Biopharma Lawsuit Tracker 2023: Novo Nordisk, Gilead and Teva

 Between the hotly debated Inflation Reduction Act, tightening Federal Trade Commission regulation and ongoing patent battles, biopharma legal news is abundant.

Here, we debut our new, exclusive Biopharma Lawsuit Tracker. Follow along as we keep you up to date on who’s headed to court and why, and let BioSpace be your news source for industry lawsuits through 2023. 

July

July 7: 

Novo Nordisk filed lawsuits in a Florida federal court against TruLife Pharmacy, Brooksville Pharmaceuticals and WellHealth Inc. The pharma accused these pharmacies of engaging in unlawful practices by selling products that falsely claim to contain semaglutide, the active ingredient found in Novo Nordisk's medications for weight loss and diabetes treatment.

Wegovy, an FDA-approved drug, is specifically designed for weight loss purposes, while Ozempic and Rybelsus have received FDA approval for the treatment of Type 2 diabetes.

July 3: 

Gilead and Teva Pharmaceuticals won a lengthy four-year legal battle, where they were accused of striking an illicit agreement that caused the prices of HIV drugs to soar. A California jury unanimously concluded the companies did not participate in any anti-competitive conspiracy to obstruct the introduction of generic versions of Truvada—an HIV pre-exposure prophylaxis (PrEP) medication—and other drugs.

Consumers and various direct purchasers, including the Blue Cross Blue Shield Association, initiated the lawsuit in 2019. They alleged that Gilead maintained a monopoly in the HIV drug market by unlawfully extending patent protection for their drugs, thus impeding the entry of generic competitors.

June

June 30:

• Following a lawsuit filed by the FTC in May aiming to block a multi-billion-dollar merger between Amgen and Horizon, the companies have filed a counter suit against the FTC claiming the original suit is unconstitutional, Law360 reported on June 30. “The FTC’s case is wholly novel and impossibly speculative,” the companies wrote, according to Endpoints News.

June 29:

• Alexion-Portola faced Securities and Exchange Commission (SEC) insider trading charges against a pharmaceutical executive, doctors and individuals involved in an alleged scheme surrounding the deal, as reported by several outlets. According to the SEC, Joseph Dupont, a former vice president at Alexion and member of the company's acquisitions team, is accused of initiating the tip-off. The charges, filed in the U.S. District Court for the Southern District of New York, assert that Dupont knowingly or recklessly shared confidential information about the acquisition with his close friends, who then passed it along to other associates.

• Liquidia intends to defend itself against a potential new patent related to United Therapeutics' treprostinil for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD) in response to an SEC filing. The two companies have been locked in an ongoing legal dispute over the drug. Liquidia stated in its SEC filing that United Therapeutics had received a notice of allowance for its patent application, which broadly covers the treatment of PH-ILD using an inhaled form of treprostinil. This notice indicates that the U.S. Patent and Trademark Office has determined that United Therapeutics is entitled to the patent.

June 23:

• The Amgen-Horizon deal saw more scrutiny as six states joined the FTC in requesting the District Court of the Northern District of Illinois grant a preliminary injunction against the acquisition. This injunction would remain in effect while the FTC prepares an administrative complaint and until decisions are made regarding the complaint.

June 21:

• PhRMA, Merck and Bristol-Myers Squibb have jointly filed a lawsuit against the federal government concerning the price-setting provisions outlined in the IRA. The lobbying group and the two pharmaceutical companies have come together in their legal action, claiming that the legislation violates the U.S. Constitution.
• Novo Nordisk initiated lawsuits against medical spas, wellness and weight loss clinics and pharmacies. The lawsuits allege that these establishments have been advertising and selling products containing semaglutide, the active ingredient found in Novo Nordisk's diabetes medications Ozempic and Rybelsus, as well as the weight loss injection Wegovy.

June 20:

• Sanofi announced that an arbitration tribunal from the International Chamber of Commerce had dismissed a claim made by Boehringer Ingelheim. The claim was related to legal responsibilities associated with the ranitidine-based product Zantac.
• BioNTech, a German company specializing in mRNA-based vaccines, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccine, developed in partnership with Pfizer and authorized for emergency use in 158 countries.

