Entresto sales soar… rises 22% in 1 year

Patent challenge by generic companies remain a variable

Entresto Q2 sales reached KRW 17.1 billion...its year-end target of KRW 70 billion in sight

2nd trial ruling over patent dispute imminent…generic early release may serve as turning point

Pic of Entresto

Sales of Novartis' heart failure drug 'Entresto' continues to grow over 20% YoY in its 7th year on the market.

 

At this rate, the drug is expected to generate prescription sales of around KRW 70 billion by the end of this year.

 

The variable is the patent dispute.

 

The company is currently awaiting its second judgment on its patent dispute with generic companies.

 

The patent court’s ruling is expected to serve as a turning point for the early release of generics.

 

Entresto in its 7th year of release, continues to grow 22% YoY According to the drug market research firm UBIST on the 5th, Entresto posted prescription sales of KRW 17.1 billion in Q2.

 

This is a 22% YoY increase from the KRW 14 billion it had posted in Q2 last year.

 

Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril.

 

It was granted reimbursement and released in 2017.

 

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

The drug is still showing strong growth in its 7th year of release.

 

Since its launch, its drug price has been reduced by 21%, through 7 price cuts until earlier this year through the price-volume agreement and voluntary reductions, but it did not have a significant impact on the upward sales trend.

 

This is likely due to the fact that the drug's reimbursement coverage has been expanded at the same time as the price cuts.

 

When Entresto was first added to the reimbursement list in 2017, it was reimbursed as a treatment for patients with chronic heart failure with reduced ejection fraction (HFrEF).

 

Coverage was limited to patients previously receiving an ACE inhibitor or ARB inhibitor in combination with standard therapy at a stable dose for at least four weeks.

 

In March 2022, the reimbursement standard was extended to first-line therapy and became available for patients who were previously untreated with an ACE inhibitor or an ARB inhibitor.

 

In July of the following year, the drug became available for prescription in both inpatient and outpatient settings.

 

The drug's longtime dominance of the heart failure treatment market has also contributed to its steady rise in sales.

 

Entresto was the only prescribed treatment targeting heart failure for 6 years until Bayer launched Verquvo (vericiguat) in September last year.

 

Will its sales exceed KRW 70 billion by the end of the year?...the 2nd ruling of the patent dispute remains a variable The industry expects Entresto to generate prescription sales of around KRW 70 billion by the end of the year.

 

Entresto’s sales have grown rapidly since exceeding the KRW 10 billion mark in annual prescription sales in 2019.

 

The drug posted KRW 57.5 billion last year.

 

In the first half of this year, it generated KRW 32.9 billion.

 

If sales continue to grow at this pace, sales could reach KRW 70 billion in annual prescription sales.

 

The variable is in the patent dispute.

 

Domestic pharmaceutical companies have filed patent appeals against several of Entresto's patents at the same time.

 

Since January 2021, generic companies have filed a challenge on Entresto's crystalline form patent, salt and hydrate patent, 2 use patents, and 2 formulation patents.

 

The generic companies won the first trial.

 

After losing the first trial, Novartis appealed 3 cases: the crystalline form patent, the use patent, and the salt and hydrate patent.

 

Of these, the patent court rejected the use patent case in November last year.

 

Novartis appealed again to the Supreme Court, but the court ordered the discontinuance of the trial in April this year.

 

Entresto Patent Dispute Status (Source:KIPO)

As a result, 2 patent disputes now remain.

 

The arguments for the salt-hydrate patent have been finalized.

 

The crystalline patent is also reportedly in the final stages of defense.

 

The industry expects the patent court to make a ruling as early as this year.

 

The decision of the second trial is expected to serve as a turning point for early generic launches.

 

Even if Novartis loses the second trial, the company will likely appeal to the Supreme Court, but if generic companies win both the first and the second trial, it will raise the probability of the early launch of Entresto generics.