Plethora Solutions Holdings Plc Regulatory News (PLE)

29 August 2014

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Placing & Subscription to raise £15.9 million ($26.2 million) at 9 pence per share

Acquisition of Remaining Royalty Rights and Transfer of Patents to Plethora

Potential European Licensing Agreement

And

Notice of General Meeting

Plethora Solutions Holdings plc (AIM: PLE) is pleased to announce that it has entered into agreements to conditionally raise approximately £15.9 million ($26.2 million) by way of a Placing and Subscription for a total of 176,998,486 New Ordinary Shares at 9p per share and 88,499,236 Fundraising Warrants exercisable at 15p each. The Placing was conducted by Daniel Stewart & Company Plc and Hybridan LLP.

The Company is also pleased to announce that it is in advanced stages of agreeing a European Licensing Agreement with a European Partner, under which the Company would license the rights to commercialise PSD502™ in Europe, Russia, the Commonwealth of Independent States, Turkey and North Africa to the European Partner. See below for further information. However, there is no guarantee that such an agreement will be entered into on the terms set out in this announcement, or at all.

The definitions that apply throughout this announcement are set out towards the end of this announcement. Shareholders and investors should read the whole text of this announcement.

Summary:

Placing & Subscription

· Gross proceeds of the conditional fundraising amount to a total of £15.9 million ($26.2 million), estimated to be £15.1 million net of expenses in relation to the proposals set out in this announcement

· Placing and Subscription of a total of 176,998,486 New Ordinary Shares at a Placing Price of 9p per share and 88,499,236 Fundraising Warrants exerciseable at 15p each

· The proceeds of the fundraising together with an intended subscription by Regent Pacific Group Limited (as detailed further below) will be used to:

o to fund the payments to Shionogi, Paul Capital and the Original Patent Holder for PSD502™, pursuant to the Cessation Agreements and Patent Transfer Agreement. This will result in Plethora owning the entire economic benefit of all revenue streams generated from PSD502™ in the future on a global basis;

o to finance the ongoing costs of the processes required to prepare an NDA and file and prosecute this with the FDA;

o to finance the ongoing costs of the manufacturing and development work with PSNW for a new 6 dose can; and

o to provide ongoing working capital including to the Group.

· As detailed further below, the Placing and Subscription are conditional on, amongst other things, the entering into of a European Licensing Agreement and the passing of resolutions at a general meeting of the Company. For the avoidance of doubt, neither the Placing nor the Subscription will occur if each of the conditions set out further below are not fulfilled.

The New Ordinary Shares to be issued pursuant to the Placing & Subscription will be issued to a range of institutional funds, family offices and high net worth individuals.

· Regent Pacific Group Limited ("Regent Pacific"), a current Shareholder in which Jim Mellon has a 15.2% interest and Jamie Gibson has a 4.08% interest, is unable to participate in the Placing or the Subscription by virtue of the Company being in a close period and both Jim Mellon and Jamie Gibson being Directors. It is intended that Regent Pacific will subscribe for approximately £2.3 million (the "Regent Pacific Subscription") as soon as the Company is no longer in a close period, which will be once the Company's Interim Results for the six months ended 30 June 2014 and information relating to the Placing & Subscription, Cessation Agreements and Patent Transfer Agreement and the potential European Licensing Agreement have been announced.. This will bring the aggregate amount of monies raised by the Company to approximately £18.2 million. The details of any such subsequent Regent Pacific Subscription will be separately announced.

Potential European Licensing Agreement

It is anticipated that the potential European Licensing Agreement, if entered into, would involve Plethora receiving:

· a payment of €5 million upon the signing of the European Licensing Agreement (in limited circumstances, if there are material issues in the final development stages of a six dose can, €4m may be refundable to the European Partner);

· a payment of €6 million upon grant of variant approval from EMA for a new six dose can;

· a payment of up to €10 million in total upon first commercial sales of PSD502™ in France, Germany, Italy, Spain and Portugal;

· up to €25 million in sales-based milestones; and

· tiered percentage royalties on net sales, ranging from the mid-teens to the mid-twenties for 10 years from first commercial sale, and thereafter at a single digit royalty rate.

It is further anticipated that the potential European Licensing Agreement would involve the European Partner assuming responsibility for commercialisation activities in the licensed territories, with the European Partner also funding all costs associated with the sales and marketing programmes, and all additional regulatory filings that it intends to pursue in the licensed territory.