June 19:

• Bristol Myers Squibb (BMS) filed a lawsuit against the Biden administration. The lawsuit contends that an upcoming Medicare drug negotiation program via the IRA infringes upon the First and Fifth Amendments of the U.S. Constitution.

June 15:

• AbbVie initiated a lawsuit alleging patent infringement by China-based BeiGene regarding their new blood cancer drug, Brukinsa (zanubrutinib). The lawsuit claims that Brukinsa infringes on AbbVie’s patent for Imbruvica (ibrutinib), a drug developed in collaboration with Janssen and AbbVie’s Pharmacyclics. Imbruvica received FDA approval in 2014 as a therapy for chronic lymphocytic leukemia.

June 12:

• The U.S. Chamber of Commerce has filed a lawsuit in federal court against the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). The lawsuit challenges the constitutionality of the drug price negotiation program outlined in the IRA.

June 9:

• Pharmacies and drug manufacturers Allergan and Teva Pharmaceuticals, along with retail chains CVS, Walgreens, and Walmart,have agreed to pay state and local governments an additional $18.75 billion to resolve lawsuits accusing them of fueling the opioid epidemic.

• After a two-month trial, Walgreens agreed to pay $500 million settlement to the state of New Mexico for failing to recognize abuse of opioid prescriptions.

June 8:

• Eli Lilly and Takeda were hit with a class action suit accusing the pharmaceutical companies of racketeering, certified by a California Federal Judge. The allegations stem from the companies' purported failure to disclose the risk of bladder cancer associated with their diabetes drug, Actos (pioglitazone), during its marketing.

June 7:

• Promosome filed individual lawsuits against Moderna and Pfizer. The lawsuits allege that both companies infringed upon patent protections associated with mRNA technology. In the filings presented to the Southern District Court of California, Promosome asserted that its affiliated scientists made a breakthrough in 2009. They reportedly discovered a method for enhancing protein expression by making minor modifications to mRNA. This is the latest in a growing number of patent suits over the COVID mRNA vaccines.

June 6:

• Merck initiated a lawsuit against the Biden administration in the U.S. District Court for the District of Columbia. The lawsuit challenges the IRA’s constitutionality, encompassing provisions related to drug price negotiation.

https://www.biospace.com/article/biospace-lawsuit-tracker-2023-alexion-portola-liquidia-and-others-under-scrutiny/

BioSpace FDA Decision Tracker 2023: Eisai, Biogen and Amneal

 The FDA has been on a roll in the first half of 2023, approving 28 novel treatments thus far. And if the first six months is any indication, the biopharma industry should expect several more novel therapies to be greenlit, including a few more first-in-class treatments. But it’s not always good news that companies have to deliver to their stakeholders; the year has already seen its fair share of Complete Response Letters.

July

July 6:

A short workweek in the U.S. ended with big news as the FDA granted traditional approval to the first anti-amyloid antibody—and the first disease-altering drug—for Alzheimer’s disease. The accelerated approval for Eisai and Biogen’s Leqembi (lecanemab) was converted to a full approval based on results from the confirmatory Clarity-AD trial, which the FDA said in its statement verified the drug’s benefit. With the approval, Medicare coverage for Leqembi is expected to begin right away, with the requirement of a patient registry intended to collect further information on the effectiveness of this drug class in Alzheimer’s. 

July 3:

Amneal Pharmaceuticals received a Complete Response Letter for IPX203—a novel oral formulation of carbidopa/levodopa (CD/LD), a well-established combination for the management of Parkinson’s disease. In its rejection letter, the FDA said that while Amneal was able to adequately establish the safety of levodopa, it was not able to sufficiently do so for carbidopa. The regulator has requested additional pharmacokinetic data. The New Jersey–based company stated it plans to meet with the FDA to determine the best path forward for the treatment.

