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'.

Interesting that you mention this today, Nav. I was looking at this this morning and thinking similar things. I don't hold yet but have been thinking about it for a while now.

soul'. One thing's for sure, it'll take people by surprise imo. Good fortune to you, don't think too long :o)

LOL - you're right; I shouldn't spend too long thinking about it. Wish I had a little more cash to throw at these things!

The clue on the deal was in the last RNS - the license deal on PE will now become a massive deal because now the PSD502 product has another massive market product application ref wound pain. The multiple partners will want to have the license to the full the asset product PSD502 no doubt and therefore the deal will take this into account no doubt also.
Remember that the broker gave a 5+ target based on PE application so with the wound pain application its alot higher.
Personally I shall hold out for a 10 bid after other products have been licensed.
Great share -glad that only a few of us private investors have spotted this gem.

The clue on the deal was in the last RNS - the license deal on PE will now become a massive deal because now the PSD502 product has another massive market product application ref wound pain. The multiple partners will want to have the license to the full asset product PSD502 no doubt and therefore the deal will take this into account no doubt also.
Remember that the broker gave a 5+ target based on PE application so with the wound pain application its alot higher.
Personally I shall hold out for a 10 bid after other products have been licensed.
Great share -glad that only a few of us private investors have spotted this gem.

great to be in this share -yes its had its fluctuations but was expected with the acquisition of Timm medical.
The PSD502 deal is gonna happen anytime now and before the end of 2006. Which ever large outfit gets the license will most likely pay an even significant amount now cause PSD502 is worth a whole lot more cause of the additional burns relief application.
A years hold in this one will reap a 7 return I reckon and a takeout bid of alot more.
All this is possible because PLETHORA now have 5 major products with massive markets and with only 25M shares in issue - a gem this one!!

From today's FT following Plethora's interim results:-

"Plethora Solutions added 5.6 per cent to 178p after Collins Stewart repeated its "buy" recommendation and 526p price target on the stock. The broker said it expected Plethora to announce a licensing deal for its PSD502 premature ejaculation treatment within weeks"

In today at 191.75, unfortunately for a pretty small holding - wish it could be more, but I am hopeful that this will produce a nice return.

you will be looking at 4+ so a great return!

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.

What's the bottom line? It's difficult to predict how this might impact PLE's overall turnover, although it's bound to be positive. However, in terms of the product itself it seems like a big step forward, and it's good to see PLE making continued progress, particularly with the regulators.

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.

we should be seeing 4 in a short while !

Honda, from memory of reading the Shares article, you've about got the gist of it. PSD502 is the drug it talked about - obviously if and when the licensing deal comes through then that will be the kicker. The delay has been explained by the house broker as being due to the fact that PLE is in talks with more than one partner. Takeover is certainly a possibility due to PSD502 plus range of products for sexual health. One analyst (Navid Malik at (?)Collins Stewart) sees a 526p price target.

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!!

overhang cleared at last!! come on baby!

Hondaman, thanks very much for the informative update and your views. I have long been convinced that this company should get a significant re-rating; how long I will hold is another thing as I know that products can take a long time to get to market and I may prefer to get out early rather than sit through a lot more quiet patches.

Just seen the SP, and am delighted to report that my purchase has broken even :o)

PLE Bid: 195p Offer: 202p Change: 6.5

I had not been aware of a stock overhang but it makes sense given the shape of the chart this year.

Nice to see that the spread has narrowed a bit too.

FWIW there has been a nice 50-point rise on the FTSE so far today, which must be helping sentiment.

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.

HM, have you seen Renesola (SOLA)? Results due out in two days' time, and they ought to be a real cracker. It's already profitable, expanding rapidly, may be a bit risky as it is in China but has chosen to list on AIM. huge amount of potential cash generation, though. Best place for the reports and articles is FT.com (you may want to print stuff out as they don't seem to make it available for very long). It's worth having a read of the thread on this BB too (and over the road if you have a lot of time on your hands!)

Tipped by two analysts so far, each with target price of 300p; could easily be 5 - 8 between end of 2007 and mid-2008 or by the 2008 FY results.

I got in initially at 145p and increased about ten days ago at just under 200p. You could say it's may favourite stock at the mo.

PDYOR, etc.

thanks soul I'll have a look. keep em coming!

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!

Honda, I don't get all my timing right - it's a case of not always having the csh to invest when I want to, plus of course we all make errors of judgment.

I do read a lot of different threads on here though, as well as doing a fair bit of research into the co's behind them.

Another nice bit of progress today though: PLE Bid: 200p Offer: 208p Change: 4

some more info showing confidence Plethora have signed a deal with Inyx to manufacture the aerosol for PSD502 for phase III trials.

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!

some more info showing confidence Plethora have signed a deal with Inyx for them to manufacture the aerosol for PSD502 for phase III trials for Plethora.
(http://www.inyxinc.com/page420618.aspx)

Just my feeling but I am going for a deal to be announced this month.
Lets see -good luck all!! although we have been informed by RNS that it will be in second half so not long to go anyways!

from recent results -this is the interesting part for me!
" In the second half of 2006 we look forward to the continued growth of product revenues and are confident that we will add significant licensing income from PSD502 to the top line.'

Timm Medical is bringing in great revenue going by the RNS and on top will be immediate licensing revenue from PSD502.

I am going to stick with next week as news week on deal news.
Good luck all!

