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Plethora Solutions (AIM: PLE) is a speciality pharmaceutical company dedicated to the development and marketing of products for the treatment and management of urological disorders. The diagnosis and treatment of urological conditions represents an expanding market with many poorly met medical needs that offer significant commercial potential for new pharmaceutical products and medical devices.

Website:
http://www.plethorasolutions.co.uk
Phone:
+44 (0)20 3077 5400
Address:
1st Floor, St Andrew?s House, 18-20 St Andrew Street, London, EC4A 3AG
Super Sector:
Pharmaceuticals & Biotechnology
Sector:
Pharmaceuticals & Biotechnology
Industry:
Pharmaceuticals
EPIC / Symbols:
LON:PLE
chart-size
*subject to change and depends on individual circumstances.

Plethora Solutions RNS Press Releases

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Plethora Solutions Articles, News, and Media Files

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Plethora Solutions Related Media

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  • 12/06/2012

    Stocktube video - Plethora Solutions now focused on commercialisation of its premature ejaculation treatment

    Ronald Openshaw, CEO at Plethora Solutions (LON:PLE), tells Proactiveinvestors that the early submission of the dossier to the European Medicines Agency for the approval of the premature ejaculation treatment PSD502 is “huge news”. Ronald says that it’s likely to take 12-18 months for approval then it’s the launch. Ahead of that then management will look at a partnering agreement which it is anticipated will contain upfront, milestone and royalty payments.

Broker press

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  • 12/03/14
    +0.25 +11.25

    Daniel Stewart reiterates its "buy" rating and raised its price target to 25.6p from 18.9p.

  • 20/07/11

    Press: 20.07.11: -1.62, (4.38) Press: Plethora Solutions fell on news that full-year results would be lower than expected. Source - Financial Times

  • 03/12/10

    Press: 03.12.10: -0.75, (10.25) Press: Plethora Solutions lost ground following a placing of 8.23m shares at 8.5p. The GBP750,000 raised is to... read more

  • 08/09/10
    +1.50 +13.00

    an article in the Mail reports: Plethora Solutions rose 0.5p to 11.5p. Broker FinnCap, which has a target price of 57p, says the company already has five products in... read more

  • 27/04/10
    +0.00 +14.75

    the U.K. launch of Johnson & Johnson?s (JNJ) premature ejaculation pill Priligy highlights the prospects for Plethora Solutions? (PLE.LN) premature ejaculation spray PSD502, says FinnCap analyst Keith Redpath. Priligy has gone on sale for GBP25 a tablet, and if 33,000 men took one a month sales would hit GBP10 million a year, he says. Notes 33,000 men represent less than 0.2% of the estimated U.K. male population affected by the condition. PSD502 has advantages over Priligy: it has fewer side effects and is effective within seconds, not hours, Redpath says. PSD502 launch is expected in 12 to 18 months. Has 57p target.

Director dealings

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Date Director Trans Amount Type Price(p) Value (£) Holding %
15/10/13 J. Mellon TAKE 20,000,000 ORD 9.00 1,800,000 116,512,808 29.50
15/10/13 J.R. Openshaw TAKE 333,500 ORD 9.00 30,015 750,169 0.20
15/10/13 G. Bailey TAKE 555,600 ORD 9.00 50,004 555,600 0.10
15/10/13 M.G. Wyllie TAKE 333,500 ORD 9.00 30,015 1,353,327 0.30
18/03/13 W.J. Robinson FEES 515,000 ORD 0.00 0 1,648,333 0.50

BASIC RESULTS INFORMATION

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Date Type Turnover Profit EPS (p) Dividend (p) Currency
31/12/13 Full year 0.00 -8.76 -2.60 0.00 GBX
30/06/13 Interim 0.00 -1.06 -0.26 0.00 GBX
31/12/12 Full year 0.58 -3.87 -1.90 0.00 GBX
30/06/12 Interim 0.28 -2.03 -1.00 0.00 GBX
31/12/11 Full year 0.19 -1.74 -1.90 0.00 GBX

Company Statement

More than 25 million men across Europe alone suffer from premature ejaculation (PE), for which there is no known cure. As well as the physical and sexual issues associated with PE, it can also cause extreme emotional distress.

 

Following the regulatory approval by European Medicines Agency (EMA) in November 2013, PSD502 is the first clinically effective, fast-acting treatment for PE, offering hope for millions of men - and their partners.

 

Current Operations

Premature Ejaculation

WHAT IS PE?

Premature ejaculation (PE) is possibly the most common form of sexual dysfunction in men, affecting more men than erectile dysfunction. Quite simply, PE is a man's inability to delay ejaculation for more than a minute or two after penetration (the accepted 'normal' duration of intercourse is between four and seven minutes), and which leads to him - and often his partner - feeling distressed and/or upset.

 

Premature Ejaculation

And PE can have adverse effects on the sexual behaviour, self-esteem and quality of life of men who suffer from it. In some cases, PE can be sufficiently serious that men are unable to form meaningful sexual relationships.

