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The first round of Medicare drug price negotiations has come to an end – but we still don't know the final prices that the U.S. government and pharmaceutical companies have agreed on. They all maintain that Medicare drug price negotiations are a long-term threat to the pharmaceutical industry's drug innovation and profits, but the immediate dust has somewhat settled. That's based on executive commentary during the recent quarterly earnings calls of Bristol Myers Squibb and Johnson & Johnson , among other companies. Novartis CEO Vasant Narasimhan said on July 18 that the short-term impact from Medicare drug price negotiations "might be manageable on our first set of drugs." Executives at each of the drugmakers similarly emphasized their opposition to Medicare drug price negotiations on their respective earnings calls.
Persons: Joe Biden, Johnson, Joe Biden's, Christopher Boerner, Bristol Myers, Robert Michael, We've, Michael, Jennifer Taubert, Vasant Narasimhan, Narasimhan, Bristol Myers Squibb's Boerner, Boehringer Ingelheim, Annika Organizations: National Institutes of Health, Medicare, Bristol Myers Squibb, Johnson, Pfizer, J, Novartis, Merck, Novo Nordisk, AstraZeneca Locations: Bethesda , Maryland, U.S, annikakim.constantino@nbcuni.com
It’s the best news that few people seem to know about: Prescription drug costs are falling this year for more than a million seniors — in many cases, by thousands of dollars. Its changes to Medicare, which will help people who are enrolled in the prescription drug coverage plans known as Part D, are significant. expands eligibility for financial assistance with Part D costs for low-income seniors. The law has also authorized Medicare to negotiate prices for expensive drugs with pharmaceutical companies for the first time. The first negotiations will be over 10 drugs, including the blood thinners Eliquis and Xarelto and the diabetes drugs Jardiance and Januvia.
Persons: Biden, Jardiance Organizations: Medicare
(Reuters) - The Biden administration is sending drugmakers opening offers for the U.S. Medicare program's first ever price negotiations on Thursday, the White House said in a statement. President Joe Biden's signature Inflation Reduction Act (IRA) allows Medicare, which covers 66 million Americans mostly aged 65 and older, to negotiate prices for some of its most costly drugs. The initial offers have been sent to manufacturers of 10 high-cost medicines, which include Bristol Myers Squibb and Pfizer's blood thinner Eliquis, Merck & Co's diabetes drug Januvia and Johnson & Johnson's blood thinner Xarelto. The HHS and White House did not disclose details on the offers. (Reporting by Urvi Dugar and Sriparna Roy in Bengaluru; Editing by Toby Chopra and Sriraj Kalluvila)
Persons: Biden, Medicare program's, Joe Biden's, Januvia, Johnson, Urvi Dugar, Sriparna Roy, Toby Chopra, Sriraj Organizations: Reuters, U.S, Medicare, U.S . Department of Health, Human Services, Bristol Myers Squibb, Merck, HHS, White Locations: Bengaluru
Signage is seen outside the Blackstone Group headquarters in New York City, U.S., January 18, 2023. Anthos, which does not generate any revenue because its products have not yet hit the market, could be worth several billion dollars in a potential sale, significantly more than the $250 million that Blackstone invested when it founded Anthos in 2019, the sources said. The company's anticoagulants have made significant progress in late-stage clinical trials, the sources added. Blackstone is working with investment bankers to explore a sale of Anthos, the sources said, cautioning that no deal is certain and requesting anonymity because the matter is confidential. Anthos has licensed from Novartis an antibody used in the development of its blood thinners and granted it a minority stake.
