Navajo
- 30 Aug 2006 13:55
Well after all the earlier promises, now slightly overdue and the SMA chart starting to indicate a reversal of fortune I think you might be wise to buy some. Or if you hold some, top up as I've been doing lately.
For those not familiar with this stock check on previous news over the last year or so re 'promises'.
Navajo
- 22 Feb 2007 09:13
- 57 of 141
More progress (at last)
Plethora Solutions Holdings PLC ('Plethora', AIM : PLE), the specialist
developer of products for the treatment and management of urological disorders,
has announced that it has filed an Investigational New Drug (IND) application
with the FDA to initiate the final phase of clinical development of PSD502, a
product for the treatment of premature ejaculation. This follows positive
outcomes from meetings with regulatory authorities in both the USA (FDA) and
Europe (MHRA) which have defined the clinical development programme required to
take this project to marketing authorisation.
As announced previously, Plethora is in the advanced stage of partnering
discussions for PSD502. Having reviewed the PSD502 development plans with
potential development and marketing partners, Plethora has now completed its
filing with the FDA ahead of moving the product into Phase III once partnering
agreements have been concluded.
This is another key step towards the commercialisation of PSD502 and follows the
recent conclusion of a manufacturing and supply agreement between the company
and Inyx Inc of New York, USA. Under the terms of this agreement, Plethora has
secured supply of PSD502 both for the Phase III study and any subsequent
potential commercial requirements.
PSD502 is a proprietary formulation of two marketed drugs, lidocaine and
prilocaine, dispensed by a metered dose aerosol developed for the treatment of
premature ejaculation, a disorder affecting up to 30% of men in Europe and the
USA and for which there is no approved treatment. The product is applied locally
when needed (often referred to as 'on demand' therapy) and is effective within
five minutes. Other key advantages of the product are a minimal risk of safety
issues, minimal partner transfer eliminating the need to use a condom and the
potential for the dose to be self titrated or adjusted under physician
direction. The product was shown to increase ejaculation latency time
substantially when compared with placebo in a multi-centre Phase II study. This
data has been published recently in BJU International (Dinsmore W et al 2007
BJU int 99: 369-35)
The programme to secure product registration in the USA and Europe will involve
less than 600 patients and could be completed within 15 months. This residual
development programme reflects both the excellent efficacy data generated by
Plethora to date and the extensive historical clinical safety database available
on the components of PSD 502. The suitability of this development programme has
been confirmed via recent meetings with the FDA and the European authorities
(MHRA).
The design and structure of the Phase III study has also been discussed
extensively with potential marketing partners. The combined worldwide Phase III
programme will involve in the region of 20 European and 20 North American
centres and will be supported by Plethora and its future development marketing
partners.
Professor Culley Carson of the University of North Carolina and a past president
of the Sexual Medicine Society of North America (SMSNA) stated 'The fact the
regulatory authorities require relatively little additional safety data would
appear to vindicate Plethora's approach of using a product that does not result
in systemic exposure. Given the proposed track of the programme, welcome relief
for the many hundreds of thousands of PE sufferers is in sight at last.'
Steven Powell, Plethora CEO, concluded:
'We are pleased to be advancing PSD502 into the final phase of clinical
development for treatment of premature ejaculation. With the relatively short
development path to registration and the proximity to securing partnering
agreements these are exciting times for Plethora'.
-Ends-
soul traders
- 16 Mar 2007 10:20
- 59 of 141
Plethora Solutions - Exercise of share options
RNS Number:7763S
Plethora Solutions Holdings PLC
12 March 2007
Plethora Solutions Holdings plc ('the Company')
Exercise of Options
The Company has today made application for a total of 444,444 ordinary shares of
1p each ('New Shares') to be admitted to AIM in connection with the exercise of
share options, by its broker and Nominated adviser, Collins Stewart Europe
Limited ('Collins Stewart').
The share options were exercised on 9th March 2007, pursuant to an option
agreement made between the Company and Collins Stewart dated 17th March 2005.
Admission of the New Shares to AIM is expected to become effective at 8.00 am on
16th March 2006.
Following the issue of these New Shares, the Company's share capital consists of
26,241,859 Ordinary 1p shares with voting rights attached (one vote per Ordinary
share). No shares are held in Treasury.
Therefore the total number of voting rights in Plethora Solutions Holdings plc
is 26,241,859.
The above total voting rights figure may be used by shareholders as the
denominator for the calculations by which they will determine whether they are
required to notify their interests in, or a change to their interest in,
Plethora Solutions Holdings plc under the FSA's Disclosure and Transparency
Rules.