The first consensus definition of PE by a group of international experts (Ad Hoc Committee of the International Society for Sexual Medicine (ISSM)) was confirmed in October 2007:

Premature ejaculation is a male sexual dysfunction characterised by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.

The International Society for Sexual Medicine (ISSM)

 

WHO SUFFERS FROM PE?

PE affects men across all demographics irrespective of race, education, marital status or age.

The cause of PE has not been identified, although hypersensitivity of the penis is believed to be a significant factor. This is combined with performance anxiety, repetitive conditioning to ejaculate quickly in adolescence, excessive arousal and muscular tension.

Multiple epidemiological studies show the rate of PE to be anywhere between 18- 30% of sexually active men. Based on this, the potential patient population is estimated at one in four men.

 

RELATIONSHIP DISTRESS

But it is not just men who suffer when PE is an issue: women very often have to deal with their partner’s frustrations, anger or depression; and they may also be left feeling sexually frustrated and/or upset.

This puts a great deal of stress on a couple’s relationship, and can lead to wider unhappiness, conflict, separation or divorce.

 

Premature Ejaculation

Please visit the Clinical Data section for more information.

 

HOW PSD 502 WORKS

PSD 502 is an easy-to-use metered-dose (one dose = three sprays) aerosol formulation of lidocaine and prilocaine. It is applied topically to the glans penis (head of the penis) and left for five minutes to be absorbed into the skin. This allows a couple to benefit from the treatment without it interfering with the spontaneity of the moment. Once administered, PSD 502 is effective for up to one hour.

 

PSD 502 has been formulated to be absorbed only through the non-keratinised skin of the glans penis. The dose of the drug has been carefully determined to ensure that it does not cause numbing or anaesthesia, and that sexual sensation is maintained by the man.The drug was designed to ensure that it did not transfer to the partner; it is important that the woman does not accidentally loose any sexual sensation as a result of her partner's treatment.

 

Over 26,000 doses of PSD 502 have been used in clinical trials, with patients being treated for up to 12 months. Results showed substantial improvement in men's sexual satisfaction and control, and delayed ejaculation, from the very first use.

 

Long-term use showed significant improvements as sexual confidence builds and negative psychological conditioning of feelings of 'being out of control' diminished. This resulted in a further increase in the time taken to ejaculation.

 

HOW TO USE IT

Simply apply one dose (three sprays) of PSD 502 directly to the glans penis five minutes before intercourse. PSD 502 has been extensively tested with a range of condoms of different materials, with no impact on their effectiveness.

 

HOW IS IT DIFFERENT?

PE has a significant, unmet medical need: patients (and their doctors) are seeking an effective, fast-acting product with limited side effects.

 

The market currently offers largely ineffective or unsuitable 'treatments', all of which have various negative side effects.

 

There is currently only one drug approved for treatment, Priligy®, and this has only been approved for use in a small number of European countries. This is an oral medication that must be taken several hours prior to intercourse. In a recent study (Mondaini et al), 90% of men who used Priligy® discontinued using it due to adverse side effects, ineffectiveness and other negative factors.

 

PE is most commonly treated with off-label medicines. These generally include anti- depressants and topical anaesthetic creams. Published data for their use is generally not conclusive and physicians prescribe them at their own risk.

 

There are a number of anaesthetic spray products sold. These are generally marketed under a product monograph, either approved as a topical anaesthetic or as a desensitising agent. However, they have not been rigorously tested or approved for use in PE as a medical condition.

 

PSD 502 IS DIFFERENT FROM OTHER PRODUCTS

  • Effective from the first dose
  • Takes just 5 minutes to work
  • Over 85% of men trialled enjoyed delayed ejaculation time from under one minute into the 'normal' range of three to four minutes
  • No systemic side effects
  • No transfer to the woman
  • Very low incidence of side-effects, no serious drug related adverse events
  • Ejaculation time continues to increase as drug treatment is continued for several months
  • Discreet and easy to use aerosol
  • Highly rated by patients and partners
  • Subject of extensive clinical trials
  • When approved will offer physicians a safe and effective on-label treatment

 

View more information on intellectual property relating to PSD 502.

Management

Mr. Jim Mellon (Chairman & Non-Executive Director)

Jim Mellon is an investor with interests in several industries. After leaving Oxford, where he studied PPE, he worked in Asia and the United States in two fund management companies, GT and Thornton, before establishing his own business in 1991. This now has two components: a listed fund management company, Charlemagne Capital; and an Asian investment group, Regent Pacific. In addition, Jim is the controlling shareholder and a director of Manx Financial Corporation, an Isle of Man-based bank; Speymill Group, a property business; and Webis Holdings; and a co-founder of Uramin and Red Dragon Resources, both mining groups. Burnbrae, his private company, is a substantial landlord in Germany and in the Isle of Man, and it owns outright the hotel chain, Sleepwell Hotels. Jim spends most of his time working on startup ideas and on investing. His first book, 'Wake Up!' was published in 2005, and the second, ‘10 Investments for the Ten Years Ahead', in 2008. Jim lives in the Isle of Man, Brussels and Ibiza and is an honorary fellow of Oriel College, Oxford. 

