Novo Nordisk Canada, Inc.

Novo Nordisk CEO Lars Fruergaard Jorgensen will testify before the U.S. Senate in September on the pricing of its GLP-1 drugs Ozempic and Wegovy. Novo Nordisk CEO Lars Fruergaard Jorgensen has agreed to face questions at a Senate hearing in September after Sen. Bernie Sanders, I-Vermont, threatened to subpoena the company over its pricing of popular weight loss drugs Ozempic and Wegovy. Sanders, who chairs the Senate Committee on Health, Education, Labor and Pensions (HELP), announced the agreement on Friday. It came three days after Sanders revealed that the committee was set to vote on whether to require Novo’s North America operations chief Doug Langa to appear at a Senate hearing on July 10. The subpoena vote was scheduled for Tuesday, June 18. “I enjoyed the opportunity of chatting with Mr. Jorgensen this afternoon and thank him for voluntarily agreeing to testify,” Sanders said in the release. “The scheduled subpoena vote is no longer necessary and will be canceled.” Novo said that Jorgensen had a “productive call” with Sanders, agreeing to find a “mutually acceptable date for a hearing.” “We look forward to discussing solutions that ensure access and affordability for all patients within the complex U.S. healthcare system,” Novo added. The hearing figures to pose questions similar to those raised in February when CEOs from Bristol Myers Squibb (Chris Boerner), Johnson & Johnson (Joaquin Duato) and Merck (Rob Davis) appeared before the Senate in a high-profile but largely inconsequential event. Two months ago, the HELP Committee launched an investigation into Novo’s pricing which revealed that it charges $969 per month in the U.S. for type 2 diabetes drug Ozempic versus $155 in Canada, $122 in the company’s home country of Denmark and $59 in Germany. Likewise for obesity drug Wegovy, Novo charges $1,349 per month in the U.S. while the same product can be had in Germany for $140 and in the U.K. for $92 per month. Last week, when Sanders announced his subpoena effort, Novo responded that it was “unnecessary” based on the company’s “continued cooperation.” A June 7 letter obtained by The Hill from Novo to the HELP Committee asked for "a fair hearing which includes a range of stakeholders that impact what patients pay for GLP-1 medicines in the complex U.S. healthcare ecosystem—rather than focus on just one participant.” Novo’s reference in the letter is to rival Eli Lilly, which charges a higher price per month in the U.S. ($1,069) for its type 2 diabetes drug Mounjaro than Novo charges for Ozempic. Both companies have been targets of Sanders for their U.S. pricing of insulin products to treat type 1 diabetes. Last week, the U.S. Chamber of Commerce wrote that Sanders is "abusing the power of his committee to intimidate companies." "In a country founded on the principles of the rule of law and respect for free enterprise, the spectacle of an elected official targeting reputable companies for what appears to be political gain undermines the very foundations of the American economic system," the Chamber added. In 2023, sales of Ozempic and Wegovy accounted for 55% of the company’s revenue. The GLP-1 treatments racked up combined sales of $18.4 billion, up from $9.3 billion in 2022. With the surge in demand, Novo has become Europe's most valuable biopharma company as measured by market cap. 

Pictured: Novo Nordisk's corporate headquarters in Denmark/iStock, Ole Schwander Sen. Bernie Sanders (I-Vt.) on Tuesday moved to subpoena Novo Nordisk President Doug Langa, forcing him to testify before the Senate’s Health, Education, Labor and Pensions Committee regarding the pricing of the pharma’s top-selling semaglutide brands Wegovy and Ozempic. Sanders, chair of the committee, wants to know why Novo charges up to 10 to 15 times more for Ozempic and Wegovy in the U.S. compared with other developed countries. The committee is set to vote on the subpoena on June 18 and a hearing is scheduled for July 10. “It is not acceptable to me or the American people that we continue to be ripped off by giant pharmaceutical companies who make huge profits every year while charging us outrageous prices,” Sanders said in a statement, adding that the committee has “time and time again” reached out to Novo to request its voluntary attendance at a hearing. “Unfortunately, despite all of our efforts, they have repeatedly denied our requests,” Sanders said. Tuesday’s news comes after the senate committee in April 2024 launched a probe into the pricing of Ozempic and Wegovy. At the time, Sanders highlighted the differences in cost of these treatments among countries. In the U.S., Ozempic goes for $969 per month, while the drug is available for $155 in Canada and $59 in Germany. Wegovy, which costs $1,349 a month in the U.S., can be bought for $92 in the U.K. Sanders reiterated these figures in his statement on Tuesday, adding that at their current prices, Wegovy and Ozempic could have far-reaching implications for the U.S. healthcare system. The senator