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By Brendan Pierson
Sept 18 (Reuters) - Drugmaker Eli Lilly LLY.N on Wednesday urged a federal appeals court to overturn a $183 million judgment against it in a case accusing it of defrauding Medicaid, arguing that it was being wrongly held liable despite following its reasonable interpretation of the government health insurance program's requirements.
The case, before a three-judge panel of the Chicago-based 7th U.S. Circuit Court of Appeals, has attracted attention from major business groups including the U.S Chamber of Commerce, the nation's biggest business lobbying group, and leading drug industry association Pharmaceutical Research and Manufacturers of America (PhRMA), which argued in an amicus brief that allowing the judgment to stand would create "untenable uncertainty and chaos" for regulated companies.
7th Circuit Judges Candace Jackson-Akiwumi, Kenneth Ripple and Joshua Kolar asked relatively few questions and did not clearly indicate how they would rule.
The case stems from a 2014 whistleblower lawsuit brought in Chicago federal court by Ronald Streck, a lawyer and pharmacist who accused Lilly of short-changing Medicaid, a state- and federally-funded insurance program for low-income people.
Medicaid requires participating drugmakers to pay the program rebates on drugs prescribed to Medicaid beneficiaries, with larger rebates for higher-priced drugs. Streck said that, until 2017, Lilly underreported the prices for prescription drugs that it charged its distributors.
Specifically, Streck said, Lilly failed to report that, when it increased prices, it billed distributors for the additional price on any unsold drugs they had bought at the old price and still had in stock.
Lilly denied the allegations, saying that those price increases were offset against service charges it paid to distributors, and did not result in any net increase in price.
Lilly began reporting price increase charges to distributors in 2017 after the U.S. Centers for Medicare and Medicaid Services issued a new rule stating that many price increase charges would likely have to be reported.
However, Lilly said that it had told regulators about its methodology several times before then and received no pushback, and that the government declined to intervene in Streck's case, reinforcing its belief that its interpretation was correct.
U.S. District Judge Harry Leinenweber in Chicago denied Lilly's motion for summary judgment in 2022 while granting Streck's motion for summary judgment that Lilly's price statements were false, allowing the case to go to trial on damages and on the issue of whether Lilly had committed fraud knowingly. In May 2023, a jury found the company liable for $61 million, which the judge tripled to $183 million as allowed by the federal False Claims Act.
John O'Quinn of Kirkland & Ellis, arguing for Lilly on appeal, told the panel that the jury should have been allowed to weigh in on whether Lilly's reported prices were actually false, and to hear more evidence that the government led it to believe its interpretation of the law was right.
"This case turns on the reasonableness of Lilly's price reporting assumptions," he said.
Daniel Miller of Walden Macht Haran & Williams, arguing for Streck, urged the panel to uphold the judgment, calling Lilly's price increase bills to distributors "a pure cash grab." He noted that, while the government had declined to intervene, it was supporting the lawsuit as an amicus.
Joshua Dos Santos, a lawyer for the U.S. Department of Justice, said that the jury "was entitled to disbelieve either the reasonableness of (Lilly's) explanation, or the sincerity of it."
He said overturning the judgment would undermine a U.S. Supreme Court ruling last year in a case against pharmacy operator SuperValu that a company cannot avoid liability for fraud by citing an objectively reasonable interpretation of the law that it did not actually believe.
Lilly said in its appeal brief that its case was "fundamentally different" from the SuperValu case because it actually believed in its interpretation.
The case is United States ex rel Streck, 7th U.S. Circuit Court of Appeals, No. 23-2134.
For plaintiff: Daniel Miller of Walden Macht Haran & Williams
For the government: Joshua Dos Santos of the U.S. Department of Justice
For Lilly: John O'Quinn of Kirkland & Ellis
Read more:
Whistleblower's claim that Eli Lilly short-changed Medicaid will go to jury
U.S. Supreme Court gives boost to whistleblowers in drug pricing case
Keywords: HEALTH-FRAUD/LILLY
Merck MRK announced that a phase study evaluating its Daiichi Sankyo-partnered HER3-directed DXd antibody drug conjugate (ADC), patritumab deruxtecan, for treating EGFR-mutated non-small cell lung cancer (NSCLC), met its primary endpoint of progression-free survival (PFS).
The HERTHENA-Lung02 evaluated the efficacy and safety of patritumab deruxtecan versus pemetrexed and platinum chemotherapy for treating locally advanced or metastatic EGFR-mutated NSCLC in patients who had received prior EGFR tyrosine kinase inhibitor treatment. In the study, patritumab deruxtecan demonstrated a statistically significant improvement in PFS — the study’s primary endpoint — versus platinum plus pemetrexed induction chemotherapy.
As regards overall survival, a key secondary endpoint of the study, the data were immature at the time of the analysis. The study will continue to further assess overall survival.