 

Mr. Jamie Gibson (Chief Executive Officer)

Jamie Gibson is the CEO and Executive Director of Regent Pacific, which is a substantial shareholder in the Company. Mr. Gibson has spent most of his professional career with the Company specialising in corporate finance, direct equity investments and structuring emerging market investment products. Prior to joining the Company, he worked at Clifford Chance, Coopers & Lybrand and KPMG. Mr. Gibson has a law degree from Edinburgh University. He is also director of a number of subsidiaries of Regent Pacific Group, including Amerinvest Coal Industry Holding Company Limited, which in turn holds a 25% equity interest in West China Coking & Gas Company Limited.

Mr. Gibson was formerly: (i) a non-executive director of BC Iron Limited ("BCI", a company listed on the Australian Securities Exchange (“ASX”)), having been appointed on 16 July 2012, representing the Company's 23.11 per cent interest then held in BCI, and resigned on 18 December 2012 in anticipation of the Company's contemplated disposal of its entire interest in BCI; and (ii) the alternate director to James Mellon on the board of Venturex Resources Limited (a company listed on ASX), having been appointed on 12 March 2013 and resigned on 10 June 2013.

 

Dr. Michael Wyllie (Chief Scientific Officer)

Dr. Mike Wyllie is a co-founder of Plethora Solutions. He has over 25 years of experience in senior management level positions within the pharmaceutical industry, with American Home Products and Pfizer. He has considerable hands-on experience in all aspects of the drug discovery and development process, and has been involved with new project inception, drug discovery and safety testing, early and late stage clinical development, regulatory filing, and the successful commercialisation of products, including Cardura® (doxazosin) and Viagra® (sildenafil). Mike sits on the Clinical Trial Design and Future Therapies in BPH Committees of the World Health Organisation International Consultations on Urological Disease, and he is an assistant editor of the British Journal of Urology in the Sexual Medicine Section. He has over 100 publications and is the named inventor of over 80 patents.

He is an independent director on the board of the NASDAQ listed reproductive health company, Repros (RPRX).


Mr Michael Collis (Non-Executive Director)

Mike Collis is an advisor to Maven Capital Partners LLP ("Maven"), which manages the Capital for Enterprise Fund ("CfE"). CfE provided a £1m facility to the Company under which it has the right to appoint a director to the board. Mr Collis is a Chartered Accountant and a specialist in business turnarounds and holds a practicing certificate with the Institute for Turnaround. He is managing director of Arc Portfolio Management Limited. He was previously Head of Portfolio Management at Aberdeen Asset Managers Private Equity. He has served on the boards of a number of private companies often as a nominee of the investor. Mr Collis qualified as a Chartered Accountant with Arthur Andersen.

 

Dr Greg Bailey (Non-Executive Director)

Gregory H. Bailey, M.D., is managing partner of Palantir Group, Inc., a merchant bank specializing in biotech and intellectual property and is chairman of Portage Biotech, Inc. a publicly traded drug development company. Dr. Bailey has over fifteen years' experience in investment banking and has also founded several companies. Along with comprehensive experience in healthcare, finance and medicine Dr. Bailey also brings to the board of directors an extensive involvement in corporate governance. Dr. Bailey has served on multiple public company boards of directors. Dr. Bailey was a practicing physician for ten years and holds a M.D. degree from the University of Western Ontario.

Major Shareholders

 

 

  • Additional Information
    Market
    AIM
    EPIC
    PLE
    Share Price
    10.88p
    Change
    0.88
    Volume
    791,684
    Dividend
    0
    EPS
    -2.60
    Shares
    415.27 m
    Offer
    11.25
    Bid
    10.5
    Avg. Vol
    84,012
    Yield
    0.00
    P/E
    0.54
    Mkt Cap
    £45.18 m
  • Contact Information

    REGISTERED OFFICE

    Hampden House 

    Monument Business Park 

    Warpsgrove Lane 

    Chalgrove 

    Oxfordshire 

    OX44 7RW 

    Corporate Information

    Nominated Advisor and Joint Broker

    Daniel Stewart & Company Plc

    36 Old Jewry

    London

    EC2R 8DD

     

    Joint Broker

    Hybridan LLP

    29 Throgmorton Street

    London

    EC2N 2AT

     

    Solicitors to the Company

    Proskauer Rose LLP 

    Ninth Floor

    Ten Bishops Square

    London

    E1 6EG

     

    Bankers

    Lloyds TSB Bank plc

    2nd Floor

    PO Box 18436

    39 Threadneedle Street

    London EC2R 8PT

     

    Registrars

    Equiniti Limited

    Aspect House

    Spencer Road

    Lancing

    West Sussex BN99 6QQ

     

    Independent Auditors

    Pricewaterhouse Coopers

    Chartered Accountants & Statutory Auditors

    Abacus House 

    Castle Park

    Cambridge

    CB3 0AN

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