At present, which are the markets that Novo Nordisk is catering to through its product Semaglutide? What percentage of the overall revenue does it bring to the company?
Oral Semaglutide has been approved for use in 64 countries till date across Asia, Europe, North and South America, Africa and Australia. We aim to make oral Semaglutide available across the globe and as a priority market for Novo Nordisk. Further, India was the sixth country in the world to launch Oral Semaglutide.
To us, it is not the revenue, but the access and launch of innovative medicine in India which counts.
What potential do you see for Semaglutide in the Indian market as far as the financial viability for Novo Nordisk is concerned?
Oral Semaglutide is a brand-new type of drug to be launched for people with type-II diabetes. Most of the people living with diabetes are not controlled (77 per cent uncontrolled). The average HbA1c in the country is 8.6 per cent vs the goal of seven per cent. Oral Semaglutide offers a remarkable reduction in HbA1c. The clinical trials have demonstrated up to 1.5 per cent reduction in HbA1c from baseline of around eight per cent.
Added to this is the weight reduction benefit offered by oral Semaglutide. Research indicates that weight management in diabetes is an important aspect and that reducing weight in people with diabetes leads to reduction of complications. This is a strong unmet medical need in India, and we believe addressing this need gap will add value to people with diabetes in the long run.
Oral Semaglutide has demonstrated dose-dependent reduction in body weight up to five kilograms across a wide range of clinical trials in people with type-II diabetes. Almost one in two people achieved a clinically meaningful weight loss of greater than five per cent.
With oral Semaglutide, Health Care Professionals (HCPs) can provide robust HbA1c control to their type-II diabetes patients, and also help them manage their weight.
We believe that it has excellent growth prospects. We have already seen strong adoption in India within few months of launch.
Give us a brief about Semaglutide (its origin and regulatory approvals), and tell us what makes it stand out in the crowd?
Semaglutide, as a new type of medicine, is recognised as a gamechanger across the world. Novo Nordisk first launched Semaglutide for diabetes in a once-weekly injectable form (injectable Semaglutide 1 mg) which has been launched in several countries across the world. Injectable Semaglutide for obesity management (injectable Semaglutide 2.4 mg) has also been launched in the US and has demonstrated significant weight loss (approximately 16 per cent) in clinical trials.
Oral Semaglutide, which we are talking about today, is a breakthrough innovation in diabetes care. It was awarded the Prix Galien Award in 2020 – considered to be equivalent of the Nobel Prize in biopharm research. What is remarkable about oral Semaglutide is that we have been able to take a peptide and deliver it orally. We all know that peptides (like insulins) are destroyed by stomach enzymes, and, therefore, need to be delivered as injections. Novo Nordisk has been able to use absorption enhancers and convert Semaglutide in an oral form so that it is protected from chemicals and gets absorbed in the stomach, providing the desired therapeutic effect like reduction in blood glucose and weight. This is unprecedented in pharma innovation.
Oral Semaglutide was approved by the Drugs Controller General of India (DCGI) in 2020 and launched in India in January 2022.
When and where were the clinical trials conducted for oral Semaglutide? What differences were found between Indian and other countries’ clinical trial results?
Oral Semaglutide has undergone 10 rigorous phase-III(a) clinical trials called Pioneer, across several countries including India. The completed and ongoing global trials with oral Semaglutide include more than 10,000 patients of which more than 1,000 participants are from India. In addition to unprecedented glycemic control, oral Semaglutide demonstrated unsurpassed weight loss and consistent cardiovascular safety in clinical trials.
When it comes to the global market, how do the pharma industry’s stakeholders’ see the shift from insulin to oral Semaglutide? How does Semaglutide’s growth prospects look?
Insulin continues to be an important treatment for people with type-I and type-II diabetes. Oral Semaglutide is approved for people with type-II diabetes, the management of which is still dominated by the Modern Oral Anti-Diabetic Drugs (MOADs). Taking into consideration its benefits in providing unsurpassed weight loss and proven cardiovascular safety in addition to robust glycemic control, oral Semaglutide has a high chance of disrupting this MOAD market. The medication can be administered at any stage of the type-II diabetes care cycle; however, its benefits may be best accrued when introduced earlier.