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'.
hondaman
- 28 Sep 2006 13:36
- 10 of 141
you will be looking at 4+ so a great return!
soul traders
- 09 Oct 2006 10:31
- 11 of 141
RNS out today - extended application of an existing Timm/Plethora product approved by the US FDA.
Plethora Solutions - FDA grants label extension
RNS Number:1312K
Plethora Solutions Holdings PLC
09 October 2006
PLETHORA SOLUTIONS HOLDINGS PLC
Product Update
Osbon ErecAid(R): FDA Allows Labeling for Use of ErecAid after Radical Prostate
Surgery.
Plethora Solutions Holdings PLC ('Plethora', AIM : PLE), the specialist
developer of products for the treatment and management of urological disorders,
today announces that its Osbon ErecAid(R) product marketed through Plethora's US
subsidiary, Timm Medical, has received permission from the US FDA for extended
labeling. This clarifies that the product may be used to create and maintain
erections by providing arterial blood to the penis during recovery from
prostatectomy ('penile rehabilitation') and thus aid in maintaining preoperative
sexual function. The Osbon ErecAid is the first device or drug to be cleared by
the FDA for this specific wider indication.
Men treated for localised prostate cancer by either radical prostatectomy (RP)
or radiotherapy can expect some degree of erectile dysfunction (ED) and the
condition may persist long into the recovery period. Prostate cancer screening
has led to the detection of more cases in younger men and an increasing focus on
restoring sexual activity after treatment. According to the American Cancer
Society, around 230,000 new cases of prostate cancer were diagnosed in the
United States during 2005. The majority had localised (Stage II) disease at
diagnosis and between 25% and 30% of this patient group will be treated by
radical prostatectomy, resulting in a potential penile rehabilitation treatment
population of around 50,000 patients each year in the United States alone.
ErecAid is already known to be highly effective in patients who either don't
respond to oral drugs, those who can not tolerate their side effects or in those
patients who are precluded from using phosphodiesterase inhibitors, e.g. nitrate
users or patients with high cardiovascular risk. Impressive new clinical
evidence (Monga et al, World Congress of Endourology, August 2006) has helped
convince the regulators that ErecAid can be of considerable benefit in
maintaining erectile function in men who experience erectile dysfunction after
prostate surgery, a situation where oral drugs may be of only limited use.
The time from prostate surgery to restoration of normal sexual function may be
up to two years, even with correctly applied nerve-sparing techniques.(i),(ii)
Given the possible consequences of prolonged lack of erections and resulting
penile hypoxia, there has been an increased focus in recent years on so called
rehabilitation programmes to promote early nerve recovery following RP. 'The
overall concept of penile rehabilitation is to prevent cavernous tissue damage
from occurring during neural recovery, by providing adequate arterial blood
(oxygenation) to the erectile tissues.' Encouraging results have been
demonstrated from use of the Osbon ErecAid, a vasoactive therapy.(iii),(iv) In
their recent review, Kendirci et al. concluded that pharmacological penile
rehabilitation protocols are beneficial after radical prostatectomy and that '.
. .either intracavernous injections or a vacuum erection device can be
recommended as a first-line option for the early post operative months, as their
mechanism of action does not require intact neural transmission.'
Previous studies have indicated that early penile rehabilitation can reduce the
impact of ED. Nerve damage after radical prostatectomy causes a loss of natural
nocturnal erections, reducing blood flow to the penis which causes fibrosis of
the penile tissue, resulting in a reduction in penile length. Early penile
rehabilitation is aimed at increasing blood flow to the penis so that the penile
tissue is maintained while nerve function is restored. The efficacy of oral ED
drugs is greatly reduced in patients with nerve damage so alternative treatments
are required.
Mr. Roger Kirby, The Prostate Center, London commented
'In situations where sexual function can be adversely affected by surgical
procedures ErecAid would appear to have an important role in restoring potency
in a cost effective and timely manner'.
Dr Steven Powell, Plethora CEO, concluded:
'The Osbon ErecAid is frequently prescribed for patients that are unable to use
PDE-5 Inhibitors either because they are contraindicated, find the drug is
limited in its effectiveness or because they cannot tolerate the associated side
effects. This regulatory endorsement of the use of the Osbon ErecAid during
recovery from prostatectomy provides physicians and their patients with a tool
to fight the significant quality of life impact associated with prostate
cancer'.
-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
DeFacto Communications
Richard Anderson
About Plethora:
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 products for the treatment of erectile
dysfunction (ED) to urology clinics through a US-based specialty sales team. 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
(i) Walsh PC. Patient-reported urinary continence and sexual function after
anatomic radical prostatectomy. J Urol2000; 164: 1929-1934.
