Roche and Zealand Pharma Forge $5.3 Billion Partnership to Develop Novel Obesity Treatments
• 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
• 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.
Structure Therapeutics Advances Oral Obesity Drug Programs with Completed Enrollment in Key Aleniglipron Trials
• Structure Therapeutics has completed enrollment for ACCESS and ACCESS II trials evaluating aleniglipron in obesity treatment, with topline data expected by end of 2025.
• The company's oral amylin receptor agonist ACCG-2671 is advancing toward Phase 1 trials, expanding their portfolio of oral small molecule therapeutics for metabolic diseases.
• With $883.5 million in cash reserves, Structure Therapeutics is well-positioned to fund operations through 2027, supporting development of their innovative obesity treatment pipeline.
Landmark Report Establishes New Diagnostic Framework for Clinical Obesity, Moving Beyond BMI
• A new international commission of 58 experts has redefined clinical obesity as a chronic systemic disease caused by excess adiposity, distinguishing it from preclinical obesity in a groundbreaking Lancet report.
• The framework moves beyond traditional BMI measurements, incorporating multiple body measurements and functional criteria to provide more accurate diagnosis and treatment guidance.
• The commission emphasizes the need for evidence-based treatments, reduced weight stigma, and updated healthcare policies to improve access to care for patients with clinical obesity.
Kailera's HRS9531 Shows Strong Phase II Weight Loss, Pfizer Cautious on Danuglipron
• Kailera Therapeutics' HRS9531, a dual GLP-1/GIP receptor agonist, demonstrated a 21.1% placebo-adjusted weight reduction in Phase II trials over 36 weeks.
• Pfizer CEO Albert Bourla expressed caution regarding their oral obesity candidate, danuglipron, despite plans for late-stage studies of the once-daily formulation.
• Kailera reported that 59% of patients on HRS9531 achieved at least 20% body weight loss, with no plateau observed, suggesting potential for greater efficacy with longer use.
• Pfizer abandoned a twice-daily danuglipron formulation due to toxicities, focusing on a once-daily version, but analysts remain divided on its prospects in the competitive obesity market.
Schrödinger Announces Strategic Priorities for 2025, Advances Clinical Programs
• Schrödinger expands collaboration with Otsuka Pharmaceutical and anticipates $150 million upfront payment from Novartis in Q1 2025.
• The company plans to present initial Phase 1 data for SGR-1505, SGR-2921, and SGR-3515 in 2025, targeting various cancers.
• Schrödinger's co-founded companies, including Ajax, Nimbus, and Structure Therapeutics, reported significant clinical and financial progress in 2024.
Viking Therapeutics Initiates Phase 2 Trial of Oral VK2735 for Obesity
• Viking Therapeutics has commenced a Phase 2 clinical trial for oral VK2735, a dual GLP-1/GIP agonist, to treat obesity.
• The VENTURE-Oral Dosing Trial will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy over 13 weeks in approximately 280 adults.
• Prior Phase 1 data showed promising weight reductions up to 8.2% and encouraging tolerability with the oral tablet formulation of VK2735.
• Viking plans to initiate Phase 3 development for the subcutaneous formulation of VK2735 in the first half of 2025, following positive Phase 2 results.
Structure Therapeutics Earns Buy Rating for Innovative Oral Obesity Treatments
Structure Therapeutics, Inc. has been awarded a Buy rating by Stifel Nicolaus analyst Annabel Samimy, thanks to its innovative oral small molecule treatments for obesity. The company's lead candidate, GSBR-1290, has shown promising early trial results, indicating potential for widespread use in primary care settings. Despite challenges, the company's strategic approach and diversified pipeline support the positive outlook.
Viking Therapeutics and Structure Therapeutics Seen as Key Partners in Weight Loss Market
JPMorgan highlights Viking Therapeutics and Structure Therapeutics as attractive options for pharmaceutical companies aiming to enter the T2D/obesity market, citing their potential for strategic partnerships and clinical trial data.
Growing Evidence Supports GLP-1s' Role in Combating Heart Disease
Recent studies and FDA approvals highlight the cardiovascular benefits of GLP-1 agonists, initially developed for diabetes and obesity. The SELECT trial and Dandelion Health study underscore their potential in reducing major adverse cardiovascular events, suggesting a broader application beyond weight loss and diabetes management.
Emerging Biotechs Vie for Position in Lucrative GLP-1RA Market Dominated by Novo Nordisk and Eli Lilly
• Altimmune's pemvidutide, currently in Phase II trials for obesity and metabolic dysfunction-associated steatohepatitis, is projected to reach $1.21 billion in sales by 2030.
• Structure Therapeutics' GSBR-1290, an oral formulation in Phase II for obesity and type 2 diabetes, is forecasted to generate $1.2 billion in sales by 2030.
• Viking Therapeutics, Altimmune, and Structure Therapeutics are emerging as potential disruptors in the GLP-1RA market, challenging the dominance of industry giants like Novo Nordisk and Eli Lilly.
Corxel Pharmaceuticals Acquires Oral GLP-1 Agonist CX11 for Obesity and Diabetes
• Corxel Pharmaceuticals acquired global rights (excluding Greater China) to CX11, an oral small molecule GLP-1 receptor agonist, from Vincentage Pharma.