For more information contact:
Plethora Solutions Tel: 020 7269 8630
Brad Hoy
Maitland Tel: 020 7379 5151
Brian Hudspith/Liz Morley
soul traders
- 08 May 2007 10:43
- 63 of 141
Just as I was on the point of gnawing my own arm off out of sheer boredom, an RNS:
Plethora Solutions - Product Acquisitions
RNS Number:1753W
Plethora Solutions Holdings PLC
08 May 2007
PLETHORA SOLUTIONS HOLDINGS PLC
Timm Medical Acquires Marketing Rights to Two Additional Products.
Plethora Solutions Holdings PLC ('Plethora', AIM: PLE), a company specialising
in the development and marketing of products for the treatment and management of
urological disorders, today announces that its US subsidiary, Timm Medical
Technologies, Inc. ('Timm'), has acquired marketing rights to two new products;
the ActicufTM device for the management of light to moderate male urinary
incontinence and the Midstream Cleancatch(R) device for the collection of
midstream urine samples.
ActicufTM is a simple to apply, discrete and disposable device designed to help
prevent urine leakage in men suffering from urinary incontinence, a condition
affecting more than two million men in the USA. Timm has secured international
marketing rights to the product and has already achieved first sales of the
product in the USA. A large number of men are either transiently or permanently
afflicted with some degree of bladder leakage. In circumstances where treatment
is either ineffective or not available then ActicufTM may provide a highly
effective and safe alternative for the management of the condition.
Midstream Cleancatch(R) is a collection device, for the collection of midstream
urine samples in men and women. Midstream urine samples (MSU) are collected
routinely as part of the diagnosis and management of urological and other
disorders. It is estimated that there are over 70 million urine samples
collected every year in the UK alone. This novel device has been proven
clinically to reduce contamination rates and spillage and improve diagnosis. It
is designed to help standardise sample collection, make sampling easier and
cleaner for the patient and the health care worker. The product is already being
used in some parts of the UK's National Health Service and Timm will launch the
product through its US sales force and international distribution network in the
coming months.
Steven Powell, Plethora CEO, commented:
'The Timm operation has made substantial progress with the marketing of its
ErecAid(R) and Rigiscan(R) products for the treatment and management of erectile
dysfunction. We believe that the time is right to begin to implement the next
phase of our growth strategy for Timm which is to utilise its sales and
marketing capability to market a broader portfolio of urology products and, in
so doing, accelerate revenue growth'.
-Ends-
hondaman
- 24 May 2007 07:34
- 65 of 141
Solutions Holdings PLC
24 May 2007
Plethora Enters Into Exclusive License Agreement with
Sciele to Market PSD502
for the Treatment of Premature Ejaculation
Sciele Pharma to Purchase $7 Million Equity Stake in Plethora
ATLANTA, LONDON (May 24, 2007) Sciele Pharma, Inc. (NASDAQ:SCRX) and Plethora
Solutions Holdings plc ('Plethora', AIM:PLE) announced today that they have
signed an exclusive license agreement for the marketing of PSD502 for premature
ejaculation (PE) in the United States together with an agreement for Sciele to
purchase a $7 million equity stake in Plethora. Plethora is developing
innovative products for women's health and male sexual dysfunction. Plethora has
products in clinical development for the treatment of premature ejaculation,
overactive bladder, stress urinary incontinence, interstitial cystitis and
gynecological pain.
Under the terms of the license agreement, Plethora will receive payments upon
achievement of regulatory and sales milestones, and royalty payments on product
sales. Plethora will have co-promotion rights for urologists in the United
States.
PE is the most common form of sexual dysfunction among men. PE is estimated to
affect approximately 25% to 30% of men of all ages (Laumann et al1999 JAMA
281537-44). According to the results of this survey, approximately 25 million
men between the ages of 18 and 59 in the U.S. experience PE.
PSD502 comprises a unique, proprietary, and rapidly absorbed formulation of two
well-established local anesthetics, lidocaine and prilocaine, dispensed in a
metered dose spray. Plethora has completed a phase II clinical trial using
PSD502, and Plethora is expected to begin a phase III study in the second half
of 2007.
Under the agreement to purchase a $7 million equity stake in Plethora, Sciele
has purchased 1,772,505 new Ordinary Shares in Plethora at 2.00 per share.
Patrick Fourteau, Chief Executive Officer of Sciele, said, 'We are pleased to
take an equity stake and enter into this collaboration with Plethora as they are
developing new products for Women's Health and sexual dysfunction. This
partnership will enable us to further expand our product pipeline and leverage
our sales force. We are enthusiastic about PSD502, which may provide a potential
PE treatment, addressing an unmet medical need for millions of men.'
Steven Powell, Chief Executive Officer of Plethora, said, 'We are delighted to
have Sciele as a licensing partner and welcome them as a shareholder. We look
forward to working with Sciele and to updating our shareholders on progress with
licensing PSD502 for premature ejaculation elsewhere in territories outside the
USA.'
