Regent Pacific Group, a Hong Kong-listed company that transformed itself three times over three decades, said it had secured regulatory approvals and a licence to sell a spray for treating premature ejaculation in Hong Kong and Macau, and not a moment too soon.
The company licensed Shanghai Fosun Pharmaceutical’s unit Wanbang Pharmaceutical last month to help it obtain approval and sell Fortacin, a prescription-only topical spray in mainland China. Separately, Regent licensed Taiwan-listed EuroPharma to distribute the drug in Hong Kong, Macau, Taiwan and six Southeast Asian markets.
“We hope our product will alleviate any distress [that accompanies] sexual dysfunction, and bring confidence back to the [sufferer] so that he can perform in line with the average male,” Regent’s chief executive officer Jamie Gibson said in an interview with the South China Morning Post.
The approvals and licensing would offer an additional option to existing treatments to men who suffer from premature ejaculation, a form of sexual dysfunction that also includes impotence, which attracts more public attention due to the blockbuster drug Viagra approved for use two decades ago.
Regent’s founder Jim Mellon had said his company would begin selling the spray in Hong Kong by the end of 2017, during an interview in 2016.
Premature ejaculation is not uncommon, afflicting between 25 per cent and up to 40 per cent of the world’s adult men, according to a 2006 paper by the International Journal of Impotence Research. As many as 140 million men in mainland China are estimated to suffer from impotence. An equal number of people may be afflicted with premature ejaculation, typically defined as the condition of less than two minutes of ejaculatory latency time.
Treatment of sexual dysfunction is a multibillion dollar industry in Asia, with a range of cures that run the gamut from folk remedies like rhinoceros horn powder to Western drugs such as Pfizer’s Viagra.
Fortacin, developed by the British drug maker Plethora Solutions to treat premature ejaculation, was a spray with low doses of the anaesthetics lidocaine and prilocaine, which took effect almost immediately upon application, and can reduce sensitivity to stimulation, Gibson said.
Regent bought Plethora in 2016 for £102.9 million (US$131 million), making the product available in the European Union since late 2016 through its Italian partner Recordati. The drug is still pending an approval by the Food and Drug Administration (FDA) for use in the US.
Gibson said 23,500 prescriptions for the topical stray had been filled by patients in the EU since approval, and Regent was doing clinical studies in the US to show its efficacy and safety.
Given its ingredients, Fortacin appeared to be similar to some desensitising products that were already available on the market, such as condoms laced with numbing lubricants, said Hong Kong urologist Justin Lam Kin-Man.
The effects were “local and generally manageable,” the regulator said.
“To date, there have been no complaints registered by any patients or doctors of interference with any aspect of normal sexual function or hypersensitivity,” Wyllie said. “The potential for side effects will only have minimal impact on patient demand.”
While EMLA cream, which also contains lidocaine and prilocaine, is already available to patients without prescription, Wyllie said Fortacin was “unique” because it brought the desired effect quickly and its ingredients did not get transferred to users’ partners even without using a condom.
EMLA takes up to an hour after application before it had the desired result, and must be used with a condom to avoid partner transfer, he added.
One of Regent’s rivals is California-based Absorption Pharmaceuticals, producer of Promescent that was launched in 2011 and sells online for just under US$60 for a 60-spray bottle.
It said on its website its lidocaine-based “FDA-compliant over-the-counter” spray was “clinically proven” to reduce sensitivity and treat premature ejaculation.
Gibson declined to reveal Regent’s sales targets nor its guided pricing for Fortacin distribution partners.
Regent’s closing price of 31 HK cents on Friday gave it a market value of HK$569.5 million (US$72.7 million).
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