Heart failure drug Entresto makes KRW 10 bil in Q3

Quarterly sales exceed KRW 10 bil for the first time in 5 years of its release

Q3 outpatient prescription sales exceed KRW 10.5 billion... rises 2.6 times in 3 years

Generics’ patent challenges and SGLT-2 inhibitor diabetes drugs remain a variable

Pic of Entresto

Novartis’ chronic heart failure treatment ‘Entresto’ is growing rapidly.

 

Its quarterly sales first exceeded KRW 10 billion in 5 years since its release in Q3 this year.

 

The analysis is that its rapid growth was due to its de facto domination of the market.

 

However, with the nearing entry of ▲SGLT-2 class diabetes treatments, ▲new chronic heart failure treatments, ▲Entresto generics, various prospects are being raised on whether Entresto will be able to maintain its growth rate.

 

◆Quarterly prescriptions of Entresto exceed KRW 10 billion…2.6 time growth in 3 years According to the market research institution UBIST on the 12th, Entresto’s Q3 prescriptions amounted to KRW 10.5 billion.

 

This is a 21% increase from KRW 8.6 billion in Q3 last year and a 2.6-time increase from the same period 3 years ago in Q3 2019.

 

Entresto is a drug used to reduce the risk of death and hospitalization in patients with left ventricular (LV) dysfunction.

 

As a combination of neprilysin inhibitor sacubitril and an angiotensin receptor blocker (ARB) valsartan, it has a double mechanism of action.

 

where sacubitril works on the neurohormonal system and reinforces the heart protection effect and valsartan blocks the angiotensin II receptor.

 

Novartis received approval for the drug in Q2 2016 and released the drug with reimbursement in Q4 2017.

 

Until now, no suitable treatment existed for chronic heart failure before Entresto.

 

ACE or ARB inhibitors were mainly prescribed with not much effect.

 

Quarterly prescriptions of Entresto (Unit: KRW 100 million, Data: UBIST)

Entresto’s sales rose rapidly based on its sole lead in the field of chronic heart failure.

 

After recording KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then to KRW 32.3 billion in 2021.

 

Its cumulative sales recorded KRW 29.2 billion in Q3 this year.

 

At this pace, its sales are expected to reach nearly KRW 40 billion by the end of the year.

 

◆SGLT-2 inhibitors, new treatments, and generics knock to enter the heart failure treatment market However, varying prospects are being made on how long this growth will last.

 

The biggest variable is that the SGLT-2 class antidiabetics were approved for the heart failure indication.

 

The Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of chronic heart failure.

 

The SGLT-2 inhibitors specified in the guidelines are limited to 'Jardiance (empagliflozin)' and ‘Forxiga (dapagliflozin).’ If reimbursement is also extended to chronic heart failure after the amendment of the guidelines, the market is expected to grow further.

 

Pic of Forxiga(left), Jardiance (right)

SGLT-2 inhibitors have a larger scope of indication than Entresto.

 

Entresto can be used in patients with heart failure with reduced ejection fraction, heart failure with mildly reduced EF, and heart failure with preserved ejection fraction.

 

On the other hand, Entresto cannot be used for HFpEF.

 

Therefore, if Jardiance and Forxiga are reimbursed, they will compete with Entresto in the heart failure market.

 

On the other hand, there is also a prospect on the possibility of combined prescription using SGLT-2 inhibitors and Enhertu based on study results that showed improved prognosis with combined use.

 

In that case, sales of Entresto and Jardiance/Forxiga will all rise in synergy.

 

Pic of Verquvo

Another variable is the introduction of new chronic heart failure treatments with a new mechanism of action.

 

Currently, Bayer has announced the release of ‘Verquvo (vericiguat).’ Bayer received approval for Verquvo in Korea in December last year and submitted an application for reimbursement in August this year.

 

Verquvo is a drug with a new mechanism of action.

 

Entresto blocks the harmful effects from the natural neurohormonal system activated by myocardial and vascular dysfunction.

 

Verquvo improves myocardial and vascular function by stimulating the synthesis of intracellular cyclic guanosine monophosphate (cGMP) that regulates vascular tone, cardiac contractility, and cardiac remodeling.

 

Also, the possible entry of Entresto’s generics can also act as a big variable in Entresto’s sales growth.

 

13 Korean pharmaceutical companies have won the first trial against Novartis on Entresto’s patent and were qualified to release Entresto generics.

 

If the companies succeed in releasing Entresto generics, their price will automatically be discounted by 30%.

 

One year after its release, the price will be further reduced to 53.55% from the existing price.