News can still come November 2006 -still a few days to go -otherwise December 2006 it will defo come -company have stated this in the results RNS that PSD502 will bring in SIGNIFICANT licensing revenue in 2006 .

Honda, I too am hoping that news will soon be forthcoming, but predictions of when deals will be made can be very unreliable. I'm content to wait a while if necessary; happy to get in ahead of the herd.

soul -todays news is a start of more news -thats my take and PSD502 news this year 2006 will mean a great mark up so yes its best to get in before that happens.

These relatively minor items of news are good and lift the price steadily in prelude to major news. After all, doube 2 is better than double 1.50p :o)

Plethora Solutions - Product Update PSD401
RNS Number:7197M
Plethora Solutions Holdings PLC
27 November 2006


PLETHORA SOLUTIONS HOLDINGS PLC

Product Update

PSD401 - Sexual Activity Monitor (SAMTM)
Plethora Enters Into Agreement with Global Pharmaceutical Company

Plethora Solutions Holdings plc ('Plethora' or the 'Company', AIM : PLE), the
specialist developer of products for the treatment and management of urological
disorders, today announces that it has entered into an agreement with a major
multi-national pharmaceutical company to supply Plethora's Sexual Assessment
Monitor (SAMTM, PSD401), a device for the measurement and automated recording of
ejaculation time, into a clinical programme using time to ejaculation as a
primary endpoint. The use of PSD401 to measure time to ejaculation introduces a
new level of accuracy over the traditional method of measurement using a hand
held stop watch. A similar agreement was entered into with Johnson & Johnson in
2005.

Plethora recently published the successful conclusion of development trials on
PSD401. (Dinsmore et al (2006) BJU Int, 98; 613-61). These trials, monitoring
both healthy volunteers and patients suffering from Premature Ejaculation (PE),
established the reproducibility, efficacy and safety of the product and the
ability to discriminate between healthy patients with 'normal' latency times and
PE sufferers.

Dr. Mike Wyllie, CSO of Plethora, commented; 'We are delighted that another
leading pharmaceutical company has selected PSD401 for use in their development
of treatments for sexual dysfunction. This second agreement demonstrates clearly
that PSD401 can be a valuable aid to clinical development within major
pharmaceutical companies and is a key component in our commercialisation of the
product.'

As well as working with pharmaceutical companies that utilise the product in
clinical development and marketing programmes for drugs for the treatment of PE,
PSD401 will ultimately be used by the urologists, andrologists, other relevant
specialists and primary care physicians who are responsible for the diagnosis
and management of the large PE patient population. For this purpose, Plethora
has obtained both European and US marketing approval for the device, which will
be marketed through its subsidiary, Timm Medical. The recent 510K approval for
marketing of the device should also expedite acceptance in the US as a front
line diagnostic system. In this context, many of the key sexual health opinion
leaders in the USA are to take delivery of PSD401s in Q1 2007

In the expanding sexual health market, PSD401 complements Plethora's therapeutic
product PSD502 for the treatment of PE which is about to enter phase III
clinical trials once on-going partnering discussions are finalised.


-Ends-

Definitely good news today, and that's one thing you can say about PLE, is that there is a steady trickle of good news and product updates.

A slightly muted response from the market, though - only 8,805 shares traded so far today, but I guess until the big deal comes through, this may be travelling below many poeples' radar.

PLE Bid: 198p Offer: 205p Change: 3.5

Navajo -good point
Todays news is great -they have stated that more large pharmas are to take delivery of PSD401 - means more product revenues -thats what we want to hear.
Notice they haven't stated the Pharmas name or deal amount -I wonder if its the same company who they will announce the deal for PSD502 with? interesting.

PSD401 is apparently due for many deliveries in Q1 2007.

BTW, Hondaman, since you asked me for tips: Just want to let you know I have been persuaded to join the GTL club. This is the ethanol producer - they have big plans for growth and will soon be producing far more than RVA, which currently has a bigger market cap. New plant due to start commercial production in early December; capacity will then double as they extend the plant over the following year or so, plus they want to build a further three plants. Shares Mag has tipped it consistently this year.

Prospects for growth look excellent, but please DYOR, etc.

Anyone think this company will produce a deal by Christmas?

The suspense is killing me.

RNS out on 4th Dec - I missed it because I was too busy watching SOLA, but it's more good press for PLE!

Plethora Solutions - Product Update - ErecAid
RNS Number:2428N
Plethora Solutions Holdings PLC
05 December 2006


PLETHORA SOLUTIONS HOLDINGS PLC

Product Update

Osbon ErecAid(R): Use of ErecAid after Radical Prostate Surgery reduces
incidence of penile shortening.

Plethora Solutions Holdings plc ('Plethora', AIM: PLE), the specialist developer
of products for the treatment and management of urological disorders, notes the
publication of new research that shows that regular use of the Osbon ErecAid(R)
product marketed through Plethora's US subsidiary, Timm Medical, can reduce the
incidence of penile shortening in men recovering from prostate cancer surgery; a
procedure known as radical prostatectomy ('RRP').

