The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.

Less Ads, More Data, More Tools Register for FREE

Pin to quick picksPlethora Solutions Holdings Plc Regulatory News (PLE)

  • There is currently no data for PLE

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

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
18th Nov 20154:56 pmBUSForm 8.3 - Plethora Solutions Holdings Plc
18th Nov 20158:08 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
17th Nov 20159:00 amRNSForm 8 (OPD) Plethora Solutions Holdings PLC
17th Nov 20159:00 amRNSForm 8 (OPD) (Regent Pacific Group Limited)
17th Nov 20159:00 amRNSForm 8 (OPD) (Plethora Solutions Holdings plc)
17th Nov 20158:09 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
16th Nov 20158:47 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
13th Nov 20158:59 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
12th Nov 20155:26 pmRNSUpdate in relation to Letters of Intent
12th Nov 20159:03 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
11th Nov 20153:14 pmRNSForm 8.3 - AMENDMENT Plethora Solutions Holdings
11th Nov 201510:54 amRNSForm 8.3 - Plethora Solutions Holdings PLC
11th Nov 20157:41 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
10th Nov 20158:32 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
10th Nov 20158:15 amRNSLetter of Intent Signed
9th Nov 20155:10 pmRNSHolding(s) in Company
9th Nov 20152:36 pmRNSForm 8.3 - Plethora Solutions Holdings Plc
9th Nov 201511:50 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
6th Nov 20153:20 pmRNSRULE 2.10 UPDATE
6th Nov 20159:14 amRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
5th Nov 20153:53 pmRNSForm 8.3 - Plethora Solutions Holdings Plc
5th Nov 20151:14 pmRNSForm 8.5 (EPT/RI) - Plethora Solutions PLC
5th Nov 20158:27 amRNSForm 8.3 - Regent Pacific Group Ltd
4th Nov 20156:28 pmRNSRULE 2.10 UPDATE
4th Nov 20154:35 pmRNSForm 8 (DD) - Plethora Solutions Holdings plc
4th Nov 201510:03 amRNSPossible Offer for Plethora Solutions Holdings plc
28th Oct 20152:21 pmRNSDirector's Shareholding
28th Aug 20154:21 pmRNSHalf Yearly Report
11th Jun 201512:00 pmRNSResult of AGM
5th Jun 201512:16 pmRNSAgreement with Regent Pacific
12th May 20157:01 amRNSBoard Appointment
27th Apr 20154:30 pmRNSHolding(s) in Company
15th Apr 20155:05 pmRNSHolding(s) in Company
13th Apr 20158:16 amRNSHolding(s) in Company
1st Apr 20157:00 amRNSDirector Dealing and Issue of Equity
30th Mar 20151:30 pmRNSFinal Results
13th Feb 20152:33 pmRNSDirector/PDMR Dealing
9th Jan 20155:00 pmRNSTo attend J.P. Morgan's 33rd Healthcare Conference
22nd Dec 20147:00 amRNSDirector/PDMR dealing
11th Dec 20147:00 amRNSAppointment of NOMAD and Broker
11th Nov 20147:00 amRNSCompany Update
10th Nov 20147:00 amRNSRecordati Upfront Payment Received
31st Oct 20147:00 amRNSChange of Adviser
7th Oct 20147:00 amRNSPSD502 to be marketed as Fortacin in the EU
3rd Oct 201411:11 amRNSHolding(s) in Company
30th Sep 20145:38 pmRNSTotal Voting Rights
29th Sep 20142:26 pmRNSIssue of Equity
29th Sep 20147:00 amRNSUpdate regarding the European License Agreement
23rd Sep 20145:28 pmRNSHolding(s) in Company
19th Sep 20142:25 pmRNSHolding(s) in Company

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.