Astellas Pharma voluntarily dismissed its lawsuit against the Biden administration earlier this month after its drug Xtandi was not among the initial list of 10 drugs selected for the Inflation Reduction Act’s Drug Price Negotiation Program. While Astellas was the first pharma company to do so, it might not be the last as the legal battle over the IRA has moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring over the law.
The U.S. Chamber of Commerce has requested a ruling on its motion for a preliminary injunction by Oct. 1—the date by which manufacturers of the drugs the Centers for Medicare and Medicaid Services has chosen for the first negotiation round must decide whether to participate.
The Inflation Reduction Act, signed in August 2022, would permit Medicare to negotiate prices for certain prescription drugs. Several pharma companies have filed lawsuits against the federal government to prevent the policy from going into effect. Similar to the Chamber of Commerce, the companies claim that the Drug Price Negotiation Program is unconstitutional as it allegedly amounts to the forced taking of their property without just compensation, while compelling drugmakers to agree that CMS’ prices are fair.
While Astellas withdrew its suit, the company in a statement said it still believes that the IRA’s price negotiation provision is “bad policy and unconstitutional.” Astellas asserted in its original legal complaint that the IRA violated the First and Fifth Amendments, an argument shared by several other companies.
Astellas did not state why it withdrew its suit, but it was the only company to file a suit that wasn’t on CMS’ initial price negotiations list. All other pharma companies that filed suit to prevent the provision from going into effect have at least one drug on the list, including Novartis, Merck, AstraZeneca and J&J.
Michelle Mello, a professor of health policy and law at Stanford University, told BioSpace that Astellas may have withdrawn its lawsuit due to the company not having any grounds to sue.
“In Astellas’ case, there may have been a standing issue, meaning that once it became clear that none of their products were going to be subjected to negotiation they began to worry whether courts would recognize their right to bring a claim at this time,” Mello wrote in an email statement. She also said she could not speculate on why a particular company might choose to sue, beyond pharma companies generally being opposed to changes to their pricing practices.
Standing has already come up in other legal complaints against the IRA.
In its request for a preliminary injunction, which is currently before the U.S. District Court for the Southern District of Ohio, the Dayton Chamber of Commerce has asked for a judge to halt the Drug Price Negotiation Program before Oct. 1 as it will cause its members “substantial irreparable harm.” The Chamber’s lawsuit specifically calls out AbbVie, which is a member of the business group and markets the drug Imbruvica. Novo Nordisk and Amgen, which also have drugs on the Medicare negotiation list, are also members.
“The IRA’s price controls would cause AbbVie to suffer extremely significant financial harm, and AbbVie is already incurring, and will continue to incur, substantial costs to comply with the IRA’s burdensome requirements,” according to the Chamber of Commerce lawsuit.
However, in August, the federal government filed a motion to dismiss the case claiming that AbbVie and other Chamber members lacked standing. The reason AbbVie was said to lack standing was because only the primary manufacturer—Pharmacyclics, a subsidiary of AbbVie—will be invited to negotiations. AbbVie’s ownership of Pharmacyclics doesn’t give them the right to sue, the motion stated. The government also argued that the plaintiffs are merely speculating about the risk the IRA poses to drug companies.
In the first hearing in federal court in Ohio over the IRA’s Drug Price Negotiation Program, the Department of Justice also argued that the Chamber doesn’t have legal standing to challenge the program and the court should throw out the case given that any financial injury to drugmakers wouldn’t happen until 2026, when the negotiated prices take effect. The Chamber has asked Judge Michael Newman to release his ruling on the motion for a preliminary injunction by Oct. 1.
Not having standing for a lawsuit has not stopped other drug companies from making their positions known. In late August, Fresenius Kabi filed an amicus brief in support of J&J’s lawsuit saying that the IRA disincentivizes the production of generics and biosimilars.
“I think there is some concern that if the market for a brand drug is essentially diminished or injured through effectively some form of price setting, that will affect the incentive for a generic or biosimilar to enter the market as well,” said John Bennett, a litigator at Allen & Overy who works with biopharma clients.
