Korean pharmaceutical companies have recently concentrated their R&D capabilities on developing drugs that treat urinary diseases, such as benign prostatic hyperplasia (BPH) and erectile dysfunction, that affect many elderly patients.
According to industry watchers, such a move is inevitable to keep with the trend in which population aging has become a global phenomenon, stressing the need for healthcare for the elderly.
It also aligns with the global pharmaceutical industry’s attempts to increase compliance by developing combination treatments that reduce the number of medications taken by older adults with various diseases. Regarding urinary diseases, many patients are suffering multiple at the same time, and the single drug currently forms a considerable market size.
Hanmi Pharmaceutical is taking the lead in Korea, as the company launched Gugutams, a combination treatment for BPH and erectile dysfunction, in 2016.
The product, which combines tadalafil, an erectile dysfunction treatment, and tamsulosin, a BPH treatment, is the only combination treatment approved by the Ministry of Food and Drug Safety to treat BPH and erectile dysfunction.
While the initial sales did not live up to expectations due to low awareness of the combination drug for urinary system diseases, the product has continued to grow with the treatment recording sales of 21 billion won ($17.8 million) last year.
Dongkook and Yuyu are also focusing their R&D efforts to develop a combination drug for treating BPH and erectile dysfunction.
According to Dongkook, the company recently started its phase 3 clinical trial for DKF-313, a combination of tadalafil and dutasteride, a BPH treatment, at Asan Medical Center earlier this month with goals to complete the trial by the end of next year.
If approved, the treatment will be the first combination treatment that uses tadalafil and dutasteride.
Yuyu is also developing a combination treatment in the area. While the company received approval from regulators to conduct phase 3 clinical trials in 2018, the company has had a setback due to a change in formulation and has decided to restart the development process from phase 1 clinical trials.
Dongkoo Biopharma and Kyungdong Pharmaceutical are currently developing a combination treatment for BPH and overactive bladder.
Dongkoo and Kyungdong received approval for phase 3 clinical trial for their combination drugs that combine mirabegron, an overactive bladder treatment, with tamsulosin from regulators in January and March of this year.
CTC Bio is the only company developing a combination drug for premature ejaculation and erectile dysfunction.
The company’s treatment combines clomipramine, a premature ejaculation treatment, and sildenafil, an erectile dysfunction treatment. The company plans to complete phase 3 clinical trials within this year and apply for product approval.
With R&D for urinary combination drugs active, local urologists also showed high expectations for new treatment options in the field.
“Eighty percent of erectile dysfunction patients have BPH, with elderly accounting for most of the patient population,” a urologist running a clinic in Seoul said to Korea Biomedical Review. “Therefore, the development and launch of a combination drug are welcome in terms of medication compliance.”