Company announcement - No. 41 / 2022
Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients with Short Bowel Syndrome (EASE 1)
Glepaglutide treatment met the primary endpoint with twice weekly dosing achieving a statistically significant reduction in weekly parenteral support volume by 5.13 Liters/week from baseline at 24 weeks
66% of patients in the twice weekly group had a clinically meaningful response (>20% reduction in parenteral support volume)
In total 9 patients treated with glepaglutide were weaned off parenteral support, while no placebo treated patients were able to wean off parenteral support
Glepaglutide treatment was assessed as safe and was well-tolerated in the trial
Conference call scheduled today at 8:00 a.m. ET / 2:00 p.m. CET
Copenhagen, Denmark and Boston MA, U.S. September 30, 2022 - Zealand Pharma A/S (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced positive topline results from the pivotal Phase 3 trial of glepaglutide, a long-acting GLP-2 analogue designed for once or twice weekly subcutaneous delivery via auto-injector, in patients with short bowel syndrome (SBS).
A total of 106 SBS patients with intestinal failure who were dependent on parenteral support (PS) for at least three days per week 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.
Glepaglutide given twice weekly significantly reduced the total weekly volume of parenteral support at 24 weeks as compared to placebo (p=0.0039). When administered once weekly, glepaglutide treatment also resulted in a numeric reduction in weekly parenteral support, however this did not achieve statistical significance. At 24 weeks, the average reduction in parenteral support from baseline was 5.13 Liters/week for patients treated with glepaglutide twice weekly and was 3.13 Liters/week for patients treated with glepaglutide once weekly. Placebo treatment resulted in a reduction in parenteral support of 2.85 Liters/week.
Clinical response, defined as a patient achieving at least 20% reduction in weekly parenteral support volume from baseline at both 20 and 24 weeks, was significantly higher with twice weekly glepaglutide compared to placebo (p=0.0243). Among patients receiving glepaglutide twice weekly 65.7% achieved a clinical response. While 45.7% and 38.9% of patients achieved a clinical response in the once weekly and placebo treatment groups, respectively.
In the twice weekly dosing group, 14% of patients (n=5) were completely weaned off parenteral support (enteral autonomy). In total 9 patients treated with glepaglutide achieved enteral autonomy, while no placebo treated patients were able to discontinue parenteral support.
"We are extremely pleased with the results of the Phase 3 EASE 1 trial," said David Kendall, M.D., Chief Medical Officer of Zealand Pharma. "In EASE 1, glepaglutide significantly reduced the volume of parenteral support required compared to placebo when administered to patients with SBS and intestinal failure. We are particularly encouraged that a number of patients treated with glepaglutide were able to significantly reduce the burden of parenteral support - both reducing the number of days and completely eliminating the need for parenteral support in a substantial number of patients. We believe the outcome of this trial supports the potential of glepaglutide as an effective treatment for people living with SBS and intestinal failure and can reduce the burden of both parenteral support and daily dosing of GLP-2 treatment. We look forward to seeing the results of the ongoing EASE 2 and 3 long term extension trials and engaging with the regulatory authorities as we plan for submission of our NDA."
Glepaglutide appeared to be safe and was well-tolerated in the trial. The most frequently reported adverse events were injection site reactions and gastrointestinal events. In total, 102 of 106 participating patients completed the trial, of which 96 continued into the ongoing safety and efficacy extension trials, EASE 2 and EASE 3.
"We are enormously privileged to have such a rich pipeline of proprietary peptides that in the last six months have reported two positive Phase 3 trials for two separate programs aimed at changing the lives of patients living with rare and severe diseases," said Adam Steensberg, M.D., Chief Executive Officer of Zealand Pharma. "Today's robust results for glepaglutide represent a tremendous milestone for Zealand and patients living with SBS, and we are well-positioned to continue toward delivering next generation peptide therapeutics that make a difference to patients' lives,"
Conference call today at 2 PM CET / 8 AM ET
Zealand's management will host a conference call and webcast today at 2:00 pm CET / 8:00 am ET to discuss topline results from the Phase 3 EASE 1 trial followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg, and Chief Medical Officer, David Kendall. The conference call will be conducted in English.
Telephone dial-in information and a unique personal access PIN will be provided upon registration at https://register.vevent.com/register/BI20c985a584b842489c0009561f316e59. A live listen-only audio webcast of the call, including an accompanying slide presentation, will be accessible at https://edge.media-server.com/mmc/p/9n7vxaw3. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand's website at https://www.zealandpharma.com/events-cal.
About EASE 1
EASE 1 is a randomized, double-blind Phase 3 trial to evaluate the safety and efficacy of once- and twice-weekly subcutaneous administration of glepaglutide compared to placebo in up to 108 SBS patients with intestinal failure who were dependent on perenteral support (PS) at least three days per week. The trial is designed to confirm the efficacy of glepaglutide in reducing the parenteral PS volume and to evaluate the efficacy of glepaglutide on other efficacy endpoints as well as the safety and tolerability of glepaglutide in patients with SBS. The primary endpoint in the trial is the absolute change in weekly PS volume from baseline at 24 weeks. Participants in EASE 1 may subsequently enroll in the extension trials, EASE 2 and 3, designed to assess long-term safety and efficacy of glepaglutide. EASE 4 is a Phase 3b trial to assess long-term effects of glepaglutide on intestinal fluid and energy uptake. For more information on the EASE trials, please visit ClinicalTrials.gov (IDs: NCT03690206, NCT03905707, NCT04881825, NCT04991311).
About Short Bowel Syndrome
Short Bowel Syndrome (SBS) is a complex chronic and severe condition associated with reduced or complete loss of intestinal function. Many patients have to be connected to infusion lines and pumps every day, which pose significant restrictions on their ability to engage in daily activities. In addition, they are at risk of experiencing a number of serious and life-threatening complications such as sepsis, blood clots, liver damage and renal impairment.
