The next Saxenda? Companies race to occupy GLP-1 RA market

Saxenda becomes the sole lead with tis approval in the obesity treatment market… supported by its safety and long-term use data

Novo Nordisk prepares launch of its long-acting new formulation… increases convenience with a once-weekly dose from the previous once daily dose

Lilly expands into the obesity market with tirzepatide… domestic companies also in the run to develop new products

GLP-1 class drugs are taking over the obesity treatment market.

 

With ‘Saxenda’ in the lead, pharmaceutical companies in Korea and abroad are racing to catch up with Novo Nordisk, while the company is working to bring another improved GLP-1 analogue into the market.

 

According to industry sources on the 14th, pharmaceutical companies in Korea and abroad are busy developing obesity treatments using GLP-1 analogues.

 

Lilly is spurring up the development of its product in the market currently occupied by Novo Nordisk, with Hanmi Pharmaceutical and Humedix in Korea also conducting research.

 

◆Novo Nordisk spurs up development of an improved product based on Saxenda’s success

Novo Nordisk is conducting domestic clinical trials for the injection-type and oral-type formulation of its long-acting GLP-1 analogue, ‘semaglutide.’ For the semaglutide injection that was approved in September, a Phase IIIb clinical trial is being conducted on 150 Asians with the Body Max Index (BMI) standard set at ‘25㎏/㎡or higher’ in line with the local obesity standard.

 

The semaglutide injection being studied is ‘Wegovy,’ which has been approved by the US FDA in June last year.

 

Then in November of the same year, a Phase IIIa trial was approved for an oral formulation of the injected semaglutide on 198 overweight or obese East Asians.

 

The oral semaglutide is the first modified GLP-1 analogue formulation made by Novo Nordisk.

 

The drug was approved by the US FDA as ‘Rybelsus’ in September 2019 and is being reviewed for approval in Korea as a diabetes treatment.

 

Previously, Novo Nordisk had made a breakthrough in the obesity treatment market with its GLP-1 analogue.

 

The company had changed the dosage of its GLP-1 analogue ‘Victoza’ that is used to treat diabetes and transformed it into the obesity treatment ‘Saxenda.’ Immediately upon its release, Saxenda rose to the top in the domestic obesity treatment market in 2018.

 

In only 2 years since the release, its sales exceeded 30 billion won.

 

According to the pharmaceutical research institute IQVIA, Saxenda’s sales recorded 36.8 billion won in 2020.

 

Before Saxenda, ‘Belviq (lorcaserin)' and phentermine and phendimetrazine class antipsychotics were commonly used to treat obesity.

 

Among these drugs, Belviq withdrew from the market, and sales of ‘Qsymia’ that combined phentermine and topiramate have surged recently.

 

The reason why Saxenda gained popularity despite being an injection was in its relatively less amount of side effects.

 

Drugs that had previously led the obesity treatment market were banned due to safety issues.

 

‘Reductil (sibutramine)’ and ‘Belviq (lorcaserin)’ have both withdrawn from the market due to cardiovascular and carcinogen risk.

 

Patients are also required to exercise caution in the long-term use of antipsychotics like phentermine and phendimetrazine due to the risk of CNS side effects such as depression and insomnia.

 

A Novo Nordisk official said, “Developing an obesity treatment is more difficult than other chronic diseases because maintaining the lost weight is as difficult as losing the weight.

 

Novo Nordisk aims to close the gap between anti-obesity drugs and metabolic surgery through long-acting, combination drugs, etc.” ◆Lilly fiercely chases Novo Nordisk… Hanmi attempts at a winning bid with 'efpeglenatide'

Lilly, which had been at the forefront of the race in developing GLP-1 analogues in diabetes, is at the other end of the race and is chasing Novo Nordisk in the obesity treatment market.

 

This is because Lilly’s long-acting once-weekly GLP-1 analogue ‘Trulicity’ has a stronghold over the diabetes treatment market but does not own an indication for treating obesity.

 

As a result, Lilly is looking to overtake the obesity treatment market with its next-generation GLP-1 analogue, its dual GIP, and GLP-1 receptor agonist ‘tirzepatide.’ GIP is a hormone that stimulates insulin secretion that works with GLP-1 to increase the weight loss effect.

 

Tirzepatide’s diabetes indication is anticipated to be approved within this year by the US FDA.

 

The drug has ranked No.2 among most-marketable drugs this year that was selected by the global biopharmaceutical market research institution, Evaluate Vantage.

 

Domestic pharmaceutical companies have also jumped into the competition.

 

Hanmi Pharm intends to apply its once-weekly administered GLP-1 class 'efpeglenatide' to obesity as well as diabetes.

 

Currently, the company completed a global phase III trial for efpeglenatide on patients with diabetes or cardiovascular disease.

 

Although slow to enter the competition, Humedix also started developing its own GLP-1 analogue.

 

Humedix has signed an agreement with HLD to jointly research and develop a long-lasting injection for obesity treatment in August last year.

 

Yuhan Corp is also developing a GDF15 inhibitor to compete with GLP-1 analgogues.

 

Its candidate drug YH34160 binds specifically the GDF15 receptor that is mainly present in the brain to induce weight loss through appetite suppression.

 

The company plans to complete the preclinical toxicity test on YH34160 within the year.