Petrelintide

Roche has been “highly engaged” in discussions with governments in the U.S., Switzerland, China and the EU about the impact of tariffs, the company's CEO Thomas Schinecker said. Roche is working to mitigate potential impacts from tariffs by moving production of its medicines to the U.S. and petitioning the President Trump administration for an exemption.Roche is trying to reason with the U.S. government that, as long as the Swiss pharma exports the same amount of product in the U.S. as it imports, “we would not be impacted by tariffs,” CEO Thomas Schinecker said during a call with reporters Thursday, as quoted by Reuters.Besides the U.S., Roche has been “highly engaged” in discussions with governments in Switzerland, China and the EU as well about the impact of tariffs, he said.Schinecker’s comment comes after Roche pledged this week a $50 billion investment push in the U.S. over five years with new and expanded/upgraded manufacturing and R&D facilities. Roche has already started shifting its pharmaceuticals manufacturing to the U.S.Four of Roche’s medicines make up 92% of its potential tariff exposure, Schinecker told reporters on the call without identifying the name of the products. For three of the four meds, Roche expects to mitigate any U.S. tariffs impact by increasing the volume of manufacturing stateside. For the last remaining drug, the company has started tech transfer weeks ago to enable its production in the U.S. for the first time, according to Schinecker.“We are operating in the U.S. at 50% drug substance capacity,” Schinecker said. “This gives us plenty of room to scale our manufacturing in the U.S.” Because Roche has kept its intellectual property in the U.S. rather than shifting to more tax-friendly countries like Ireland, “I believe we’re well-positioned compared to other companies,” the Roche chief said.President Donald Trump has targeted Ireland in his pharmaceuticals tariff threats, having floated import tax levels as high as 200% for drugs from the European country, although it’s not entirely clear if those levies will affect IP.In the near term, Roche has bulked up its inventories in China and the U.S. for the next few weeks, according to Schinecker.“Things can change quite quickly,” the CEO said. “But for us as a company, it’s always important that […] we are prepared for all scenarios.”Schinecker stressed that the new U.S. investments are necessary and that they won’t lead to increases in Roche’s overall capital expenditures. The company has been operating at about 3.5 billion Swiss francs to 4 billion Swiss francs in capital expenditures each year, he noted.“These are new investments in terms of new areas in technology such as continuous glucose monitoring, but also in new manufacturing modalities where we need to invest in because of our research work in incretin and amylin, which are both peptides,” he said.In a $1.65 billion upfront deal with Zealand Pharma signed in March, Roche gained the right to codevelop and co-commercialize long-acting amylin analog petrelintide in the weight-loss field. Investment in the U.S. doesn’t mean Roche has stopped growing its presence in other countries, Schinecker said, pointing to the company’s ongoing manufacturing expansion projects in China, Switzerland and Germany.“Over the past years, it’s really been our strategy to make sure that we have strong manufacturing presence in all of the major markets,” Schinecker said.In the first quarter of 2025, Roche recorded 11.95 billion Swiss francs in sales, up 9% year over year. These include 6.22 billion Swiss francs from the U.S., which enjoyed a foreign exchange windfall from a depreciating U.S. dollar. 

COPENHAGEN, Denmark I April 24, 2025 I Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the first participant has been enrolled in ZUPREME-2, a Phase 2b trial in people with overweight or obesity and type 2 diabetes comparing once-weekly subcutaneously administered petrelintide, a long-acting amylin analog, versus placebo with regards to efficacy and safety 1 . “We are excited to announce the initiation of ZUPREME-2, the second Phase 2 trial initiated with petrelintide and an important part of our clinical development plan for establishing petrelintide as a best-in-class alternative to incretin-based therapies and a future foundational therapy for weight management”, said David Kendall, MD, Chief Medical Officer at Zealand Pharma. “ Amylin agonism has shown great potential to provide clinically meaningful weight loss and may also provide additional improvements in glycemic control in people with overweight or obesity and type 2 diabetes, and we look forward to evaluating the efficacy and safety of petrelintide as a weight loss therapy in this population.” About ZUPREME-2 ZUPREME-2 is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase 2b clinical trial (NCT06926842). The trial will compare three doses of once-weekly petrelintide with placebo, when added to a reduced-calorie diet and increased physical activity in participants with overweight or obesity and type 2 diabetes. The trial includes a screening period, a dose escalation treatment period up to 16 weeks with dose escalation every fourth week followed by a maintenance treatment period until week 28, and a follow-up period after treatment is completed until week 38. ZUPREME-2 is expected to enroll a total of approximately 200 participants. The primary endpoint in the trial is the percentage change in body weight from baseline to week 28. Secondary endpoints include, but are not limited to, body weight loss of ≥5% and ≥10%, absolute change in body weight, change in waist circumference, change in hemoglobin A1c (HbA1c), change in high-sensitivity C-reactive protein (hsCRP), change in fasting glucose, and change in fasting lipids. For more information about the ZUPREME-2 clinical trial of petrelintide, please visit https://clinicaltrials.gov/study/NCT06926842 . About petrelintide Petrelintide is a long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation and co-administration with other peptides 2 . Amylin is produced in the pancreatic beta cells and co-secreted with insulin in response to ingested nutrients. Amylin receptor activation has been shown to reduce body weight by restoring sensitivity to the satiety hormone leptin 3,4 , inducing a sense of feeling full faster. Current clinical data or pre-clinical data suggest a potential of petrelintide to deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability for a better patient experience and high-quality weight loss. In November 2024, Zealand Pharma presented detailed results from the Phase 1b 16-week multiple ascending dose (MAD) trial at the Obesity Society Annual Meeting (ObesityWeek) 2024. For the presentation, please visit Scientific publications – Pipeline – Zealand Pharma . Petrelintide is also being evaluated in ZUPREME-1, a Phase 2 trial in participants with overweight or obesity (NCT06662539), evaluating five target doses of petrelintide up to 9 mg over 42 weeks of treatment. Enrollment and randomization in ZUPREME-1 was completed in three months. In March 2025, Zealand Pharma and Roche entered a collaboration and license agreement to co-develop and co-commercialize petrelintide as a future foundational therapy for people with overweight and obesity. The closing of the transaction is subject to regulatory approvals and other customary closing conditions. The parties expect that the agreement will close in the second quarter of 2025. About Zealand Pharma Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com . Sources 1. ClinicalTrials.gov. Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2). Available at https://clinicaltrials.gov/study/NCT06926842 . Last accessed April 2025. 2. Eriksson et al. Presentation at ObesityWeek, November 1–4, 2022, San Diego, CA. Link: https://www.zealandpharma.com/media/0gnfxg4b/zp8396-sema-coformulation-obesityweek-2022.pdf . 3. Mathiesen et al. Eur J Endocrinol 2022;186(6):R93–R111. 4. Roth et al. Proc Natl Acad Sci U S A 2008;105(20):7257–7262. SOURCE: Zealand Pharma