Plethora will retain full commercialisation rights for the Rest of the World, including but not limited to North America, LATAM, the Asia Pacific region, the Middle East and Sub-Sahara Africa.

Acquisition of Remaining Royalty Rights

The Directors have negotiated the termination of the existing royalty agreements with Shionogi, Paul Capital and the Original Patent Holder and the Patent Transfer Agreement in order to acquire the patents and other intellectual property related to PSD502, which will result in Plethora owning the entire economic benefit of all revenue streams generated from the 'out licencing' of PSD502™ in the future on a global basis. See below for further information.

Jamie Gibson, CEO of Plethora said:

"The conditional fundraising, if completed, will give Plethora the chance to repatriate and consolidate 100 per cent of the future income stream generated from the 'out licencing' of PSD502™ to commercial marketing partners, a potentially life-changing treatment in men's sexual health. I am confident that, upon completion, it will enhance shareholder value by being accretive to earnings and is expected to generate long-term shareholder returns. Furthermore, once completed, the anticipated commercialisation agreement with the European partner to promote and distribute PSD502™ will represent a major milestone in the development of the business and herald further progress in the rest of the world."

A circular to shareholders (the "Circular") which will contain a notice of General Meeting for 17 September 2014 at which the resolutions will be put to shareholders will be posted today and made available on the Company's website, www.plethorasolutions.co.uk

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Placing & Subscription to raise £15.9 million ($26.2 million) at 9p per share

Posting of Circular

Proposed Placing & Subscription

The last twelve months have been a period of significant activity for Plethora. The Group has made progress with the regulatory status of PSD502™, having received EU marketing approval from EMA on 15 November 2013 and commenced the process for a New Drug Application with the FDA. PSNW has been appointed as Plethora's manufacturing partner. Further to the Company's announcement on 26 March 2014, work on the development of a new six dose canister has been completed enabling the commencement of the next phase, which is a 5 litre pilot study followed by 3 100 litre GMP batch stability and validation studies that are scheduled to complete by the end of this year.

Plethora is also in the advanced stages of agreeing a European Licensing Agreement with a European Partner, under which the Company would license the rights to commercialise PSD502™ in Europe, Russia, Commonwealth of Independent States, Turkey and North Africa to the European Partner. It is anticipated that the European Licensing Agreement would involve Plethora receiving a payment upon the signing of the agreement, followed by further payments based upon certain milestones, plus tiered royalties on product sales. It is emphasised that the European Licensing Agreement is in the process of being negotiated and that no binding agreement has been entered into, nor can it be guaranteed that such an agreement will be entered into on the terms set out in this announcement or at all.

It is against this backdrop, and the potential opportunity that PSD502™ consequently represents, that the Directors have negotiated the Cessation Agreements terminating the existing royalty agreements with Shionogi, Paul Capital and the Original Patent Holder and the Patent Transfer Agreement in order to acquire all the patents and other intellectual property related to PSD502™. Under the terms of the Cessation Agreements and the Patent Transfer Agreement, Plethora will make cash payments totalling US$25m (approximately £15.2m) to Shionogi, Paul Capital and the Original Patent Holder. This will result in Plethora owning the entire economic benefit of all revenue streams generated from the 'out licencing' of PSD502™ to commercial marketing partners in the future on a global basis.

The Directors believe that, upon completion, these proposals will enhance Shareholder value by being accretive to earnings and are expected to generate long-term Shareholder returns.

In order to the finance the cash payments that Plethora is required to make pursuant to the Cessation Agreements and Patent Transfer Agreement, the Company announced today that it has secured £15.9 million, before expenses, through the Placing & Subscription of 176,998,486 New Ordinary Shares at a price of 9p per Ordinary Share and 88,499,236 Fundraising Warrants exercisable at 15p each, conditional upon Plethora entering into the European Licensing Agreement and shareholder approval. The proceeds of this financing together with an intended subscription by Regent Pacific Group Limited (as detailed further below) will be also used to fund the ongoing cost of (i) the filing and prosecution of the New Drug Application in the US, (ii) the development of a new six dose can with PSNW, including filing of the variant approval with the EU, and (iii) to provide additional working capital to the Group.

This announcement describes the background to these matters and the Placing & Subscription.