About Plethora Solutions:
Plethora is focused on the development and marketing of products for the
treatment of urological disorders. The Company has products in clinical
development for the treatment of overactive bladder, stress urinary
incontinence, interstitial cystitis, gynecological pain and premature
ejaculation. In January 2006, Plethora acquired Minneapolis (MN) based Timm
Medical Technologies, Inc. which markets the ErecAid(R) and Rigiscan(R) products
for the treatment of erectile dysfunction (ED) to urology clinics through a
US-based specialty sales team. Most recently, the ErecAid has been found to be
effective for men that fail Medical Management and for men recovering from
prostatectomy The Company is headquartered in the UK and is listed on the London
Stock Exchange (AIM:PLE) Further information is available at
www.plethorasolutions.co.uk
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing
and development of branded prescription products focused on Cardiovascular/
Diabetes and Women's Health. The Company's Cardiovascular/Diabetes products
treat patients with high cholesterol, hypertension, high triglycerides, unstable
angina and Type 2 diabetes, and its Women's Health products are designed to
improve the health and well-being of women and mothers and their babies. Founded
in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than
800 people. The Company's success is based on placing the needs of patients
first, improving health and quality of life, and implementing its business
platform - an Entrepreneurial Spirit, Innovation, Speed of Execution,
Simplicity, and Teamwork.
Safe Harbor Statement
This press release contains forward-looking statements that are subject to risks
and uncertainties that could cause actual results to materially differ from
those described. Although we believe that the expectations expressed in these
statements are reasonable, we cannot promise that our expectations will turn out
to be correct. Our actual results could be materially different from and worse
than our expectations. With respect to such forward-looking statements, we seek
the protections afforded by the Private Securities Litigation Reform Act of
1995. These risks include, without limitation
hondaman
- 24 May 2007 07:35
- 66 of 141
Plethora Solutions Holdings PLC
24 May 2007
PLETHORA SOLUTIONS HOLDINGS PLC
Plethora Solutions Holdings PLC ('Plethora', AIM: PLE), a company specialising
in the development and marketing of products for the treatment and management of
urological disorders, will be announcing its preliminary results for the year
ended 31st December 2006 on Wednesday 30th May 2007.
An analyst meeting will be held at 10am at the offices of Collins Stewart, 9th
Floor, 88 Wood Street, London EC2V 7QR
-Ends-
For further information contact:
Plethora Solutions Tel: 020 7269 8630
Steven Powell
City/Financial Enquiries Tel: 020 7379 5151
Maitland
Brian Hudspith/Liz Morley
Scientific/Trade Press Enquiries Tel: 020 7861 3838
De Facto Communications
Richard Anderson
About Plethora Solutions:
Plethora is focused on the development and marketing of products for the
treatment of urological disorders. The Company has products in clinical
development for the treatment of overactive bladder, stress urinary
incontinence, interstitial cystitis, gynaecological pain and premature
ejaculation. In January 2006, Plethora acquired Minneapolis (Mn) based Timm
Medical Technologies Inc which markets the ErecAid(R) and Rigiscan(R) products
for the treatment of erectile dysfunction (ED) to urology clinics through a
US-based specialty sales team. Most recently, the ErecAid has been found to be
effective for men that fail Medical Management and for men recovering from
prostatectomy The Company is headquartered in the UK and is listed on the London
Stock Exchange (AIM:PLE) Further information is available at
www.plethorasolutions.co.uk
hondaman
- 24 May 2007 07:57
- 67 of 141
Patience always pays off with good stocks!
hondaman
- 24 May 2007 09:06
- 70 of 141
soul traders -don't forget the other PSD502 deals for woundpain and PE for other world areas have yet to come. Next week they will probably give actual figures to the deal. I like the deal because Plethoras other major products fit well into Sciele's organisational portfolio too -The OAB products are even massive.
David10B
- 24 May 2007 10:17
- 71 of 141
And they have a good deal with MLR
hondaman
- 24 May 2007 13:56
- 72 of 141
they have
signed an exclusive license agreement for the marketing of PSD502 for premature
ejaculation (PE) in the United States together with an agreement for Sciele to
purchase a $7 million equity stake in Plethora.
This is interesing because they state that they have signed an exclusive license agreement together with the stake -so that means the agreement terms will be announced I guess next week on 30th May ref royalty payments etc -just my conclusion!!!
hondaman
- 24 May 2007 14:17
- 74 of 141
soul -its clear that we haven't had the whole information -reason I guess is that the results are on 30th May so it would make sense to blend everything in together with all other financial info. But the wording in todays news is clear that more info will be given. The clue is the word "together" in the news. Together is the Sciele purchase of shares but the deal agreement info should follow -some peeps haven't cottoned on yet I guess.
It'll get to 2 anyway I guess based on the purchase info.
hondaman
- 24 May 2007 15:35
- 75 of 141
MM's have woken up -they are buying now -ready for next week and beyond!