Amgen exec: Biosims may have lagged in the U.S., but now they’re paying off

For years, industry watchers have wondered whether the U.S. biopharma business needed a jump-start as new launches languished and brands kept their dominant market positions. But Amgen’s latest quarterly results show there’s still plenty of potential for a dedicated player. Amgen’s biosimilars—a group that includes copycats to Roche cancer blockbusters Avastin and Herceptin—generated $480 million during the third quarter, the company said Wednesday. The franchise is now running at about a $2 billion-per-year rate, about double the revenue of last year, Bernstein analyst Ronny Gal pointed out on Wednesday’s call.

Despite the COVID-19 pandemic, the company has “done a really nice job …. establishing strong penetration into the U.S. oncology market,” Amgen’s executive vice president of commercial operations, Murdo Gordon, said on Wednesday’s call.

After earlier biosim launches were slow to gain steam, some experts wondered whether the U.S. would be better off giving up on the money-saving promise of biosimilars. Instead, they said, the government could regulate prices directly after biologic drugs lose exclusivity. Others, such as former FDA Commissioner Scott Gottlieb, M.D., said it was too soon to call it quits.

For his part, Gordon said it’s an “efficient market” and that “when there is a clear value on the table, healthcare systems, providers and payers are able to capitalize on it.”

“That’s what’s driving of course the uptake of our biosimilars,” he added.

Amgen’s situation is different from that of some companies marketing copycat biologics. The company has defended its own brands—such as white blood cell booster Neulasta—against biosimilar competition, and that effort has “positioned us well to understand how accounts are looking to purchase biosimilars,” Gordon said.

Further, Amgen has a “very effective provider-focused commercial presence,” the exec said, meaning the same Amgen sales reps who are discussing innovative drugs with doctors are also talking about biosimilars. The company has a patient services group that helps with reimbursement and co-pay assistance, too.

While uptake for Amgen’s oncology biosims has been stronger than the company initially expected, Gordon cautioned against making assumptions about its immunology biosimilar franchise. Amgen’s biosim to Johnson & Johnson’s Remicade has been on the market for under a year and hasn’t yet taken off. The company’s biosim to Roche’s Rituxan is set for a December decision at the FDA.

Looking forward, Bernstein’s Gal questioned whether Amgen expects to maintain its level of biosim growth next year. Gordon said the company can “continue to capture good volume albeit at some price erosion” as new competitors launch. Still, Amgen has “a lot of headroom for growth,” Gordon said.

Amgen’s results come several years after the first biosimilar launches in the U.S. Pfizer’s biosimilar to Remicade was among the early launches, hitting the market in October 2016 at a 15% discount to the brand. The copycat was slow to take off, and Pfizer sued J&J for “anticompetitive” contracting to protect its important brand. J&J hit back in a public statement that Pfizer wasn’t offering enough value to win business. This year, the lawsuit has been in the discovery process, according to law firm Goodwin.

Pfizer itself generated $424 million in sales for the biosim franchise during the third quarter. Back in August, Bernstein’s Gal wrote that the biosims market is entering a “golden age” and that the companies will generate billions of dollars in revenues from the market.

For Amgen, the biosimilar contribution helped propel the company to third-quarter revenue growth of 12% to $6.4 billion despite challenges associated with the pandemic. New immunology acquisition Otezla chipped in $538 million, while Enbrel’s quarterly haul was $1.33 billion.

Pharma Tested by a pandemic, pharma supply chain showed resilience

When the COVID-19 pandemic began to sweep across the U.S. this year, early fears of shortages of critical pharmaceutical supplies and life-saving drugs were quickly abated by a responsive and resilient supply chain. As the crisis unfolded and the public’s attention was focused on shortages of everyday items like toilet paper, paper towels and disinfectants, patients with critical needs for treatments that ranged from insulin to inhalers also began to fret.

Manufacturers worried as well. Was the pharmaceutical industry prepared to meet the challenge? Particularly since—according to industry averages—between 70% to 80% of APIs (active pharmaceutical ingredients) are manufactured in China and roughly 40% to 50% of generic drugs are produced in India. On top of that were early shortages of protective equipment like face masks, face shields and gowns for front-line healthcare workers and other essential workers like associates at AmerisourceBergen’s distribution centers. AmerisourceBergen is one of the nation’s primary pharmaceutical wholesale distribution entities. The company picks, packs and ships nearly 4 million pharmaceutical and healthcare products daily and services more than 65,000 hospitals, pharmacies, physicians’ practices and clinics annually.

