Tuesday, March 26, 2024

by David Kliff of the Diabetic Investor 

It almost seems presumptuous to look beyond the current crop of drugs like Ozempic, Wegovy and Mounjaro. All three have patent protection well into the next decade, sales continue to skyrocket plus Novo Nordisk and Eli Lilly have robust pipelines of follow on products. This is a huge and growing market that is vastly underpenetrated. Still, it would be foolish not to look ahead, as Novo and Lilly aren’t the only companies who want to play in this sandbox.

Before we look ahead, let’s review the current situation. Novo has Ozempic and Wegovy, in addition to Rybelsus which is currently the only oral in the space. Lilly has Mounjaro. It should be noted that Bydureon also falls in this class of drugs but has failed to capitalize on the insatiable demand for these drugs. Byetta the very first in this category but being a twice daily injection is out of touch with the others which are once weekly administration. 

Before we examine what’s coming, it’s critical to examine the changing attitude towards obesity/diabetes management. Thankfully people are finally recognizing that obesity and to some extent Type 2 diabetes are not character flaws. These are chronic conditions that require management. The success of these drugs has opened new doors of thought, obesity is no longer being seen as a character flaw and that it’s a real condition just as diabetes is. As we all know there are several costly comorbidities associated with obesity and poorly controlled diabetes. It’s appropriate to state that these two chronic conditions are not just creating a healthcare but economic crisis. 

Along with these changing attitudes and treatment paradigms comes several new therapy options. Both Novo and Lilly are working on oral versions of their injectable options. Rybelsus the only current oral in the category. The drug works well IF the administration protocol is followed. Patients must take it on an empty stomach with no more than 4 ounces of water and not eat for a minimum of 30 minutes after.  This is why most when prescribing the drug tell their patients to take the drug in the morning when they wake up. 

The newer oral options don’t come with these dosing restrictions. They can be taken basically anytime with any amount of liquid. And just as the injectable options are very effective, the data we have seen so far on their oral versions looks equally effective. There is no doubt in my mind that while being an injectable hasn’t hurt sales, oral versions will be even more successful. Given the choice most will choose pills over injections.

 With orals well on their way, these drugs will evolve from one size fits all to more targeted approaches. The fact is not every patient is morbidly obese and needs to lose substantial amounts of weight. In the future different drugs will produce different weight loss targets. Some patients will require the maximum, others less so. Additionally, these offerings will be used in combination, starting with one to lose the weight and then transitioning to another to keep the weight off. 

There is some debate as to the relevance of less frequent dosing. Byetta the first drug in the category was injected twice daily. Along comes Victoza which dosed once per day, and now there are multiple once weekly options.  Some believe that once monthly would lead to poorer patient adherence. As one physician put it, most everyone does something once a week, laundry grocery shopping etc. But there aren’t too many things you do once a month. Or to put simply it’s easier to form a weekly habit than it is to form a monthly one. 

The other area of interest is alternate delivery systems. Rather than injecting or taking pills the drug would be automatically dosed via an implantable device. This isn’t as far-fetched as you’d think, as unlike insulin there is little chance of adverse hypoglycemic events, which as we know can be serious even life-threatening. The benefit with an implantable device is adherence is 100%. Now some will say, what happens if the device fails or how is it implanted? Great questions of course and we all know that no device works 100% of the time. However, the implantation procedure is actually very simple and can be done in the office. Even better there are reimbursement codes for this procedure. In the past the device was implanted, removed after six months and new one inserted. Whether this becomes a reality is of course based on multiple factors but it’s an intriguing approach. 

Keep in mind that this market is still in its very early stages. That the current offerings are very effective and will continue to see increased adoption. Reimbursement is improving and should Medicare begin to cover these drugs the floodgates could swing wide open. Still, it’s interesting to look ahead. It’s also very positive that attitudes along with drugs are improving. Lots of positives in this very large very underpenetrated developing market.  

About the Author

David Kliff is the founder and publisher of Diabetic Investor, the premier publication that provides in-depth analysis of the business of diabetes. With over 30 years of experience as a diabetes industry analyst, consultant, and speaker, David has a unique perspective and insight into the diabetes market and its trends, challenges, and opportunities.

David leverages his financial expertise and personal experience as a person living with diabetes to deliver unbiased and candid commentary on the diabetes biotech, and device sector. He closely monitors the existing and emerging products, services, and technologies that promise to improve the lives of people with diabetes. He also connects the dots between the patients, the companies, the research community, and the emerging technology, and offers compelling and provocative insights on the industry.