Search This Blog

Friday, May 3, 2024

Boehringer, Walgreens Team Up for Obesity Trial as Weight-Loss Drug Race Heats Up

 Boehringer Ingelheim is tapping consumer health chain Walgreens to conduct a large-scale Phase III clinical trial in obesity and type 2 diabetes, the companies announced on Thursday.

The strategic collaboration will make use of certain Walgreens community pharmacies as clinical trial sites, allowing patients to participate “within the familiar and accessible environment of Walgreens pharmacies,” according to the announcement. The partnership aims to optimize recruitment and make clinical trials “more accessible, inclusive and equitable.”

Boehringer Ingelheim will also collaborate with EmVenio Research, a provider of decentralized trial solutions, to provide patients with more participation options through mobile research units.

Lennart Jungersten, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, in a statement said that the company is “proud to embrace this community-centric approach to clinical research,” which will allow the pharma to reach more patients living with overweight and obesity.

“By bringing clinical trials into the heart of local communities, we’re making them more accessible, helping to provide access to diverse populations with pressing health needs to participate in our clinical trials,” Jungersten said.

Though the partners did not name the specific obesity program that they will work on, Yahoo! Finance reported that the community-focused clinical trial is Walgreen’s first large pharma partnership and will focus on Boehringer Ingelheim’s survodutide, an investigational dual agonist of the GLP-1 and glucagon receptors. This mechanism of action allows survodutide to trigger two key gut signaling cascades, which could make it more effective than current single-hormone analog treatments, as Boehringer Ingelheim looks to challenge Novo Nordik and Eli Lilly in the lucrative weight-loss drug market.

Boehringer Ingelheim is developing survodutide in collaboration with Zealand Pharma under a 2011 partnership, which gives the German pharma the responsibility over all R&D and commercialization activities for survodutide with Zealand remaining eligible to milestones and royalties.

In May 2023, Boehringer Ingelheim launched five Phase III trials to assess survodutide as a weight-loss treatment. This program includes SYNCHRONIZE-1 and SYNCHRONIZE-2, which will test the candidate in overweight and obese participants without and with type 2 diabetes, respectively.

The pharma is also running SYNCHRONIZE-CVOT, which will focus on overweight and obese patients with cardiovascular disease, chronic kidney disease or other risk factors for cardiovascular disease.

In June 2023, Boehringer Ingelheim released Phase II data showing that survodutide could cut body weight by around 20%. At the time, however, weight loss in the study had not yet plateaued, suggesting that survodutide could show even greater efficacy at longer follow-ups.

The pharma in February 2024 reported that survodutide could elicit significant biopsy-proven improvements in metabolic dysfunction-associated steatohepatitis without worsening fibrosis.

https://www.biospace.com/article/boehringer-walgreens-team-up-for-obesity-trial-as-weight-loss-drug-race-heats-up/

J&J: to present advances in retinal diseases

 Johnson & Johnson announces that it will sponsor eight data presentations at the 2024 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), to be held in Seattle from May 5 to 9, 2024.



In particular, J&J will highlight new research into the economic value of genetic testing for retinal diseases, and also show the role that automated algorithms based on deep learning can play for geographic atropia.

The laboratory will also present EYE-RD, a global registry that will collect real-world data, gathering more holistic information about disease progression and patient experiences.

' These data presented at ARVO 2024 demonstrate our commitment to bringing innovative new therapies that preserve and restore vision to patients worldwide, ' commented Hideo Makimura, Vice President and Global Head of Ophthalmology R&D at Johnson & Johnson Innovative Medicine.

Moderna, Inc.: Jefferies raises the target price from USD 125 to USD 155.

 maintains its buy recommendation

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/

Cvs Health Corporation: HSBC downgrades to hold from buy

  price target reduced from USD 91 to USD 62.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/

Amgen Inc.: Barclays upgrades to equalweight from underweight

 price target raised from USD 230 to USD 300.

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/

FTC seeks more information on Novo Nordisk parent-Catalent deal

 The U.S. FTC has sought more information on Novo Nordisk parent's $16.5 billion bid for contract drug manufacturer Catalent, weeks after an application to the regulator was refiled for approval of the deal.

Catalent said on Friday the companies were in the process of gathering information to respond to the U.S. Federal Trade Commission's request received on May 2.

Novo Holdings in February agreed to buy Catalent to boost output of the popular weight-loss drug Wegovy. To that end, it would sell three of Catalent's fill-finish sites to Novo Nordisk for $11 billion.

Access to the three Catalent sites would be a win for Novo Nordisk, which is gradually increasing production of Wegovy to meet explosive demand.

David Ricks, CEO of Novo's main rival in the obesity market - Eli Lilly, has said that Novo's proposal to buy the plants was "unusual" and raises potential antitrust concerns.

Lilly manufactures weight-loss drug Zepbound and related diabetes treatment Mounjaro.

Catalent and Novo Holdings, Wegovy producer's parent, continue to expect to close the deal by the end of 2024, but a refiled application for its approval in April have raised doubts that the transaction may not complete within the target period.

Novo did not disclose details about why the application was refiled.

Novo is the investment arm of Novo Nordisk's controlling shareholder, the Novo Nordisk Foundation.

https://finance.yahoo.com/news/us-ftc-seeks-more-information-125812911.html

Tandem Diabetes strong start to 2024, ups sales guidance

 

  • Revenue: Q1 worldwide sales grew 12% year-over-year to $193 million.

  • U.S. Sales: First quarter sales of $131 million with approximately 15,000 pump shipments.

  • International Sales: Grew over 60% to $62 million with nearly 10,000 pump shipments.

  • Gross Margin: Reported at 50%, consistent with the prior year.

  • Adjusted EBITDA Margin: Improved nearly 5 percentage points year-over-year to negative 7%.

  • Operating Expenses: Increased by 5% on 12% sales growth.

  • 2024 Sales Guidance: Increased to approximately $868 million, or 12% growth year-over-year.

  • Profitability Guidance: Maintaining full year guidance of 51% for gross margin and breakeven for adjusted EBITDA.

  • Q2 Sales Forecast: Worldwide sales anticipated to be $205 million.

  • Q2 Gross Margin: Expected to be approximately 50%.

  • Q2 Adjusted EBITDA: Expected to improve to negative 5%.