Regeneron Loses Appeal to Block Amgen’s Eylea Biosimilar

 

The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.

A U.S. federal appeals court on Friday handed Regeneron another legal loss in its patent fight against Amgen over the latter’s biosimilar to Regeneron’s blockbuster eye injection Eylea.

The ruling, though expected, could still be a “headwind that could be difficult to overcome” for Regeneron, BMO Capital Markets analysts wrote to investors on Friday afternoon. “This decision adds incremental risk to the Eylea story,” which is already running into other difficulties.

Regeneron sued in January 2024, claiming that by developing and marketing its VEGF blocker Pavblu, Amgen was violating more than 30 Eylea patents. Regeneron at the time asked the court to permanently block Amgen from commercializing “any current or future versions of a product that infringes, or the use or manufacturing of which infringes” the Eylea patents in the suit.

A West Virginia court in September 2024 ruled against Regeneron, though the order was issued and remains under seal.

Writing for the United States Court of Appeals for the Federal Circuit, Judge Alan David Lourie affirmed the lower court’s ruling, noting that Regeneron had failed to sufficiently make its case that Pavblu’s specific formulation clearly violates Eylea’s patents.

“There is at least a substantial question of noninfringement,” Lourie wrote of Amgen’s Pavblu, noting a distinct difference in its formulation to Eylea. “Regeneron has therefore not established a likelihood of success on the merits of its infringement allegations.”

As noted by BMO, it has not been smooth sailing of late for Eylea.

As per Regeneron’s full-year business report last month, for instance, sales of the therapy dipped 11% year-on-year in the fourth quarter, capping off a year of disappointing sales and mounting competition from other biosimilars. Hoping to shore up revenues for the franchise, Regeneron is developing a high-dose formulation of Eylea, though its rollout has been rough. In the fourth quarter of 2024, the high-dose injection made $305 million, missing the analyst expectation of $336 million.

Still, BMO appears to be optimistic about Regeneron overall, pointing to its “catalyst-filled 2025.” Foremost of these is the launch of its prefilled syringes for high-dose Eylea by midyear. Additionally, the BMO analysts pointed to readouts for the biologic itepekimab in chronic obstructive pulmonary disease (COPD) and for the LAG-3 therapy fianlimab in non-small cell lung cancer and melanoma.

Also helping boost Regeneron’s business is the recent approval of its Sanofi-partnered Dupixent in COPD, making the IL4 and IL13 blocker the first-ever biologic cleared for this indication.

https://www.biospace.com/policy/regeneron-loses-appeal-to-block-amgens-eylea-biosimilar

Altimmune Jumps On Takeover Spec After Launching Alcohol Use Disorder Study

 

The company unveiled plans last week to test its GLP-1/glucagon dual receptor agonist in alcohol use disorder and alcohol-related liver disease.

Altimmune is reportedly being pursued by three powerhouse suitors seeking to take over the biotech as it seeks to expand its incretin pipeline into alcohol-related disorders, according to a SeekingAlpha report on Friday.

The takeover rumors come after Altimmune announced that it will assess the potential of its GLP-1/glucagon dual receptor agonist pemvidutide for alcohol use disorder. A Phase II trial is slated to start in the second quarter, company officials said during a virtual R&D event on Thursday. Another mid-stage study, this one in alcohol-related liver disease, is being planned for the third quarter.

Citing the British website Betaville—which focuses on dealmaking scoops, and which itself cited sources familiar with the matter—SeekingAlpha noted that Altimmune is currently working with an adviser regarding these offers. BioSpace has been unable to independently review the Betaville alert but has reached out to Altimmune for comment.

Altimmune shares were up almost 14% at Friday’s close.

In an investor note on Friday, reacting to Altimmune’s expanded pemvidutide plans, William Blair analysts wrote that alcohol-related disorders “are logical extensions for evaluation of pemvidutide’s efficacy, given its mechanisms of action.” Indeed, several other biopharma players are exploring the potential of GLP-1 therapies beyond obesity and type 2 diabetes.

For instance, Novo and Lilly, both leaders in the weight-loss arena, are testing their respective GLP-1 medications semaglutide and tirzepatide for metabolic dysfunction-associated steatohepatitis (MASH). Meanwhile, Danish biotech Kariya Pharmaceuticals is proposing its dual GLP-1/GIP receptor agonist KP405 for neurodegenerative disorders, including Parkinson’s disease and Alzheimer’s disease.

