With the BPH drug Duodart be the first combo to succeed?

Will the drug trigger the development of combo drugs for benign prostatic hyperplasia+overactive bladder among Korean pharmaceutical companies in Korea?

Prescription of GSK’s dutasteride+tamsulosin combo ‘Duodart’ surges

The only previously available combo urology drug was Gugutams... development of some was discontinued right before commercialization

Pic of Duodart

GSK’s benign prostatic hyperplasia (BPH) drug ‘Duodart (dutasteride+tamsulosin)’ has been making rapid growth in the outpatient prescription market in Korea.

 

Until now, the market for combination drugs in the field of urology was considered barren.

 

Unlike other chronic disease areas, combination drugs are rare in the area.

 

Companies have been dropping the development of their combo drugs shortly before commercialization due to low marketability.

 

This is why the industry is focused on the success of Duodart’s soft landing in the Korean market.

 

If Duodart paves the way and makes success as a combination drug in the field of urology, the industry believes it will encourage the development of other combination drugs in the market.

 

Duodart’s annual sales to rise to record KRW 10 billion in its second year of release According to the market research institution UBIST on the 11th, GSK’s Duodart posted outpatient prescriptions of KRW 3.9 billion in Q2 this year This is a 4.5 time rise from the KRW 0.9 billion the drug had made in Q2 last year.

 

Duodart is a combination of dutasteride tamsulosin.

 

Both ingredients are used to treat BPH.

 

The company received approval for the drug in May 2021 and released the drug with reimbursement in March last year.

 

Duodart’s sales had grown rapidly upon its release.

 

Its sales rose from KRW 0.9 billion in Q2 last year to KRW 1.5 billion in Q3, then to KRW 2.8 billion in Q1 this year, and KRW 3.9 billion in Q2 this year.

 

At this pace, its sales will likely exceed KRW 10 billion by the end of this year.

 

▲ Quarterly prescription of Duodart (Unit: KRW 0.1 bil, Source: UBIST)

The pharmaceutical industry is keenly eying the success potential of Duodart because the market for combination drugs in urology was considered barren until now.

 

Although the patent for BMH drugs such as tamsulosin, finasteride, dutasteride, OAB drugs such as mirabegron, solifenacin, and erectile dysfunction drugs sildenafil and tadalafil had expired until now, news of combination products being released that use these various off-patent ingredients are rare in Korea.

 

Hamni Pharm’s tamsulosin+tadalafil combination drug ‘Gugutams’ i which was released in 2014, is virtually the only combination drug that is available in the market.

 

However, Gugutams fell short of market expectations, as it has been posting annual sales that range around KRW 2 billion.

 

The industry analysis is that the market has a strong loyalty for original drugs.

 

Also, its total market size is small compared to those of hypertension, diabetes, or hyperlipidemia, and as nearly 100 generics are already available for each ingredient, the marketability of developing combination drugs is not high compared to the input cost.

 

Duodart shows rapid growth...Will this spark the development of combo drugs in urology? This was why so many companies had discontinued their development of combination drugs in the field.

 

Pic of Gugutams, the only urology combo drug available in the market

Ildong Pharmaceutical, Yungjin Pharm, and Chong Kun Dang, which had started the development of their tamsulosin+tadalafil at the same time as Hanmi Pharm, had all discontinued the development of their respective combinations.

 

Ildong Pharmaceutical had also jumped into the development of a tamsulosin+solifenacin combination for BPH but decided not to release the product just before commercialization.

 

Ildong Pharmaceutical started Phase III trials for its combination drug in 2015 and completed the trial in 2019, but decided not to release the drug after internal discussions.

 

Similarly, Jeil Pharmaceutical had started developing a combination drug with the same ingredients as Ildong but did not apply for marketing authorization for its drug even after completing the Phase III clinical trial in 2019.

 

The industry interprets that the company had stopped development of the combination.

 

However, attention is focused on whether the sales growth of Duodart will bring about change in this atmosphere as it hints at the possibility of success in the field of urology as a combination drug.

 

Currently, there are four to five clinical trials in progress for combination drugs in urology.

 

They are combination drugs for BPH+erectile dysfunction or combination drugs for BPH+OAB.

 

DOngkook Pharmacuetical recently completed Phase III trials for its combination of dutasteride and tadalafil.

 

Yuyu Pharma also started developing a combination drug with the same ingredients.

 

Although the plan for its Phase III trials was approved in 2018, the need to change its formulation had been raised before its initiation, and the company decided to restart its development from Phase 1.

 

Development of a combination drug that treats BPH and OAB at the same time is also in full swing.

 

Kyungdong Pharm and DongKoo Bio&Pharma have started Phase III trials at about the same time and are competing to develop their combination drugs.

 

DongKoo Bio&Pharma also received approval to initiate a Phase III clinical trial for its tamsulosin+mirabegron combination.

 

Kyungdong Pharmaceutical received approval to initiate Phase III trials using the same combination 2 months later.

 

In addition, CTCBio has completed its Phase III trial for its clomipramine+ sildenafil combination, as a treatment for premature ejaculation and erectile dysfunction at the same time, and is preparing to apply for its marketing approval in Korea.