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Manufacturing Appointment

26 Mar 2014 07:00

RNS Number : 1884D
Plethora Solutions Holdings PLC
26 March 2014
 



 

 

26 March 2014

 

Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Manufacturing Appointment

 

Plethora Solutions Holdings plc (AIM: PLE) is pleased to announce the appointment of Pharmaserve North West Limited (PSNW) to undertake the manufacturing development leading to the successful introduction of the new 6 dose canister of PSD502 for premature ejaculation. This is a key final step in making product available for the Company's marketing partners that will enable a launch of the product in multiple territories.

Whilst the terms of the agreement with PSNW are governed by confidentiality provisions, the Company estimates that it will spend around £1 million on manufacturing, including the supply of raw materials (prilocaine, lidocaine and other components) and external consultants to the end of 2014.

Subsequent to the assessment of several manufacturing options, PSNW has now been secured as the supply chain and manufacturing development partner for PSD502. PSNW will undertake the work generating data suitable for EU license variation, in conjunction with EUDRAC Ltd, and for inclusion in the initial submission of the New Drug Application (NDA) with the United States Food and Drug Administration (FDA).

PSNW is a leading contract development and manufacturing organisation (CDMO) specialising in the development and manufacture of metered dose inhalers (MDI's), dry powder inhalers (DPI's) and other pharmaceutical aerosols. The dedicated development group, under the guidance of Dr Andrew Brown, have over 20 years experience in developing these dosage forms for both the European and US markets.

 

Jim Mellon Chairman of Plethora said:

"We welcome Pharmaserve as our manufacturing partner for developing the six dose canister and more importantly providing commercial supplies of PSD502 for the EU market and other territories. This is an extremely important milestone for the Company in its ability to provide commercial supplies to its potential marketing partners in our efforts to commercialise PSD502. In this respect, our efforts continue at pace in securing marketing partners for PSD502."

 

Dr Padraic O'Brien Managing Director of Pharmaserve Northwest said:

"We are delighted to be partnering Plethora on this program. Relationships such as these support our strategic position as a Leading CDMO in MDI's, DPI's and pharmaceutical aerosols, as well as validating the investment in facilities and the senior management team undertaken over the last few years. We look forward to the successful commercialisation of PSD502."

 

-Ends-

 

Enquiries:

Plethora Solutions

Jamie Gibson, CEO

Mike Wyllie, CSO

Mike Collis, CFO

Tel : +44(0) 20 3077 5400

Daniel Stewart (Nomad & Joint Broker)

David Hart / Ciaran Walsh (Nomad)

Martin Lampshire (Broker)

Tel : +44(0) 20 7776 6550

 

Hybridan LLP (Joint Broker)

Claire Louise Noyce

William Lynne

 

Tel: +44(0) 20 7947 4350

Tel: +44(0) 20 7947 4361

 

Britton Financial PR

Tim Blackstone

Tel: + 44 (0) 20 7242 9786

+44 (0) 7957 140416

 

 

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 launchPSD502 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 Company anticipates launch in 2014.

 

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.

 

 

 

 

 

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
AGRSEDESIFLSEDD
Date   Source Headline
30th Sep 20087:00 amRNSInterim Results
30th Sep 20087:00 amRNSClinical Update - PSD502
11th Aug 20087:00 amRNSBoard Change
21st Jul 20082:20 pmRNSHolding(s) in Company
1st Jul 20087:05 amRNSDirector/PDMR Shareholding
1st Jul 20087:00 amRNSChange of Adviser
27th Jun 20087:00 amRNSBoard Change
23rd Jun 20082:44 pmRNSAGM Statement
19th Jun 20087:00 amRNSClinical Update PSD502 Phase
22nd May 200810:00 amRNSAnnual Report and Accounts
29th Apr 20087:00 amRNSFinal Results
24th Apr 20087:00 amRNSClinical Update - PSD508
21st Apr 200811:13 amRNSNotice of Results
1st Apr 20087:01 amRNSRe $28m Financing
10th Mar 20085:49 pmRNSHolding(s) in Company
5th Feb 20087:00 amRNSClinical Update - PSD506
10th Jan 200810:39 amRNSChange of Registered Office
19th Dec 20077:01 amRNSClinical Update - PSD502
6th Dec 20077:00 amRNSClinical Update - PSD508
29th Nov 20077:01 amRNSClinical Update PSD503
30th Oct 200712:30 pmBUSSciele Pharma and Plethora Solutions Holdings PLC Announce Initiation of Pivotal Phase III Trials for PSD502 for Premature Ejaculation
30th Oct 20077:01 amRNSClinical Update PSD502 Ph III
8th Oct 20077:00 amRNSClinical Update PSD597
26th Sep 20077:02 amRNSInterim Results
25th Sep 20074:55 pmRNSHolding(s) in Company
10th Sep 20079:27 amRNSNotice of Results
6th Sep 20077:01 amRNSClinical Update PSD597
16th Aug 20072:44 pmRNSAIM Rule 26
12th Jul 20077:01 amRNSClinical Update - PSD502
10th Jul 20074:11 pmRNSResult of AGM
2nd Jul 20073:14 pmRNSDirector/PDMR Shareholding
2nd Jul 20077:01 amRNSProduct Update - Invicorp
29th Jun 20071:20 pmRNSTotal Voting Rights
29th Jun 200710:29 amRNSShare Options Award
25th Jun 20077:01 amRNSClinical Update PSD597 for IC
14th Jun 20074:46 pmRNSHolding(s) in Company
14th Jun 20074:39 pmRNSHolding(s) in Company
1st Jun 200710:00 amRNSDirectorate Change
30th May 20077:01 amRNSPreliminary Results
24th May 20071:00 pmBUSSciele Enters Into Exclusive License Agreement with Plethora Solutions Limited to Market PSD502 for the Treatment of Premature Ejaculation
24th May 20077:05 amRNSNotice of Results
24th May 20077:03 amRNSLicensing deal
8th May 20077:02 amRNSProduct Acquisitions
5th Apr 20077:36 amRNSAcquisition
21st Mar 20075:05 pmRNSHolding(s) in Company
21st Mar 20075:05 pmRNSHolding(s) in Company
21st Mar 20075:04 pmRNSHolding(s) in Company
13th Mar 20071:08 pmRNSHolding(s) in Company
12th Mar 20072:16 pmRNSExercise of share options
1st Mar 20077:03 amRNSDirectorate Change

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