Persons: Blackstone, Anthos, Bayer, Eliquis, David Carnevali, Leslie Adler Organizations: Blackstone Group, REUTERS, Blackstone Inc, Anthos Therapeutics, Novartis AG, Novartis, Myers Squibb, Alnylam Pharmaceuticals, Thomson Locations: New York City, U.S, Cambridge , Massachusetts, Anthos, Bristol, German, New York
Logo and flags of Bayer AG are pictured outside a plant of the German pharmaceutical and chemical maker in Wuppertal, Germany August 9, 2019. REUTERS/Wolfgang Rattay/File Photo Acquire Licensing RightsNov 19 (Reuters) - Germany's Bayer (BAYGn.DE) has aborted a large late-stage trial testing a new anti-clotting drug due to lack of efficacy, dealing a fresh blow to the embattled drugmaker and throwing its most promising medium-term development project in doubt. The trial halt, which followed recommendation of independent trial supervisors, marks another setback for a company burdened by a weak herbicide business, high debt and by U.S. lawsuits over the alleged carcinogenic effect of its commonly used Roundup weedkiller. Bayer said it will further analyse the data of the discontinued trial, known as OCEANIC-AF, which was initiated in August 2022. It said the independent trial supervisors recommended the continuation of a separate phase III trial, OCEANIC-STROKE, testing asundexian to prevent repeated strokes in participants who have already suffered one.
Persons: Wolfgang Rattay, Germany's Bayer, Bill Anderson, Bayer, Stefan Oelrich, Johnson, Ludwig Burger, Jose Joseph, Miranda Murray, Christopher Cushing Organizations: Bayer AG, REUTERS, Bristol, Myers Squibb, Johnson, Thomson Locations: Wuppertal, Germany, United States, asundexian, U.S, Frankfurt, Bengaluru
A pharmacist holds a bottle of the drug Eliquis, made by Pfizer Pharmaceuticals, at a pharmacy in Provo, Utah, January 9, 2020. All drugmakers of the first 10 medicines selected for Medicare drug price negotiations have agreed to participate in the talks, even after many of them sued to halt the process last month. The Centers for Medicare & Medicaid Services did not immediately respond to a request to confirm that all drugmakers agreed to the talks. President Joe Biden's Inflation Reduction Act, which passed last year, empowered Medicare to negotiate drug prices for the first time in the program's six-decade history. The pharmaceutical industry also argues that the process will threaten revenue growth, profits and drug innovation.
Persons: Joe Biden's, Boehringer Ingelheim, Johnson Januvia, Merck Farxiga, Novartis Enbrel, Amgen Imbruvica, AbbVie Stelara, Janssen, Bristol Myers, Biden Organizations: Pfizer Pharmaceuticals, CNBC, Medicare, Services, Sunday, Bristol Myers Squibb Jardiance, Johnson, Merck, AstraZeneca Entresto, Novartis, Novo Nordisk, U.S, CMS, Bristol, Bristol Myers Squibb Locations: Provo , Utah
U.S. President Joe Biden delivers remarks on Social Security and Medicare at the University of Tampa in Tampa, Florida, U.S. February 9, 2023. The ruling is the first to come from multiple lawsuits by drug companies and industry groups challenging the program. The drug price negotiation program is part of the Inflation Reduction Act, which Biden, a Democrat, signed last year. The Biden administration has repeatedly said there is nothing in the Constitution that prohibits drug price negotiations. Many other countries already negotiate drug prices.
Persons: Joe Biden, Jonathan Ernst, vindicating, Joe Biden's, Michael Newman, Biden, drugmakers, Newman, Karine Jean, Pierre, Donald Trump, Johnson, Januvia, Bristol Myers, Boehringer, Brendan Pierson, Nate Raymond, Costas Pitas, Alexia Garamfalvi, Bill Berkrot, Chris Reese, Leslie Adler Organizations: Social Security, University of Tampa, REUTERS, U.S, District, U.S . Chamber of Commerce, Medicare, Commerce, U.S . Justice, Republicans, Big Pharma, Republican, U.S . Centers, Medicaid Service, CMS, Bristol Myers Squibb, Pfizer, Johnson, Merck, Co's, Pharmaceutical Research, Manufacturers of America, Companies, Thomson Locations: Tampa , Florida, U.S, Dayton , Ohio, New York, Boston
In a textbook free market, “fair” is whatever the market will bear. But these drugs don’t fit that model. Patents protect them from competition, allowing their producers to price them high. On the other hand, because of their high upfront development costs, pricing the drugs very low, at marginal cost, would be unrealistic. If that’s all the manufacturers earned from them, they would have no incentive to stay in business and develop new drugs.
