ZEALAND PHARMA AS

GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment

8 days ago

• GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion. • The acquisition includes an upfront payment of $1.2 billion, with potential for additional success-based milestone payments totaling $800 million. • This strategic move strengthens GSK's pharmaceutical portfolio in the liver disease therapeutic area, addressing significant unmet medical needs.

Zealand Pharma Considers Accelerating Obesity Drug Launch Following Landmark Roche Partnership

25 days ago

• Zealand Pharma CEO Adam Steensberg has indicated that the company's obesity drug candidate petrelintide could reach the market earlier than planned following a strategic partnership with Roche. • The collaboration with one of the world's largest pharmaceutical companies provides Zealand with significant backing while allowing it to maintain its independence in the competitive weight-loss drug market. • Despite the potential for accelerated market entry, Zealand's leadership emphasizes a measured approach, stating they "will not be jumping through hoops" to rush the development process.

Zealand Pharma Appoints Utpal Singh as CSO to Advance Peptide Therapeutics for Obesity

a month ago

• Zealand Pharma has appointed Utpal Singh as Chief Scientific Officer to lead discovery research and translational sciences, bringing nearly 25 years of pharmaceutical industry experience to the company. • Singh will focus on integrating data science and machine learning with Zealand's peptide discovery expertise to develop innovative therapies targeting obesity and related complications. • The strategic appointment comes as Zealand Pharma aims to strengthen its position as a leader in peptide-based medicines, with the company currently having multiple candidates in late-stage development.

Roche and Regeneron Announce Multi-Billion Dollar Investments in US Manufacturing Amid Tariff Concerns

a month ago

• Roche has committed $50 billion to expand its US operations over five years, including new manufacturing facilities and R&D centers, with plans to create over 12,000 new jobs nationwide. • Regeneron is investing more than $3 billion in US operations through a partnership with Fujifilm Diosynth Biotechnologies, nearly doubling its large-scale manufacturing capacity in the country. • These pharmaceutical investments come as President Trump continues to threaten sector-specific tariffs, with Roche stating it will eventually export more medicines from the US than it imports.

Ironwood Pharmaceuticals Faces Setback as FDA Requires Additional Phase 3 Trial for Apraglutide

a month ago

• Ironwood Pharmaceuticals' stock plummeted by 37% after the FDA required a confirmatory Phase 3 trial for apraglutide, a treatment for short bowel syndrome with intestinal failure. • Pharmacokinetic analysis revealed that exposure and dosing in the original STARS Phase 3 trial were lower than intended due to preparation and administration issues. • Despite promising efficacy data showing 27 patients achieving enteral autonomy in the long-term extension trial, the company has engaged Goldman Sachs to explore strategic alternatives.

Roche's OCREVUS Shows Strong Efficacy in MUSETTE Phase III Trial for Multiple Sclerosis

2 months ago

• Roche Holding's MUSETTE Phase III trial demonstrated strong efficacy of the approved 600 mg dose of OCREVUS for multiple sclerosis, reinforcing its position in the treatment landscape. • The company has launched a new subcutaneous formulation of OCREVUS, expanding administration options for patients while continuing to build its neuromuscular disease portfolio. • Roche has outperformed both the Swiss market and pharmaceutical industry with a 33.01% total shareholder return over the past year, bolstered by strategic collaborations and regulatory approvals.

Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia

2 months ago

• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately. • The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026. • Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.

Roche and Zealand Pharma Forge $5.3 Billion Partnership to Develop Novel Obesity Treatments

2 months ago

• Roche has entered into a $5.3 billion collaboration with Zealand Pharma to co-develop petrelintide, a promising amylin analog for obesity treatment, both as monotherapy and in combination with Roche's incretin asset CT-388. • The partnership includes upfront payments of $1.65 billion to Zealand Pharma, with profits and losses to be shared 50/50 in the US and Europe, while Roche gains exclusive commercialization rights for the rest of the world. • Clinical data suggests petrelintide could deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability, potentially addressing unmet needs in the obesity market that is projected to affect 4 billion people globally by 2035.

Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients

3 months ago

• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage. • The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022. • Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.

EMA Recommends Approval for New Cancer Treatments and Vaccines

4 months ago

• The European Medicines Agency (EMA) has recommended eight new products for EU-wide approval, expanding treatment options for various conditions. • Several cancer treatments have received positive recommendations, potentially offering new hope for patients with different types of malignancies. • A new antiparasitic combination has been endorsed for use in non-EU markets, addressing a critical need in regions affected by parasitic infections. • The EMA is also reviewing new safety information regarding Leqembi, an Alzheimer's disease treatment, ensuring ongoing monitoring of its benefit-risk profile.

FDA Issues Complete Response Letter for Zealand Pharma's Glepaglutide in Short Bowel Syndrome

5 months ago

• The FDA issued a Complete Response Letter for Zealand Pharma's glepaglutide, a GLP-2 analog, intended for short bowel syndrome (SBS) treatment, citing insufficient evidence of efficacy and safety. • The FDA recommends Zealand Pharma conduct an additional clinical trial to provide further evidence to confirm the efficacy and safety of glepaglutide at the to-be-marketed dose. • Zealand Pharma plans to initiate a Phase 3 trial in 2025 to support marketing authorizations outside the U.S. and EU and provide confirmatory evidence for U.S. resubmission. • Glepaglutide had orphan drug designation and showed promise in Phase 3 trials for reducing parenteral support in SBS patients, particularly with twice-weekly dosing.

Zealand Pharma's Petrelintide Enrolls First Participant in Phase 2b Obesity Trial

5 months ago

• Zealand Pharma has initiated a Phase 2b trial (ZUPREME-1) for petrelintide, a long-acting amylin analog, in overweight or obese individuals. • The trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of weekly subcutaneous petrelintide. • ZUPREME-1 aims to enroll 480 participants across multiple sites in the US, Poland, and Romania, with primary endpoint at percentage change in body weight at week 28. • A second Phase 2b trial is planned for H1 2025 to evaluate petrelintide in overweight or obese individuals with type 2 diabetes.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

6 months ago

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.

Zealand Pharma and Palatin Technologies Advance Obesity and Metabolic Disease Pipelines

6 months ago

• Zealand Pharma reported positive Phase 1b results for petrelintide and dapiglutide, advancing both into Phase 2b trials for overweight and obese patients. • Boehringer Ingelheim's survodutide, a Zealand Pharma-partnered asset, showed positive Phase 2 results in MASH and progresses to Phase 3 trials. • Palatin Technologies anticipates topline results from its Phase 2 BMT-801 trial of bremelanotide with tirzepatide for obesity in Q1 2025.

Madrigal's Resmetirom Nears Full Approval for NASH Cirrhosis Treatment Following Phase 3 Enrollment Completion

8 months ago

• Madrigal Pharmaceuticals completed patient enrollment for its MAESTRO-NASH OUTCOMES trial, evaluating resmetirom for compensated NASH cirrhosis. • The Phase 3 trial involves 845 patients and aims to measure the progression to liver decompensation events over two to three years. • Positive outcomes from the trial could support full approval of Rezdiffra for noncirrhotic NASH and expand its indication to cirrhotic patients. • Resmetirom, a liver-directed THR-β agonist, has already received accelerated approval for NASH with moderate to advanced liver fibrosis.

FDA Approves Rezdiffra (Resmetirom) as First Treatment for NASH with Liver Fibrosis

a year ago

• The FDA has granted accelerated approval to Rezdiffra (resmetirom) for adults with noncirrhotic NASH and moderate to advanced liver fibrosis. • Rezdiffra, a THR-β agonist, is the first FDA-approved medication for NASH, also known as MASH, marking a significant milestone. • Approval was based on Phase 3 MAESTRO-NASH trial data, which demonstrated improved liver fibrosis and NASH resolution compared to placebo. • Madrigal plans to launch Rezdiffra in the U.S. in April, with a patient support program to aid access and affordability.