An estimated 235,000 American men will be diagnosed with prostate cancer in 2006
(1), of which approximately 25% will be treated by having their prostate
surgically removed via a radical prostatectomy. Consequent tissue and nerve
damage and scar formation can lead to temporary or sometimes permanent loss of
erectile function and changes in penile dimension. Penile shrinkage occurs in
more than two-thirds of men undergoing radical prostatectomy, with reductions in
length of more than 1cm reported in almost half of men three months after
surgery(2),(3)

In a paper entitled 'Preservation of Penile Length After Radical Prostatectomy
(RRP): Early Intervention With a Vacuum Erection Device (VED)' presented at the
7th Annual Society of Urologic Oncology on December 1, 2006, Dr. Bruce Dalkin
reported that of the 28 men recovering from radical prostatectomy who made daily
use of the Osbon ErecAid(R) vacuum system, only one experienced a reduction in
penile length greater than 1cm. Of the four patients who did not make daily use
of the vacuum system, three experienced a reduction in penile length of more
than 1cm. The incidence of penile shrinkage in the experimental group of 3.5%
compared favorably to 48% incidence of penile shortening after RRP reported in
historical controls(2).

The study concludes that '...early intervention with VED should be recommended
in all potent men undergoing nerve-sparing RRP to preserve penile length.'


Dr Steven Powell, Plethora CEO, commented:

'The Osbon ErecAid(R) is frequently prescribed for patients for whom oral drugs
are ineffective treatments for erectile dysfunction. This new research
highlights the potential for the ErecAid(R) device to play a significant role in
minimising the impact of radical prostate surgery on a patient's quality of
life.'

--------------------------
(1) American Cancer Society 2006

(2) Munding MD, Wessells HB, Dalkin BL.Pilot study of changes in stretched
penile length 3 months after radical retropubic prostatectomy. Urology 2001;58:
567-93

(3) Savoie M, Kim SS, Soloway MS.A prospective study measuring penile length in
men treated with radical prostatectomy for prostate cancer. J Urol2003; 169 :
1462-44

-Ends-

chart is far from encouraging ..... on that basis, i would not be a buyer

It's the potential for a Phse III trials deal and/or takeover that makes this one appealing.

You might not like the shares, but are you able to provide a product review?? ;o)

nope .... never even heard of the company

:o)

wish I had bought SOLA -nevermind -I can see Plethora doing the same -broker has already given a target of 5+ on Plethora but I can see this going well above that because all their products have been given FDA approval whereas top Pharmas are struggling to get this which puts Plethora in a great position.
Their products have billions of market potential. I reckon by end of 2007 this company will be bought out and I am putting a 10 tag/share based on fundamentals. They have a revenue stream from Timm Medicals.
Neutech Pharma was bought out at 10+ and there are many similarities in number of shares in issue etc. I am happy with the top guys in the management as they know their stuff and have worked in top Pharmas and have the right connections.The top PLE scientist has 80 Patents+ to his name including Viagra which he commercialised at Pfizer.
I am gonna sit tight -see you all on deal news which I expect will double the price and more onwards. I still expect before year end although am happy whenever it arrives as the deal can only get bigger.

soul traders I wish you had forced me to buy some SOLA shares at 2 or so!!!
Infact did you buy any for me?

Honda, I did buy some for you, but as I was on the way to deliver them to you, I sold them for myself :o)

LOL!!

A disappointing year in terms of progress in the shareprice.
Although looking at the fundamentals especially with Timm Medicals and PSD401 bringing in great revenues this will do itself justice next year with the news data from so many products and with licensing deals. No doubt they want to do a deal to speed up phase III of PSD502 ,also the PSD502 product can now be licensed as an asset as it has wound pain relief application as well as for PE so any deal for the asset will be large no doubt.
Next year will be very interesting imho and in the next results they should be in profit and with the deal well well above in profit. The top man Mr Evans of Merlin Sciences has also stated that Plethora Solutions will certainly be one of the companies that will be taken over by cash rich USA Pharmas.
I shall wait for that bid can't see it being less than 10 meself and that'll be worth the wait.

It would be great if they could pull their finger out . . . !!

(Yawn)

RNS out today:

Plethora Solutions - Clinical Update
RNS Number:9118Q
Plethora Solutions Holdings PLC
08 February 2007


PLETHORA SOLUTIONS HOLDINGS PLC

Clinical Programme Extension - Plethora initiates parallel study for PSD597 as
analgesic therapy in urogynaecological procedures.

Plethora Solutions Holdings PLC ('Plethora', AIM : PLE), the specialist
developer of products for the treatment and management of urological disorders,
announces the initiation of a new clinical programme in an additional clinical
indication for PSD597, a novel therapy under development for the treatment of
interstitial cystitis and painful bladder syndrome (IC/PBS).

Following positive feedback from the clinical centres involved in its existing
IC study, Plethora has, in parallel, initiated a second study to demonstrate
efficacy of the product as an analgesic therapy in urogynaecological procedures
such as cystoscopy and bladder biopsy. These procedures are often performed
currently in the absence of any analgesic agent. As a result of its fast onset
of action, PSD597 may bring immediate pain relief to these patients during this
short procedure. It has been estimated that at least 62,000 Americans undergo a
bladder biopsy each year to confirm the presence of bladder cancer, while over
150,000 women undergo hydrodistension procedures for IC/PBS. Recruitment is
already under way in five centres in this second PSD597 study, which is
scheduled to report in the first half of 2007.