About Glepaglutide
Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is being developed as a liquid product in an autoinjector designed for subcutaneous administration, 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 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 and partnerships with a number of blue-chip pharma companies as well as commercial partnerships for its marketed products.
Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand has a team in the U.S. For more information about Zealand's business and activities, please visit http://www.zealandpharma.com.
Forward-Looking Statements
This press release contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. 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, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; 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 fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. 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 press release and are based on information available to Zealand Pharma as of the date of this release. 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:
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
David Rosen (U.S. Media)
Argot Partners
Email: media@zealandpharma.com
This messsage was distributed by Nasdaq's GlobeNewswire.
(165 Broadway, New York, NY, 10006, USA, 1.212.401.8700, www.nasdaq.com)
On behalf of Zealand Pharma Sydmarken 11, Søborg, 2860 DK zealandpharma.com
This message was sent to hl@proinvestor.com.
If you wish to no longer receive these messages you can unsubscribe.
Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients with Short Bowel Syndrome (EASE 1)
Glepaglutide treatment met the primary endpoint with twice weekly dosing achieving a statistically significant reduction in weekly parenteral support volume by 5.13 Liters/week from baseline at 24 weeks
66% of patients in the twice weekly group had a clinically meaningful response (>20% reduction in parenteral support volume)
In total 9 patients treated with glepaglutide were weaned off parenteral support, while no placebo treated patients were able to wean off parenteral support
Glepaglutide treatment was assessed as safe and was well-tolerated in the trial
Conference call scheduled today at 8:00 a.m. ET / 2:00 p.m. CET
Copenhagen, Denmark and Boston MA, U.S. September 30, 2022 - Zealand Pharma A/S (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced positive topline results from the pivotal Phase 3 trial of glepaglutide, a long-acting GLP-2 analogue designed for once or twice weekly subcutaneous delivery via auto-injector, in patients with short bowel syndrome (SBS).
A total of 106 SBS patients with intestinal failure who were dependent on parenteral support (PS) for at least three days per week 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.
Glepaglutide given twice weekly significantly reduced the total weekly volume of parenteral support at 24 weeks as compared to placebo (p=0.0039). When administered once weekly, glepaglutide treatment also resulted in a numeric reduction in weekly parenteral support, however this did not achieve statistical significance. At 24 weeks, the average reduction in parenteral support from baseline was 5.13 Liters/week for patients treated with glepaglutide twice weekly and was 3.13 Liters/week for patients treated with glepaglutide once weekly. Placebo treatment resulted in a reduction in parenteral support of 2.85 Liters/week.
Clinical response, defined as a patient achieving at least 20% reduction in weekly parenteral support volume from baseline at both 20 and 24 weeks, was significantly higher with twice weekly glepaglutide compared to placebo (p=0.0243). Among patients receiving glepaglutide twice weekly 65.7% achieved a clinical response. While 45.7% and 38.9% of patients achieved a clinical response in the once weekly and placebo treatment groups, respectively.
In the twice weekly dosing group, 14% of patients (n=5) were completely weaned off parenteral support (enteral autonomy). In total 9 patients treated with glepaglutide achieved enteral autonomy, while no placebo treated patients were able to discontinue parenteral support.
"We are extremely pleased with the results of the Phase 3 EASE 1 trial," said David Kendall, M.D., Chief Medical Officer of Zealand Pharma. "In EASE 1, glepaglutide significantly reduced the volume of parenteral support required compared to placebo when administered to patients with SBS and intestinal failure. We are particularly encouraged that a number of patients treated with glepaglutide were able to significantly reduce the burden of parenteral support - both reducing the number of days and completely eliminating the need for parenteral support in a substantial number of patients. We believe the outcome of this trial supports the potential of glepaglutide as an effective treatment for people living with SBS and intestinal failure and can reduce the burden of both parenteral support and daily dosing of GLP-2 treatment. We look forward to seeing the results of the ongoing EASE 2 and 3 long term extension trials and engaging with the regulatory authorities as we plan for submission of our NDA."
Glepaglutide appeared to be safe and was well-tolerated in the trial. The most frequently reported adverse events were injection site reactions and gastrointestinal events. In total, 102 of 106 participating patients completed the trial, of which 96 continued into the ongoing safety and efficacy extension trials, EASE 2 and EASE 3.
"We are enormously privileged to have such a rich pipeline of proprietary peptides that in the last six months have reported two positive Phase 3 trials for two separate programs aimed at changing the lives of patients living with rare and severe diseases," said Adam Steensberg, M.D., Chief Executive Officer of Zealand Pharma. "Today's robust results for glepaglutide represent a tremendous milestone for Zealand and patients living with SBS, and we are well-positioned to continue toward delivering next generation peptide therapeutics that make a difference to patients' lives,"
Conference call today at 2 PM CET / 8 AM ET
Zealand's management will host a conference call and webcast today at 2:00 pm CET / 8:00 am ET to discuss topline results from the Phase 3 EASE 1 trial followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg, and Chief Medical Officer, David Kendall. The conference call will be conducted in English.
Telephone dial-in information and a unique personal access PIN will be provided upon registration at https://register.vevent.com/register/BI20c985a584b842489c0009561f316e59. A live listen-only audio webcast of the call, including an accompanying slide presentation, will be accessible at https://edge.media-server.com/mmc/p/9n7vxaw3. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand's website at https://www.zealandpharma.com/events-cal.
