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☆ Moderna expects to price its COVID vaccine at about $130 in the US
▼ + stars: | 2023-03-21 | by ( Patrick Wingrove | ) www.reuters.com time to read: +2 min

REUTERS/Hannah BeierMarch 20 (Reuters) - Moderna Inc (MRNA.O) expects to price its COVID-19 vaccine at around $130 per dose in the U.S. going forward as purchases move to the private sector from the government, the company’s president Stephen Hoge said in an interview on Monday. Hoge said the government's Medicare health plan for seniors pays $70 per dose for the seasonal influenza vaccine. Sanders, chair of the Senate’s powerful Health, Education, Labor and Pensions Committee, has said Moderna should not raise the price of its vaccine because of the government funding it received. He plans to question Moderna Chief Executive Stephane Bancel on the price increase at the hearing on Wednesday. Moderna in February forecast significantly declining 2023 COVID-19 vaccine sales, which reached $18.4 billion in 2022.

☆ Sanofi to cut US price of its most-prescribed insulin by 78%
▼ + stars: | 2023-03-16 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

In addition to Lantus, Sanofi said it will cut by 70% the list price for its fast-acting insulin, Apidra. The branded list price of Lantus is $438.07 for the pre-filled pens and $292.07 for a 10 ml vial. Rival Novo Nordisk on Tuesday said it would cut U.S. list prices for several insulin products by up to 75% next year. That followed Lilly's March 2 decision to cut list prices by 70% for Humalog and Humulin, its most commonly prescribed insulin products. Most Americans with insurance do not regularly pay list price for insulin, but they may have an insurance co-pay based on the drug's list price or pay full price up to a certain amount of money spent.

☆ Sanofi to cut price of its most-prescribed insulin by 78% in US
▼ + stars: | 2023-03-16 | by ( ) www.reuters.com time to read: 1 min

March 16 (Reuters) - Sanofi SA (SASY.PA) said on Thursday it would cut U.S. list prices by 78% for its most-prescribed insulin product starting next year, following rivals Novo Nordisk (NOVOb.CO) and Eli Lilly and Co (LLY.N). The move comes as U.S. President Joe Biden has pushed to extend to most Americans the $35 cap on out-of-pocket insulin costs made available to Medicare recipients by the Inflation Reduction Act. Novo Nordisk and Eli Lilly bowed to political pressure earlier this month to make these life-sustaining diabetes treatments more affordable. Reporting by Patrick Wingrove in New York, Pratik Jain in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

Although insulin list prices are high in the U.S., drugmakers typically pay substantial rebates to private insurers and government programs, resulting in lower prices for most Americans with insurance. U.S.-listed Novo Nordisk shares rose as much as 1.7% to $142.95, while Denmark-listed shares closed marginally higher on Tuesday. Eli Lilly shares were down slightly. "I think it is a relatively natural consequence of what we have seen their competitor Eli Lilly do. Eli Lilly, Sanofi and Novo Nordisk make up 90% of the U.S. market for insulin.

☆ SVB fall casts shadow on early-stage U.S. biotech
▼ + stars: | 2023-03-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

March 13 (Reuters) - The collapse of Silicon Valley Bank (SIVB.O) will leave early-stage biotechnology companies with a funding void, investors and analysts said on Monday, but larger, publicly-traded drug companies should escape unscathed. About 50% of U.S. biotech companies, developing drugs for everything from cancer to heart disease and rare conditions, banked with Silicon Valley Bank (SVB), including a large number of private firms, according to WBB financial analyst and managing partner Steve Brozak. Analysts said the direct impact to U.S. biotech companies overall was limited, although several drugmakers such as Axsome Therapeutics Inc (AXSM.O) and Rhythm Pharmaceuticals Inc (RYTM.O) disclosed cash deposits with the bank. Startup-focused lender SVB Financial Group last week became the largest bank to fail since the 2008 financial crisis, sending shockwaves through the global financial system and prompting regulators to step in to contain the fallout. SVB’s demise likely leaves smaller biotech clients without an alternative lender, said Brozak, since other banks will now probably raise their funding thresholds to points that make investment difficult for smaller entities.

[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.