Persons: Biden, Seshamani — Organizations: Big Pharma, pharma, Producers
Ohio Governor Mike DeWine, right, shakes hands with Judge Thomas Rose of the U.S. District Court Southern District of Ohio after taking his oath of office, Monday, Jan. 14, 2019, in Cedarville, Ohio. A federal judge on Friday withdrew from a case that could block Medicare from negotiating over drug prices, just hours after a watchdog group revealed his ownership of stock in two pharmaceutical companies that would be directly impacted by the new program. He also owns Moderna stock worth between $15,000 and $50,000, the filing shows. The suit asked the court to rule that for Medicare to negotiate drug prices would be unconstitutional. Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the drugmaker lobby PhRMA have all filed complaints in different districts courts.
Persons: Mike DeWine, Judge Thomas Rose, Judge Thomas M, Rose, Biden, George W, Bush, Johnson, Boehringer Ingelheim, Robert Davis, Davis Organizations: U.S, District Court Southern District of Ohio, Southern, Southern District of Ohio, Johnson, AstraZeneca, Republican, Moderna, U.S . Chamber of Commerce, Department of Health, Human Services, Centers, Medicare, Merck, Bristol Myers Squibb, Court, Circuit Court Locations: Cedarville , Ohio, Southern District
Eli Lilly's revenue from Jardiance — which it markets alongside privately held German biotech firm Boehringer Ingelheim — is likely to suffer due to Medicare negotiations. Compared to those growth drivers, Jardiance is a minor character in the Eli Lilly investment story. However, the deceleration is not entirely due to likely lower realized prices from Medicare negotiations. Eli Lilly looks "relatively protected" from early Medicare negotiations, BMO's Seigmerman said. Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023.
Persons: Eli Lilly, Biden, Myers Squibb, Johnson, Eli Lilly's, , Evan Seigerman, Seigerman, BMO's Seigmerman, Lilly, Jim Cramer's, Jim Cramer, Jim, AJ Mast Organizations: pharma, Myers, Club, Johnson, Medicare, donanemab, Bank of America, FactSet, Mounjaro, Merck, Constitution, Wall Street, Bristol Myers Squibb, BMO Capital, CNBC, Services, drugmakers, and Drug Administration, FDA, Trulicity, Bloomberg, Getty Locations: Bristol, U.S, Indianapolis , Indiana
The medications on the list are taken by millions of older Americans and cost Medicare billions of dollars annually. The drugs were selected by the Centers for Medicare & Medicaid Services through a process that prioritized medications that account for the highest Medicare spending, have been on the market for years and do not yet face competition from rivals. Drugs Selected for Price Negotiations1. Eliquis, for preventing strokes and blood clots, from Bristol Myers Squibb and Pfizer2. Xarelto, for preventing strokes and blood clots, from Johnson & Johnson4.
Persons: Biden, Price, Boehringer Ingelheim, Eli Lilly, Johnson Organizations: Tuesday, Medicare, Centers, Services, Bristol Myers Squibb, Pfizer, Johnson, Merck, AstraZeneca, Novartis, Novo Nordisk Locations: AbbVie, Novo
Fiasp and NovoLog, insulins made by Novo Nordisk The Medicare negotiations are the centerpiece of the Biden administration's efforts to rein in the rising cost of medications in the U.S. Drugmakers such as Merck and Johnson & Johnson and their supporters aim to derail the negotiations, filing at least eight lawsuits in recent months seeking to declare the policy unconstitutional. Drugmakers' legal challengesMerck, Johnson & Johnson, Bristol-Myers Squibb and Astellas Pharma are among the companies suing to halt the negotiation process. The suits make similar and overlapping claims that Medicare negotiations are unconstitutional. Biden and his top health officials have embraced the lawsuits as evidence that they're making progress in the fight to cut drug prices.