About EASE 1
EASE 1 is a randomized, double-blind Phase 3 trial to evaluate the safety and efficacy of once- and twice-weekly subcutaneous administration of glepaglutide compared to placebo in up to 108 SBS patients with intestinal failure who were dependent on perenteral support (PS) at least three days per week. The trial is designed to confirm the efficacy of glepaglutide in reducing the parenteral PS volume and to evaluate the efficacy of glepaglutide on other efficacy endpoints as well as the safety and tolerability of glepaglutide in patients with SBS. The primary endpoint in the trial is the absolute change in weekly PS volume from baseline at 24 weeks. Participants in EASE 1 may subsequently enroll in the extension trials, EASE 2 and 3, designed to assess long-term safety and efficacy of glepaglutide. EASE 4 is a Phase 3b trial to assess long-term effects of glepaglutide on intestinal fluid and energy uptake. For more information on the EASE trials, please visit ClinicalTrials.gov (IDs: NCT03690206, NCT03905707, NCT04881825, NCT04991311).
About Short Bowel Syndrome
Short Bowel Syndrome (SBS) is a complex chronic and severe condition associated with reduced or complete loss of intestinal function. Many patients have to be connected to infusion lines and pumps every day, which pose significant restrictions on their ability to engage in daily activities. In addition, they are at risk of experiencing a number of serious and life-threatening complications such as sepsis, blood clots, liver damage and renal impairment.
About Glepaglutide
Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is being developed as a liquid product in an autoinjector designed for subcutaneous administration, 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 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 and partnerships with a number of blue-chip pharma companies as well as commercial partnerships for its marketed products.
Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand has a team in the U.S. For more information about Zealand's business and activities, please visit http://www.zealandpharma.com.
Forward-Looking Statements
This press release contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. 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, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; 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 fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. 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 press release and are based on information available to Zealand Pharma as of the date of this release. 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:
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
David Rosen (U.S. Media)
Argot Partners
Email: media@zealandpharma.com
This messsage was distributed by Nasdaq's GlobeNewswire.
(165 Broadway, New York, NY, 10006, USA, 1.212.401.8700, www.nasdaq.com)
On behalf of Zealand Pharma Sydmarken 11, Søborg, 2860 DK zealandpharma.com
This message was sent to hl@proinvestor.com.
If you wish to no longer receive these messages you can unsubscribe.
30/9 2022 13:09 Helge Larsen/PI-redaktør 9
106550 Kommentar fra Per Hansen, Investeringsøkonom, Nordnet
Zealand Pharma har fremlagt gode fase 3 data for deres korttidssyndrom. Det er bingo. Aktien stiger markant og det er helt naturligt
Korttarmssyndrom er potentielt ZP største produkt
Dataene er gode.
I 2015 købte Shire/Takeda, NPS pharma for 5,2 mia. USD
Det primære produkt i NPS var et middel mod korttarmssyndrom - Gattex
Det er ikke urealistisk, at der kan kommet et bud på Zealand Pharma
Takeda/Shires produkt tidligere været vurderet til at være et ringere produkt og med større bivirkninger end det som Zealand Pharma har arbejdet med
Zealand Pharma har ramt bingo med et produkt hvis værdi skal tælles i mia. USD. Derfor stiger aktien markant
Zealand Pharma har fremlagt gode fase 3 data for deres korttidssyndrom. Det er bingo. Aktien stiger markant og det er helt naturligt
Korttarmssyndrom er potentielt ZP største produkt
Dataene er gode.
I 2015 købte Shire/Takeda, NPS pharma for 5,2 mia. USD
Det primære produkt i NPS var et middel mod korttarmssyndrom - Gattex
Det er ikke urealistisk, at der kan kommet et bud på Zealand Pharma
Takeda/Shires produkt tidligere været vurderet til at være et ringere produkt og med større bivirkninger end det som Zealand Pharma har arbejdet med
Zealand Pharma har ramt bingo med et produkt hvis værdi skal tælles i mia. USD. Derfor stiger aktien markant
30/9 2022 17:39 ProInvestorNEWS 6106569 Zealand-aktie banker op efter positive resultater - NY2
https://www.proinvestor.com/investornyt/885244/zealand-aktie-banker-op-efter-positive-resultater-ny2
https://www.proinvestor.com/investornyt/885244/zealand-aktie-banker-op-efter-positive-resultater-ny2
Jeg tror at Novo kunne overtage Zealand efter de nye test resultater. Novo betaler roalitys på nød pensalget. Zealand prissættes er kun 8 mia kr.
1/10 2022 08:01 ProInvestorNEWS 8106577 Helge Larsen besøger Zealand Pharma, en dansk biofarmaceutisk virksomhed grundlagt i 1998 og dobbeltnoteret på den amerikanske og danske børs. Han taler med CMO Adam Steensberg om virksomhedens historie og ikke mindst deres aktuelle forretning med en pipeline, som ser stærk ud i 2022 med bl.a. resultater i tredje kvartal på et fase 3- studie inden for korttarmssyndrom.
Disclaimer - Zealand Pharma har betalt digital IR-samarbejde med ProInvestor.com.
Disclaimer - Zealand Pharma har betalt digital IR-samarbejde med ProInvestor.com.
Tillykke til alle Zealand Pharma medarbejdere & aktionærer, samt naturligvis de patienter som får glæde af Glepaglutide i fremtiden!
2/10 2022 10:14 B.Andersen 8106591 Zealand Pharma bliver den danske vinderaktie i 2022. Ingen tvivl hos mig om det.
Aktien er i plus 20% i år. Vil være underligt, hvis den faldt under dette med de gode data for selskabets hovedprodukt. I næste uge kommer analytikerne på banen. Det må give yderligere skub i kursen i positiv retning.
3/10 2022 06:55 ProInvestorNEWS 5106605 Zealand/Jefferies: Kan have milliardaftale i sigte - GENT
3/10 06:34
Børshuset Jefferies ser mulighed for en kommende milliardaftale til Zealand Pharma, efter at biotekselskabet fredag har præsenteret succesrige fase 3-studie med lægemiddelkandidaten Glepagltud til behandling af korttarmsyndrom.