“Our family and friends used to say they didn’t really understand what we did every day,” Heather Zenk, Senior Vice President for Strategic Global Sourcing at AmerisourceBergen, said. “Now supply chain is something we talk about around the kitchen table.”

The immediate response from the company was to ensure that its front-line associates—primarily distribution center associates, patient-facing nurses and pharmacy staff—were monitored for health and provided the protective equipment they needed. If anyone across AmerisourceBergen could work from home, they were asked to do so.

Concurrent with those actions was a program to support front-line associates that provided day-care needs and paid time off for employees who either needed to quarantine themselves or their families. Additional steps included daily temperature checks, constant sanitization of warehouse sites that now utilize ultraviolet robots, and an app with Centers for Disease Control questions to help monitor associates’ health.

Having a good business continuity plan

“What served us, our partners and customers well was our ability to be resilient and have a nimble business continuity plan,” Erin Horvath, President of AmerisourceBergen’s Distribution Services, said. “We were able to handle certain circumstances like having to close a distribution center for a short period of time, divert product orders to another facility and still meet the needs of our customers.”

An example was the company’s closure for several days of its Newburgh, N.Y. distribution facility at the height of that state’s COVID-19 outbreak last spring although the site’s positive tests for the virus were very low.

“We saw associates were getting uneasy about coming in and we wanted them to know we cared and wanted to protect them, so we decided to close that center,” Horvath said. “We could take that action because we knew we had the network to support customers by servicing them through our other distribution centers.”

With a network of 33 human health and specialty distribution centers and 19 animal health distribution centers and depots nationwide and about 4,000 associates manning them, AmerisourceBergen was able to implement a robust business plan with a long track record of responding to other natural disasters like hurricanes, earthquakes and wildfires. Only, instead of day and weeks of response, the pandemic has persisted for months and will likely continue through the first half of next year.

That history of successful crisis response is supported by close partnerships with a variety of government agencies, as well as its relationship with Healthcare Ready, a Washington, D.C.-based nonprofit focused on supporting the healthcare supply chain by collaborating with government entities and the private industry sector.

Such collaboration between the private sector, government agencies and with non-profit health organizations will play an integral part as vaccines developed to fight COVID-19 start to become available in the coming months and year.

Partnerships across the board will be a key part when it comes to distributing and administering those vaccines, and both Horvath and Zenk agree that the centerpiece to a successful outcome has and will continue to be open and transparent communication.

“Early on, we knew to invest the time in that kind of communication so that everyone wasn’t fighting the same battle for resources,” Zenk said. “Because of that, we were able to respond to customers very honestly and quickly. We saw hospital customers changing therapies as they learned more about how to treat the virus; we were able to routinely check in with them on the therapeutics they needed most and start supporting them right away.”

Zenk also points out that with the attention mostly focused on the pandemic response this year there were about 20 launches of new oncological treatments. A clear indication that despite the immediate crisis, innovation in the pharmaceutical industry continues, and that innovation needed to be distributed to patients in the same manner they were accustomed to getting under normal circumstances.

Preparing for a vaccine rollout

As vaccines become available, they will initially be allocated to those most at risk like front-line health-care workers, essential workers and populations such as the elderly and people with co-morbidities. When a nationwide vaccine program is rolled out and begins to reach critical mass deeper into 2021 it will likely involve multiple manufacturers offering multiple treatments, all of which will need the strength of the full national supply chain and distribution system.

“Something of this scale has never been undertaken before,” Horvath said. “We are talking about a vaccine that includes two doses and requires frozen and ultra-frozen storage and transportation capabilities—and will need to be available to the entire population of the United States.”

AmerisourceBergen has extensive experience in managing ultra-low temperature products and is standing ready to support the vaccine distribution effort when needed, both Horvath and Zenk said.

Clearly it will involve an enormous effort by the government and private industry and will require independent neighborhood pharmacies, large retail pharmacies and physicians to have a voice in the project.

“We have invested hundreds of millions of dollars in our technology and in our distribution network in the last 10 years and in the past months we’ve seen that those investments pay off. They have given us the agility and resilience to do things in a very quick manner,” said Horvath.

“One of the great things I’ve observed during this time is how the national healthcare system has been working more like a community,” Zenk added. “A hospital in one region might say they are doing okay, but then ask us to make sure another hospital in another area that might be a hot zone gets what they need.”

