Johnson & Johnson yesterday notched up the world’s first approval for a pill designed specifically to treat premature ejaculation, when regulators in Finland and Sweden granted a marketing license for dapoxetine, a short-acting, selective serotonin reuptake inhibitor (SSRI).
Wider approval across Europe should follow swiftly for the drug, to be branded Priligy, and consensus for sales in 2014 currently sits at $200m. For J&J, a drug of this size is not massively pivotal, although approval in the US would make it a more significant product. However, the company has not revealed its strategy in this regard, having received a non-approvable letter from the FDA in 2005, meaning another product which has taken an entirely different approach to the disorder could be the first to reach the lucrative US market (see table below).
Considering that up to 30% of men are thought to be affected by the disorder research into clinical solutions has been limited, although there are many unapproved products of dubious nature available.
Use on demand
Antidepressants are often used off label for the condition, hence the development of Priligy. The pill is designed to be taken when needed, one to three hours before sexual intercourse, rather than every day. This on demand approach will hopefully avoid some of the side effects sometimes seen when antidepressants are taken long term.
J&J has always been cagey about the reasons why the FDA refused to grant approval for Priligy, but safety is a likely issue, and the company has still not said whether it intends to re-file. The register of clinical studies at www.clinicaltrials.gov indicates that since the rejection no new studies have been initiated, suggesting it may have decided to shelve US plans. Still, fresh data from a large trial of more than 1,000 participants was presented in March last year.
Whilst most analysts do not include US sales in their models, some are assuming a launch there in the near future. For example JP Morgan has pencilled in sales of $575m by 2011, $300m of which come from the US, where the bank is predicting a launch in 2010. Unless J&J re-files in the next few months, those numbers will start to look highly optimistic.
Still, the analyst clearly anticipates strong demand from the very beginning. Considering erectile dysfunction drugs like Viagra have been huge commercial successes, suggesting that not everybody will be reluctant to pop a pill to solve the problem, this is probably not an unreasonable assumption.
Taking a completely different approach is Britain’s Plethora Solutions, which has developed PSD502, a combination of two well-known anaesthetics, lidocaine and prilocaine, in a topical spray. The product was licensed to Sciele Pharma in the US, which has since been bought by Shionogi.
Results from the second of two phase III trials are due in the next few months, and regulatory filings in both the US and Europe will follow.
Before the takeover, analysts covering Sciele had pencilled in sales of $32m by 2014, whilst analysts covering Plethora believe the product could generate peak sales of $150m, worldwide. With the search for a European partner well underway, the product clearly represents an interesting opportunity.
Further back are two phase II projects, one from fellow UK company Vectura, which is a drug delivered by an inhaler. This will be out-licensed at some point, presenting another opportunity for a bigger player looking to get into the space. Pfizer, meanwhile, has not provided an update on its candidate for some time.
The development of the erectile dysfunction market, which is now worth around $4bn annually and contains several competing products, suggests that there will room for more than one new treatment for premature ejaculation.
|Premature ejaculation pipeline||Annual Sales WW - Sales ($m)|
|Market Status||Product||Company||Pharmacological Class||Indication Summary||2009||2010||2011||2012||2013||2014||Launch WW|
|Approved||Priligy (dapoxetine)||Johnson & Johnson||SSRI||Premature ejaculation [Approved]||44||84||127||154||182||200||31/12/2009|
|Phase III||PSD502||Shionogi/Plethora Solutions||Local anaesthetic||Premature ejaculation [Phase III]; Pain [Phase II]||-||8||14||20||26||32||31/12/2010|
|Phase II||VR776||Vectura||Noradrenaline & 5HT (serotonin) reuptake inhibitor||Premature ejaculation [Phase II]||-||-||-||-||-||-||31/12/2011|
|UK-390,957||Pfizer||5HT (serotonin) modulator||Premature ejaculation [Phase II]||-||-||-||-||-||-||-|