Det fremgår af et notat, hvor Jefferies uddeler masser af roser til fase 3-data, der blev offentliggjort fredag middag.
Ikke blot er Glepaglutid, der skal tages to gange ugentligt, nemlig mere bekvem, men virker også bedre, end det nuværende middel på markedet, Gattex, der skal injiceres dagligt, mener Jefferies.
- På grund af bekvemmelighed og effektfordele sammenlignet med Gattex forventer vi, at Glepaglutid vil fremme klinisk brug og tiltrække sig partnerskabsinteresse.
Samlet vurderer Jefferies, at salget af Glepaglutid på sigt vil kunne toppe i helt op mod 580 mio. dollar om året. Desuden har børshuset regnet sig frem til, at det alene repræsenterer en værdi på 60 kr. per aktie for Zealand, når der kun indregnes en sandsynlighed for, at midlet kommer på markedet på 60 pct.
Jefferies estimerer nemlig, at Zealand kan håbe på en partneraftale til en værdi af omkring 600 mio. dollar, eller knap 4,6 mia. kr., et beløb der endda kan blive større endnu.
- Vi bemærker, at en konkurrent sikrede sig en aftale til en samlet værdi af 200 mio. dollar plus royalties, alene for japanske rettigheder. Og derfor kan vores samlede estimerede værdi på 600 mio. dollar for de globale rettigheder - der kun svarer til én gang topsalget - vise sig at være konservativt, skriver Jefferies.
Meldingen kommer, efter at Zealand midt på dagen kunne melde om positive toplinje-resultater fra fase 3-studiet med Glepaglutid, hvorefter aktien tordnede i vejret og lukkede 28 pct. højere i 173,80 kr.
Korttarmsyndrom er en lidelse, hvor patientens tarm ikke kan optage næringsstoffer og energi i tilstrækkelige mængder, eksempelvis fordi store dele af tyndtarmen er fjernet efter operation, eller fordi tarmen virker utilstrækkeligt efter strålebehandling.
.\˙ MarketWire
3/10 06:34
Børshuset Jefferies ser mulighed for en kommende milliardaftale til Zealand Pharma, efter at biotekselskabet fredag har præsenteret succesrige fase 3-studie med lægemiddelkandidaten Glepagltud til behandling af korttarmsyndrom.
Det fremgår af et notat, hvor Jefferies uddeler masser af roser til fase 3-data, der blev offentliggjort fredag middag.
Ikke blot er Glepaglutid, der skal tages to gange ugentligt, nemlig mere bekvem, men virker også bedre, end det nuværende middel på markedet, Gattex, der skal injiceres dagligt, mener Jefferies.
- På grund af bekvemmelighed og effektfordele sammenlignet med Gattex forventer vi, at Glepaglutid vil fremme klinisk brug og tiltrække sig partnerskabsinteresse.
Samlet vurderer Jefferies, at salget af Glepaglutid på sigt vil kunne toppe i helt op mod 580 mio. dollar om året. Desuden har børshuset regnet sig frem til, at det alene repræsenterer en værdi på 60 kr. per aktie for Zealand, når der kun indregnes en sandsynlighed for, at midlet kommer på markedet på 60 pct.
Jefferies estimerer nemlig, at Zealand kan håbe på en partneraftale til en værdi af omkring 600 mio. dollar, eller knap 4,6 mia. kr., et beløb der endda kan blive større endnu.
- Vi bemærker, at en konkurrent sikrede sig en aftale til en samlet værdi af 200 mio. dollar plus royalties, alene for japanske rettigheder. Og derfor kan vores samlede estimerede værdi på 600 mio. dollar for de globale rettigheder - der kun svarer til én gang topsalget - vise sig at være konservativt, skriver Jefferies.
Meldingen kommer, efter at Zealand midt på dagen kunne melde om positive toplinje-resultater fra fase 3-studiet med Glepaglutid, hvorefter aktien tordnede i vejret og lukkede 28 pct. højere i 173,80 kr.
Korttarmsyndrom er en lidelse, hvor patientens tarm ikke kan optage næringsstoffer og energi i tilstrækkelige mængder, eksempelvis fordi store dele af tyndtarmen er fjernet efter operation, eller fordi tarmen virker utilstrækkeligt efter strålebehandling.
.\˙ MarketWire
3/10 2022 07:20 ProInvestorNEWS 5106607 Zealand Pharma: Data er formentlig en game changer. Kulminerer mange års hårdt arbejde nu?
https://www.proinvestor.com/boards/106606
https://www.proinvestor.com/boards/106606
3/10 2022 08:38 ProInvestorNEWS 4106612 Zealand Pharma/Nordea: Kursmål løftes til 246 kr. fra 195 kr.
https://www.proinvestor.com/investornyt/885621/zealand-pharma-nordea-kursmal-loftes-til-246-kr-fra-195-kr
https://www.proinvestor.com/investornyt/885621/zealand-pharma-nordea-kursmal-loftes-til-246-kr-fra-195-kr
3/10 2022 08:55 ProInvestorNEWS 4106614 ZEALAND PHARMA/CARNEGIE: KURSMÅL HÆVES TIL 255 KR. FRA 200 KR.
3/10 2022 10:57 ProInvestorNEWS 3106629 ZEALAND PHARMA/DANSKE BANK: KURSMÅL HÆVES TIL 290 KR. FRA 250 KR.
3/10 2022 13:09 ProInvestorNEWS 4106649 Zealand Pharma OVERBLIK: Kursmål løftes efter positive forsøgsdata
3.10.2022 11.32 • MarketWire •
Zealand Pharma har mandag fået opmærksomhed hos finanshusene, der har regnet på aktiens potentiale, efter at selskabet fredag fremlagde positive toplinjeresultater for behandling med Glepaglutid hos patienter med korttarmssyndrom.