Altimmune is similarly advancing pemvidutide in MASH, with Phase Ib data showing normalization of liver fat content in more than half of patients 12 weeks after treatment, according to its website. Altimmune called these findings “class-leading.”

The company is running the Phase IIb IMPACT trial of pemvidutide in MASH, with data expected in the second quarter of 2025.

In obesity, pemvidutide has also shown potential as a treatment option that can preserve lean muscle mass. Findings from the Phase II MOMENTUM trial in June 2024 showed that nearly 80% of weight lost from pemvidutide was attributable to fat loss.

https://www.biospace.com/business/altimmune-jumps-on-takeover-rumors-after-launching-alcohol-use-disorder-study

Novo Nordisk membership in UK pharma body restored after suspension

 Novo Nordisk has been accepted back into the fold. Two years after suspending Novo, the Association of the British Pharmaceutical Industry (ABPI) has reinstated the Danish drugmaker after seeing “clear, significant and sustained improvements.”

ABPI suspended Novo in March 2023 over serious breaches of its code of practice. The action followed an investigation into sponsored courses offered on LinkedIn that, in the view of a code of practice appeal board, amounted to a “large-scale Saxenda promotional campaign which Novo Nordisk knowingly paid for and which was disguised.”

The resulting suspension was imposed for two years. 

ABPI said Monday that the suspension had been lifted after the Prescription Medicines Code of Practice Authority (PMCPA), the body that enforces the code, carried out “extensive audits of Novo Nordisk’s compliance procedures and governance.” The details of those audits are kept confidential.

Based on the audit reports and other evidence, the ABPI board ruled Novo has made the necessary progress “to ensure it is able to properly adhere to the strict industry standards” in the code of practice. 

Sebnem Avsar Tuna, general manager of Novo Nordisk U.K., said in a statement that the company has “considerably strengthened” its compliance processes so it can “be fully and effectively self-regulating.”

Other issues came to light as Novo worked to improve its processes. The company voluntarily admitted to failing to disclose payments in 2023, leading the PMCPA to rule it brought discredit to the industry the following year. The ruling, a breach of clause 2 of the code, was one of four times Novo was found to have brought discredit to the industry last year.

With some of the cases covering similar topics, the documentation publicly released by the PMCPA throughout the suspension period often provided a look at where Novo was making progress and what gaps remained in terms of its compliance with the trade group’s code of practice.

https://www.fiercepharma.com/marketing/novo-nordisk-accepted-back-abpi-after-sustained-improvements-get-suspension-lifted

Putin decree authorises US hedge fund to buy foreign-owned Russian securities

 Russian President Vladimir Putin has given a U.S. hedge fund permission to buy securities in Russian companies from certain foreign stakeholders and authorised their future sale to two Russian funds, a presidential decree showed on Monday.

Moscow has steadily tightened restrictions on foreign asset sales since the start of the conflict in Ukraine, with any transactions involving the energy and finance sectors requiring Putin’s approval.

Investors are on the lookout for any signs that the thaw in U.S.-Russia relations instigated by President Donald Trump’s return to the White House could unlock ways for Western investors to trade Russian assets. Monday’s decree, light on detail, provided limited clues.

The decree authorised U.S. hedge fund 683 Capital Partners, LP, to acquire the securities of Russian companies owned by around a dozen other Western financial entities, including Jane Street, Templeton Asset Management, Franklin Advisers and Carrhae Capital.

The decree then gave two Russian companies, Cepheus-2 and Modern Real Estate Funds, permission to acquire securities owned by 683 Capital Partners without the need for additional authorisation from Putin.

Reuters could not immediately reach 683 Capital Partners for comment.

International sanctions against Moscow over the Ukraine war have blocked many Russian investors’ access to securities held in jurisdictions outside the country, while Russian countermeasures have frozen Western funds within.

https://www.investing.com/news/economy-news/putin-decree-authorises-us-hedge-fund-to-buy-foreignowned-russian-securities-3932314

Bayer Gets Speedy FDA Review of Kerendia in Heart Failure

 Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.

Bayer on Monday said the application covers Kerendia for the treatment of adults with heart failure with a left ventricular ejection fraction, or LVEF, of at least 40%, also known as mildly reduced or preserved LVEF.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

German drugs-to-crops giant Bayer said about 6.7 million adults in the U.S. live with heart failure, with roughly 55% having mildly reduced or preserved LVEF.