June

June 29:

Capping a busy week, the FDA approved BioMarin’s Roctavian (valoctocogene roxaparvovec-rvox) as the first gene therapy for adults with severe hemophilia A. Hemophilia is a rare genetic bleeding disorder caused by a mutation in the gene that encodes factor VIII (FVIII), which is necessary for blood to clot. A one-time gene therapy, Roctavian contains a healthy gene for factor VIII. Delivered through an adeno-associated virus (AAV) vector, the gene is expressed in the liver to increase blood levels of FVIII, thereby reducing the risk of uncontrolled bleeding. 

June 28:

The FDA notched another milestone with the approval of the first cellular therapy for type 1 diabetes. Lantidra (donislecel) developed by Chicago-based CellTrans, is a cell therapy made from the pancreatic islet cells of deceased donors. It is intended for adult patients whose repeated hypoglycemic episodes leave them unable to hit average blood glucose levels. In a clinical trial of 30 patients, 21 were insulin-free for at least a year; 11 didn’t require insulin for between one and five years and 10 were insulin-free for more than five years. Five patients failed to achieve any days of insulin independence.

June 28:

Pfizer’s bet on OPKO Health’s human growth hormone analog paid off as the FDA approved the treatment—which will be marketed as Ngenla—to treat children whose production of growth hormones is impaired. Pfizer purchased exclusive global commercialization rights for the then-experimental treatment in December 2014 for $295 million upfront and a promise of up to $275 million in milestones. This was the partners’ second try for FDA approval after the regulator rejected Ngenla’s first bid in January 2022. Pfizer and OPKO did not state the reasons for the initial denial.

June 28:

The FDA declined to approve Eton Pharmaceuticals’dehydrated alcohol injection for the treatment of methanol poisoning, citing concerns related “primarily to Chemistry Manufacturing and Controls.” This is the second Complete Response Letter issued to Eton for this proposed treatment. In the first, issued in March 2021, the FDA indicated that travel restrictions due to the COVID-19 pandemic prevented a timely inspection of the company’s European contract manufacturing site.

June 27:

The FDA approved UCB’s Rystiggo (rozanolixizumab), a subcutaneously administered humanized IgG4 monoclonal antibody, to treat generalized myasthenia gravis, a rare muscle-wasting autoimmune disease. Rystiggo is the only treatment approved to treat patients who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive. The regulatory green light was based on a Phase III trial that showed Rystiggo led to significant improvements in symptoms related to breathing, talking, swallowing and rising from a chair.

June 23:

The FDA greenlit Pfizer’s Litfulo (ritlecitinib) for the treatment of patients as young as 12 years with severe alopecia areata, an autoimmune disease characterized by patchy or complete hair loss on the scalp, face or body. Litfulo inhibits Janus kinase 3 and the tyrosine kinase and is believed to work by blocking the signaling of cytokines and cytolytic activity of T cells, which are implicated in alopecia areata.

June 22: 

In one of the year’s most-anticipated regulatory decisions, the FDA approved Sarepta’s Elevidys—formerly SRP-9001—for children 4 to 5 years with Duchenne muscular dystrophy. Elevidys is the first-ever gene therapy for DMD, a neuromuscular disease characterized by progressive muscle weakness and atrophy that strikes primarily young boys. The gene therapy was approved via the FDA’s accelerated approval pathway based on data that established it increased the expression of the Elevidys micro-dystrophin protein.

June 21:

Eli Lilly and Boehringer Ingleheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) picked up another indication, becoming the first and only SGLT2 inhibitors approved for children 10 years and older with type 2 diabetes. Previously, there had only been one oral drug for this indication: metformin, which was approved in 2000.

June 20:

Argenx will bring to market the first subcutaneous injectable for generalized myasthenia gravis (gMG), a rare muscle-wasting autoimmune disease. Vyvgart (efgartigimod) was first approved in 2021 as a one-hour intravenous infusion. Vyvgart is an antibody fragment that binds to the neonatal Fc receptor to prevent recycling of immunoglobulin G back into the blood. This includes a reduction in abnormal AChR antibodies, which are present in approximately 85% of gMG patients. AChR antibodies block the acetylcholine receptors from being able to receive signals from the nerve to stimulate a muscular response. Their normalization should ostensibly improve muscular function.

https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/

Roche’s Tecentriq Boosts Survival in NSCLC Patients Ineligible for Platinum Chemo

 Data from the Phase III IPSOS trial showed that first-line treatment with Roche’s Tecentriq (atezolizumab) significantly improves overall survival in advanced non-small cell lung cancer patients who are not fit enough to withstand platinum-based doublet chemotherapy.

