Market withdrawal and indication transfer

evolving co-promotion strategy

AstraZeneca cancels Forxiga approval…transferred heart failure indication to HK inno.N’s 'Dapa N'

'Dapa N' essentially assumes the original position…HK inno.N is expanding its position in diabetes the market

AZ Korea to transfer the Forxiga indication to HK inno.N

AstraZeneca Korea voluntarily withdrew approval for ‘Forxiga (dapagliflozin),’ an SGLT-2 inhibitor class diabetes treatment, and transferred the chronic heart failure·chronic kidney disease indication to its partnering company H.K.

 

inno.N’s 'Dapa N.' Due to this clever co-promotion strategy between AstraZeneca Korea and HK inno.N, the prescription market worth KRW 50 billion annually is expected to significantly shift.

 

In particular, HK inno.N’s Dapa N, assuming the indication that no other generics have, is expected to become a dark horse in the SGLT-2 inhibitor market.

 

HK inno.N ‘Dapa N’ assumes the original indication…anticipated to expand its presence in the diabetes market According to pharmaceutical industry sources on the 30th, AstraZeneca Korea recently voluntarily canceled domestic approval for Forxiga tab.

 

At the same time, the company transferred chronic heart failure and chronic kidney disease indications to HK inno.N’s Dapa N.

 

The company granted the clinical documents to HK inno.N.

 

Dapa N will have the same reimbursement criteria as Forxiga.

 

In terms of indications, Dapa N essentially acquired the original product’s market position.

 

The analysis suggests that this transaction benefits both AstraZeneca Korea and HK inno.N.

 

HK inno.N’s expansion in the market for SGLT-2 inhibitor class diabetes treatment is expected.

 

This market has shifted significantly following the changes made by Forxiga, which ranked as the No.1 product.

 

Since Forxiga’s patent expired in April, generics have been launched.

 

In December, AstraZeneca decided to withdraw Forxiga from the Korean market.

 

Consequently, Forxiga’s prescription performance significantly dropped.

 

According to the medical market research firm UBIST, Forxiga’s prescription sales in Q1 were KRW 11.3 billion, down 22% compared to Q1 of last year.

 

AstraZeneca plans to stop distributing additional products once current stocks are depleted.

 

A significant drop in prescription sales is inevitable after Q2.

 

On the other hand, Forxiga generics have competed fiercely, showing rapid growth over the past year.

 

Forxiga generics, officially launched in Q2 last year, generated a prescription performance of net KRW 10.2 billion in Q1.

 

The market share for diabetes treatments containing dapagliflozin has expanded to 48%.

 

Quarterly prescription sales of Forxiga and Forxiga generics.

 

(unit: KRW 100 million, source: UBIST)

However, HK inno.N’s Dapa N did not generate satisfactory performance compared to other generic products.

 

Dapa N’s prescription performance in Q1 was KRW 359 million.

 

Dapa N is ranked 9th among those products that generated less than KRW 1 billion, such as Boryung’s ‘Dapapro’ and Hanmi Pharmaceutical’s ‘Dapalon.’ In these circumstances, the analysis suggests that Dapa N has established an opportunity to expand its prescription performance by assuming the original product indication.

 

At the same time, Dapa N is expected to expand its presence in the market for diabetes treatment, including SGLT-2 inhibitors.

 

Forxiga generics are currently approved for diabetes treatment indications.

 

They cannot be used for treating chronic heart failure·chronic kidney disease, which AstraZeneca gained approval for these indications through additional clinical studies.

 

Separate usage patents protect indications of chronic heart failure and chronic kidney disease.

 

AZ Korea minimizes an annual KRW 50 billion gap…the key would be switching Forxiga→Dapa N in the prescription field The analysis suggests that this transfer is a favorable decision for AstraZeneca Korea.

 

It is expected to minimize the KRW 50 billion annual sales gap, especially after headquarters decided to withdraw Forxiga from the Korean market.

 

At the end of last year, AstraZeneca Korea signed a co-promotion agreement with HK inno.N for Xigduo·Sidapvia, a combination therapy containing dapagliflozin.

 

Accordingly, HK inno.N signed a contract to assume the role of domestic distribution of Forxiga until its withdrawal from South Korea.

 

This previous transaction resulted in both companies deciding to transfer the Forxiga indication to Dapa N.

 

Through this comprehensive collaboration for the diabetes treatment portfolio, AstraZeneca Korea can maintain its market presence.

 

Since this is the first case of a generic product inheriting the original product indication, it is a matter of great interest to the pharmaceutical industry.

 

The analysis indicates that indication transfer via granting clinical documents was the first, as it is unusual for a blockbuster original product to withdraw from the market in South Korea.

 

The key would be the preference for Dapa N in the prescription field.

 

In the endocrine field, general hospitals tend to prefer the original product.

 

Although Dapa N assumed the original product’s indication, it is uncertain whether the prescription field would regard it as the original product.

 

Top 10 highest prescription sales of Forxiga generics (Trudapa, Daparon, Daparil, Exiglu, Dapazin, Dapapro, Dapaone, Fosugbet, Dapa N, and Floga).

Dapa N is priced at KRW 393 per tablet, about 53.5% of Forxiga’s KRW 734.

 

It is estimated to generate quarterly prescription performance of KRW 5 billion to 6 billion when it successfully substitutes Forxiga after the second quarter.