contends that Wegovy and other anti-obesity medications would cost Medicare and Medicaid $166 billion per year if half of its beneficiaries with obesity took these treatments. This sum rivals “what the two federal health programs spent on all retail prescription drugs in 2022,” according to Sanders. In March 2024, a study was published in the Journal of the American Medical Association which found that injectable formulations of semaglutide, such as Wegovy and Ozempic, could be profitably manufactured for less than $5 per month, much lower than the treatments’ current list prices. Generic versions of these treatments, as well as a more robust competitive landscape, could further push GLP-1 prices down to as low as $0.75 per month, according to the study. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Pictured: A fatty liver over a cell/Taylor Tieden for BioSpace You would be forgiven if, with all the cancer news from ASCO24 in Chicago this week, you missed the hepatology data dump at the 2024 Congress of the European Association for the Study of the Liver in Milan, Italy. However, there’s a battle brewing between Eli Lilly and the partnered companies Boehringer Ingelheim and Zealand Pharma in metabolic dysfunction-associated steatohepatitis (MASH), previously referred to as nonalcoholic steatohepatitis (NASH). The drugs being tested in MASH belong to the now-blockbuster class of therapies known as glucagon-like peptide-1 receptor agonists (GLP-1s). Lilly’s tirzepatide is already approved for type 2 diabetes (marketed as Mounjaro) and weight loss (marketed as Zepbound), spaces it shares with Novo Nordisk’s semaglutide products Ozempic and Wegovy—a duopoly that has led to skyrocketing revenue for both companies, which continue to seek additional indications. Meanwhile, Boehringer and Zealand are looking to leap into the space with its own GLP-1 agonist, survodutide, which is under investigation for obesity and other indications. What was interesting this week at EASL24 was the GLP-1 clash between Lilly and Boehringer/Zealand in the MASH space, with both sides providing readouts on their latest Phase II data and each declaring victory. MASH is a potentially deadly fatty liver disease that affects more than 115 million people globally and is expected to increase to 357 million by 2030. In March, the FDA approved Madrigal Pharmaceuticals’ Rezdiffra, a liver-directed thyroid hormone receptor (THR)-β agonist, as the first-ever treatment for the disease. On Wednesday, Lilly’s Phase II data was presented at the European Association for the Study of the Liver (EASL24), showing that 54.9% of MASH patients treated with a 5-mg dose of tirzepatide saw at least a one-stage improvement in fibrosis. In the study of MASH patients with F2 and F3 fibrosis, tirzepatide treatment was found to be more effective than placebo in achieving MASH resolution without worsening of fibrosis. Just two days later, following a data leak snafu at EASL24 on Thursday, Boehringer and Zealand announced that survodutide demonstrated “breakthrough improvement” in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis. The companies said the new data also revealed up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis without worsening of MASH. Survodutide, which is licensed to Boehringer from Zealand, is moving into a Phase III study. While GLP-1 drugs may have beneficial effects on MASH by improving insulin sensitivity, reducing liver fat accumulation and reversing fibrosis, Jefferies analysts said in a note to investors this week that they “don’t think GLP-1s will eliminate the market opportunity” for Madrigal in MASH. Likewise, Evercore ISI analysts opined, “there is room for different treatment options for patients with different needs, including daily oral pills and injectable products.” Evercore estimated a potential U.S. market opportunity for Madrigal’s Rezdiffra of $4 billion, while Jefferies’ estimate was considerably lower, pegging peak U.S. sales for Rezdiffra at $2.3 billion. Of course, there are a host of other promising MASH candidates, including Akero Therapeutics. Also at EASL24 this week, Viking Therapeutics announced its candidate VK2809—a thyroid hormone beta receptor agonist—significantly improved secondary histologic endpoints at 52 weeks with no worsening of fibrosis, as assessed by hepatic biopsy. And tomorrow, 89bio will be presenting Phase IIb data for pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21. Meanwhile, new data from Altimmune and a preclinical poster presentation from Aligos Therapeutics also hint at promise in the treatment of MASH. Still, MASH is a complex and confounding disease that has caused many once-promising programs to be discontinued. However, with a projected $25.7 billion total market by 2032 in the U.S., France, Germany, Italy, Spain, the U.K. and Japan, competitors will continue to be in hot pursuit of Madrigal, which has set the standard. Let the clash of the MASH titans begin! Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.