Companies Bayer AG FollowNEW YORK, March 9 (Reuters) - Bayer AG (BAYGn.DE) plans to spend $1 billion on drug research and development in the U.S. this year as it works to double its sales in the country by the end of the decade, Bayer's top U.S. pharmaceutical executive told Reuters. "It's time for us to double down on the U.S.," Guth said, noting that Bayer plans to sell the drugs it is developing itself in the country, rather than partner with U.S. companies like it has in the past. Bayer is looking to build up its portfolio of new drugs as it hopes to improve share prices, which have been hit by concerns over litigation surrounding weedkiller Roundup and a lack of trust in the company's leadership. Guth said he expects peak sales of 12 billion euros from cancer drug Nubeqa, kidney medication Kerendia, and two of its top pipeline assets, experimental stroke drug asundexian and experimental women's health drug elinzanetant. Reporting by Michael Erman; Editing by David GregorioOur Standards: The Thomson Reuters Trust Principles.

Eli Lilly, along with Sanofi (SASY.PA) and Novo Nordisk (NOVOb.CO) make up 90% of the U.S. market for insulin. Biden, a Democrat, on Tuesday called on Congress and other manufacturers to lower the price of insulin as Lilly had done. The list price for Lispro, a cheaper version of its Humalog insulin, is currently $82.41 for 100 units/mL vials. List prices for drugs often differ from what patients actually pay, including after insurance and other assistance programs. Ricks said the company's insulin price cuts had been planned for some time and were accounted for in Eli Lilly's December financial forecast, which projected 2023 revenue of at least $30.3 billion.

It failed to meet its goal of non-inferiority compared to the conventional vaccine for the B/Victoria and B/Yamagata-lineage strains, the drugmaker said. "We have always said our goal is to produce a flu vaccine, and then to iterate it, and to fine tune it over time to really make it exceptional," Chief Medical Officer Paul Burton said in an interview. Seventy percent of those who received Moderna's shot reported mostly mild adverse reactions compared to 48% for the conventional flu vaccine. The company also has an ongoing late-stage efficacy study on the mRNA-1010 flu vaccine, which could have data within weeks. The flu, an infection of the nose, throat and lungs, kills 290,000 to 650,000 people worldwide annually.

Stabilization of Humira sales after the initial erosion, coupled with strong growth of its newer drugs Skyrizi and Rinvoq for autoimmune disorders, could provide a floor to its earnings in 2024. "Now it's a question of what will the volume erosion look like?" In the fourth quarter, Humira sales dropped 26.5% to $573 million in international markets such as Europe, where it already faces competition from multiple less expensive versions. Overall, Humira sales rose 4.6% to $5.58 billion, in line with estimates, lifted by growth in the U.S. market. Excluding items, AbbVie earned $3.60 per share in the fourth quarter, beating analysts' average estimates by 4 cents.

☆ U.S. government to start imposing inflation penalties on drugmakers in 2025
▼ + stars: | 2023-02-09 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Russell Boyce/IllustrationWASHINGTON, Feb 9 (Reuters) - The U.S. government will begin imposing penalties in 2025 on drug companies that charge its Medicare program prices that rise faster than inflation, the Centers for Medicare & Medicaid Services said on Thursday. The agency issued initial guidance on how it will implement a provision in President Joe Biden's signature Inflation Reduction Act that penalizes drugmakers for raising prices faster than inflation. "The Medicare Prescription Drug Inflation Rebate Program will require drug companies with excessive increases in drug prices to pay rebates to Medicare," CMS Administrator Chiquita Brooks-LaSure said in a statement. Companies that raise prices higher than the inflation rate will be required to pay Medicare the difference in the form of a rebate. Price increases for half of all drugs covered by Medicare outpaced inflation from 2019 to 2020, which averaged 1% that year.

"When you think about traditional drug and vaccine development and longevity of sales, it's usually much more spread out," Morningstar analyst Damien Conover said. The sudden inflow of revenue should prod companies to strike deals and link up with new partners, he said. Vaccine maker Moderna also expects 2023 revenue to fall sharply. The company's only product - its messenger RNA COVID vaccine - pulled in around $18.4 billion in 2022. Eli Lilly and Co (LLY.N) made $2 billion in 2022 from monoclonal antibody COVID treatments and is not expecting any revenue from the business in 2023.

RSV, which produces symptoms similar to a cold but can be fatal for young children and older adults, causes about 14,000 deaths annually in adults ages 65 and older. Moderna, Pfizer Inc (PFE.N) and GSK Plc (GSK.L) are racing to get their RSV vaccines to market first. Pfizer's RSV vaccine was found to be 66.7% effective against two or more symptoms in late-stage trials. "It's very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well," Hoge said. The RSV vaccine market could be worth more than $10 billion globally, half of which would come from the United States, according to Cowen analyst Tyler Van Buren.

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