The study was led by the University College London (UCL) and was supported by Roche. Its findings were published online Thursday in The Lancet.

Patients given Tecentriq saw a median overall survival of 10.3 months, as opposed to 9.2 months in counterparts treated with standard single-agent chemotherapy with either vinorelbine or gemcitabine. This corresponded with a 22% drop in the risk of death after Tecentriq treatment.

At two years, patients treated with Roche’s PD-L1 blocker had a 24% survival rate, as opposed to only 12% among chemotherapy counterparts. Tecentriq also led to either more stable or improved patient-reported health-related quality of life compared with chemotherapy.

Tecentriq also induced fewer grade 3 to 4 treatment-related adverse events than the chemotherapy control.

“For over two decades, clinical trials have failed to provide significant therapeutic benefits to older NSCLC patients with poor health who are unfit for standard platinum doublet chemotherapy,” Siow Ming Lee, chairperson of the study’s steering committee, oncology professor at UCL and a consultant oncologist at UCL Hospitals, said in a statement.

The Phase III, open-label and randomized study enrolled 453 patients, all of whom had stage III to IV NSCLC. All IPSOS participants were ineligible for standard platinum-based doublet chemotherapy (PDC) treatment, as assessed by their Eastern Cooperative Oncology Group Performance Status, comorbidities, contraindications and age.

IPSOS is the first randomized late-stage study assessing first-line Tecentriq specifically in this patient population with poor prognosis, which has successfully demonstrated significant improvement in survival, Lee said.

Patients who are unfit for PDC comprise more than 40% of all advanced NSCLC patients. Due to this limitation, these patients have very limited treatment options and are typically given suboptimal single-agent regimens or best supportive care, according to UCL’s news release.

Data from IPSOS could pave the way for a strong therapeutic option for this patient subgroup. Currently, Tecentriq’s only first-line indication in NSCLC is for adult patients with metastatic malignancies with known high levels of PD-L1 expression.

Tecentriq is also approved to treat NSCLC as an adjuvant treatment after surgery and platinum chemistry and as a combination regimen with other chemotherapeutic agents.

https://www.biospace.com/article/roche-s-tecentriq-boosts-survival-in-nsclc-patients-ineligible-for-platinum-chemo/

'Biden Says Assad Must Go'

 by Connor Freeman via The Libertarian Institute,

While on the campaign trail, President Joe Biden spoke with some “Syrian American activists” who favor increased sanctions on the country as well as regime change in Damascus, during a private fundraiser in Maryland last month. According to neoconservative columnist Josh Rogin – one of Bill Kristol’s protégés –  Biden told these regime change advocates that, among other things, Assad must go. Rogin says these activists “took advantage of their audience with Biden… to implore him to do more to oppose” Syrian President Bashar al-Assad.

Alla Tello, a Syrian American from Massachusetts, said she declared to Biden that “Assad must go,” to which the president responded “I agree.” That rallying cry was first uttered in 2011, when the Barack Obama administration began launching its dirty war against Damascus, an ultimately failed but extremely bloody regime change effort.

Al-Qaeda affiliated militants and Islamic State fighters waged a war against the people of Syria and its government that is estimated to have resulted in the deaths of more than 500,000 people. The terrorist forces that carried out the failed regime change attempt were supported often by the CIA and its allies, including the British, the French, Israel, Saudi Arabia, Turkey, and Qatar.

Consequently, Russia maintains a significant military presence in Syria, having intervened at the request of Assad in 2015 to help beat back ISIS and al Qaeda elements wreaking havoc. Iran and Hezbollah also came to the aid of Damascus. Tello demanded that that Washington do more to “help the Syrian people free themselves from the grip” of Assad, Tehran, and Moscow. “[Biden] said, ‘I can’t promise you, but I will do the best I can,’” she told Rogin.