Dataene kastede et plus på 28,5 pct. af sig, og mandag fortsætter opturen - dog mere behersket tempo - med et løft på 0,8 pct. til 175,10 kr. på børsen i København.
Behandlingen med Glepaglutid nåede det primære endemål, da 66 pct. af patienterne viste betydningsfuld respons ved brug af to doser om ugen.
Det har fået analytikere til at løfte kursmålene for selskabets aktie. Her er et overblik over kursmålsløftene:
#
Anbefaling før Anbefaling nu Kursmål før Kursmål nu
Nordea "Køb" "Køb" 195 246
Carnegie "Køb" "Køb" 200 255
Kempen "Køb" "Køb" 250 275
Danske Bank "Køb" "Køb" 250 290
----------------------------------------------------------------
#
.\˙ MarketWire
Morten Frederik Heltoft
3.10.2022 11.32 • MarketWire •
Zealand Pharma har mandag fået opmærksomhed hos finanshusene, der har regnet på aktiens potentiale, efter at selskabet fredag fremlagde positive toplinjeresultater for behandling med Glepaglutid hos patienter med korttarmssyndrom.
Dataene kastede et plus på 28,5 pct. af sig, og mandag fortsætter opturen - dog mere behersket tempo - med et løft på 0,8 pct. til 175,10 kr. på børsen i København.
Behandlingen med Glepaglutid nåede det primære endemål, da 66 pct. af patienterne viste betydningsfuld respons ved brug af to doser om ugen.
Det har fået analytikere til at løfte kursmålene for selskabets aktie. Her er et overblik over kursmålsløftene:
#
Anbefaling før Anbefaling nu Kursmål før Kursmål nu
Nordea "Køb" "Køb" 195 246
Carnegie "Køb" "Køb" 200 255
Kempen "Køb" "Køb" 250 275
Danske Bank "Køb" "Køb" 250 290
----------------------------------------------------------------
#
.\˙ MarketWire
Morten Frederik Heltoft
3/10 2022 13:13 ProInvestorNEWS 4106651 Zealand/Danske: Fase 3-data er et "home run"
3.10.2022 11.06 • MarketWire •
Zealand Pharmas succesrige fase 3-studie med Glepaglutid til behandling af korttarmssyndrom falder i god jord hos Danske Bank, der beskriver studiet som et "home run" og løfter sit kursmål for Zealand til 290 kr. fra 250 kr. Anbefalingen er uændret "køb".
Det fremgår af et notat fra banken.
Danske Bank ser nu en sandsynlighed for, at Glepaglutid kommer på markedet på 90 pct. mod tidligere 65 pct. Fair værdi af udviklingsprojektet estimeres at være 127 kr. per aktie mod tidligere 87 kr.
Zealand stiger mandag yderligere 0,6 pct. til 174,80 kr. efter en gevinst på over 28 pct. fredag, da Zealand annoncerede de positive data fra studiet med Glepaglutid til behandling af korttarmssyndrom.
Behandlingen nåede det primære endemål, da 66 pct. af patienterne viste betydningsfuld respons ved to doser om ugen.
Korttarmsyndrom er en lidelse, hvor patientens tarm ikke kan optage næringsstoffer og energi i tilstrækkelige mængder, eksempelvis fordi store dele af tyndtarmen er fjernet efter operation, eller fordi tarmen virker utilstrækkeligt efter strålebehandling.
.\˙ MarketWire
Jakob Dalskov
3.10.2022 11.06 • MarketWire •
Zealand Pharmas succesrige fase 3-studie med Glepaglutid til behandling af korttarmssyndrom falder i god jord hos Danske Bank, der beskriver studiet som et "home run" og løfter sit kursmål for Zealand til 290 kr. fra 250 kr. Anbefalingen er uændret "køb".
Det fremgår af et notat fra banken.
Danske Bank ser nu en sandsynlighed for, at Glepaglutid kommer på markedet på 90 pct. mod tidligere 65 pct. Fair værdi af udviklingsprojektet estimeres at være 127 kr. per aktie mod tidligere 87 kr.
Zealand stiger mandag yderligere 0,6 pct. til 174,80 kr. efter en gevinst på over 28 pct. fredag, da Zealand annoncerede de positive data fra studiet med Glepaglutid til behandling af korttarmssyndrom.
Behandlingen nåede det primære endemål, da 66 pct. af patienterne viste betydningsfuld respons ved to doser om ugen.
Korttarmsyndrom er en lidelse, hvor patientens tarm ikke kan optage næringsstoffer og energi i tilstrækkelige mængder, eksempelvis fordi store dele af tyndtarmen er fjernet efter operation, eller fordi tarmen virker utilstrækkeligt efter strålebehandling.
.\˙ MarketWire
Jakob Dalskov
4/10 2022 12:36 ProInvestorNEWS 4106678 Zealand Pharma/Kempen: Sænker kursmål med 25 kr efter tilsvarende løft
https://www.proinvestor.com/investornyt/886121/zealand-pharma-kempen-saenker-kursmal-med-25-kr-efter-tilsvarende-loft
5/10 2022 06:16 ProInvestorNEWS 4106688 Zealand Pharma announces directed issue and private placement of approximately 4.5m new shares
https://www.globenewswire.com/news-release/2022/10/04/2528063/0/en/Zealand-Pharma-announces-directed-issue-and-private-placement-of-approximately-4-5m-new-shares.html
The net proceeds from the Offering are intended to:
• Support the Phase 3 EASE clinical program for glepaglutide and potential regulatory submission for SBS, and pursue a strong strategic partner for future commercialization
• Advance the clinical-stage candidates, including the obesity/metabolic disease portfolio
• Progress additional peptide candidates into early clinical development
• Strengthen the Company's capital base and cash preparedness (general corporate purposes)
Zealand expects the new funds to provide cash runway until Q2 2024 and expects to advance the clinical pipeline and as such reach several potential key milestones within this time frame.
https://www.globenewswire.com/news-release/2022/10/04/2528063/0/en/Zealand-Pharma-announces-directed-issue-and-private-placement-of-approximately-4-5m-new-shares.html
The net proceeds from the Offering are intended to:
• Support the Phase 3 EASE clinical program for glepaglutide and potential regulatory submission for SBS, and pursue a strong strategic partner for future commercialization
• Advance the clinical-stage candidates, including the obesity/metabolic disease portfolio
• Progress additional peptide candidates into early clinical development
• Strengthen the Company's capital base and cash preparedness (general corporate purposes)
Zealand expects the new funds to provide cash runway until Q2 2024 and expects to advance the clinical pipeline and as such reach several potential key milestones within this time frame.