PSD502™ - a treatment for premature ejaculation

Plethora was founded in 2004 to develop a number of pharmaceutical products in the area of sexual health. At the centre of this development portfolio was PSD502™, a treatment for premature ejaculation. At the time, Plethora acquired a global exclusive licence over all intellectual property related to PSD502™ from the Original Patent Holder in return for a 5% royalty on future sales.

PSD502™ is now the sole focus of the Group's activity as the Directors believe PSD502™ has significant potential value based on the prevalence of premature ejaculation and the lack of a widely available effective treatment. Against this backdrop, Plethora has made significant progress in a number of areas in the recent past in order to maximise the potential value of the treatment:

Regulatory

On 15 November 2013, Plethora was granted a marketing authorisation for PSD502™ from the EMA. This was a significant event in the development of the business following many years of research, investment in clinical studies and the preparation of regulatory dossiers. This marketing authorisation enabled the Group to commence negotiations with potential partners for the commercial exploitation of PSD502™ in the European Union.

The Group has already commenced preparations for a New Drug Application to the FDA. In the first quarter of 2014, the Group and its consultants had an initial guidance meeting with the FDA to discuss the proposed NDA. The Group is working towards submitting the NDA by the end of 2015, following which the PDUFA timeline is usually set at a 10-month period for approval of the NDA. Taking this 10-month timeline for NDA approval beginning when Plethora submits the NDA to the FDA, the date for approval (the PDUFA date) would be Q4 2016. The PDUFA date is a target date for the FDA, but the agency can, and many times does, announce a decision prior to the PDUFA date.

Manufacturing partnership

In March 2014, Plethora announced that it had entered into an agreement with PSNW to develop a new six dose canister and establish a production line for the manufacture of PSD502™, allowing the Group to achieve optimal price points per unit sold in accordance with the advice provided by specialist marketing consultants. This manufacturing partnership was a key development in the process of bringing PSD502™ to market in the EU and assisting in the submission of the NDA in the US.

Work on the development of a new six dose canister has been completed enabling the commencement of the next phase, which is a 5 litre pilot study followed by 3 100 litre GMP batch stability and validation studies that are scheduled to complete by the end of this year.

Following the completion of the GMP batch stability and validation studies at the end of 2014, an application will be submitted to the EMA for an approval of a variation of the existing Marketing Authorisation for a new 6 six dose can. The Company now expects CHMP approval to be granted during Q3 of 2015 because, on 21 March 2014, EMA changed its guidelines for stability testing related to variation applications made after 21 September 2014. The new guidelines require 6 months stability data on GMP batches rather than the previous 3 months under the old guidelines. It is this varied marketing authorisation that will pave the way to the commercial launch of the product in Europe via the European Partner immediately thereafter.

Commercialisation of PSD502™

Plethora is in the advanced stages of agreeing a European Licensing Agreement with the European Partner, under which the Company would license the rights to commercialise PSD502 in Europe, Russia, the Commonwealth of Independent States, Turkey and North Africa to the European Partner. Plethora would retain full commercialisation rights for the rest of the World, including but not limited to North America, Latin America, the Asia Pacific region, the Middle East and Sub-Sahara Africa.

It is anticipated that the potential European Licensing Agreement, if entered into, would involve Plethora receiving:

· a payment of €5 million upon the signing of the European Licensing Agreement (in limited circumstances, if there are material issues in the final development stages of a six dose can, €4m may be refundable to the European Partner);

· a payment of €6 million upon grant of variant approval from EMA for a new six dose can;

· a payment of up to €10 million in total upon first commercial sales of PSD502™ in France, Germany, Italy, Spain and Portugal;

· up to €25 million in sales-based milestones; and

· tiered percentage royalties on net sales, ranging from the mid-teens to the mid-twenties for 10 years from first commercial sale, and thereafter at a single digit royalty rate.

It is further anticipated that the potential European Licensing Agreement would involve the European Partner assuming responsibility for commercialisation activities in the licensed territories, with the European Partner also funding all costs associated with the sales and marketing programmes, and all additional regulatory filings that it intends to pursue in the licensed territory.

Whilst there can be no certainty or guarantee, the Board of Plethora anticipates that the European Licensing Agreement will be entered into by 18 September 2014. However, it is not yet possible to determine with accuracy the timing for completion of these discussions and it is emphasised that the Company may not be able to finalise the European Licensing Agreement. Therefore Shareholders and investors should exercise extreme caution when dealing in the securities of Plethora. Furthermore, should the European Licensing Agreement be entered into, there can be no guarantee that the summary terms above will represent the final terms. An announcement regarding the European Licencing Agreement will be made by the Company as and when necessary to update investors.

