery platform.

Pfizer-BioNTech, Regeneron sued for patent infringement with COVID-19 products

As Regeneron grabs the limelight for treating President Donald Trump with its experimental COVID-19 antibody cocktail, the company now finds itself alongside vaccine developers Pfizer and BioNTech on the defensive in a lawsuit that claims their coronavirus products infringe upon a patent. Allele Biotechnology and Pharmaceuticals filed two lawsuits against the three drugmakers on Monday. The San Diego firm alleges that Pfizer and BioNTech, with its investigational COVID-19 vaccine BNT162, and Regeneron’s REGN-COV2, were developed using Allele’s mNeonGreen fluorescent protein without the company’s permission.

To compensate for the alleged infringement, Allele is seeking damages that amount to no less than a reasonable royalty, the company said in its complaint. It’s not immediately clear how much Allele is seeking.

In a statement, Regeneron said it disagrees with Allele’s claims of infringement and that it will “vigorously defend our position against this lawsuit.” Pfizer didn’t immediately respond to a request for comment.

Pfizer and BioNTech’s lead candidate, an mRNA shot dubbed BNT162b2 that’s supported by the Trump’s Administration’s Operation Warp Speed, entered a phase 3 efficacy trial in July as the second U.S. program to do so. The pair said on Tuesday that they have started a rolling submission to the European Medicines Agency, which allows for the agency to review an application as clinical data come through.

As for Regeneron, the company a few days ago unveiled encouraging data from the first 275 patients in a phase 1/2/3 study of REGN-COV2, which combines two types of antibodies against the virus, showing it could help non-hospitalized patients clear the virus and improve in symptoms. The drug made headlines this past week as President Trump received a high dose of the cocktail as part of his COVID-19 treatment.

But Allele claims that the Regeneron drug was developed with the help of mNeonGreen, pointing to several academic papers published in Science and co-authored by Regeneron employees that include information on how antibodies against SARS-CoV-2’s spike protein were tested with the fluorescent protein.

In medical research, fluorescent proteins are injected into living cells so that scientists can visualize the molecular changes to determine the cells’ response to treatments. Among them, mNeonGreen is one of the brightest and most stable monomeric fluorescent proteins to date, and therefore allows for rapid detection of changes, according to Allele. “This research tool is even more critical in a global pandemic where the need for a vaccine to save lives has never been more crucial,” the company said in its complaint.

According to Allele, it “sought on multiple occasions to discuss Regeneron’s taking a license to that patent” but got no reply.

In Pfizer and BioNTech’s case, Allele said development and testing of the pair’s BNT162 vaccine candidate was made possible “only through use of mNeonGreen,” but the partners never reached out for a license, according to the complaint.

The tech earned the companies “an immediate $445 million in grants and over $4 billion in sales of the vaccine to date,” the complaint said, likely referring to the government contracts the pair has secured, including a $1.95 billion supply deal with the U.S. government.