Eli Lilly may face FDA warning letter after recent inspection at COVID-19 antibody plant found more issues: report

Eli Lilly’s chances at an emergency use authorization for a COVID-19 antibody took a big hit after a major trial was stopped for safety concerns and the FDA flagged problems at a manufacturing site producing the therapy. Now, the FDA is back for more, and it could spell even bigger problems. Lilly could face an FDA warning letter after a follow-up inspection at the plant that showed “a major failure of quality assurance,” sources told Bloomberg. Located in Branchburg, New Jersey, the site is manufacturing Lilly’s COVID-19 antibody LY-CoV555, among other drugs.

An FDA warning letter, which signals continuing deficiencies at a drug manufacturing plant, would escalate the current “official action indicated” notice Lilly received for a previous FDA inspection at the site in November 2019.

In that notice, the FDA cited Lilly on two counts of inadequate “control of computer systems,” the drugmaker confirmed last week. The agency cited the plant for improperly deleting data on its manufacturing processes and failing to review quality-control audits, sources told Reuters.

Despite that earlier citation, FDA inspectors again found problems at the plant in August, Bloomberg reported, and is asking the agency to “take action.” The Branchburg site is one of five that produce the antibody, Lilly said in a Tuesday statement, and the FDA has yet to issue a warning letter to the drugmaker.

In response to the FDA’s findings in November, Lilly has added staff at the Branchburg site and hired an external consultant to review its data handling, the company said.

While Lilly maintains that the shortfalls flagged by the FDA haven’t affected the quality of its antibody, which the agency is reviewing for an emergency authorization, sources painted a different picture for Bloomberg.

Compliance officers conveyed one incident in which a Lilly employee used the wrong material in a “crucial” purification process, Bloomberg said. Employees also reportedly retested samples for impurities to get back a positive result and denied FDA investigators’ requests to review human resources documents related to potential data handling citations.

A Lilly spokesman refused to comment in an email on the specific allegations in the Bloomberg report, saying the company was “not in receipt of any of the documents referenced by Bloomberg and thus cannot confirm their authenticity.”

The Branchburg site also produces migraine med Emgality, and Lilly has requested FDA authorization to produce GLP-1 diabetes med Trulicity on-site as well, Bloomberg said.

Potential quality issues for Lilly’s antibody come as an ill omen after the National Institutes for Health halted a phase 3 study of the therapy earlier this month on safety concerns.

The trial’s independent data safety monitoring board recommended the company pause enrollment, a Lilly spokesperson told CNBC in an email, adding, “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The trial halt came just days after Lilly asked the FDA to clear LY-CoV555 for emergency use based on phase 2 data showing it cut the rate of hospitalizations in patients recently diagnosed with mild to moderate COVID-19. However, two of the three doses tested in the study failed to beat placebo in terms of reducing viral load by the 11-day mark.

Does Roche’s Actemra work in COVID-19? New studies once again paint mixed picture

Roche’s arthritis drug Actemra was one of the earliest-identified COVID-19 treatment prospects. But the latest clinical studies have yielded mixed data—and seemingly contradictory results. A large observational study that looked at 3,924 critically ill COVID-19 patients admitted to intensive care units across top U.S. institutions linked Actemra treatment to a 29% reduction in the risk of death after a median follow-up of 27 days, according to results published in JAMA Internal Medicine.

Overall, an estimated 27.5% of patients who got Actemra within two days of ICU admission would die after 30 days, versus 37.1% for those who didn’t receive it. The beneficial effect was most pronounced in patients who had a more rapid disease trajectory and were admitted to the ICU within three days of symptom onset, the study finds.

Dysregulated inflammation plays an important role in COVID-19 disease progression. As the body fights the coronavirus, it may release too many inflammatory agents that may lead to organ failure or death. IL-6, which Actemra targets, is among those molecules found to be elevated in this cytokine release syndrome.

However, controlling IL-6 with Actemra hasn’t consistently translated into clear clinical benefits as scientists had hoped.

In a randomized clinical trial of 126 severe COVID-19 patients in Italy, investigators found no evidence of an Actemra-related improvement in disease progression—namely, the lungs’ ability to exchange air, ICU admission or death, according to results also published Tuesday in JAMA Internal Medicine. Specifically, 17 patients (28.3%) in the Actemra arm and 17 (27.0%) in the standard care group showed clinical worsening in 14 days.