Patients with metastatic EGFR-mutated NSCLC who are initially treated with an EGFR TKI sometimes experience disease progression. This creates a need for therapies like patritumab deruxtecan as treatment options for this type of lung cancer in the second-line setting are limited.
Merck plans to discuss the data with regulatory authorities to decide the next steps.
Merck’s stock has risen 8.5% so far this year compared with an increase of 25.9% for the industry.
More on MRK’s Patritumab Deruxtecan
A biologics license application (BLA) seeking accelerated approval for patritumab deruxtecan for previously-treated EGFR-mutated NSCLC is already under review in the United States supported by data from the HERTHENA-Lung01 pivotal phase II study.
In June, the FDA issued a complete response letter to the BLA based on observations made after the inspection of a third-party manufacturing facility. The FDA has not requested any additional efficacy/safety studies, nor has it identified any issues related to the safety and efficacy of the candidate. Merck is working closely with the FDA and the third-party manufacturer to resolve the issue.
Merck’s Deal With Daiichi Sankyo
Merck acquired global co-development and co-commercialization rights to patritumab deruxtecan/MK-1022 and two other ADCs, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400 from Japan’s Daiichi Sankyo in October last year for a total potential consideration of up to $22 billion. While raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer, ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.
Daiichi Sankyo has retained exclusive rights for the development of the candidates in Japan. In August this year, Merck expanded its deal with Daiichi to co-develop and co-commercialize MK-6070, an investigational T-cell engager targeting delta-like ligand 3, which it obtained from its acquisition of Harpoon Therapeutics.
Other Companies Making ADC Products
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancer, being developed utilizing its DXd ADC technology. It markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca AZN. Daiichi Sankyo and AstraZeneca have also developed datopotamab deruxtecan (Dato-DXd), a TROP2-directed ADC. Dato-DXd is under FDA review for advanced nonsquamous NSCLC as well as previously treated metastatic HR-positive, HER2-negative breast cancer. The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
Pfizer PFE also has a strong portfolio of ADC drugs, which were added with last year’s acquisition of Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio. Adcetris, Padcev, Tukysa and Tivdak contributed $279 million, $394 million, $121 million and $33 million, respectively, to Pfizer’s oncology revenues in the second quarter. Pfizer is particularly witnessing strong demand for Padcev.
MRK’s Rank and Stock to Consider
Merck has a Zacks Rank #4 (Sell) currently.
Merck & Co., Inc. Stock Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
A top-ranked large drugmaker is Eli Lilly LLY, carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for 2024 have risen from $13.71 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.42 to $23.97 per share over the same timeframe. LLY’s stock is up 55.5% year to date.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
Zacks Investment Research
The weight-loss drug market is heating up with the introduction of GLP-1 pills. Novo Nordisk’s NVO Wegovy and Eli Lilly’s LLY Zepbound have been dominating this market and several other companies are also vying for a slice of the lucrative business. The latest data from Roche Holdings RHHBY, Novo Nordisk and smaller biotech proved that an oral option could be as effective as injectables.
The new drugs in the pipeline are getting approval with potential for improvements such as less frequent administration by pill rather than by injection and fewer side effects (patients currently report nausea and vomiting and even more serious side effects such as intestinal blockage).
Investors seeking to tap the boom in weight-loss drug treatments could consider Roundhill GLP-1 & Weight Loss ETF OZEM, Amplify Weight Loss Drug & Treatment ETF THNR and GLP-1, Obesity & Cardiometabolic ETF HRTS.
Weight-Loss Pills Take Center Stage
Last week, Roche’s early Phase 1 clinical trial data showed its pill provided 6.1% weight loss over four weeks. The study's sample size was small, just 12 patients, which is typical of early-stage trials.
Meanwhile, Novo Nordisk and another biotech firm, Terns Pharmaceuticals, also released data last week for their oral GLP-1 candidates. Novo Nordisk's oral candidate beat the company's own injectable weight-loss drug, Wegovy. Patients showed 13.1% weight loss after 12 weeks on the pill, compared to 6% after 12 weeks in Wegovy's early trial. Terns’ data showed its early-stage candidate caused 4.9% weight loss over four weeks, which is in line with competitors. However, the company said it would start the second phase of trials next year.
According to estimates from analysts at Morningstar and Pitchbook, the market for weight-loss treatment is expected to see 16 new drugs by 2029 that will potentially expand the market size to $200 billion by 2031. Spherical Insights projects the global weight loss supplement market to grow from $28.65 billion in 2023 to $101.83 billion by 2033, at a CAGR of 13.5% (read: ETFs to Profit from the Weight Loss Drug Boom).
Obesity has become a major global health crisis impacting every corner of the world, with more than 1 billion individuals living with obesity. Obesity is linked to numerous health risks, including diabetes, heart disease, stroke and cancer.
GLP-1 medications mimic the effects of the naturally occurring hormone glucagon-like peptide-1, which is produced in the intestine after eating. These drugs were initially used to treat diabetes but were later found to control blood sugar levels, reduce appetite and promote weight loss.