PSD597 is currently undergoing a Phase II clinical study in North America to
demonstrate its efficacy in the treatment of interstitial cystitis; a chronic
syndrome characterised by bladder pain and increased urinary frequency and
urgency. A self-reported survey of American households indicated that almost 1%
of women had received a diagnosis of IC/PBS suggesting that there are at least
900,000 female sufferers in the USA alone. Current treatments for IC/PBS are
limited in their effectiveness. The objective of the ongoing clinical programme
is to provide additional confirmation of the findings from two pilot studies in
which PSD597 was shown to provide immediate, effective and long-acting symptom
relief in these major, poorly-controlled, debilitating conditions. Recruitment
in this current Phase II study is on track to report results in the first half
of the year.

Professor Alvaro Morales of Queens University, Ontario, Canada commented:
'Based on the degree of benefit and duration of clinical effect emerging in the
current IC study together with the results of the previous two previous studies,
PSD 597 could be of considerable benefit to patients suffering not only from
chronic IC and bladder pain but also in this second area of un-met clinical
need'.

Dr Steven Powell, Plethora CEO, concluded:
'Existing, published clinical data for the efficacy of PSD597 in the treatment
of IC is promising and we have already received a strong level of interest in
this product from potential partners. The development path for the new,
additional indication is short as the product would be used in an acute setting
with no long term safety issues. We may therefore be in a position to consider
retaining marketing rights to the second indication whilst continuing partnering
discussions around the primary, IC/PBS indication'.

-Ends-

Plethora seems to be good at finding secondary applications for its products. The new application for PSD597 ought to be a winner in market terms, IMO, as long as the drug itself is proved safe and effective.

It would be nice to hear news of a deal on the PE treatment, though!!

WDIK, PDYOR, etc.

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-

Nav, well done for beating me to the post!

Good news - and about time we had an update, too!

With 20 centres in the US and another 20 in Europe, there is clearly quite a lot of work involved with the Phase III trial, so maybe that explains the delay.

Hope to see this rocket when the partnership deal is announced.

PLE Bid: 180p Offer: 187p Change: 3 Only 7,000 or so traded, though.

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

Plethora Solutions - Holding(s) in Company

RNS Number:8591S
Plethora Solutions Holdings PLC
13 March 2007


Plethora Solutions Holdings plc ('the Company')

Holding(s) in Company

The Company was notified on 12th March 2007 that AMVESCAP plc has an interest in
1,315,056 ordinary shares representing approximately 5.09% of the issued share
capital of the Company.

The shares are held as follows;
Chase Nominees 769,315 shares 2.98%
Vidacos Nominees 545,741 Shares 2.11%

13th March 2007

Up 2p today: PLE Bid: 172p Offer: 175p Change: 2 on almost 11K traded.

Three RNS's released on 21st March announce the following large shareholdings:

New Star Asset Management:

Number of voting rights % of voting rights


2,263,479 8.63


Fidelity's FMR Corp:

Number of voting rights % of voting rights


431,818 1.65


Fidelity International Limited:

Number of voting rights % of voting rights


634,100 2.42


The RNS's did not say whether these fund managers had increased or decreased their holdings, but all three are known for not messing around, so IMHO we can be encouraged that they are holders.

PDYOR/WDIK, etc.

Off a bit this morning: PLE Bid: 166p Offer: 173p Change: -4

amazing given that only 2,183 shares have been traded.

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-

PLE Bid: 153p Offer: 160p Change: 3 - Only 500 traded, though!

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

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

Patience always pays off with good stocks!

Hondaman, well done with the posts. I just hope that this will prove to be a good stock, as my patience has been a little bit tried over the past few months!

I wonder how big the PSD502 deal actually is . . . .

However, it's definitely a good sign that Sciele paid 2 a share for its equity stake.

I think another good sign is that PLE is meeting with analysts once its results are published. Clearly the co thinks it can provoke a rerating.

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.

And they have a good deal with MLR

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!!!

I have my doubts as to whether we'll learnt the terms of the deal. Why did PLE not announce them today?

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.

MM's have woken up -they are buying now -ready for next week and beyond!

Up again today: PLE Bid: 174p Offer: 181p Change: 2.5

Dumped this and bought HAWK. Have spent too long waiting for PLE to do something spectacular on the back of the PE product deal, which it hasn't done. Will watch and see how increased revenues affect this in the future, but am on the sidelines for now.

Good luck to holders.

does anyone understand why PLE has moved to FTSE AIM 50??

watch PLE watch MLR

watch PLE - based on??

The fact that a 100% of males, real males that is, not whimpish poofters, want a hard on and only about 75%(BMJ) are able to.

It's about half the sp when you posted David10B - what can you suggest is the reason? . . . . I agree that this appears to be a product men would give their rt arm for (almost), yet now it's at an all-time low - although not that low I'm tempted to buy for "recovery". This slide looks like carelessness - eyes-off-balls etc.

I note that a PhIII-trial is to start for premature ejaculation - something like the hullabaloo over the SP a few years ago....Maybe it's the "Jam tomorrow" problem over again...

EDIT(17Nov08)-16p/19p . . . As I read it, the erectile product is a vacuum-device, whereas I was believing this company was offering a drug-pased product. Doh! - this was 1 only last November!
- Anyone? -

LONDON (ShareCast) - Plethora Solutions (LSE: PLE.L - news) is definitely a small cap stock to watch and in an exclusive interview with Sharecast, Daniel Stewart analyst Vadim Alexandre has reiterated the bull case for the biotech tiddler.

