EyesOn The Competitive Edge

This week we're sharing a couple of articles focused on competitive advantage in US BioPharma. Take a look at how the Oral GLP-1 market is shaping up, and the new US Initiative Operation TrialBlazer is trying to boost US Early-Stage Clinical Development Capabilities.

Name familiarity turned out to be Novo Nordisk’s secret weapon to defeat Eli Lilly and prevail in the ongoing market war over their oral GLP-1 obesity medication.

Analysts who have researched the rivalry have written monthly reports on the uptake of the treatments, both of which were introduced to the market earlier this year, and surveyed fifty primary care physicians and fifty endocrinologists in the United States.

Novo Nordisk's impressive start is consistent with the information provided by the firm. The Wegovy pill’s familiarity scores are significantly higher than Foundayo’s.

The benefit of Novo’s pill, which was introduced in January, is that it shares the same name as the company’s injectable weight-loss medication, Wegovy, and both formulations are made from the same GLP-1 molecule, semaglutide.

Launched in April, Lilly’s Foundayo (orforglipron) is a completely different chemical from the company’s injectable GLP-1/GIP blockbuster, tirzepatide. The dual agonist is referred to as Mounjaro for Type 2 diabetes and Zepbound for obesity in the United States. Conversely, Foundayo is a single-target GLP-1 agonist similar to Novo’s Wegovy medication.

Although Novo’s early success has been attributed by many analysts to its first-to-market advantage, analysts believe that familiarity is more important based on feedback from physicians. Being familiar with semaglutide offers a level of comfort that knowing orfoglipron does not.

Analysts said that 159,000 prescriptions for oral Wegovy and 19,879 for Foundayo were written during the most recent weekly reporting period. Wegovy was in its 22nd week on the market, while Foundayo was on its ninth.

Analysts have warned that while data analysis based on prescription patterns may be flawed, it may miss a substantial number of telehealth referrals for the increasingly common obesity medications.

Novo revealed earlier this month that the Wegovy tablet has received over 3 million prescriptions since its introduction on 5th January. According to Novo at the time, the majority of such prescriptions come from patients who are new to the GLP-1 family.

PCPs are more likely than endocrinologists to prescribe oral Wegovy, according to another finding from the competition. Furthermore, endocrinologists are more likely than PCPs to have seen representatives from both companies, according to study and intelligence data.

Feedback on efficacy comparisons between the medications and how patients perceive Wegovy’s limitations comes next. While Lilly has attempted to highlight Foundayo’s lack of food or water limitations, Novo’s medication must be taken on an empty stomach.  Another form of incoming data is how many patients are discontinuing injectables instead of beginning a GLP-1 orally for the first time.

With the introduction of several initiatives to catch up to China’s rapidly increasing early-stage clinical development capabilities, the Department of Health and Human Services has generated a lot of discussion points.

Jay Bhattacharya, M.D., Ph.D., director of the National Institutes of Health and acting director of the Centers for Disease Control and Prevention, along with Acting FDA Commissioner Kyle Diamantas, outlined a set of reforms aimed at accelerating phase 1 trials and encouraging companies to carry them out in the United States instead of faster locations like China and Australia.

According to Diamantas, the activities are a part of Operation Trial Blazer, an HHS-wide operation.

The FDA saw an increase in the percentage of phase 1 clinical trials being conducted abroad, which delayed prospects for American patients and undermined the country’s standing as a global leader in biomedical research. The FDA is now acting to stop that trend.

According to Diamantas, the FDA is working to shorten phase 1 timescales by six to twelve months. They include updated guidelines on the use of sophisticated computer models for dose determination, updated frameworks for clinical trial master protocols, and what he dubbed an accelerated investigational new medication pilot program.

In addition to offering additional information on moving away from animal models for preclinical testing and giving sponsors more guidance on dose, the FDA will be making clear what must be done for a first-in-human phase 1 with regard to the chemical manufacturing controls.

The FDA will also introduce a website and a call center designed especially to help sponsors with all of their phase 1 trial enquiries. Small businesses in particular will find it easier to traverse the agency and acquire the answers they need to continue their experiments.

Three draft guidelines pertaining to the officials’ announcements were shared by the FDA. The other two describe the intended master protocol and dose selection reforms, while the first restates the regulator’s previously expressed desire for approvals to be based on just one clinical trial.

Marty Makary, M.D., the recently departed FDA Commissioner, regularly expressed his wish to modernise the phase 1 trial procedure. The agency has been working on these projects for a long time before Makary left. Both of the agency’s drug product centers continue to place a high priority on this.

According to Bhattacharya, the NIH intends to test possible novel research designs through its clinical trial network before implementing them more widely. In order to improve protocol feasibility, recruitment planning, and evidence creation in ways that make trials appear quicker and more informative, the agency will expand its use of real-world data and causal inference techniques.  Additionally, efforts will be made to guarantee that underprivileged and rural communities have access to trials.

Soon, NIH will solicit feedback on its reform initiatives, which include plans to change the conditions under which institutional review boards must approve study designs. Simplifying trials while upholding human rights is the aim.

China and Australia’s superiority in early-stage research has received a lot of attention in recent years, and America’s more lengthy process is frequently cited as a major drawback in competitiveness with China’s biotech sector. HHS Secretary Robert F. Kennedy, Jr. claims that although America should be the world’s top location for the development of new medications, a system has been established that pushes too much clinical research elsewhere. In order to reclaim America’s position as a leader in clinical research, eliminate needless obstacles, and increase clinical research and investment in the country, HHS is initiating a department-wide concerted effort.

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