Background to the rights to commercialise PSD502™

In 2007, Plethora entered into the first of several agreements with Shionogi under which the parties agreed that they would co-promote PSD502™ in the US following regulatory approval. In two successive agreements in the first half of 2009, the global rights for PSD502™ were acquired by Shionogi. Paul Capital had historically provided funding to Plethora in connection with the development of PSD502™. As part of the 2009 agreements, Paul Capital's then existing financial interests in Plethora and PSD502™ were extinguished and replaced by two separate royalty entitlements granted by Plethora and Shionogi respectively.

In September 2011, Plethora entered an agreement with Shionogi whereby it regained operational and economic control of PSD502™ in Europe and the Rest of the World (defined to exclude the Shionogi Territory). In return, Plethora agreed to pay to Shionogi an undisclosed minority percentage share of the net income it received from the commercialisation of PSD502™.

In August 2013, Plethora entered into a further agreement with Shionogi to take operational and economic control of PSD502™ for the Shionogi Territory. This meant that the rights to exploit the global commercial and economic rights of PSD502™ had been consolidated and placed under the control of the Group. This was a significant development in terms of the Group's ability to engage with potential manufacturing and commercial partners as the exclusive custodian of these rights throughout the world. Under the terms of this agreement, Plethora undertook to file, at its own cost, a NDA with the FDA. In addition, the parties agreed that they would share the income arising from the additional territories in a fixed proportion, with Plethora retaining the majority proportion.

Plethora has today announced that it has entered into, conditional upon the completion of the European Licence Agreement and the Placing & Subscription, the Cessation Agreements and the Patent Transfer Agreement pursuant to which it will, own the entire economic benefit of all revenue streams generated from the 'out licencing' of PSD502™ to commercial marketing partners in the future on a global basis. In return for entering into the Cessation Agreements, Plethora will pay to Shionogi, Paul Capital and the Original Patent Holder a sum totalling US$25m (approximately £15.2m). Further information on the Cessation Agreements and the Patent Transfer Agreement is set out below.

Terms of the Cessation Agreements and Patent Transfer Agreement

The Cessation Agreements and Patent Transfer Agreement are conditional upon the passing of the Resolutions and the successful completion of the Placing & Subscription and the European Licence Agreement.

Furthermore, the Cessation Agreement between the Company and Paul Capital is conditional upon all funds payable under it being paid to Paul Capital by no later than 22 September 2014. It may possible that such date may be extended by agreement between Paul Capital and Plethora however there is no guarantee of this.

In exchange for the payment of $25m (approximately £15.2m) in aggregate to Paul Capital, Shionogi and the Original Patent Holder by the Group, the Cessation Agreements and Patent Transfer Agreement provide for the termination of all royalty entitlements for Paul Capital, Shionogi and the Original Patent Holder relating to PSD502™ and the acquisition by the Group of all patents and all other intellectual property rights related to PSD502™. In addition, the Cessation Agreements provide for the termination and release of all other claims that Paul Capital, Shionogi and the Original Patent Holder may have against the Group or PSD502™. As such, the Cessation Agreements constitute a "clean break" between the Group on the one hand and Paul Capital, Shionogi and the Original Patent Holder respectively on the other.

Following completion of the Cessation Agreements and Patent Transfer Agreement, the Group will be free to pursue the development, marketing and distribution of PSD502™ without any involvement from Paul Capital, Shionogi or the Original Patent Holder and the Group will control the entire economic benefit of all future revenue streams generated from the 'out licencing' of PSD502™ to commercial marketing partners on a global basis.

The Placing & Subscription

The Company announces that it had conditionally agreed the terms of the Placing & Subscription to raise approximately £15.9 million before expenses through the issue of 176,998,486 New Ordinary Shares at a placing price of 9p per share and estimated to be £15.1 million, net of expenses relating to the proposals set out in this announcement.

In addition, conditional upon Admission, one Fundraising Warrant will be issued for every two New Ordinary Shares issued through the Placing & Subscription. Further detail on the Fundraising Warrants is set out below.

