Latest news with #DavidKendall
Associated Press
3 days ago
- Business
- Associated Press
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutide Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial Program The Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand 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 was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statements This press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Contacts Adam Lange (Investors) Vice President, Investor Relations [email protected] Neshat Ahmadi (Investors) Investor Relations Manager [email protected] Anna Krassowska, PhD (Investors and Media) Vice President, Investor Relations & Corporate Communications [email protected]
Yahoo
4 days ago
- Business
- Yahoo
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutideGlepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial ProgramThe Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/SZealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand 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 was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statementsThis press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. ContactsAdam Lange (Investors)Vice President, Investor Relationsalange@ Neshat Ahmadi (Investors)Investor Relations Managerneahmadi@ Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate Communicationsakrassowska@
Yahoo
4 days ago
- Business
- Yahoo
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutideGlepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial ProgramThe Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/SZealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand 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 was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statementsThis press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. ContactsAdam Lange (Investors)Vice President, Investor Relationsalange@ Neshat Ahmadi (Investors)Investor Relations Managerneahmadi@ Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate Communicationsakrassowska@
Yahoo
12-05-2025
- Business
- Yahoo
Zealand Pharma to participate in upcoming healthcare investor conferences in May and June 2025
Press release – No. 8 / 2025 Zealand Pharma to participate in upcoming healthcare investor conferences in May and June 2025 Copenhagen, Denmark, May 12, 2025 – 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 company will participate in the following healthcare investor conferences in May and June 2025: Bank of America Global Healthcare Conference, May 13-15 in Las Vegas David Kendall, Executive Vice President and Chief Medical Officer, will present on Wednesday, May 14 at 8:00am PT (5:00pm CET). A live audio webcast of the presentation will be available at Berenberg European Conference, May 20-22 in New York Adam Steensberg, President and Chief Executive Officer, to host investor meetings on Tuesday, May 20. Barclays European Leadership Conference, May 22 in London David Kendall, Executive Vice President and Chief Medical Officer to participate in a panel discussion about obesity on Thursday, May 22 at 11:30am UKT (12:30pm CET). The panel will not be webcast. Jefferies Global Healthcare Conference, June 3-5 in New York Anna Krassowska, Vice President, Investor Relations & Corporate Communications to participate in a fireside chat on Thursday, June 5 at 11:40am ET (5:40pm CET). The fireside chat will not be webcast. Goldman Sachs Annual Global Healthcare Conference, June 9-11 in Miami Adam Steensberg, President and Chief Executive Officer, to participate in fireside chat on Wednesday, June 11 at 4:00pm ET (10:00pm CET). A webcast of the fireside chat will be available at in the coming weeks, where replays of all webcasts are also archived. About Zealand Pharma A/SZealand 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 ContactsAdam Lange (Investors)Vice President, Investor Relationsalange@ Neshat Ahmadi (Investors)Investor Relations Managerneahmadi@ Anna Krassowska, PhD (Investor and Media)Vice President, Investor Relations & Corporate Communicationsakrassowska@
CNBC
02-05-2025
- Business
- CNBC
Inside the deal: Roche and Zealand Pharma's $5.3 billion obesity drug gambit
COPENHAGEN, Denmark — The ballooning obesity drug market may have a new contender after Roche struck a $5.3 billion deal to develop Danish biotech Zealand Pharma's "next generation" weight loss candidate. The deal, announced in March and set to close in the second quarter, marks the Swiss pharma's latest bid to compete with weight loss heavyweights Novo Nordisk and Eli Lilly, after building out its obesity treatment portfolio over recent years. Zealand Pharma's petrelintide amylin analog could be the asset that sets it apart. Amylin analogs are a nascent form of weight loss treatment, which mimic a hormone co-secreted with insulin in the pancreas to increase satiety. This differs from currently prevalent GLP-1 obesity drugs such as Zepbound and Wegovy, which mimic incretin hormones produced in the gut to suppress appetite. But while analysts saw Roche as an early contender for petrelintide, both firms insisted it was by no means a done deal. "It was a very competitive process, with a number of parties until the end," David Kendall, chief medical officer at Zealand Pharma, told CNBC. Early clinical data points to comparable weight reduction between amylin analogs and GLP-1s, but with potentially superior tolerability