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October 12, 2023

Big Pharma News Watch

Novavax Taps Breakout Star of TV Show to Spread COVID Vaccine Choice Message + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Novavax Taps Breakout Star of TV Show to Spread COVID Vaccine Choice Message

Fierce Pharma reported:

Novavax is throwing marketing muscle behind its bid to capture a piece of the fall COVID-19 booster vaccine market. Having seen mRNA vaccines dominate the market, the biotech wants the public to know there is an alternative to Moderna and Pfizer — and has tapped Nicole Ari Parker to spread that message.

Maryland-based Novavax largely missed out on the COVID-19 vaccine gold rush, leading to pressures that threatened to sink the company. Outside investment steadied the ship, and Novavax received emergency use authorization for the updated XBB version of its COVID-19 vaccine last week, positioning it to provide a protein-based alternative to the dominant mRNA shots.

Novavax must overcome two challenges to turn the vaccine into a commercial success. First, the biotech needs as many people as possible in the U.S. to get vaccinated in a season in which Pfizer expects a 24% vaccination rate. Second, it needs to persuade people to choose its vaccine over the mRNA shots.

Novavax has enlisted Parker, a Black actor who The Washington Post called the breakout star of the “Sex and the City” sequel “And Just Like That …,” to front the campaign.

Court OKs Mallinckrodt Restructuring, $1 Billion Cut to Opioid Settlement

Reuters reported:

Drugmaker Mallinckrodt (MCD0.F) on Tuesday won court approval for a bankruptcy plan that cuts $1 billion from what it must pay opioid crisis victims, cancels existing equity shares, and trims nearly $2 billion in other debt.

The Ireland-based company reached a relatively swift conclusion to its second Chapter 11, which began on Aug. 28, just 14 months after its previous bankruptcy concluded.

U.S. Bankruptcy Judge John Dorsey approved the restructuring plan at a court hearing in Wilmington, Delaware.

Mallinckrodt, which makes branded and generic drugs, first filed for bankruptcy in 2020 to address its high debt load, litigation over its allegedly deceptive marketing of highly addictive generic opioids and disputes over its drug pricing.

Latinas Behind RSV, COVID Vaccines Aim to Boost Hispanic Rates

Axios reported:

Latinas who had key roles in the development of the respiratory syncytial virus (RSV) and COVID-19 vaccines are hopeful their work can contribute to improving vaccination rates among Hispanics.

The big picture: Latinos in the U.S. have consistently low inoculation rates against the flu, polio, HPV or hepatitis, and are less likely than other racial or ethnic groups to be vaccinated against COVID-19, research shows.

Having a growing number of Latino researchers who can explain the science, and do so in Spanish if needed, is also important to temper the effect of politicization, Alejandra Gurtman, an Argentine-born infectious disease specialist who is senior vice president of vaccine clinical research and development at Pfizer, tells Axios Latino.

GSK Settles Another California Lawsuit on Heartburn Drug Zantac

Reuters reported:

GSK (GSK.L) on Wednesday said it agreed to settle another lawsuit in California alleging its discontinued heartburn drug Zantac caused cancer, as the British drugmaker sought to end costly litigation that has weighed on shares.

The company, which has so far only settled cases in California, did not give the financial details of the settlement but said it was a “non-material” sum.

Citi analysts estimate GSK will settle all the Zantac cases against it for a total of about $5 billion in the first quarter of 2024, clearing what it called a “still relevant” overhang for its investment case and a distraction for management.

The latest settlements in California were related to cases due to go to trial in November, with a further set scheduled to begin in Delaware courts in January, GSK said. The company still faces about 79,000 cases related to Zantac in the United States, with 73,000 of them in Delaware.

Weight Loss Drugs Haven’t Hurt Pepsi’s Business, CEO Says

CNN Business reported:

Snack and beverage maker PepsiCo has so far seen a “negligible” impact on its business from drugs used for weight loss or diabetes, CEO Ramon Laguarta said during an analyst call Tuesday.

Still, he said, the company is keeping an eye on them: “We’re observing the growth of these new drugs and its potential impact.”

Some food analysts have warned that long-term adoption of semaglutide drugs like Ozempic and Wegovy, which generally work by suppressing appetites, could meaningfully alter the consumption habits of shoppers. Food companies, they say, need to prepare for that possibility.

About 1.7% of America’s population was prescribed a semaglutide drug in 2023 — up 40-fold in the past five years. Already, its popularity has buoyed the economy of Denmark, where Novo Nordisk, maker of Wegovy and Ozempic, is based. It has also strained supply in the United States, even as researchers find evidence of troubling side effects. It’s still early days but, if widely adopted, the drugs could significantly change people’s health, and how they eat.

Pfizer Inks Another EpiPen Antitrust Settlement, This One Worth $50 Million

Fierce Pharma reported:

Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.

The lawsuit, which dates to 2020 and was brought in federal court in Kansas, was filed by direct purchaser plaintiffs who claimed Pfizer and its EpiPen marketing and distribution partner Mylan conspired with Teva to delay the entry of a generic version of EpiPen.

The settlement is on top of a 2021 agreement by Pfizer to pay $345 million to resolve an antitrust suit brought in 2017 by indirect purchasers — such as insurers, consumers and pension funds — also in U.S. court in Kansas.

EU Leads More Than 1 Billion-Euro Commitment to Eradicate Polio

Reuters reported:

The European Union together with the Bill & Melinda Gates Foundation and the European Investment Bank have announced a new financing package of more than 1 billion euros ($1.06 billion) to eradicate polio, the EU and the foundation said on Wednesday.

Vaccine-derived polio can occur when children are immunized with a vaccine containing a weakened version of the live virus. They are protected, but the weakened virus excreted by these immunized children can spread and mutate among an unvaccinated population, ultimately becoming harmful.

Both forms of the disease are often asymptomatic, but in rare cases can paralyze and kill children.

Study Links Opioid Exposure to Colonization With Drug-Resistant Bacteria

CIDRAP reported:

A study conducted at two Rhode Island hospitals found that exposure to opioids was associated with a nearly four-fold risk in vancomycin-resistant Enterococci (VRE) colonization, researchers reported this week in the American Journal of Infection Control.

“This is a novel finding as previous studies of factors associated with VRE colonization have not focused on non-antimicrobial medications,” the study authors wrote.

The authors explain that opioids have been shown to induce gut microbiome dysbiosis, which can reduce microbial diversity and lead to an increased risk of multidrug-resistant organisms (MDRO) colonization in the gut.

Although more research is needed to elucidate the mechanisms behind the association, they say there may be a need to implement infection prevention strategies aimed at limiting the acquisition and spread of MDROs among opioid users.

GSK Signs Shingles Vaccine Deal With China’s Zhifei for Around $3 Billion

Reuters reported:

China’s largest vaccines company Zhifei (300122.SZ) will pay British drugmaker GSK (GSK.L) 2.5 billion pounds ($3.05 billion) for the exclusive rights to distribute GSK’s shingles vaccine in the world’s No.2 pharmaceuticals market.

The deal is one of a series of moves by Western pharmaceutical firms to seize a bigger share of China’s market, including announcements from companies such as AstraZeneca.

The vaccine, named Shingrix, is GSK’s top-selling medicine. GSK said the deal with Zhifei is part of its efforts to more than double sales of Shingrix, to more than 4 billion pounds ($4.88 billion), by 2026.

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