Bennett said the Ohio case is one to watch because the judge’s decision may come relatively soon.
For now, most of the legal proceedings are continuing. Novartis was the latest company to file a suit on Sept. 1. BMS, J&J, Merck and PhRMA have all filed for summary judgment in their respective cases. In the meantime, despite filing respective lawsuits challenging the IRA, AstraZeneca and BMS have decided to participate in the first round of Medicare drug price negotiations.
Despite being staunchly opposed to the Inflation Reduction Act’s Drug Price Negotiation Program, AstraZeneca and Bristol Myers Squibb have been left with no choice but to participate, according to Endpoints News.
Under the Inflation Reduction Act (IRA) provisions, companies whose drugs are set to join the first round of drug price negotiations have until Oct. 1 to signify whether they are participating or not. AstraZeneca will negotiate for its type 2 diabetes therapy Farxiga (dapagliflozin), while BMS will discuss the prices for its blood thinner Eliquis (apixaban).
“We have no choice other than to sign the ‘agreement,’” a BMS spokesperson told Endpoints. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid. That is not a real choice.”
In late August 2023, the Centers for Medicare and Medicaid Services (CMS) named the first 10 drugs included in the first round of negotiations. Aside from Farxiga and Eliquis, the list also included diabetes drugs Jardiance (empagliflozin) and Januvia (sitagliptin), as well as the anticoagulant Xarelto (rivaroxaban), heart failure therapy Entresto (sacubitril/valsartan) and psoriasis treatment Enbrel (etanercept).
The companies that own these drugs—including Johnson & Johnson, Eli Lilly and Novartis—will also have to register their participation into the program by the Oct. 1 deadline, according to CMS.
President Joe Biden signed the IRA into law in August 2022, seeking to generate around $25 billion in drug cost savings for the government over the next eight years. The Medicare Drug Price Negotiation Program is set to cover some of the most widely prescribed medicines, with their new prices set to take effect in 2026.
According to a recent research brief published last month in the Journal of Managed Care & Specialty Pharmacy, the program will save approximately $1.8 billion for Medicare in just its first year of implementation.
Analysts also expect that the program would only lead to minimal financial losses for companies, at least initially, since most of the drugs that are up for negotiation are also nearing the end of their patent protections. Januvia, for example, will lose its market exclusivity in 2026, the same year that the renegotiated prices are set to take effect.
Nevertheless, the biopharma industry—led by some of its largest companies—has strongly opposed the IRA’s Drug Price Negotiation Program. Merck kicked off the legal battle in June 2023, when it filed the first lawsuit attempting to block the negotiations program. It has since been joined by BMS, AstraZeneca, Novartis and Boehringer Ingelheim.
Earlier this month, Astellas voluntarily dismissed its lawsuit against the Biden administration after its drug Xtandi was not among the initial list of 10 drugs selected for the program.
AbbVie has walked away from its collaboration and license agreement with Caribou Biosciences, the Berkeley-based biotech announced in an SEC filing posted Tuesday.
AbbVie’s decision was a strategic move by the company “and was unrelated to Caribou’s performance under the agreement or the data generated to date,” Caribou said in the document filed with the regulatory agency. The termination will officially take effect on Oct. 25, 2023.
First announced in February 2021, the partnership between AbbVie and Caribou focused on advancing allogeneic CAR-T therapeutics for two unspecified AbbVie programs. The Illinois-based pharma made $40 million in an upfront cash payment and promised up to $300 million in potential milestones, and in return Caribou provided access to its Cas12a chRDNA genome-editing and CAR-T cell therapy platforms.
At the time, Caribou CEO Rachel Haurwitz took the agreement with AbbVie as evidence that the company’s platform can “provide best-in-class efficiency and specificity.” However, Caribou revealed in its SEC filing on Tuesday that AbbVie has “elected to not advance these two programs.” Following the contract’s termination, all licenses granted under the agreement will also end.
Typically, CRISPR-based genome editing tools use an RNA guide molecule to help locate its target DNA sequence. This results in limited specificity of the genome editors, which can lead to substantial off-target effects. Caribou has tried to advance the technology by adding DNA to the guide molecule. This approach—which the company calls chRDNA—is meant to improve the guide molecules’ precision, thereby forcing the Cas complex to only make cuts at intended sites, according to the company’s website.