The New Ordinary Shares will be issued on a non pre-emptive basis. The 176,998,486 New Ordinary Shares issued in the Placing & Subscription will represent 29.9% of the Enlarged Share Capital.

The Placing of 119,759,430 New Ordinary Shares to raise £10.8 million has been arranged by Daniel Stewart and Hybridan as joint brokers to the Company. The Subscription, which has been arranged by the Company, comprises the issue of 57,239,056 New Ordinary Shares to raise £5.1 million and is being subscribed directly with the Company. The New Ordinary Shares pursuant to the Placing & Subscription are being issued to a range of institutional funds, family offices and high net worth individuals.

The Placing & Subscription is being conducted by way of a non pre-emptive share issue. The Directors believe that this is the most cost effective and time efficient method to raise funds in the current circumstances.

Completion of the Placing & Subscription and the issue of the New Ordinary Shares and the Fundraising Warrants are subject to:

(i) the approval of the Resolutions at the General Meeting;

(ii) the Company entering into the European Licensing Agreement materially on the terms set out above with the European Partner;

(iii) the Placing Agreement becoming unconditional in all respects and not having been terminated in accordance with its terms on or before 8.00am on 19 September 2014 (or such later date not being later than 8 October 2014 or as may be determined); and

(iv) Admission having occurred not later than 8.00am on 19 September 2014 (or such later date not being later than 8 October 2014 or as may be determined).

Furthermore, the Placing and Subscription are, in effect, conditional on each other and are conditional on completion of the Cessation Agreements. In particular, if the European Licensing Agreement is not entered into as provided in (ii) above, then the Placing and Subscription will lapse and the arrangements described in this announcement for the Company to own the entire economic benefit of PSD502TM revenue streams on a global basis will, accordingly fall away.

The New Ordinary Shares will, on Admission, be credited as fully paid and will have the same rights in all respects with the Existing Ordinary Shares, including the right to receive all dividends and other distributions declared.

The Placing is to be effected on behalf of the Company jointly by Daniel Stewart and Hybridan, under the terms of the Placing Agreement. Completion of the Placing is subject to certain conditions including those listed above. Under the terms of the Placing Agreement, the Company has agreed to pay Daniel Stewart and Hybridan commission on funds raised by them. The Placing Agreement contains certain warranties given by the Company with respect to its business and the Group and certain matters connected with the Placing. In addition, the Company has given indemnities to Daniel Stewart and Hybridan in connection with the Placing and their performance of services in relation to the Placing. The Placing Agreement may be terminated by Daniel Stewart and/or Hybridan in respect of their own placees at any time before Admission for, inter alia, a material breach by the Company of the terms of the Placing Agreement or the warranties contained in it or on the occurrence of certain specified events or of certain force majeure events.

Regent Pacific Group Limited ("Regent Pacific"), a current Shareholder in which Jim Mellon has a 15.23% interest and Jamie Gibson has a 4.08% interest, is unable to participate in the Placing or the Subscription by virtue of the Company being in a close period and both Jim Mellon and Jamie Gibson being Directors. It is intended that Regent Pacific will subscribe for approximately £2.3 million together with associated warrants (the "Regent Pacific Subscription") as soon as the Company is no longer in a close period, which will be once the Company's Interim Results for the six months ended 30 June 2014 and information relating to the Placing & Subscription, Cessation Agreements and Patent Transfer Agreement and the potential European Licensing Agreement have been announced. This will bring the aggregate amount of monies raised by the Company to approximately £18.2 million.

The details of any such subsequent Regent Pacific Subscription will be separately announced and accordingly Shareholders should refer to the Company's website or the Company's regulatory information service announcements, to check whether such an announcement has been made by the Company. If the Regent Pacific Subscription is agreed by the Independent Directors of the Company, it is likely that it would occur on the same terms and conditions as the Placing & Subscription and accordingly would be dependent, inter alia, on approval of the share authority resolutions being sought at the General Meeting. Therefore, for the purpose of calculating the share authorities being sought at the General Meeting and to ensure that there are sufficient authorities to allow for the intended Regent Pacific Subscription (including any associated warrants issued to Regent Pacific), should it occur, it has been assumed that the minimum price at which the Regent Pacific Subscription could occur would be 9 pence.