Then, to further complicate the situation, a randomized clinical trial, which enrolled hospitalized patients in France with moderate-to-severe COVID-19 pneumonia, also found mixed results for Actemra.

Patients on the Roche drug were 42% less likely to require ventilation or die by day 14, according to a third study that appeared Tuesday in JAMA Internal Medicine. However, on the study’s other co-primary endpoint, the drug didn’t cut the risk of disease progression to a prespecified WHO clinical status benchmark by day 4.

The three studies add to a growing body of evidence that has yet to reach a conclusion about Actemra’s role in COVID-19. They have their limitations, which makes interpreting their findings difficult. For example, there are potentially important differences in treatment groups at baseline in the U.S. observational study, Jonathan Parr of the University of North Carolina at Chapel Hill pointed out in an editorial that ran alongside the papers. Some of the patients in the Italian study who were not assigned to the experimental group actually got Actemra as their disease worsened, he noted.

He also questioned the significance of the French finding that Actemra may improve outcomes at 14 days, given mixed 28-day findings from two Roche-sponsored trials. The Covacta study showed Actemra couldn’t significantly improve clinical status or prevent death compared with placebo. But in the Empacta trial, which primarily enrolled patients from minority racial and ethnic groups, the drug led to a major reduction of mechanical ventilation or death by day 28, though the death rate difference was not statistically significant.

Parr said he would wait for detailed, peer-reviewed results from those two studies and others. The Actemra arm in the U.K.’s massive Recovery trial “will better define [Actemra’s] role in COVID-19 management,” he said. That study recently found low-cost steroid dexamethasone could reduce the death rate in hospitalized patients.

“For now, however, findings from the randomized trials described herein do not support routine [Actemra] use in COVID-19,” Parr said.

Pfizer CEO, facing pushback, shifts COVID-19 vaccine timeline to late November

For months, Pfizer CEO Albert Bourla had maintained that the company would know this month whether its BioNTech-shared COVID-19 vaccine works. But top scientists pushed back, the FDA released detailed guidelines and critics grew increasingly louder.

Now, finding himself alone in the biopharma world with that bullish estimate, the Big Pharma chief is changing his tone.

Pfizer won’t apply for FDA emergency use authorization before the third week of November, Bourla wrote in an open letter on Friday.

What about October? That’s when the company might know whether the vaccine, dubbed BNT162, is effective, but the company still needs to gather enough safety data for an application, Bourla explained.

That’s a clear shift from Bourla’s previous comments, which constantly featured “October” as the key word—at a time when President Donald Trump was touting a vaccine before the Nov. 3 election, and mentioning Pfizer by name.

“Right now, our model, our best case, predicts that we will have an answer by the end of October,” Bourla previously said on the “Today” show. During a digital event in September, he also said the company expected initial results in late October and would seek FDA authorization as soon as possible. In October, “the truth will be revealed,” was what he told The Washington Post.

That October timeline sounded even more aggressive when Moderna CEO Stephane Bancel, known for touting ambitious goals, said his company’s shot, which was the first in the U.S. to move into clinical testing, likely wouldn’t have data until November.

Then, in late September, more than 60 researchers and bioethicists urged Pfizer to wait until late November at earliest to file its vaccine for FDA review, arguing a submission before accruing at least two months of safety data would “severely erode public trust and set back efforts to achieve widespread vaccination.”

For an emergency use application, the FDA is requiring at least two months of safety data on half of the trial participants after their final vaccine doses, according to a guidance document released last week.

To understand the vaccine’s efficacy—that is, whether it can protect individuals from COVID-19—a certain number of COVID-19 cases in the phase 3 trial need to be counted before investigators can compare the effectiveness of the vaccine with placebo. That means the data may come earlier—by October—if infections come quickly, Bourla explained in the open letter.

But effectiveness is only one of three metrics Pfizer will use for applying its vaccine for public use, he added. “Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years,” he said.

What’s more, the company will also gather manufacturing data to demonstrate “the quality and consistency of the vaccine that will be produced,” Bourla said. And that information will be ready before the safety readout, he said.

Despite his previous timeline falling in line with Trump’s, Bourla has said Pfizer is only “moving at the speed of science,” not politics. “In this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay,” he wrote in another open letter earlier this month. “Neither of those options are acceptable to me.”

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.