“Encouragingly, these activists told me, Biden not only seemed to care deeply about the plight of Syrians but also seemed to want to do more about it,” Rogin writes. This rings hollow as for years, on a near-weekly basis, Tel Aviv has dropped bombs on Syria. Last year, the Wall Steet Journal reported that a large portion of these air raids are carried out with the US military’s coordination. The Israelis claim their constant airstrikes are meant to counter Iranian forces in the country, though they routinely target and kill Syrian soldiers as well as civilians, along with airports, and other civilian infrastructure. This year, following a devastating earthquake which killed thousands of Syrians, the Aleppo airport – which was a vital channel for aid – was bombed on three separate occasions and rendered inoperable by the Israeli Air Force.

During the last several decades, Biden has been known as apartheid “Israel’s man in Washington.” Since becoming president, including in the wake of the Israeli military’s murder of Shireen Abu Akleh, an American journalist, he has said emphatically that US ties with Tel Aviv are “bone-deep.” In May, Israeli Defense Minister Yoav Gallant boasted that since Prime Minister Benjamin Netanyahu came to power last December, the airstrikes in Syria have doubled. Reportedly, Israel has bombed Syria at least 19 times this year alone.

Muhammad Bakr Ghbeis, Tello’s husband, told Biden “We have to save Idlib.” This northwestern province has been controlled by al Qaeda affiliates for years as a result of Washington’s policy. Even the hawkish Brett McGurk, the former anti-ISIS envoy under Obama and Trump, admitted in 2017 that “Idlib Province is the largest Al Qaeda safe haven since 9/11.” McGurk is now Biden’s top Middle East official on the National Security Council.

“Please save Idlib, Mr. President,” Ghbeis pleaded, to which Biden replied “I hear you, but I can’t send U.S. soldiers to Syria.” Washington currently has about 900 troops illegally deployed to eastern Syria, backing the Kurdish-led SDF, and occupying about a third of the country, where US forces control most of Syria’s oil and wheat resources. This is not the first time Biden has forgotten he has US forces engaged in combat in Syria and dropping bombs.

As Gen. Michael “Erik” Kurilla, the commander of CENTCOM, has conceded, the American troops’ unwanted presence is becoming increasingly dangerous as there have been numerous close calls with Russian forces as well as aircraft and dozens of attacks by ostensibly Iranian backed groups. Nevertheless, Biden is not reducing troop levels, instead another base is being built in the northern province of Raqqa.

If Biden believes Syria's Assad should go, he should take action
- The Washington Posthttps://t.co/Ss609rMIwC

— Ayman Abdel Nour (@aabnour) July 6, 2023

Ultimately, these so-called activists at the Maryland fundraiser were agitating for a more bellicose sanctions policy aimed at thwarting the regional realignment which has taken place this year, namely with Riyadh normalizing relations with Damascus and Syria being welcomed back into the Arab League. Syria’s neighbors including former adversaries have largely accepted that Assad is not going anywhere. However, Biden’s administration opposes these moves toward bringing Assad in from the cold and, following the Arab League’s decision, imposed more sanctions on Syria.

Rogin said these activists insisted “[the White House] publicly support a bipartisan bill called the Assad Regime AntiNormalization Act that would stiffen penalties on any entity that aids the Assad regime.”

After more than a decade of brutal war, rebuilding Syria will cost an estimated $250-400 billion. Secretary of State Antony Blinken, America’s top diplomat, has made clear that the administration is absolutely committed “to oppose the reconstruction of Syria” absent regime change. To that end, Washington has for years implemented a harsh sanctions regime on Syria using the bipartisan Caesar Act, a law which can target any person or entity of any nationality that attempts to do business with the war-torn country. These sanctions deliberately target the country’s engineering and construction sectors.