Plethora Solutions has a drug, PSD502, aimed at treating premature ejaculation, which has passed two phase III trials and is currently awaiting European approval. This approval is expected late in the third quarter or early fourth quarter of 2013.

Importantly, it announced at its interims on December 28th that talks "had commenced with multiple parties to identify a commercial partner to bring PDS502 product to market.

Alexandre believes the stock is "grossly undervalued" and has placed a price target of 15.7p on it, 214% upside on its current 5p price.

Now, as house broker you might perhaps expect him to be keen on the stock but he's positively enthusiastic, while noting that its closing cash balance at the interims was only £0.2m, which means: "We estimate that the company will need to secure further financing."

He's confident that the next 12 months will see the transformation of the company, with the signing of a deal probably before EU approval, as any partner would have to factor in a ramp-up period prior to the product's launch. With that deal would come some sorely needed funds.

With an estimated 30m European men as potential targets for this treatment it may be a compelling investment case.

Alexandre thinks it is: "We believe that PSD502 has the potential to 'go mass market'. Should this transpire, our estimates of the treatment's market potential would be significantly increased. That said, even if the treatment achieves a fraction of this market penetration, Plethora's business would be substantially transformed."

For those of a cautious disposition, who like to invest in well-funded companies, it might be worth holding off until any deal is announced. Yet, the fact that billionaire Jim Mellon, a non-executive director of the company, has been funding the company in return for shares, ought to offer some reassurance for those prepared to gamble on this biotech play.

:-))

Tipped in this weeks share mag. Analysts at Daniel Stewart carry a 15.7p target price in the view strong sales growth and expected launch of the new drug could ''substantially'' transform the business. Management expects European approval for PSD502 in the second half of 2013. The drug has completed two phase III trials and could be launched in the first half of 2014.

I'm in as of earler today...anyone else still in ? any views?

SP up a bit this morning... all looking good so far!

Doing ok for now..just waiting for the good news

Awesome! The good news has arrived... prelude to approval... looking good!

well done sky - in here myself also

a huge market awaits ple now and would suggest this will continue to trend north - many years of r&d in coming to rapid fruition here - great time to buy in & for any that like charts.....

http://www.barchart.com/quotes/stocks/PLE.LS

Looks good gibby and skyhigh.

Positive CHMP Opinion

RNS


RNS Number : 5437O

Plethora Solutions Holdings PLC

20 September 2013










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-

well done dc didn't realise you had these - and thanks - expecting much more here the global market is huge and affects normal peoples every day lives and not some mine or oil field in the middle of some war torn country somewhere

the latest ple personnel addition and other items strongly suggest take over at some point - personally holding out for a 3 figure sp especially after ema rubber stamping (but might sell some at 50p lols)

this is a very good buy in level and be interesting to see what Monday holds as most short term traders already exited Friday - likely they will be back but would suggest their re-buy price should be much higher
looking at the longer term though very good imo
cheers

looking vey good. :-))

good stuff dc - looking fwd to tomorrow & beyond - huge potential here........

Extract from an article in 2012:

From an inventor of Viagra, a spray to help love last beyond a moment

He put smiles on millions of faces when he helped invent Viagra. Now the brains behind the little blue pills claims to have done it again.

Mike Wyllie, one of the team of scientists who developed Viagra in the 1990s, has created a drug that tackles premature ejaculation.

He predicts the spray-on medication, designed to prolong the joy of sex for millions of sufferers and their partners, is likely to become ‘the next blockbuster’ drug.

Premature ejaculation affects more than one in four men – making it more common than the impotence tackled by Viagra. Most are too embarrassed to seek help and when they do, treatments are generally limited to powerful anti-depressants and counselling.

There is one pill specifically designed to treat the problem but it is expensive and not widely available in the UK. In contrast, it is hoped the spray, called Tempe, which could be on sale within months, will be cheap enough for prescription on the NHS.

In trials, some men using the spray ahead of sex lasted up to eight times longer. But the drug is generally thought to treble a man’s ‘staying power’.

Dr Wyllie, formerly of pharmaceutical giant Pfizer and now chief scientific officer of British biotech firm Plethora Solutions, calls Tempe his ‘new Viagra’.

It is as much appreciated by partners as by the sufferers,’ he said. ‘I feel in many respects the clinical data are as impressive as Viagra’s.’

Premature ejaculation can wreck self-esteem, make it difficult to form relationships and, at its worst, can make it impossible for partners to become pregnant. While the exact causes are unclear, it is thought over-sensitivity contributes to the problem.

Tempe contains low doses of two anaesthetics which help give a man more control, without creating an uncomfortable numbing sensation.

It takes about five minutes to get to work, but those who do not wish to give away their secret will be pleased to know it can be sprayed on up to two hours before sex.

A pocket-sized can will last a year, if a man has sex five or six times a month.

The average European man has staying power of six minutes, said Dr John Dean, an expert who helped run the trials. The drug is aimed at those who struggle to last a minute and is not thought to provide much extra time to those who do not have a problem.

Plethora Solutions is confident its application for a licence to sell Tempe across Europe will be approved, meaning the drug could be on sale by autumn next year. Dr Wyllie, who is also assistant editor of the British Journal of Urology, said: ‘It could be the next blockbuster, the potential is enormous.’

:-)) thanks for that info.