5/10 2022 06:54 ProInvestorNEWS 2106693 Zealand Pharma: Gennemfører emission - sikrer sig 786 mio. kr. - GENT
5/10 06:34
Zealand Pharma har tirsdag aften gennemført den rettede emission, som biotekkoncernen tidligere på dagen annoncerede.
Det fremgår af en meddelelse til fondsbørsen.
I alt har selskabet solgt 4.975.000 ordinære aktier og derigennem sikret sig et bruttoprovenu på cirka 786 mio. kr.
Aktierne er solgt til en pris på 158 kr. stykket, hvilket betyder, at der er blevet givet en rabat på 5,4 pct. i forhold til tirsdagens lukkekurs i 167 kr.
Zealand Pharma oplyste tidligere tirsdag, at det ville sælge cirka 4,5 mio. aktier til institutionelle- og professionelle investorer med henblik på at sikre biotekselskabet finansiering frem til og med andet kvartal 2024.
Beslutningen om kapitalforhøjelsen er truffet, efter at Zealand fredag annoncerede positive fase 3-data med sin lægemiddelkandidat Glepaglutid til behandling af korttarmssyndrom, hvilket den dag løftede aktiekursen med 28,5 pct. fra 135,3 kr. til 173,8 kr. Mandag og tirsdag faldt aktien imidlertid lidt tilbage.
De nye aktier ventes at blive noteret og handlet på børsen i København fra den 10. oktober.
.\˙ MarketWire
5/10 06:34
Zealand Pharma har tirsdag aften gennemført den rettede emission, som biotekkoncernen tidligere på dagen annoncerede.
Det fremgår af en meddelelse til fondsbørsen.
I alt har selskabet solgt 4.975.000 ordinære aktier og derigennem sikret sig et bruttoprovenu på cirka 786 mio. kr.
Aktierne er solgt til en pris på 158 kr. stykket, hvilket betyder, at der er blevet givet en rabat på 5,4 pct. i forhold til tirsdagens lukkekurs i 167 kr.
Zealand Pharma oplyste tidligere tirsdag, at det ville sælge cirka 4,5 mio. aktier til institutionelle- og professionelle investorer med henblik på at sikre biotekselskabet finansiering frem til og med andet kvartal 2024.
Beslutningen om kapitalforhøjelsen er truffet, efter at Zealand fredag annoncerede positive fase 3-data med sin lægemiddelkandidat Glepaglutid til behandling af korttarmssyndrom, hvilket den dag løftede aktiekursen med 28,5 pct. fra 135,3 kr. til 173,8 kr. Mandag og tirsdag faldt aktien imidlertid lidt tilbage.
De nye aktier ventes at blive noteret og handlet på børsen i København fra den 10. oktober.
.\˙ MarketWire
5/10 2022 09:03 ProInvestorNEWS 1106702 Company announcement - No. 44 / 2022
Zealand Pharma announces completion of a directed issue and private placement of 4,975,000 new ordinary shares raising gross proceeds of approx. DKK 786 million
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA, EXCEPT AS PERMITTED BY APPLICABLE LAW.
THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT; ANY PUBLIC OFFERING OF SUCH SECURITIES TO BE MADE IN THE UNITED STATES WILL BE MADE BY MEANS OF A PROSPECTUS THAT MAY BE OBTAINED FROM THE ISSUER, WHICH WOULD CONTAIN DETAILED INFORMATION ABOUT THE COMPANY AND MANAGEMENT, AS WELL AS FINANCIAL STATEMENTS.
As announced on 4 October 2022, Zealand Pharma commenced a directed share offering to institutional and professional investors through an accelerated bookbuilding.
Today, 4 October 2022, Zealand Pharma's board of directors has exercised an authorization to increase the share capital by issuing 4,975,000 new shares.
The new shares will be issued at a subscription price of DKK 158 per new share.
The aggregate gross proceeds from the issue will amount to approx. DKK 786 million and Zealand intends to use the net proceeds to help fund continued development of Zealand's proprietary pipeline of investigational peptide-based therapeutics, support pre-commercial activities, and general corporate purposes.
Copenhagen, Denmark, 4 October 2022 - With reference to company announcement no. 43 / 2022 regarding the announcement of a directed issue and private placement of new ordinary shares, Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces that the board of directors of Zealand has in accordance with article 7.1 of Zealand's articles of association today exercised an authorization granted by Zealand's annual general meeting held on 6 April 2022, to increase Zealand's share capital by issue of 4,975,000 new ordinary shares (the "New Shares") at a subscription price of DKK 158 per New Share.
The issuance of the New Shares follows an offering at market price in a private placement directed at certain institutional and professional investors in Denmark and certain other jurisdictions (the "Offering"). The subscription price for the New Shares has been determined through an accelerated bookbuilding procedure as part of the Offering.
The Offering is expected to be completed on 7 October 2022 (subject to the satisfaction of customary closing conditions), and the New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen on 10 October 2022.
The Offering has not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and was made pursuant to applicable exemptions from the obligation to publish a Danish prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions, as a directed issue and private placement to eligible institutional and professional investors.