• CX11 demonstrated competitive weight loss and favorable safety in a Phase 2 trial in China, and is currently in a pivotal Phase 3 trial there.
• Corxel plans to initiate a Phase 2 clinical trial in 2025 to evaluate CX11 in obese or overweight patients, excluding China.
• The acquisition expands Corxel's cardiometabolic pipeline into obesity and diabetes, addressing a major risk factor for chronic diseases.
Hengrui Pharma's HRS9531 Shows Promising Weight Loss in Phase 2 Obesity Trial
• Hengrui Pharmaceuticals and Kailera Therapeutics reported positive Phase 2 results for HRS9531, a GLP-1/GIP receptor dual agonist, in overweight or obese adults.
• Participants receiving the 8 mg dose of HRS9531 achieved a statistically significant 21.1% placebo-adjusted mean weight loss at 36 weeks.
• The trial demonstrated a favorable safety profile, with most adverse events being mild and gastrointestinal-related during dose titration.
• Hengrui is advancing HRS9531 into Phase 3 clinical trials for obesity and type 2 diabetes in China, with Kailera developing it globally as KAI-9531.
Merck Enters Obesity Market with $112M Deal for Hansoh's Oral GLP-1 Drug
• Merck & Co. has secured global rights outside China to Hansoh Pharma's preclinical oral GLP-1 receptor agonist for obesity treatment through a $112 million upfront payment.
• The deal includes potential milestone payments up to $1.9 billion, with Hansoh retaining options for commercialization in China, marking Merck's strategic entry into the competitive obesity drug market.
• This licensing agreement represents Merck's first major move into obesity therapeutics, following the company's successful track record with diabetes drug Januvia and expanding beyond its cardiovascular portfolio.
Structure Therapeutics Advances Oral Amylin Agonist ACCG-2671 for Obesity Treatment
• Structure Therapeutics has selected ACCG-2671, an oral small molecule amylin receptor agonist, as its lead drug candidate for obesity treatment.
• Preclinical studies of ACCG-2671 demonstrated significant weight loss, potent target engagement, and a favorable safety profile supporting once-daily dosing.
• ACCG-2671, a Dual Amylin and Calcitonin Receptor Agonist (DACRA), is expected to enter Phase 1 clinical trials by the end of 2025.
• The company aims to develop ACCG-2671 as a monotherapy or in combination with its oral GLP-1 molecule GSBR-1290 for enhanced efficacy.
Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial
• 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.
Trump's Healthcare Agency Nominations Signal Major Shake-up in US Pharma Landscape
• President-elect Trump's controversial healthcare nominations, including Dr. Marty Makary for FDA and Dr. Dave Weldon for CDC, have sparked mixed reactions from industry experts, ranging from panic to excitement.
• The nominees' track records suggest a strong focus on clinical trial data transparency, vaccine safety research, and radical reforms in healthcare administration, though Senate confirmation remains uncertain.
• With Republicans holding a seven-seat majority in the Senate, the administration can only afford to lose three Republican votes for confirmations, making the upcoming hearings crucial for the future of US healthcare policy.
Amgen's MariTide Shows Promise in Phase 2 Obesity Trial, Faces Market Competition
• Amgen's MariTide demonstrated up to 20% average weight loss in obese or overweight individuals without diabetes over 52 weeks.
• Patients with type 2 diabetes achieved up to 17% average weight loss and a 2.2% reduction in HbA1c levels with MariTide.
• MariTide's less frequent dosing (monthly or less) could offer an advantage over weekly injectable competitors like Zepbound and Wegovy.
• Despite positive results, Amgen's stock fell due to side effect concerns and market expectations for higher weight loss percentages.
FDA Approves BridgeBio's Attruby, Setting Up Competition with Pfizer's Vyndamax in ATTR-CM Market
• The FDA has approved BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a heart condition leading to heart failure and death.
• Attruby demonstrated a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalizations compared to placebo in the ATTRibute-CM trial.
• BridgeBio is launching Attruby at a list price of $18,759 for a 28-day supply, positioning it to compete with Pfizer's Vyndamax, which dominates the ATTR-CM market.
• Several other companies, including Alnylam and AstraZeneca/Ionis, are also developing therapies for ATTR, potentially disrupting the current treatment landscape.
Weight Loss Drug Race Heats Up: Zepbound Outperforms Wegovy, New Therapies Target Muscle Growth
• Eli Lilly's Zepbound demonstrated superior weight loss compared to Novo Nordisk's Wegovy in a head-to-head trial, with Zepbound users losing over 20% of body weight versus Wegovy's under 14%.
• Several companies, including Eli Lilly, Regeneron, and Veru, are developing new weight loss drugs that aim to preserve or promote muscle growth, addressing concerns about muscle loss with existing GLP-1 therapies.
• The obesity treatment market is experiencing rapid growth and innovation, with over 300 GLP-1R drugs in development and analysts projecting sales to potentially reach $150 billion annually by the early 2030s.
• Upcoming trial readouts in 2025 from companies like Metsera, Skye Bioscience, and Eli Lilly may introduce novel mechanisms and improved convenience, further intensifying competition in the obesity market.
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