Use of Funds

Subject to completion, the Placing & Subscription will raise funds, net of expenses relating to the proposals set out in this announcement, of £15.1 million. These funds together with the intended subscription from Regent Pacific are expected to be used for the following purposes:

(i) to fund the payments to Shionogi, Paul Capital and the Original Patent Holder pursuant to the Cessation Agreements and Patent Transfer Agreement;

(ii) to finance the ongoing costs of the processes required to prepare an NDA and file and prosecute this with the FDA;

(iii) to finance the ongoing costs of the manufacturing and development work for a new 6 dose can with PSNW; and

(iv) to provide ongoing working capital including to the Group.

The Fundraising Warrants

Conditional on completion of the proposals in this announcement, the Company will, on Admission grant 88,499,236 warrants to subscribe for Ordinary Shares to the holders of the New Ordinary Shares. Each Fundraising Warrant will give the holder the right, but not the obligation, to acquire one Ordinary Share at an exercise price of 15 pence at any time prior to the earlier of 19 September 2019 (or such other date being the 5th anniversary from Admission) and 30 days after the date on which the Company gives the warrant holder notice of a change of control

The Fundraising Warrants are freely transferable and will be issued in certificated format. It is anticipated that certificates for the Fundraising Warrants will be posted within 10 days of Admission. No application will be made for the Fundraising Warrants to be admitted to trading on AIM.

Application to trading on AIM

Subject to fulfilment of the conditions set out above, application will be made to the London Stock Exchange for the New Ordinary Shares to be admitted to trading on AIM and it is expected that Admission will be effective and trading will commence on 19 September 2014 (or such other date, not being later than 8 October 2014, as Daniel Stewart and Hybridan may agree) following the satisfaction of all conditions to the Placing & Subscription. An announcement through a Regulatory Information Service will be made in this regard in due course.

Notice of General Meeting

The Circular contains a notice convening the General Meeting to be held at the offices of Daniel Stewart & Company, Becket House, 36 Old Jewry, London EC2R 8DD at 10:00am on 17 September 2014.

Shareholders will note that the Directors are seeking the requisite statutory authority to make non-pre-emptive share issues up to a maximum of 362,674,263 Ordinary Shares with a nominal value of £3,626,742.63. This authority will be used by the Directors in the following manner:

(i) As to 303,446,957 New Ordinary Shares having a nominal value of £3,034,469.57 to allot the Placing Shares, the Subscription Shares, the Fundraising Warrants and new Ordinary Shares in relation to the intended Regent Pacific Subscription described above (which for the purpose of this calculation have been assumed to be issued at a minimum of 9 pence per Ordinary Share and are assumed to be accompanied by the issue of warrants to Regent Pacific on the same terms as the Fundraising Warrants accompanying the Placing & Subscription); and

(ii) Up to 59,227,306 Ordinary Shares having a nominal value of £592,273.06 representing 10% of the Enlarged Share Capital and the intended Regent Pacific subscription shares at the Directors' discretion.

Recommendation

The Directors believe that the Placing & Subscription, and therefore the Resolutions, are in the best interests of the Company and Shareholders taken as a whole. The Directors unanimously recommend that you vote in favour of the Resolutions, as they intend to do in respect of their own shareholdings, which in aggregate total 131,949,742 Ordinary Shares representing approximately 31.8% of the existing issued ordinary share capital of the Company.

EXPECTED TIMETABLE OF PRINCIPAL EVENTS

If any detailscontained in the timetable above should change, the revised times and dates will be notified by means of an announcement through a Regulatory Information Service.

TRANSACTION STATISTICS

DEFINITIONS

The following definitions apply throughout this announcement unless the context requires otherwise:

-Ends-

About Plethora:

Plethora is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk 

Plethora is focussed on seeking to launch PSD502™ for the treatment of premature ejaculation.

About PSD502™ & Premature Ejaculation:

PSD502™ is a topical spray for the treatment of premature ejaculation containing lidocaine and prilocaine in a eutectic-like mixture. Premature ejaculation is possibly the most common form of sexual dysfunction in men. Epidemiological studies conducted in the US and in Europe indicate a prevalence of 20 - 30% in men of all ages. There is currently no globally approved and effective pharmaceutical treatment for this condition.

In the absence of any widely approved pharmaceutical therapy with good patient acceptance, the premature ejaculation market offers significant potential for development and growth. An effective drug therapy for premature ejaculation may have a comparable commercial potential to the erectile dysfunction drugs.