Zealand Pharma announces completion of a directed issue and private placement of 4,975,000 new ordinary shares raising gross proceeds of approx. DKK 786 million
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA, EXCEPT AS PERMITTED BY APPLICABLE LAW.
THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE IN THE UNITED STATES AND THE SECURITIES REFERRED TO HEREIN MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT; ANY PUBLIC OFFERING OF SUCH SECURITIES TO BE MADE IN THE UNITED STATES WILL BE MADE BY MEANS OF A PROSPECTUS THAT MAY BE OBTAINED FROM THE ISSUER, WHICH WOULD CONTAIN DETAILED INFORMATION ABOUT THE COMPANY AND MANAGEMENT, AS WELL AS FINANCIAL STATEMENTS.
As announced on 4 October 2022, Zealand Pharma commenced a directed share offering to institutional and professional investors through an accelerated bookbuilding.
Today, 4 October 2022, Zealand Pharma's board of directors has exercised an authorization to increase the share capital by issuing 4,975,000 new shares.
The new shares will be issued at a subscription price of DKK 158 per new share.
The aggregate gross proceeds from the issue will amount to approx. DKK 786 million and Zealand intends to use the net proceeds to help fund continued development of Zealand's proprietary pipeline of investigational peptide-based therapeutics, support pre-commercial activities, and general corporate purposes.
Copenhagen, Denmark, 4 October 2022 - With reference to company announcement no. 43 / 2022 regarding the announcement of a directed issue and private placement of new ordinary shares, Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces that the board of directors of Zealand has in accordance with article 7.1 of Zealand's articles of association today exercised an authorization granted by Zealand's annual general meeting held on 6 April 2022, to increase Zealand's share capital by issue of 4,975,000 new ordinary shares (the "New Shares") at a subscription price of DKK 158 per New Share.
The issuance of the New Shares follows an offering at market price in a private placement directed at certain institutional and professional investors in Denmark and certain other jurisdictions (the "Offering"). The subscription price for the New Shares has been determined through an accelerated bookbuilding procedure as part of the Offering.
The Offering is expected to be completed on 7 October 2022 (subject to the satisfaction of customary closing conditions), and the New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen on 10 October 2022.
The Offering has not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and was made pursuant to applicable exemptions from the obligation to publish a Danish prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions, as a directed issue and private placement to eligible institutional and professional investors.
5/10 2022 11:36 ProInvestorNEWS 1106706 Zealand/CEO: Aktiesalg gør os robuste op til partnerforhandlinger
5/10 11:14
Med stærke fase 3-data i hånden fra et studie med lægemiddelkandidaten Glepaglutid, har Zealand formået at tiltrække stor interesse fra professionelle investorer og har netop sikret sig 786 mio. kr. fra salg af nye aktier.
Pengene skal bruges til at stå stærkt i kommende forhandlinger med en potentiel partner til Glepaglutid og til udvikling af den nuværende pipeline. Det fortæller biotekselskabets topchef, Adam Steensberg, i et interview med MarketWire.
- Jeg vil ikke sætte os selv under pres, for det er et meget vigtigt produkt for os, og man skal ikke forhandle under pres. Og det slipper vi så også for nu, hvor vi har penge på bankbogen og gode data, siger Adam Steensberg.
I alt blev der tirsdag aften solgt knap 5 mio. nye aktier for 158 kr. per styk. Dermed blev der givet en rabat på 5,4 pct. i forhold til tirsdagens lukkekurs i 167 kr. Selv vurderer Zealand, at det med kapitalrejsningen har penge til sit udviklingsarbejde til og med andet kvartal 2024.
- Det giver os en robusthed i forhold til at fokusere på at levere værdi og få skabt de bedste partnerskaber og få drevet vores pipeline frem, siger Adam Steensberg.
FORHANDLINGER OM GLEPAGLUTID NÆSTE ÅR
Han fortæller, at Zealand allerede har indgået fortrolighedsaftaler med flere partneremner til Glepaglutid, men endnu ikke har lukket nogen ind i datarummet.
- Vi har set en enorm interesse, men vi har også været tydelige om, at vi gerne vil have styr på data først og opbygge et stærkt datarum, før vi lukker folk ind.
- Vi vil gerne køre en struktureret proces, og jeg tænker, at det bliver en gang til næste år, at vi åbner den proces, siger Adam Steensberg.
Han har ikke noget hastværk, da Zealand selv er godt klædt på til at håndtere processerne hen mod og også under en registreringsansøgning for Glepaglutid. Desuden har Zealand kompetencerne til at drive det kommercielle arbejde op til en lancering.
Selve registreringsansøgningen venter Zealand at kunne indsende i USA i løbet af andet halvår næste år.
JEFFERIES SPÅR STOR AFTALE
Inden markedsføringsansøgningen sendes, skal Zealand først have langtidsdata fra patienter, der har fået Glepaglutid i op til fire år. Desuden kommer der data fra et mindre studie af lægemiddelkandidaten.
De studier er dog ifølge Adams Steensberg ikke lige så afgørende, som det fase 3-studie, som Zealand kom med data fra i fredags, og som sendte aktien i vejret med 28 pct.
Amerikanske Jefferies vurderede i et notat fredag, at Glepaglutid, der skal tages en til to gange ugentligt, både er mere bekvem, men også formentlig virker bedre, end det nuværende middel på markedet, Gattex, der skal injiceres dagligt mod korttarmssyndrom.
Der er tale om en lidelse, hvor patientens tarm ikke kan optage næringsstoffer og energi i tilstrækkelige mængder, eksempelvis fordi store dele af tyndtarmen er fjernet efter operation, eller fordi tarmen virker utilstrækkeligt efter strålebehandling.
