Pharma companies speed up delivery of urology combo drugs

Following Hanmi’s ‘Gugutams,’ Dongkook Pharmacetucial and Yuyu Pharma also enters combination treatment market for benign prostatic hyperplasia +erectile dysfunction

KyungDong Pharm·Dongkoo Bio starts Phase III trial for a combination drug to treat benign prostatic hyperplasia+overactive bladder

Korean pharmaceutical companies have been rushing to develop combination treatments for various urologic diseases, such as those for prostatic hypertrophy+erectile dysfunction or benign prostatic hyperplasia+overactive bladder.

 

Many patients with urogenital disorders suffer various conditions at once, including enlarged prostate, erectile dysfunction, overactive bladder, etc.

 

The market size for the single-therapy agents that treat each separate condition is considerable.

 

With no other combination therapy than Hanmi’s ‘Gugutams’ authorized in Korea, the industry’s interest in the combo drug market has been rising.

 

Pic of Hanmi Pharm

As of the 13th, the only drug approved as a combination therapy for hypertrophy+erectile dysfunction in Korea by the Ministry of Food and Drug Safety is Hanmi Pharmaceutical's ‘Gugutams.’ Gugutams is a combination of the prostate treatment ‘tamsulosin’ and erectile dysfunction treatment ‘tadalafil.’ At the time of its release in 2016, Gugutam’s performance did not meet expectations, due to low awareness of the urogenital disease in general.

 

However, with increased awareness, the product became a steady seller, reaching ₩2.1 billion in sales last year.

 

On this, Dongkook Pharmaceutical and Yuyu Pharma have jumped in to compete in the combination treatment market for benign prostatic hyperplasia+erectile dysfunction that combines tadalafil with ‘dutasteride,’ which is another ingredient used for benign prostatic hyperplasia.

 

No combination treatment has yet been approved for this combination in Korea.

 

Dongkook Pharmaceutical has started Phase III clinical trials on its dutasteride+tadalfil combo, ‘DKF-313,’ earlier this month at the Seoul Asan Medical Center.

 

The company expects the Phase III trials to be complete by the end of next year.

 

Yuyu Pharma is also developing a combination therapy using the same two ingredients.

 

The company received approval for the Phase III trial in 2018, however, before starting the Phase III trial, a need to change the formulation was raised, and the company decided to start over from Phase I.

 

Also, the development of combination treatments for benign prostatic hyperplasia+overactive bladder is actively underway.

 

KyungDong Pharm and Dongkoo Bio&Pharma are competing to develop the combo treatment.

 

In March this year, KyungDong Pharm received approval to start Phase III trials for its ‘KDF1905,’ which combines the benign prostatic treatment tamsulosin with overactive bladder treatment ‘mirabegron.’ Dongkoo Bio&Pharma had also previously received approval for the Phase III trial of its tamsulosin+mirabegron combination in January last year.

 

Ildong Pharmaceutical and Jeil Pharmaceutical had also developed combinations using tamsulosin and another overactive bladder treatment ‘solifenacin.’ The two companies have completed Phase III trials for their combinations.

 

However, Ildong Pharmaceutical decided to discontinue the development of its drug last year.

 

Jeil Pharmaceutical had not applied for the marketing authorization of its drug for over 2 years since the completion of its Phase III trial.

 

Also, CTC Bio’s development of its combination treatment for premature ejaculation+ erectile dysfunction is in its final stages.

 

It is a combination of the premature ejaculation treatment ‘clomipramine’ and the erectile dysfunction treatment sildenafil.

 

The company plans to apply for marketing authorization of its combination drug after completing its Phase III trial within this year.