Novo Nordisk’s Obesity Drug Pipeline Stacked Up For Next 15-20 Yrs Says GBS, MD, John C Dawber

The GLP1 drugs are set to be the star performers for insulin drugmakers across the globe as the menace of diabetes and obesity is in line to rise exponentially in the years to come. GLP1 drugs or Glucagon-like peptide-1 agonists are medications which have traditionally been used to treat type 2 diabetes and more recently for obesity. The pharma majors who make GLP1 drugs globally are racing to get their drugs on the shelves with the demand for these drugs outstripping the supply in many markets. 

According to an International Diabetes Federation report in 2021 537 million people had diabetes globally, with the number slated to rise to 643 million by 2030. Another study carried out by the International Obesity Federation in 2023 revealed that 4 billion people globally or almost half of the world’s population is set to become overweight and obese by 2030 compared with 2.6 billion people in 2022. 

The reports also say that the majority of the menace by diabetes and obesity will affect low and middle-income countries. A 2023 Indian Council of Medical Research (ICMR) study revealed that India has around 101 million people living with diabetes, a 44 per cent rise over the 2019 figures when the country had 77 million diabetics. 

GLP1 drugs have become highly recommended due to their diverse treatment profile effective in lowering sugar levels, reducing obesity and providing cardiovascular risk benefits. The GLP1 agent mimics the action of a hormone in the body called glucagon-like peptide 1 stimulating the body to produce enough insulin when the body requires. 

For obesity, the clarity on how the drug actually works is still less but clinical experts believe that the drug helps in curbing hunger and also slows the movement of food from stomach to small intestine making a person eat less. 

In India, the Danish drugmaker Novo Nordisk is the market leader and presently claims around 60 per cent of the country’s insulin supply. Speaking to BW Businessworld in an exclusive interaction on the company’s GLP1 growth story, John C. Dawber, CVP and MD, Global Business Services, Novo Nordisk said that the company’s journey goes back several decades with its research beginning over 20 years ago adding that the company is continuing to see a great interest in GLP1 molecules across the world and in India.

“Globally the GLP1 market was growing at a rate of 60 per cent in 2022 and we see it continuing to grow at a similar pace going forward. This has happened due to the benefits of these particular groups of medicines, which control blood glucose for people with diabetes and also reduce weight. And some of those molecules have evidence to show protection of other complications of diabetes such as a heart attack and cardiovascular complications,” Dawber stated. 

Novo Nordisk began its GLP1 journey to treat diabetes with a once-daily injection, Victoza back in 2010, and then moved to once weekly injection Ozempic in 2017 and then further introduced a daily oral drug Rybelsus in 2019. 

“All three of these innovations continue to do pretty well. And, as you might imagine, the tablet has gone particularly well, in certain markets where people don't like injections. The GLP1 Rybelsus was launched in India a year ago and so far has been one of the most successful diabetes launches ever in India,” Dawber informed. 

Building Capacities For Drug Shortage

With the great interest shown by patients worldwide, Novo’s two injection drugs Ozempic and Wegowy are presently listed in shortage on the USFDA (United States Food and Drug Administration) website. Wegowy, the company’s first obesity drug was given approval by the FDA in 2021. 

On being asked about the shortage and the company’s efforts to build capacity, Dawber stated, “In the last year or two post-Covid, we have seen a dramatic uptake in both Ozempic and also the equivalent treatments that are licensed for obesity. The capacity and demand in some cases have outstripped supply. We have had to be very careful and responsible about where we launch these products, so that we can maintain supply.”

Dawber pointed out that Novo’s current manufacturing bases for GLP1 are running on a 24/7 capacity and the company is on a hiring spree into its product supply organisation to continue to expand its own demand.

“In addition, the company has taken some steps to work with a few contract manufacturing firms particularly in the US to meet the demand going forwards. Whilst there were some significant concerns about a year ago, particularly in the US now I think we find ourselves being able to supply all those strengths in America having both the diabetes and the obesity products. And I think it's much easier to plan over the next two to five years so that we will have the right capacity to meet the needs of the markets,” the Global Business Services MD said. 

In India, Novo Nordisk has joined hands with Torrent Pharma for manufacturing insulin treatments and the contract has been running for the last few years. Speaking on the partnership with Torrent and whether the company will partner with other firms in the country going forward Dawber stated, “There are discussions ongoing, about whether we develop that partnership further into other parts of our portfolio. I think that we will continue our partnership with Torrent rather than try to diversify into other partnerships.” 