As a result, the civilian population has been devastated. According to Alena Douhan, a UN special rapporteur on unilateral coercive measures who visited Syria for twelve days last year, the sanctions “severely harm human rights and prevent any efforts for early recovery, rebuilding and reconstruction.” She added that “12 million Syrians grapple with food insecurity” and “90% of Syria’s population currently lives in poverty,” with limited access to food, shelter, water, electricity, healthcare, heating, cooking, fuel, and transportation.

https://www.zerohedge.com/geopolitical/biden-says-assad-must-go

Tucker Carlson Says Capitol Police Chief Admitted 'Jan6 Crowd Was Filled With Feds'

 In his first public interview since being fired from Fox News, Tucker Carlson sat down with none other than Russell Brand (on Rumble).

He began by explaining why he chose to launch his show on Twitter:

“I’m not working for Elon Musk… what he’s done is offered me is what he’s offered every other user at Twitter which is a chance to broadcast your views without a gatekeeper”

The whole interview is fascinating, but one section in particular is key, when discussed the events of January 6th.

As a reminder, House Speaker Kevin McCarthy had released 40,000 hours of video footage from the riot - which Carlson had begun airing on Fox News - much of which suggested a different narrative than the craven mob of killers the Democrats (and the media) have maintained was unleashed on the Capitol by Trump's words and actions.

Admitting he was "appalled" by some of the events of that day, the former Fox News anchor said the reason he “got involved in commenting on it” was because “the lying about it was immediate: ‘This was a racist, white-supremacist insurrection.'”

“I interviewed the chief of the Capitol Police, Steven Sund, in an interview that was never aired on Fox, by the way — I was fired before it could air, I’m gonna interview him again,” Carlson said.

“But Steven Sund was the totally non-political, worked for Nancy Pelosi, I mean, this was not some right-wing activist. He was the chief of Capitol Police on January 6, and he said, ‘Oh yeah, yeah, yeah, that crowd was filled with federal agents.’ What? ‘Yes.’ Well he would know, of course, because he was in charge of security at the site.”

“So, the more time has passed... it becomes really obvious that core claims they made about January 6 were lies,” Carlson explained.

“The amount of lying around January 6, and it was obvious in the tapes that I showed, is really distressing.”

Watch the clip below:

Tucker Carlson BLOWS The Doors Off January 6th LIES.

Reveals Fox News REFUSED To Air His J6 Interview Of Capitol Chief Of Police PROVING "The US Capitol Was FILLED With Federal Agents"

Tucker Describes Fox Execs Attacking him For J6 Report: "F**k You!”

Narrative Collapse. Wow pic.twitter.com/30UijETvNq

— Benny Johnson (@bennyjohnson) July 7, 2023

Carlson's comments fit with whistleblower and witness statements on the day.

As The Daily Caller reports, defendant Dominic Pezzola’s lawyer, Roger Roots, argued there were “at least 40” undercover informants at the riot. Roots alleged there were eight FBI human sources embedded among the Proud Boys on Jan. 6, along with 13 undercover plain-clothes DC Metro Police agents. FBI whistleblower George Hill alleged during a February interview with the House Select Subcommittee on the Weaponization of the Federal Government that the field office in Washington may have had “undercover officers” and “confidential human sources” inside the Capitol on Jan. 6.

Carlson also discussed his views on Donald Trump:

"I think looking back on this ten years from now, assuming we're still around, I think we're going to see Trump's emergence as the most significant thing that happened in American politics in 100 years, because he reoriented the Republican Party against the wishes of Republican leaders."

"I'm struck by his foreign policy views. You know Trump is the only person with stature in the Republican Party really who is saying wait a second why are we sending an endless war in Ukraine. Leaving aside whether Trump is going to get the nomination or get elected President or would be a good President, I can't even asses that, all I can at this point is I'm so grateful he has that position. He's right and everyone in Washington is wrong, everyone. And Trump is right on that question and it's a big question. That war is reshaping the world. It's reshaping the economy of the world. It's reshaping populations."

"Europe will never be the same because of this war and it really matters, and Trump alone among popular figures in both parties understands that and I'm grateful for that."

"Whether he gets the nomination or gets elected, words really matter. Saying something true out loud matters, and he is saying true things about Ukraine and God bless him. That's how I feel."

Watch the full interview with Russell Brand below:

https://www.zerohedge.com/political/narrative-collapse-tucker-carlson-says-capitol-police-chief-admitted-jan6-crowd-was