Overall, recent studies have shown that GLP-1 drugs have led to a 10-20% reduction in body weight and lowered the risk of heart attack, stroke and cardiovascular death by approximately 20%.
ETFs to Tap
Roundhill GLP-1 & Weight Loss ETF (OZEM)
Roundhill GLP-1 & Weight Loss ETF is the world’s first GLP-1 ETF and is actively managed. Roundhill believes that weight loss drugs, including GLP-1 agonists, represent one of the most revolutionary advancements in the global pharmaceutical industry. OZEM holds 29 stocks in its basket, with a higher concentration on the top two holdings.
Roundhill GLP-1 & Weight Loss ETF has accumulated $47.1 million in its asset base since its inception in late May and charges 59 bps in annual fees. It trades in an average daily volume of 34,00 shares (see: all the Healthcare ETFs here).
Amplify Weight Loss Drug & Treatment ETF (THNR)
Amplify Weight Loss Drug & Treatment ETF provides access to global companies involved in the pharmaceutical manufacturing of GLP-1 agonist or enablers of such businesses. It tracks the VettaFi Weight Loss Drug & Treatment Index and holds 27 stocks in its basket, with a heavy concentration on the top two firms.
Amplify Weight Loss Drug & Treatment ETF charges 59 bps in annual fees and has AUM of $4.4 million. It trades in an average daily volume of 3,000 shares.
GLP-1, Obesity & Cardiometabolic ETF (HRTS)
GLP-1, Obesity & Cardiometabolic ETF seeks to provide long-term growth of capital by investing in GLP-1 and weight loss companies leading the fight against obesity and cardiometabolic diseases. It holds 45 stocks in its basket with a modest concentration on the top firms.
GLP-1, Obesity & Cardiometabolic ETF has AUM of $88.6 million and charges 75 bps in annual fees. It trades in a volume of 25,000 shares a day on average.
Zacks Investment Research
Novartis NVS announced that the FDA has approved breast cancer drug Kisqali (ribociclib) for a broader population.
The regulatory body approved Kisqali in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.
Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that helps slow the progression of cancer by inhibiting two proteins — cyclin-dependent kinase 4 and 6 (CDK4/6).
The broad indication in HR+/HER2- stage II and III EBC at high risk of recurrence approximately doubles the population eligible for CDK4/6 inhibitor adjuvant therapy.
Year to date, shares of Novartis have risen 14.6% compared with the industry’s growth of 24.1%.
Broader Label for NVS’ Kisqali
The FDA approval is based on strong results from the late-stage NATALEE trial. The results showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence in a broad population of patients with HR+/HER2- stage II and III EBC treated with adjuvant Kisqali plus endocrine therapy (ET) compared to ET alone, including those with high-risk N0 disease.
The invasive disease-free survival benefit was consistently observed across all patient subgroups.
Please note that Kisqali is already approved for the treatment of metastatic breast cancer (MBC) in several countries.
The latest FDA approval of Kisqali for this early breast cancer population, including those with N0 disease, should enable NVS to offer treatment with a CDK4/6 inhibitor to a significantly broader group of patients.
NVS recently presented an updated analysis from the NATALEE trial at the European Society for Medical Oncology Congress 2024. Results showed that Kisqali caused a deepening benefit beyond the three-year treatment period and reduced the risk of recurrence by 28.5% compared to ET alone, in patients with stage II and III HR+/HER2- EBC.
Novartis will continue to evaluate NATALEE patients for long-term outcomes, including overall survival.
Kisqali: A Top Drug for NVS
Kisqali is one of the key growth drivers for NVS, which is now a pure-play innovative medicine company with a focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology.
It is one of the leading breast cancer drugs in the United States and outside the country, with a dominant market share. The drug generated sales worth $1.3 billion in the first half of 2024.
Approximately 90% of breast cancer cases in the United States are diagnosed early (stages I-III). These patients remain at risk of cancer recurrence (in most cases as an incurable metastatic disease).
The drug's approval for a broader population should further fuel sales.
Regulatory reviews for Kisqali as an EBC treatment are ongoing worldwide, including in the EU and China.
Last year, the FDA also expanded Eli Lilly’s LLY Verzenio’s (abemaciclib) indication. Verzenio, a CDK4/6 inhibitor, was approved in combination with ET for the adjuvant treatment of HR+HER2-, node-positive, EBC at a high risk of recurrence.
Eli Lilly is witnessing a stupendous run in 2024, riding high on the success of its GLP-1 drugs — Mounjaro and Zepbound.
NVS’ Zacks Rank & A Stock to Consider
NVS currently carries a Zacks Rank #3 (Hold).
A better-ranked stock from the large-cap pharma industry is Pfizer PFE, which currently sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for PFE’s 2024 earnings have risen from $2.39 to $2.62 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $2.75 to $2.85 over the same time frame.
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