Persons: Biden, Joe Biden's, Boehringer Ingelheim, Johnson Januvia, Merck Farxiga, Novartis Enbrel, Amgen Imbruvica, AbbVie Stelara, Janssen, insulins, Johnson, Leigh Purvis, Drugmakers, drugmakers, Robert Davis Organizations: Bristol, Myers Squibb Jardiance, Johnson, Merck, AstraZeneca Entresto, Novartis, Novo Nordisk, Medicare, Centers, Services, Biden, AARP Public, Institute, Congressional, Office, Myers Squibb, Astellas Pharma, U.S . Chamber, Commerce, Supreme, Court, Circuit Court, Pharma, White, Big Pharma Locations: U.S, Bristol
He said that once implemented, the prices on negotiated drugs will decrease for up to 9 million seniors who currently pay as much as $6,497 in out-of-pocket costs per year for these prescriptions. This kicks off the negotiation process for the 10 drugs whose new prices will go into effect in 2026. U.S. laws had prohibited Medicare from negotiating pharmaceutical prices as part of its prescription drug program that began about 20 years ago. CMS Director Dr. Meena Seshamani said Medicare plans to use a review process to make sure insurance companies keep clinically appropriate access to negotiated drugs. Two analysts said they expect the negotiated prices to move beyond Medicare and affect commercial markets for these drugs by 2026, when they come into effect.
Persons: Joe Biden, Jonathan Ernst, Biden, Joe Biden’s, Januvia, Xarelto, Johnson, Boehringer Ingelheim, Eli Lilly's, Jardiance, Mohit Bansal, Entresto, Eli Lilly, Merck, Bristol Myers, Giovanni Caforio, Caforio, enrollees, Meena Seshamani, Stelara, Amgen, Evan Seigerman, Patrick Wingrove, Mike Erman, Manas Mishra, Nandita Bose, Caroline Humer, Bill Berkrot Organizations: Social Security, University of Tampa, REUTERS, U.S, Bristol Myers Squibb, Pfizer, Merck, Co's, Johnson, Novo Nordisk, NYSE Arca Pharmaceutical, U.S . Centers, Medicare, Medicaid Services, Reuters Graphics Wells, Novartis, AstraZeneca, Bristol, J, U.S . Department of Health, Human Services, BMO Capital, Thomson Locations: Tampa , Florida, U.S, Amgen's, Jardiance, Germany, Bengaluru, Washington
Bottles of the drug Jardiance, made by Eli Lilly and Company, sit on a counter at a pharmacy in Provo, Utah, January 9, 2020. Two blood thinners and a diabetes medication are the drugs most widely used by Medicare beneficiaries among a list of 10 drugs that will be subject to price negotiations between manufacturers and Medicare. The list names drugs with the highest spending for Medicare Part D, which covers prescription medications, for the period from June 1, 2022, to May 31, 2023. Nearly 1.6 million Medicare enrollees used Jardiance during the same time period, according to the fact sheet. Medicare Part D also spent more on those three drugs during the time period than it did on the seven other medicines on the list.
Persons: Eli Lilly, Biden, Myers Squibb, enrollees, Johnson Organizations: Company, U.S, Medicare, Myers, Centers, Services, Pfizer Locations: Provo , Utah, Bristol
Though it is still unclear which 10 drugs Medicare will select, several pharmaceutical companies have already revealed in court filings that they expect four of their blockbuster medications to be targeted. Bristol-Myers Squibb and Johnson & Johnson , in separate filings, said their blood thinners Eliquis and Xarelto will be subject to the negotiations this year. The list price of Januvia has surged 275% since 2006, according to the AARP. Johnson & Johnson reported $2.47 billion in revenue from Xarelto. "More and more people face cost-sharing that is directly affected by drug price increases," Leigh Purvis, who analyzes health-care costs for AARP, told reporters on a call Thursday.
