Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 

4-Traders Homepage  >  Equities  >  London Stock Exchange  >  Plethora Solutions Holdings plc    PLE   GB00B06GL868

No quotes available
-- GBp   0.00%
03/07 PLETHORA SOLUTI : Form 8.3 - Plethora - Position Dealing Disclosure
03/03 PLETHORA SOLUTI : Form 8.3 - Plethora - Position Dealing Disclosure
03/02 PLETHORA SOLUTI : Form 8.3 Plethora - Position Dealing Disclosure
SummaryQuotesNewsCalendarCompanyFinancials 
News SummaryMost relevantAll newsSector news 

Plethora Solutions Holdings plc : Positive CHMP Opinion for PSD502

share with twitter share with LinkedIn share with facebook
share via e-mail
0
09/20/2013 | 05:33pm CEST
20 September 2013 Plethora Solutions Holdings PLC ("Plethora" or the "Company") Positive CHMP Opinion for PSD502 a treatment for premature ejaculation

Plethora Solutions Holdings plc (AIM: PLE) announces that it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending European Commission (EC) approval for PSD502 (known in the Marketing Authorisation Application as "Lidocaine Prilocaine Plethora") for the treatment of primary premature ejaculation in adult men.
A CHMP positive opinion is one of the final steps before Marketing Authorisation is granted by the European Commission. The CHMP's positive recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Plethora anticipates a final decision from the EC shortly, as this usually occurs approximately 60 days after a CHMP recommendation. Plethora anticipates that when approved by the EC PSD502 will be launched in Europe as soon as practicable thereafter.
PSD502 is a treatment for premature ejaculation, comprising a combination of lidocaine and prilocaine in a spray formulation. Clinical studies have demonstrated that PSD502 is effective in treating premature ejaculation with an acceptable safety profile.
Ronald Openshaw, CEO Plethora said:
"Today's announcement by the CHMP is the key opinion the Company has been seeking to obtain European approval. We are delighted by today's news after such a significant period to reach this milestone.
Premature ejaculation is a highly distressing condition for patients and their partners and there remains a significant unmet medical need given the lack of effective products to treat it.
Our efforts are now focussed on achieving a European launch post EC approval and on the US filing with the FDA. The Company's goal is to see PSD502 available internationally to improve the lives of so many couples."

-Ends- Enquiries: Plethora Solutions

Ronald Openshaw, CEO

Daniel Stewart (Nomad & Joint Broker) David Hart / James Felix (Nomad) Martin Lampshire (Broker) Hybridan LLP (Joint Broker)

Claire Louise Noyce

William Lynne Britton Financial PR Tim Blackstone

About Plethora: Tel : +44(0) 20 3077 5400 Tel : +44(0) 20 7776 6550 Tel: +44(0) 20 7947 4350 Tel: +44(0) 20 7947 4361 Tel: + 44 (0) 20 7242 9786 +44 (0) 7957 140416

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. The product has completed all clinical testing.

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.

distributed by
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on PLETHORA SOLUTIONS HOLDING
03/07 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
03/03 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
03/02 PLETHORA SOLUTIONS : Form 8.3 Plethora - Position Dealing Disclosure
02/29 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
02/26 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
02/25 PLETHORA SOLUTIONS : Form 8.3 Plethora - Position Dealing Disclosure
02/04DJPLETHORA SOLUTIONS : Will Need New Funding if Regent Pacific Deal Doesn't Go Thr..
01/15 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
01/11 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
01/07 PLETHORA SOLUTIONS : Form 8.3 - Plethora - Position Dealing Disclosure
More news
Sector news : Pharmaceuticals - NEC
07:26aDJNovo Nordisk Announces Job Cuts
09/29DJGLAXOSMITHKLINE : Appoints New Consumer Healthcare Chief
09/29DJNOVO NORDISK A/S : to Cut 1,000 Jobs Amid Growing Competition -- Update
09/28DJINTRA CELLULAR THERAPIES : Shares Plunge After Disappointing Drug Trial Results
09/28DJGLAXOSMITHKLINE : to Sell Remaining 6.2% Stake in Aspen Pharmacare
More sector news : Pharmaceuticals - NEC
Advertisement
Income Statement Evolution
More Financials
Managers
NameTitle
Jamie Alexander Gibson Chief Executive Officer & Executive Director
Colin J. Kunz Chief Financial Officer
Michael Grant Wyllie Director & Chief Scientific Officer
Gregory H. Bailey Independent Non-Executive Director
Anthony Robert Baillieu Non-Executive Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
PLETHORA SOLUTIONS HOL..0.00%0
JOHNSON & JOHNSON14.16%320 836
ROCHE HOLDING LTD.-11.51%216 029
NOVARTIS AG-10.14%209 049
PFIZER INC.3.22%202 108
MERCK & CO., INC.17.21%171 194
More Results