Decreased drug price and inclusion of impurities in Januvia

Sluggish prescription volume

Januvia, Janumet, Janumet XR, 8% decline in the first half

The aftermath of drug price cuts and impurities… Anticipation of generic competition in the second half of the year

Nitrosamine impurities management hidden ambush... The standard will be significantly strengthened

Nitrosamine impurities management hidden ambush...

 

The standard will be significantly strengthened.

 

The diabetes treatment 'Januvia series', for which sales rights were recently transferred to Chong Kun Dang, is experiencing sluggishness in the prescription market.

 

Following last year's drug price cut, the company suffered voluntary withdrawals due to excess impurities in the first half of this year, and the scale shrank by 13% in two years.

 

According to UBIST, a pharmaceutical market research institute, on the 24th, the total outpatient prescriptions for the Januvia series (Januvia, Janumet, and Janumet XR) in the first half of this year were 75.4 billion won, down 8% from 81.9 billion won in the same period last year.

 

By item, Janumet decreased by 9% from 36.2 billion won in the first half of last year to 32.9 billion won this year.

 

Then, Januvia 10% (21.7 billion → 19.6 billion won) and Janumet XR 5% (24 billion → 22.9 billion won) each decreased.

 

Sitagliptin is a treatment for type 2 diabetes.

 

It is a representative DPP-4 inhibitory mechanism that led the domestic diabetes market.

 

The Januvia series consists of a total of three products.

 

▲Sitagliptin single drug 'Januvia' ▲Metformin + Sitagliptin combination drug 'Janumet' ▲Janumet extended-release formulation 'Janumet XR' with enhanced convenience.

 

Janumet, Janumet XR, and Januvia have the highest prescriptions in that order.

 

MSD opened the DPP-4 inhibitor market with the domestic approval of Januvia and Janumet in 2007, and in 2013, it had a lineup with Janumet XR.

 

DPP-4 inhibitors have become mainstream by replacing existing diabetes drugs with the advantage of having a good blood sugar-lowering effect and little concern for side effects.

 

Among them, the Januvia series has emerged as the most widely used DPP-4 inhibitor in Korea.

 

It is 2021 when prescriptions for the Januvia series reach their peak.

 

The Januvia series, which recorded 164.3 billion won in 2019 and 173.8 billion won in 2020, raised 176.3 billion won in 2021.

 

Janumet 79.2 billion won, Janumet XR 50 billion won, Januvia 47.1 billion won.

 

In particular, the number of outpatient prescriptions recorded by the three products in the second half of 2021 was 89.4 billion won, the largest half-year prescription amount ever.

 

The decline of the Januvia series started last year.

 

The biggest factor is the drug price of the Januvia series.

 

MSD has signed a 'trade-off' agreement with the government to expand reimbursement for Keytruda, an immuno-oncology drug that it has been pushing for.

 

It is content that voluntarily lowers the price of the Januvia series in exchange for allowing the expansion of the primary lung cancer benefit for Keytruda.

 

With this agreement, the prices of all three Januvia products have been lowered by an average of 6% since March last year.

 

In the aftermath of drug price cuts, last year's Januvia series recorded 81.9 billion won in the first half and 80.6 billion won in the second half, down 6% and 10% year-on-year.

 

In the first half of this year, the decline was even greater with an 8% decline.

 

It is analyzed that there was an additional drug price cut of about 1% due to the expansion of insurance coverage for diabetes drugs and that some products were affected by voluntary recalls due to the occurrence of impurities that exceeded the standard.

 

Compared to two years ago, the amount of prescriptions has decreased by 13%.

 

In the second half of this year, the decline is expected to continue due to the expiration of the Januvia patent.

 

The Januvia substance patent expires on September 1.

 

Domestic pharmaceutical companies are preparing to release sitagliptin generics in time for expiration.

 

If a generic with the same ingredients is registered for reimbursement, the price of Januvia is automatically reduced by 30%.

 

A simple calculation of drug price cuts would result in about 50 billion won of annual prescriptions being subtracted.

 

Attention is focused on the move of Chong Kun Dang, which acquired the Januvia series from MSD.

 

Chong Kun Dang paid 45.5 billion won (down payment + milestone) to acquire all rights, including license, trademark, manufacturing, sales, and distribution of Januvia.

 

Considering the annual prescription amount of the existing Januvia series, 45.5 billion won is an amount that can be recovered within half a year.

 

However, considering drug price cuts and competition among generics, Chong Kun Dang is bound to be nervous.

 

Some predict that the key to Januvia's future generic competition will be impurities.

 

Januvia carries the risk of nitrosamine-like impurities, and the tentative daily intake is set at 246.7 ng.

 

The global guidelines aim to lower the daily allowance to 37ng in the future.

 

It is expected that the stricter standards will be applied at the end of the year or next year at the earliest.

 

To this end, it is known that the Ministry of Food and Drug Safety recently instructed pharmaceutical companies to implement safety measures by setting the daily intake of Sitagliptin to 37ng.

 

The original Januvia has already been fully prepared to meet the reinforced intake allowance.

 

However, generic companies that have just entered the Sitagliptin market have a relatively short preparation time.

 

It is expected that it will be a difficult fight for generic companies as it is to manage impurities within 30% of the current standard.