Persons: Daniel Acker, Merck, Johnson, Abbvie, Imbruvica, Jardiance, Boehringer Ingelheim, Amgen Symbicort, Pfizer Xtandi, Breo, Biden, Januvia, Eliquis, Xarelto, Leigh Purvis Organizations: Merck, Co, Inc, Bloomberg, Getty, Medicare, Services, Myers Squibb, Johnson, Pharmacy, AstraZeneca Ibrance, Pfizer, Astellas Pharma, GSK, AARP, Bristol Myers Squibb, Jama Network, Industry Locations: Bristol, U.S, Januvia, Xarelto
Johnson & Johnson on Tuesday sued the Biden administration over Medicare's new powers to slash drug prices, making it the third pharmaceutical company to challenge the controversial provision of the Inflation Reduction Act. The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution. J&J also argues that the new provision forces the company to agree that the federal government is negotiating fair drug prices. The company believes the provision doesn't involve true negotiations since the government "unilaterally dictates" drug prices. HHS said in a statement it will "vigorously defend the President's drug price negotiation law, which is already helping to lower health care costs for seniors and people with disabilities."
Persons: Johnson, drugmakers Merck, Joe Biden's, J, Xavier Becerra Organizations: Biden, U.S . Constitution, Bristol Myers Squibb, U.S . Chamber of Commerce, PhRMA, . Health, Human Services Department, Medicare, Services, HHS Locations: New Jersey, U.S ., United States, Xarelto
And Bristol Myers Squibb is trying protect its blood thinner Eliquis, which brought in $11.8 billion in sales last year, or about 25% of the company's $46 billion total revenue for 2022. Long legal battle aheadMerck, the chamber and Bristol Myers Squibb filed their lawsuits ahead of two key deadlines. Bristol Myers Squibb did not either. If circuit court decisions on the matter contradict one another, the Supreme Court would step in to decide the issue, Bagby said. Bristol Myers Squibb made an identical argument in its complaint.
Persons: Richard A, Gonzalez, Pascal Soriot, Giovanni Caforio, Jennifer Taubert, Johnson, Kenneth C, Frazier, Albert Bourla, Olivier Brandicourt, Win Mcnamee, Drugmaker Merck, Drugmaker, Bristol Myers Squibb, PhRMA, Eli Lilly, Merck, Bristol Myers, Robin Feldman, Nicholas Bagley, Bagley, Gretchen Whitmer, Chris Meekins, Raymond James, Antonin Scalia, Brett Kavanaugh, Neil Gorsuch, Meekins, Long, Xavier Becerra, Randolph Daniel Moss, Barack Obama, Judge Thomas M, Rose, George W, Bush, Kelly Bagby, Bagby, Amgen, Donald Trump, Karine Jean, Pierre, Biden, Jean, we'll, Becerra, Feldman Organizations: Senate, AbbVie Inc, AstraZeneca, Myers Squibb Co, Janssen Pharmaceuticals, Johnson, Merck & Co, Inc, Pfizer, Sanofi, Getty, U.S . Chamber of Commerce, Bristol Myers Squibb, Washington , D.C, Southern, Southern District of, Democratic Party, U.S, Merck, Bristol, Pharmaceutical Research, Manufacturers of America, CNBC, Medicare, University of California College of, Justice Department, Michigan Gov, Bristol Myers, Human Services, Centers, Services, AARP Foundation, HHS, AARP, Specialty Pharmacy, Reuters, Supreme, Appeals, Democratic, U.S . Sixth, Republican, Third, White Locations: America, Washington , DC, Bristol, U.S, Washington ,, Southern District, Southern District of Ohio, New Jersey, Commerce's Dayton , Ohio, San Francisco
A version that was leaked earlier this year showed that Brussels was preparing to shorten an additional period of intellectual property protection, known as data exclusivity, which comes on top of drug patent protection. "The duration of data exclusivity, which may be reduced, could actually have a catastrophic impact for Europe," he said. He said the intentions of Brussels lawmakers - improving patient access to innovative drugs while making the European pharma sector more competitive - were noble but any shortening of intellectual property protection would have the opposite effect. Bayer shares lag'HIGHLY ATTRACTIVE'In the United States, a different set of drug market rule changes are underway, with some of the highest-selling products set to see negotiated price discounts under the Inflation Reduction Act (IRA). Among the biggest drivers was the company's decision to prepare a U.S. launch of its next-generation stroke prevention drug asundexian on its own.
[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.