The FDA approved Kerendia in 2021 to improve cardiovascular outcomes for patients with type 2 diabetes and chronic kidney disease. The drug generated sales of around $500 million last year.

https://www.morningstar.com/news/dow-jones/202503172454/bayer-gets-speedy-fda-review-of-kerendia-in-heart-failure

Schumer postpones book tour for "security reasons"

 Senate Democrat Chuck Schumer postponed his book tour events for the week of March 17 "for security reasons," according to an announcement posted on the website of the Baltimore library where he was due to speak on Monday.

Schumer has faced swift backlash from members of the Democratic Party since last week over his decision to support voting on a Republican stopgap spending bill that most Democratic lawmakers said gave President Donald Trump too much power.

https://www.usnews.com/news/politics/articles/2025-03-17/top-senate-democrat-schumer-postpones-book-tour-for-security-reasons

Astrazeneca in $1B deal for Belgian off-the-shelf cell therapy biotech

 AstraZeneca has entered the “off-the-shelf” cell therapy space, penning a $1 billion deal to acquire EsoBiotec and its lentiviral vector platform.

The deal will see AstraZeneca scoop up all outstanding equity of the Belgian biotech for a total consideration of $1 billion—split between an upfront payment of $425 million and up to $575 million in developmental and regulatory milestones.

Bringing EsoBiotech onboard will give AstraZeneca access to the biotech’s Engineered NanoBody Lentiviral (ENaBL) platform, which uses lentiviruses to deliver genetic instructions to T cells to recognize and destroy either tumor cells for cancer treatment or potentially autoreactive cells for immune-mediated diseases.

The resulting cell therapies can be administered via an intravenous injection as opposed to the standard process for autologous cell therapies, where the cells are removed from their body, genetically modified and then readministered.

“What this means is that it can offer scalability to a much larger number of patients who can have access to this transformative cell therapy treatment, and the delivery of the treatment can happen in just minutes rather than the many-weeks process, which is the current reality,” Susan Galbraith, Ph.D., executive vice president for oncology hematology R&D at AstraZeneca, told journalists on a call Monday morning.

AstraZeneca currently has seven cell therapy programs in the clinic, led by a BCMA and CD19 dual-targeting CAR-T for multiple myeloma acquired as part of 2023’s Gracell acquisition. However, executives at the Big Pharma told Fierce as far back as 2022 that they were also interested in exploring the off-the-shelf, also known as allogeneic, cell therapy space.

Galbraith confirmed on the call that AstraZeneca had “been looking at the potential for in vivo technology for a little while” but said the company had been deterred by the “many technical barriers,” including the fact that the viral capsids used to deliver mRNA often don’t last long in the peripheral circulation.

That’s where EsoBiotec comes in. The company’s lead program, which targets BCMA, is already in the clinic, and, while “only a few patients have been treated” so far, according to Galbraith, “the data we've seen gives us confidence.”

Specifically, AstraZeneca was impressed by data presented by EsoBiotech at the J.P. Morgan Healthcare Conference from the first patient to be dosed in the program, which demonstrated “really quite impressive cell kinetics,” Galbraith said.

“What this enables us to do as a platform is take the learnings from the autologous programs that we have, apply them and then scale them at pace into the off-the-shelf platform,” she added.

Lentiviral vectors have attracted interest for their ability to infect dividing and nondividing cells, in addition to their low cytotoxicity rate. Orchard Therapeutics’ approved metachromatic leukodystrophy treatment Libmeldy uses the vectors, as does bluebird bio’s sickle cell therapy Zynteglo.

Novartis got in on the action last year, paying an undisclosed amount to leverage Vyriad's active targeting lentiviral vector platform to discover and develop new in vivo CAR-T cell therapy candidates.

Mont-Saint-Guibert, Belgium-based Esobiotech is a relatively new entrant in the space, with CEO Jean-Pierre Latere, Ph.D., explaining on the call that the company was set up four years ago with the “the mission of making in vivo cell therapies much more accessible, more effective and really affordable for patients.”

https://www.fiercebiotech.com/biotech/astrazeneca-goes-vivo-penning-1b-deal-belgian-lentiviral-vector-cell-therapy-biotech