Patienterne har derfor behov for at få tilført ernæring via et drop i blodbanen, såkaldt parenteral ernæring. Med Glepaglutid kan mængden dog nedsættes, og nogle gange kan antallet af gange, hvor der er behov for parenteral ernæring, også reduceres.
Endnu er Glepaglutid og Gattex ikke målt op mod hinanden, men Adam Steensberg glæder sig over, at hele ni patienter, der fik Glepaglutid efter 24 ugers behandling helt kunne stoppe med at få tilført næring via drop. Det tilsvarende tal i studier af Gattex er ifølge Adams Steensberg nul.
Ifølge Jefferies estimater står Zealand med et lægemiddel, der vil kunne sælge for op mod 580 mio. dollar om året, og børshuset regner med, at det kan give anledning til en partneraftale i milliardklassen målt i kroner.
Selv vil Zealand gå efter en aftale, der både giver et stort beløb her og nu, men også indeholder en stor gulerod.
- Det er helt klart vigtigt for mig, at vi får en aftale, hvor der er en stor "upside", men når det er sagt, er det også vigtigt at få en partner, der er maksimalt committet, så jeg kan ikke forestille mig et scenarie, hvor der ikke er en meget stor forudbetaling. Vi kan så måske være klar til at betale nogle af de penge tilbage ind i samarbejdet, siger Adam Steensberg.
.\˙ MarketWire
5/10 11:14
Med stærke fase 3-data i hånden fra et studie med lægemiddelkandidaten Glepaglutid, har Zealand formået at tiltrække stor interesse fra professionelle investorer og har netop sikret sig 786 mio. kr. fra salg af nye aktier.
Pengene skal bruges til at stå stærkt i kommende forhandlinger med en potentiel partner til Glepaglutid og til udvikling af den nuværende pipeline. Det fortæller biotekselskabets topchef, Adam Steensberg, i et interview med MarketWire.
- Jeg vil ikke sætte os selv under pres, for det er et meget vigtigt produkt for os, og man skal ikke forhandle under pres. Og det slipper vi så også for nu, hvor vi har penge på bankbogen og gode data, siger Adam Steensberg.
I alt blev der tirsdag aften solgt knap 5 mio. nye aktier for 158 kr. per styk. Dermed blev der givet en rabat på 5,4 pct. i forhold til tirsdagens lukkekurs i 167 kr. Selv vurderer Zealand, at det med kapitalrejsningen har penge til sit udviklingsarbejde til og med andet kvartal 2024.
- Det giver os en robusthed i forhold til at fokusere på at levere værdi og få skabt de bedste partnerskaber og få drevet vores pipeline frem, siger Adam Steensberg.
FORHANDLINGER OM GLEPAGLUTID NÆSTE ÅR
Han fortæller, at Zealand allerede har indgået fortrolighedsaftaler med flere partneremner til Glepaglutid, men endnu ikke har lukket nogen ind i datarummet.
- Vi har set en enorm interesse, men vi har også været tydelige om, at vi gerne vil have styr på data først og opbygge et stærkt datarum, før vi lukker folk ind.
- Vi vil gerne køre en struktureret proces, og jeg tænker, at det bliver en gang til næste år, at vi åbner den proces, siger Adam Steensberg.
Han har ikke noget hastværk, da Zealand selv er godt klædt på til at håndtere processerne hen mod og også under en registreringsansøgning for Glepaglutid. Desuden har Zealand kompetencerne til at drive det kommercielle arbejde op til en lancering.
Selve registreringsansøgningen venter Zealand at kunne indsende i USA i løbet af andet halvår næste år.
JEFFERIES SPÅR STOR AFTALE
Inden markedsføringsansøgningen sendes, skal Zealand først have langtidsdata fra patienter, der har fået Glepaglutid i op til fire år. Desuden kommer der data fra et mindre studie af lægemiddelkandidaten.
De studier er dog ifølge Adams Steensberg ikke lige så afgørende, som det fase 3-studie, som Zealand kom med data fra i fredags, og som sendte aktien i vejret med 28 pct.
Amerikanske Jefferies vurderede i et notat fredag, at Glepaglutid, der skal tages en til to gange ugentligt, både er mere bekvem, men også formentlig virker bedre, end det nuværende middel på markedet, Gattex, der skal injiceres dagligt mod korttarmssyndrom.
Der er tale om en lidelse, hvor patientens tarm ikke kan optage næringsstoffer og energi i tilstrækkelige mængder, eksempelvis fordi store dele af tyndtarmen er fjernet efter operation, eller fordi tarmen virker utilstrækkeligt efter strålebehandling.
Patienterne har derfor behov for at få tilført ernæring via et drop i blodbanen, såkaldt parenteral ernæring. Med Glepaglutid kan mængden dog nedsættes, og nogle gange kan antallet af gange, hvor der er behov for parenteral ernæring, også reduceres.
Endnu er Glepaglutid og Gattex ikke målt op mod hinanden, men Adam Steensberg glæder sig over, at hele ni patienter, der fik Glepaglutid efter 24 ugers behandling helt kunne stoppe med at få tilført næring via drop. Det tilsvarende tal i studier af Gattex er ifølge Adams Steensberg nul.
Ifølge Jefferies estimater står Zealand med et lægemiddel, der vil kunne sælge for op mod 580 mio. dollar om året, og børshuset regner med, at det kan give anledning til en partneraftale i milliardklassen målt i kroner.
Selv vil Zealand gå efter en aftale, der både giver et stort beløb her og nu, men også indeholder en stor gulerod.
- Det er helt klart vigtigt for mig, at vi får en aftale, hvor der er en stor "upside", men når det er sagt, er det også vigtigt at få en partner, der er maksimalt committet, så jeg kan ikke forestille mig et scenarie, hvor der ikke er en meget stor forudbetaling. Vi kan så måske være klar til at betale nogle af de penge tilbage ind i samarbejdet, siger Adam Steensberg.
.\˙ MarketWire