Patience is needed with these drug companies. A huge risk in the early days but if all the phases/tests go in the companies favour there is huge reward for the shareholders. A few of them starting to show good potential.

dc the wait is over now which is why ple flying - gl

in the newspapers this is going to be huge as affects real people everywhere globally from the inventor of Viagra now working for ple:

daily mail

http://www.dailymail.co.uk/news/article-2429658/The-inventor-Viagra-gives-men-new-lift-Man-sex-wonder-drug-creates-spray-combat-premature-ejaculation.html#ixzz2fhBNEJj3

PUBLISHED: 00:19, 23 September 2013 | UPDATED: 00:20, 23 September 2013






89 shares

5

View
comments


Help: The Tempe spray could be in bathroom cabinets as early as next year
Help: The Tempe spray could be in bathroom cabinets as early as next year

He has already helped prevent millions of men from flopping in the bedroom.

Now one of the inventors of Viagra claims to have a drug that will help many more experience the joy of sex.

Mike Wyllie, one of the team of scientists who developed Viagra in the Nineties, is poised to launch a treatment for premature ejaculation.


Tempe, a spray-on medication, has been judged safe and effective by the European Medicines Agency and is expected in bedroom cabinets early next year.

Premature ejaculation is a problem that affects at least one in four men, making it more common than the impotence caused by Viagra.

In trials, men who used the spray ahead of sex lasted on average five times longer.

Women also benefited from longer love making, with both sexes expressing greater satisfaction with their sex life.

Dr Wyllie, formerly of pharmaceutical giant Pfizer and now of small British biotech firm Plethora Solutions, said: ‘Premature ejaculation doesn’t just make the patient feel bad.

‘It does affect the partner and can completely destroy relationships. I feel this could save relationships.’

Premature ejaculation can wreck self-esteem, make it difficult to form and maintain relationships and, at its worst, can make it impossible for partner to become pregnant.

Despite its toll, there is just one pill specifically designed to tackle the problem but it is expensive and not widely available in the UK.

The exact causes are unclear but it is thought over-sensitivity is part of the problem.

The Tempe spray contains low doses of two anaesthetics which help give a man more control. It only takes around five minutes to get work, although those who like to be spontaneous will be pleased to know it can be sprayed on up to two hours before sex.




More...
Revealed, the sleepy country town that has been named the Viagra capital of England
Why is the NHS ignoring erectile dysfunction when it is the number one sex problem for men?


A pocket-sized can will last a year, if a man has sex five or six times a month.

However, some of those who tested the drug experienced side-effects, including burning sensations and headaches.

And some fear that using a drug as a ‘quick fix’ will prevent couples from confronting the stress, anxiety and relationship troubles that could be at the heart of the problem.


Research: Dr Wyllie helped develop Viagra, pictured, which made £1.3billion worldwide last year
Research: Dr Wyllie helped develop Viagra, pictured, which made £1.3billion worldwide last year


Tempe will only be available on private prescription initially. But it is hoped that it will be judged cheap enough in the long-run to be prescribed to some men on the NHS.

With sales of Viagra worth £1.3billion a year worldwide, the new drug has the potential to be a blockbuster.

However, Dr Wyllie will not receive any royalties from the sales and only has a very small holding in Plethora Solutions.

He says he was motivated by scientific curiosity and that the launch will be a triumph for a small British company that lacks the manpower and resources of the big players in the market.


Tempe’s preliminary approval for sale EU is expected to be rubber-stamped by the European Commission in the next few weeks.

John Dean, one of Britain’s leading experts on male sexual problems and a past president of the International Society for Sexual Medicine, said: ‘Whilst premature ejaculation is not a life-threatening condition, its consequences can be serious.

‘This is a chronic, debilitating problem, affecting both men and their partners.’


Read more: http://www.dailymail.co.uk/news/article-2429658/The-inventor-Viagra-gives-men-new-lift-Man-sex-wonder-drug-creates-spray-combat-premature-ejaculation.html#ixzz2fhDFTW4H
Follow us: @MailOnline on Twitter | DailyMail on Facebook

Another good day

Plethora Solutions (LON:PLE) is still very much in the sights of small cap investors. Today, punters were speculating about a possible takeover from drug giant Pfizer following Friday’s news that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given its treatment for premature ejaculation their seal of approval.

The AIM-listed company received a “positive opinion” from the committee for PSD502 in one of the last few steps before marketing authorisation is granted by the European Commission (EC).

The decision will be reviewed by the EC, which has the power to give medicines the green light in Europe. It thinks a final decision will arrive shortly from the EC – typically around 60 days after a CHMP recommendation.

Before todays rise -


Plethora Solutions Plc (PLE): Target Towards 12p

http://www.directorstalk.com/plethora-solutions-plc-ple-target-towards-12p-despite-recent-gains-chart-and-commentary/

In shares today - watch the cash position as they are burning it.

INTERIM RESULTS FOR SIX MONTHS ENDED 30 JUNE 2013

RNS


RNS Number : 1858P

Plethora Solutions Holdings PLC

30 September 2013












PLETHORA SOLUTIONS HOLDINGS PLC

("Plethora" or the "Company")

INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2013



Plethora is pleased to announce its interim results for the six months ended 30 June 2013.



Highlights



· Refocusing of business solely on PSD502



· Successful placing raising £2.1 million together with debt restructuring



· Now responsible for regulatory and commercial development of PSD502 globally



· Strengthening of Plethora board



· A CHMP positive opinion in relation to PSD502 approval for European Union in September 2013



Ronald Openshaw, CEO of Plethora said:



"2013 has so far been an exceptional year for Plethora, We have focussed the Group's full effort on PSD502; expanded our geographic interest in the product; commenced work on the filing with the FDA in the United States and achieved a milestone in the European regulatory process. Our efforts are to ensure that PSD502 is brought to market to ease the distress of so many couples".