and lean muscle preservation among the former — currently key sticking points for the industry. Zealand has dubbed petrelintide a possible "future backbone therapy" for weight management, while BofA called it a "potentially best in class amylin," targeting 15-20% phase 3 weight loss as a monotherapy. "Roche was not the only company that saw that appeal," Manu Chakravarthy, Roche's global therapy area head and cardiovascular, renal and metabolism (CVRM) product development lead, told CNBC via video call. "These things are never done until the pen hits the paper." The Roche-Zealand deal will see the two companies co-develop and co-commercialize petrelintide as both a standalone treatment and as a combo-therapy with Roche's lead incretin asset CT-388. Under the terms, Zealand will receive upfront cash payments of $1.65 billion, with the potential for milestone payments taking the total to up to $5.3 billion, depending on phase 3 trials and sales development. It was heralded at the time as a win for Zealand, with analysts citing strong deal terms for the smaller biotech. Shares of Zealand Pharma jumped 38% on day of the deal, while Roche added around 4% "We view this as a best case scenario for Zealand," BofA Global Research wrote in a note on March 13, the day after the announcement, saying the deal ticked all of the biotech's — and its own — boxes for a partnership. The bank also described it as a "positive" for Roche, bringing amylin into its broader obesity portfolio. Zealand's Kendall told CNBC the 50-50 co-development, co-commercialization nature of the partnership was an "essential" part of negotiations, which commenced in earnest in September. "We pushed hard on this co-co," Kendall said. "Others could say it but when the pencil hit the paper, it didn't quite read that way. We bring the expertise in petrelintide, they bring the commercial side." Doubts were raised over whether Zealand could achieve its target profit share after an earlier AbbVie Gubra obesity drug licensing deal saw the latter agree to receive certain royalties on global net sales. However, both Roche and Zealand insisted their terms were a two-way win. "It's not that it was a win for Zealand. It's not skewed in their way or our way. It's a true partnership," Chakravarthy said. "When you have a true collaboration and equal skin in the game, that's where the magic happens." Roche has long been vocal about its desire to compete in the obesity drug market, agreeing in 2023 to acquire obesity drug developer Carmot Therapeutics and thereby bringing in-house a GLP-1 incretin treatment for combination therapy. The company was punished by investors last year after trial results for one of those experimental weight-loss pills, CT-996, was linked with temporary side effects. However, Roche has long insisted that its focus is on building a suite of weight loss therapies, with amylin analogs among its key targets. "While we had a good profile in incretins, it was also clear that there was a heterogeneity in this," Chakravarthy said. "We asked, what can we do for people who want lower weight loss? Amylin comes on the top. Then we asked what are the companies working in this space. This assessment led us to Zealand." After seven months of negotiations, including with other major pharma players, the two firms ultimately cited a strong scientific and cultural fit among the key reasons for the agreement. "It came down to how do we see things scientifically. Can we have an eye-to-eye conversation about the science. It was very clear Zealand saw things exactly how I described it," Chakravarthy said, citing a desire to target currently unmet patient needs, such as customizable weight loss. "Roche was the favorite the entire way through from a culture perspective," Christina Sonnenborg Bredal, chief people officer at Zealand Pharma, said. The race is now on to develop the drug. Zealand last week announced the initiation of a phase 2b trial of petrelintide in people with overweight or obesity and type 2 diabetes, with results due in summer 2026. Phase 3 trials will then follow. It comes as Novo Nordisk struggles to shake negative sentiment following a series of disappointing trial results for its own amylin analog candidate CagriSema, which combines cagrilintide with its signature semaglutide — the active ingredient in Wegovy. Zealand's CEO Adam Steensberg told CNBC in October that it expects to bring petrelintide to market around 2030. That would be well behind Novo Nordisk's 2026 targeted timeline for regulatory approval of CagriSema. But with Roche now on board, Zealand said that timeline could come forward. "Are we doing everything we can to accelerate?" Kendall asked. "Yes." Competition is nevertheless continuing to heat up in the fast-growing obesity drug market. Last month, Eli Lilly said its daily obesity pill orforglipron met its goals in the first of several late-stage trials, potentially opening the door to more convenient and easier-to-manufacture oral weight loss treatment. AbbVie's Gubra deal also brings another amylin contender to the table, though its development remains behind petrelintide. Meanwhile, analysts have noted the barriers to entry for new entrants given the high development costs associated with such drugs and the need to demonstrate additional or superior benefits. "We don't have a lot of luxury of time to bring this forward," Chakravarthy said. "We are definitely aspiring for a shorter horizon."