He added that Torrent Pharma has been a good partner for insulin and the company is presently investigating whether it can partner with Torrent for Semaglutide or for other parts of the drugmaker's portfolio to build capacity.

Promising Pipeline On Cards

Novo Nordisk has recently released clinical results from two of its latest drugs; higher dose oral Semaglutide 50mg and Icodec which have completed late-stage trials and are pending approvals from the global regulatory authorities. The higher dose Semaglutide has resulted in an average weight reduction of 15 per cent after 68 weeks and is set to be filed for approval this year. 

Clinical results from Icodec, the once-weekly basal insulin injection aimed at moving patients from daily insulin injection to once-weekly injection have also been encouraging for the company with the clinical data meeting the primary endpoints. 

Speaking on Icodec, Dawber stated that the drug is neither licensed nor available anywhere, hence the company has to be careful while speaking on it and not create a demand which can never be delivered as the drug is still being evaluated and is pending approval in Europe, the US and China among others countries.  

“You are moving from 365 injections per year to 52, a significant quality of life upgrade, just in the frequency of an injection, and then the clinical data is presenting at least as good blood glucose control against existing gold-standard medications. If the regulators agree, then it potentially has a big life-changing impact for many millions of people with diabetes,” he said.  

Delineating on the higher dose Semaglutide John said that the Semaglutide molecule at high dose looks very interesting and with obesity and its complications rising going forward, Novo Nordisk will look to raise the innovation bar even further to manage it all. 

The obesity drugs market is presently seeing stiff competition with market competitors racing to get approvals and market authorisations, on being asked how will Novo Nordisk maintain its lead going forward as the market grows and more players enter, the MD stated, “The last four or five years of obesity treatments available in the market have about two decades of research and a conscious decision from Novo Nordisk to invest in an entire business unit, both commercial and research to investigate the aetiology and methodologies behind the development of overweight and obesity." 

He continued, “What that means is that not only do we have two products on the market today, but we have got a pipeline, stacking up over the next 10-15, maybe the next 20 years to tackle this condition. So the starting point for Novo Nordisk was quite some years ago, and the results of that R&D and pipeline development will come out over the coming 10 years."

He added that the obesity drugs market is enormous, and there is plenty of room for other players who are innovating but for Novo Nordisk, the diverse portfolio in obesity has got a lot of promise and the company will continue to maintain its leadership.

Novo Nordisk’s research and development costs increased by 29 per cent at CER (constant exchange rate) to DKK (Danish Kroner) 24,047 million in 2022 compared with 2021 with industry estimates pegging this to be 13.6 per cent of the company's total sales. 

The Safety Profile Of Obesity Drugs

As the drug dosage of Semaglutide goes up which presently for Novo stands at 50 mg, keeping a check on the safety profile of the drug becomes of utmost importance to be wary of possible side effects. 

On being asked whether the company is keeping track of some of the side effects reported in the global media or is carrying out any longer studies to analyse possible long-term effects, Dawber said, “Our own internal pharmacovigilance is incredibly strong and robust. We have several hundred drug safety experts, and pharmacovigilance experts sitting here in Bengaluru, who are reviewing all the side effects reports for the globe and adjudicating whether those are assigned to the drug, assigned to the dose, assigned to attempt the particular patient type, and constantly reporting that to the authorities.” 

Speaking about the Semaglutide molecule, the MD agreed with the priority of the drug's safety profile and said that it's very important to evaluate the safety and efficacy profile as you go up the dose ranges of any drug. “As exciting as you may be, for increased efficacy, it always has to be traded off on is this safe? And is there a good balance to be had? So far, it seems that Semaglutide is a molecule which doesn't produce new side effects that we don't know about as we go up the dose range. But the diligence around that is quite strong because patient safety is at the heart of our reputation,” Dawber said. 

Future Ambitions In India

In India the company is growing its workforce both in its global business services arm and the Indian commercial business, describing India and Bengaluru as the company’s main hub for global services business Dawber informed that in 2022, the company’s employee footprint grew by 600 new positions. “In the next year, we will do the same. If you then look at the local commercial business, again, at a slower rate, still expanding and hiring people to serve the needs of patients and doctors here in India, we are about 1600 people in our local India affiliate, and growing that at about 10 per cent per year.”

Explaining the diabetes burden, Dawber stated that more than 101 million people are living with diabetes here in India, and Novo Nordisk whilst being the market leader, only serves a small fraction of that. “We have got the ambition to do much more. I think the GLP1 portfolio has got a lot of potential for further research and commercial expansion here in India,” he added.