- Ends -

Moving up nice, on a poor markets day.

probably reverse a bit more as from 20th September it is approximately 60 days after a CHMP recommendation to final decision - then imo watch it really fly on receipt of that

Up 11%

UPDATE - Plethora Solutions' cash call supported by institutions
By Giles Gwinnett October 15 2013, 4:51pm It will also provide working capital to continue the group's partnering activities for the commercial launch of PSD502, it saidIt will also provide working capital to continue the group's partnering activities for the commercial launch of PSD502, it said

Plethora Solutions (LON:PLE) is to raise £4.4mln to advance its treatment for premature ejaculation.



The company is issuing 49mln shares that will be purchased at 49p a pop, primarily by institutional investors, including funds associated with Jim Mellon, Plethora’s non-executive chairman.

Shares in Plethora closed at 11.13p the day before the share issue was announced.

"The proceeds of this financing will be used to complete the last steps of regulatory approval in the Europe, but importantly will fund the filing and prosecution of a New Drug Application (NDA) with the US Food and Drug Administration (FDA),” the company said in a statement.

It will also provide working capital to continue the group's partnering activities for the commercial launch of PSD502, it said.

The company disclosed that 22.33mln shares will be available through subscription, raising £2.0mln; of this, £1.8mln will come from entities associated with Jim Mellon. A further £100,000 will be subscribed to by other directors, including chief executive Ronald Openshaw, chief scientific officer Professor Michael Wyllie and non-executive director Dr Greg Bailey.

Institutional investors will sign up for 26.7mln shares to raise £2.4mln.

"Over the last few months Plethora has delivered the agreement to control global development and commercialisation of PSD502 and the positive opinion from the CHMP. Based on the positive effect on the company's valuation we have secured the resources to execute our near term strategy of seeing approval of PSD502 and generating a financial return to shareholders," Openshaw said.

This is looking good for the next fw months..potential for the share of 2014! (imho, dyor!)

another very good day - likely to end the week circa 20p
gl

onwards & upwards :-0

Hopefully see this pick up again from November onwards. Could be truly amazing.

Up 13.5%

Up 22%

Closed up just under 26%

hope you are in dc - another fantastic day
atb

:-))

looking strong before eu approval rubber stamping rns now the merlin overhang cleared

Directors dealings - (Buys) -

Chairman J Mellon 20,000,000 £1.8 million 1Nov

ce and cfo R Openshaw 333,500 £30,015 1 Nov


Dr. GH Bailey 55,600 £5,004 1 Nov


Dr. MG Wyllie 333,500 £30,015 1 Nov



All Dealings at 9p

FULLY APPROVED RNS CONFIRMS - GOING TO BE A MAD RUSH THIS MORNING................. kerrrrrrrrrrrrrrrchinnnnnnnnnnngggggggggggggggggggggggg


RNS


RNS Number : 3479T

Plethora Solutions Holdings PLC

19 November 2013








19 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

European Commission Approval





Plethora Solutions Holdings plc (AIM: PLE) announces that the European Commission has granted marketing authorisation for the Company's treatment for primary premature ejaculation in adult men under the name 'Prilocaine Lidocaine Plethora'. This product is also referred to by the Company under its development code PSD502.



PSD502 was developed by the Company for the treatment of primary premature ejaculation and demonstrated a highly statistically and clinically significant improvement in the primary measures of intravaginal ejaculation latency time (IELT), control and satisfaction in two pivotal, double-blind, placebo controlled phase III studies. In these studies, the product was shown in over 23,000 exposures to be well accepted by patients.



Premature ejaculation is probably the most prevalent sexual dysfunction in men. The condition has been characterised by the International Society of Sexual Medicine (ISSM) as being "a male sexual dysfunction" characterised by: ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy.



The Company estimates that there are in excess of 150 million men aged between 20-69 years old in the European Union. With an estimated incidence of PE of 20-30% of men, this implies that the potential population of men in the EU with the disorder is approximately 30-45 million.



Jim Mellon Chairman of Plethora said:



"Plethora was founded in 2004 to develop PSD502; in 2011 the Company regained control of the European approval process and PSD502 has now been approved by the European Commission. In August this year Plethora regained global control of PSD502 and work is well underway to file with the FDA in early New Year. We are delighted by today's news that represents an important step in the successful commercialisation of the product. Premature ejaculation can cause serious distress for those men who suffer from the condition and we hope that PSD502 will help them and their partners"

UPDATE - Plethora Solutions granted EU marketing approval
By Jamie Nimmo November 19 2013, 12:40pm The company estimates 30-45mln men between 20 and 69 years old in the EU suffer from premature ejaculationThe company estimates 30-45mln men between 20 and 69 years old in the EU suffer from premature ejaculation

--ADDS SHARE PRICE, BROKER COMMENTS--

Plethora Solutions’ (LON:PLE) treatment for premature ejaculation has been granted marketing authorisation by the EU’s executive body, the European Commission (EC).

In September, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) advised the EC to approve PSD502, which will go under the name ‘Prilocaine Lidocaine Plethora’.