Caribou is the latest casualty in AbbVie’s quest to cull its cancer pipeline. Earlier this week, the pharma company also terminated its contract with Maryland- and Shanghai-based I-Mab. The partners were previously working on the anti-CD47 antibody lemzoparlimab, which they had been developing for myelodysplastic syndrome and acute myeloid leukemia.
AbbVie pulled the plug on two Phase Ib studies in these indications in August 2022—and these discontinuations could have played a role in its decision to cancel the I-Mab contract. Rights to lemzoparlimab will go back to I-Mab.
Earlier this month, AbbVie also passed on its exclusive licensing option for Harpoon Therapeutics’ investigational TriTAC treatment HPN217, being developed for multiple myeloma. Harpoon will push through with the ongoing Phase I clinical trial and advance HPN217 through future phases of development.
In August 2023, AbbVie likewise dropped two early-stage cancer candidates from its pipeline. One was a Pfizer-partnered antibody-drug conjugate (ADC) being trialed for solid tumors, and the other was an anti-SEZ6 ADC proposed for relapsed or refractory lung cancer.
Gilead Sciences’ anti-CD47 antibody has again disappointed in a Phase III blood cancer trial. The biopharma announced the decision to discontinue another late-stage study of magrolimab Tuesday.
This is the second Phase III study ended for the investigational treatment. In July 2023, Gilead put a stop to its ENHANCE study of magrolimab for the high-risk myelodysplastic syndromes (MDS).
Now, the ENHANCE-2 study of the antibody for acute myeloid leukemia (AML) patients with TP53 mutations has also been dropped by Gilead after a mid-trial independent analysis concluded the treatment is “unlikely to demonstrate a survival benefit” compared to standard of care, the company said.
The therapy targets CD47, a “don't eat me” signal presented by cancer cells to allow them to avoid being targeted by the body’s immune system. By suppressing the signal, patients’ immune cells should be able to attack and destroy the cancer cells.
Magrolimab was picked up by Gilead in 2020 with a $4.9 billion buy of Forty Seven, an immuno-oncology biotech that spun out of Stanford. Despite promising Phase Ib results in MDS and AML, it has so far been a dud for the company in later stage trials.
While the anti-CD47 antibody was seen as a potential treatment for blood cancers, so far it has not proven very effective in the clinic. After inking a $2 billion deal in 2020, Chinese biotech I-Mab and partner AbbVie decided to call it quits on a Phase Ib trial of the former’s lemzoparlimab. The antibody was being tested in MDS and AML in combination with azacitidine and venetoclax.
This week, AbbVie made the decision to cut its losses and terminate its licensing and collaboration agreement with I-Mab for lemzoparlimab. I-Mab’s SEC filing called it a “strategic decision.” AbbVie is out the $200 million upfront it already paid out to I-Mab.
Celgene, once considered a front runner for the anti-CD47 monoclonal antibody market, terminated its Phase I trial of CC-90002 in 2018 after preliminary data for AML and MDS did “not offer a sufficiently encouraging profile for further dose escalation/expansion.”
Gilead isn’t throwing in the towel just yet on magrolimab, however. The antibody is still in the ENHANCE-3 study for patients with first-line, unfit AML currently, but the trial is under partial clinical hold to prevent new patients from joining the program. It is also in studies for diffuse large B-cell lymphoma and in solid tumors like triple-negative breast cancer, brain cancer, as well as head and neck squamous cell carcinoma.
On September 27, 2023, Biohaven unveiled an intriguing presentation outlining the latest pharmacodynamic updates for their ground-breaking drug, BHV-1300. This bispecific IgG degrader has shown remarkable potential, with repeat dosing resulting in astonishing reductions of over 90% in IgG levels. The comprehensive presentation, which can be found in a SEC filing, delves into the specifics of BHV-1300 starting from slide 57.
https://beststocks.com/title-biohaven-unveils-groundbreaking-pharmac/