Bayer said in a statement that earnings before interest, taxes, depreciation and amortisation (EBITDA), adjusted for special items, would likely be between 12.5 billion euros and 13 billion euros ($13.2 billion - $13.8 billion) this year, excluding the effect of currency swings. Bayer said this month it would replace its CEO early, recruiting former Roche (ROG.S) executive Bill Anderson, amid demands by some investors that Bayer should simplify its diversified structure and split into separate groups. A $6.4 billion provision remained on the balance sheet for glyphosate payouts, the larger of the two legal burdens. So Bayer should really not be on the buy list of many investors at the moment," said Molnar. Bayer saw herbicide sales jump 44% in 2022 after hurricane Ida damaged rival producers and constrained Chinese suppliers failed to plug the gap.
The negotiated prices for those 10 Medicare Part D drugs will go into effect in January 2026. This includes drugs for rare diseases, plasma or blood-derived products, drugs developed by small biotech companies and drugs that Medicare spends less than $200 million on. The products may not be part of the eventual price negotiations due to generic competition or a change in Medicare expenditures. In the program's second phase, HHS will select another 15 Medicare Part D drugs to negotiate, with prices taking effect in 2027. In phase four, HHS will negotiate prices for 20 Part B or D drugs, taking effect in 2029.
Bayer’s rude health lays better path for breakup
  + stars: | 2023-01-11 | by ( Aimee Donnellan | ) www.reuters.com   time to read: +4 min
Activists like Jeff Ubben’s Inclusive Capital Partners may now, however, be in a better position to push for a breakup. Smaller peer Bluebell Capital Partners has also bought in recently. Using UBS forecasts, they would be worth 50 billion euros and 88 billion euros respectively. Its smaller consumer drugs division might fetch another 18 billion euros, using peer Reckitt Benckiser’s (RKT.L) 12 times multiple. Add them up, take off debt, pension liabilities and a further 6 billion euros of future Roundup litigation costs, and Bayer’s equity could be worth nearly 110 billion euros.
Both are legacy issues from Monsanto, which Bayer acquired for more than $60 billion in 2018. Another activist, Elliott, took a 1.1 billion euro stake in Bayer in 2019 but has kept a low profile. The next-generation blood thinner is one of four new drug hopefuls that Bayer said on Tuesday had combined peak sales potential of more than 12 billion euros. That included an improved outlook for kidney drug Kerendia, with potential annual sales now seen at more than 3 billion euros. ($1 = 0.9313 euros)Reporting by Ludwig Burger and Patricia Weiss Editing by Mark PotterOur Standards: The Thomson Reuters Trust Principles.
Bayer beats Q3 profit forecast on strong herbicide sales
  + stars: | 2022-11-08 | by ( ) www.reuters.com   time to read: +1 min
The German company said in a statement third-quarter adjusted earnings before interest, taxes, depreciation and amortisation (EBITDA) rose 17.3% to 2.45 billion euros ($2.45 billion), above analysts' average estimate of 2.31 billion euros posted on the company's website. It said at that time it was targeting adjusted EBITDA of about 13 billion euros, based on June 30 foreign exchange rates, up from 11.2 billion in 2021. The crop science division saw adjusted EBITDA gain 33.5% to 629 million euros, beating a market consensus of 589 million euros, as a strong herbicides business more than offset weaker corn and soy seed sales. Its best-selling drug Xarelto saw sales decline 6.2% to 1.11 billion euros in the quarter, slightly below market estimates, on lower prices and volumes in China as well as loss of patent protection in Brazil. Revenues from anti-blindness treatment Eylea rose 6.3% to 811 million euros, gaining prescriptions in Europe and China, but also came in slightly below expectations.
With a successor search underway, Werner Baumann is entering his last chapter as Bayer's CEO. Baumann told Insider he's more excited today about Bayer's future than several years ago. The exec wants Bayer to become a top 10 cancer player by 2030, and recently opened a Cambridge lab. CAMBRIDGE, Massachusetts — Within his first month as CEO of the German giant Bayer, Werner Baumann took a big, legacy-making swing. Baumann says Bayer's future is in oncologyWerner Baumann, right, CEO of Bayer, and Werner Wenning, chairman of the Supervisory Board of Bayer.
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