(ii) Burnett AL. Rationale for cavernous nerve restorative therapy to preserve
erectile function after radical prostatectomy. Urology 2003; 61: 491-497
(iii) Gontero P, Fontana F, Zitella A, et al. A prospective evaluation of
efficacy and compliance with a multistep treatment approach for erectile
dysfunction in patients after non-nerve sparing radical prostatectomy. BJU
Int2005; 95: 359-365
(iv) Raina R, Agarwal A, Allamaneni SS, et al. Sildenafil citrate and vacuum
constriction device combination enhances sexual satisfaction in erectile
dysfunction after radical prostatectomy. Urology2005; 65: 360-364.
hondaman
- 06 Nov 2006 11:15
- 13 of 141
anyone got access to shares mag -read somewhere that there was a mention of Erecacid product and a likely takeover story -can see that myself once the imminent deal is announced and even better the deals on one product could be huge if sold as an asset namely PSD502.
Alternatively could be sold under separate licenses.
hondaman
- 06 Nov 2006 11:53
- 14 of 141
we should be seeing 4 in a short while !
hondaman
- 06 Nov 2006 12:17
- 16 of 141
soul also PLE have many products about 11 now I think -I have the company report and everytime I read it I feel more assured and confident.
Apparently the deal was delayed because the two companies they were in negotiations with merged and now the merger has happened the negotiations have advanced again. The main point of the mega deal (will happen going by the company's RNS this month/next as they state significant licensing revenue for second half 2006) is that PE market is 25-30% whereas ED is 10% so you can see how big the deal will be!!
The target 526 will be the start of things imho with other deals I see at least 10 -may sound daft now but in a year or so I feel its achievable .
Their top scientist has 80 patents in his name including Viagra which he was part of. All other managment peeps are top guys -best Pharma company for me in a longwhile! glad to have bought at these levels a bargain -even better than Matalan sales!!
hondaman
- 06 Nov 2006 13:54
- 17 of 141
overhang cleared at last!! come on baby!
hondaman
- 06 Nov 2006 14:29
- 21 of 141
soul -do us a favour -any other shares that you think will do well at anytime please let me know on this board if its ok by you.
hondaman
- 06 Nov 2006 14:45
- 23 of 141
thanks soul I'll have a look. keep em coming!
hondaman
- 07 Nov 2006 08:43
- 24 of 141
soul I actually saw SOLA a while back except I didn't jump in early enough and then saw it again below 2 and missed the chance again!!!
thats why I could do with tips before they move up so look forward to your other tips as you seem to jump in at the right time! well done!
anyways Plethora overhang has definately cleared hence the move up today so far again with a few buys which confirms that!
hondaman
- 07 Nov 2006 13:11
- 27 of 141
some more info showing confidence Plethora have signed a deal with Inyx to manufacture the aerosol for PSD502 for phase III trials.
soul traders
- 07 Nov 2006 13:18
- 28 of 141
So they did:
Inyx Signs Deal with Plethora Solutions to Produce Novel HFA Aerosol Indicated for the Treatment of Premature Ejaculation for Clinical Trial in the United States
NEW YORK, Nov. 2 /PRNewswire-FirstCall/ -- Inyx, Inc. , a specialty pharmaceutical company focused on niche drug delivery technologies and products, announced today that it has signed an agreement with Plethora Solutions Holdings plc (AIM: PLE), an emerging U.K. specialty pharmaceutical company, to manufacture a topical HFA aerosol product used in the treatment of premature ejaculation (PE) for Phase III clinical trial in the United States. The production will be conducted at Inyx USA's FDA-approved site in Puerto Rico.
Jack Kachkar, M.D., Chairman and CEO of Inyx, Inc., said, "We are very pleased that Inyx has been selected for the production of Plethora's PE product for the Phase III clinical trial. We are particularly delighted that a U.K.-based company has selected Inyx USA. This collaboration reflects our expertise in HFA aerosol production and our overall capabilities on both sides of the Atlantic."
Dr. Steven Powell, CEO of Plethora, commented, "We are very happy with our collaboration with Inyx, which allows us to progress PSD502 down the path towards Phase III clinical development."
Plethora's PE product, known as PSD502, is a topical agent comprised of a unique proprietary and rapidly absorbed formulation of two well established local anesthetics, dispensed by a metered dose spray.
PE is a medically recognized condition defined as "persistent or recurrent ejaculation with minimal sexual stimulation before, upon or shortly after penetration, and before the person wishes it." PE is the most common form of sexual dysfunction in men. According to the American Medical Association, approximately 20 million men in the U.S. experience PE. Since there is currently no approved pharmaceutical therapy, the PE market offers significant potential for development and growth. An effective drug therapy for PE may have a commercial potential comparable to the erectile dysfunction drug, Viagra(R), for which current annual sales are approximately $1.7 billion.
Source: http://www.wivb.com/Global/story.asp?S=5625837
or just Google it.
Good find, Hondaman, thanks very much!