The company estimates 30-45mln men between 20 and 69 years old in the EU suffer from the sexual dysfunction.

Chairman Jim Mellon said: “Plethora was founded in 2004 to develop PSD502; in 2011 the company regained control of the European approval process and PSD502 has now been approved by the European Commission.

“In August this year Plethora regained global control of PSD502 and work is well underway to file with the FDA [US Food and Drug Administration] in early New Year.”

He continued: “We are delighted by today's news that represents an important step in the successful commercialisation of the product.

“Premature ejaculation can cause serious distress for those men who suffer from the condition and we hope that PSD502 will help them and their partners.”

Broker Daniel Stewart estimates that the group could receive approval to the US market in the second half of 2015.

It lifts its target price from 15.7p to 18.9p to reflect the lower risk associated with investing in the company now it has secured the EC approval.

“Finally, we reiterate our belief that PSD502 has the potential to go mass-market,” said the broker, which believes such an outcome would transform Plethora into a “large business”.

Plethora’s shares spiked in early deals but settled 3% higher at 17.1p. They have risen over 1,000% in the past six months.

good post dc - ple is looking a good buy in level right now - also tipped in the daily mail this morning

gl

Commercial Update

RNS


RNS Number : 6850T

Plethora Solutions Holdings PLC

22 November 2013










22 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")


Commercial Update





Plethora Solutions Holdings plc (AIM: PLE) provides a commercial update following the announcement on 19 November 2013 of the approval of PSD502, (under the name 'Prilocaine Lidocaine Plethora') by the European Commission.



As part of its disciplined approach to increasing shareholder value, it remains the Company's strategy that PSD502 will be brought to market via partners with the sales, marketing, and distribution infrastructure to maximise the commercial potential from the product.



During 2013, the Company expanded its business development activities by retaining external consultants with expertise in identifying and securing licensing partners and in negotiating these transactions. Since the appointment of these consultants, business development activity has increased significantly. The Company is engaged in dialogue with multiple parties, including major pharmaceutical companies, for a launch of the product, with the initial focus being on the markets within the European Union, the United States (subject to regulatory approval) and other selected territories.



Given the nature of licensing talks, it is not possible to determine with accuracy the timing of completing such agreements, nor to give guidance on the terms thereof. The Company is, however, confident that given the number of parties with which it is talking and the nature of those talks, one or more partners will be secured to lead to a successful commercialisation of PSD 502.



Concurrent with and based on feedback from the licensing activities, the Company is finalising its manufacturing strategy and has identified the lead manufacturer. Plethora will not manufacture the product directly but will either have the product manufactured by a subcontractor or license manufacturing to the marketing partners. In addition, the Company has used this opportunity, at the suggestion of several potential marketing partners, to initiate the development of a canister containing fewer doses. This has been undertaken to develop the marketed product on a cost basis that will maximise the commercial return. The timing of the availability of product will drive eventual launch dates ranging from mid to late 2014.





In addition to the European commercialisation, the Company has significantly advanced its preparation for the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA). The Company believes that the commercial potential in the US is at least as great as that in Europe. Over the coming months, the Company anticipates, as it did with the European filing, to announce progress along various steps with the US approval process.



The Company will provide further commercial updates as matters develop.



Jim Mellon Chairman of Plethora said:



"The European approval is terrific news for the Company and in it delivering shareholder value. The board is committed to the delivery of commercial value at the earliest opportunity in 2014. This will be driven by the establishment of the most lucrative commercial partnerships with licensing partners, where the Company would typically expect to receive significant upfront and milestone payments, before royalties are earned on eventual product sales. The Company intends to see the launch of PSD502 at the earliest possible opportunity."





-Ends-

Plethora Solutions in talks with pharma majors over product launch
By Jamie Nimmo November 22 2013, 7:36am Plethora says these partners will have the sales, marketing and distribution networks to “maximise the commercial potential from the product”Plethora says these partners will have the sales, marketing and distribution networks to “maximise the commercial potential from the product”

Plethora Solutions (LON:PLE) has revealed it is in talks with a number of parties, including major drugmakers, over the launch of its treatment for premature ejaculation.

The AIM-listed company has just been given the go-ahead to launch the treatment across Europe and it says it is still planning to enlist the help of partners to bring PSD502, under the name ‘Prilocaine Lidocaine Plethora’, to market.

It says these partners will have the sales, marketing and distribution networks to “maximise the commercial potential from the product”.

This year, it has recruited external consultants to negotiate such a deal, with the initial focus on the European and US markets.

Despite cautioning on the timing and details of a deal, the company said it is confident that “given the number of parties with which it is talking and the nature of those talks”, one or more partners will be secured.

Plethora added that it has identified a lead manufacturer of the product and has pencilled in a launch date ranging from mid-to-late 2014.

Chairman Jim Mellon said: “The European approval is terrific news for the company and in it delivering shareholder value.

“The board is committed to the delivery of commercial value at the earliest opportunity in 2014. This will be driven by the establishment of the most lucrative commercial partnerships with licensing partners, where the company would typically expect to receive significant upfront and milestone payments, before royalties are earned on eventual product sales.

“The company intends to see the launch of PSD502 at the earliest possible opportunity,” he added.

this has been three bagger for me so far...lots more to come! (imho)

Resignation of CEO

RNS


RNS Number : 1272U

Plethora Solutions Holdings PLC

28 November 2013








28 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Resignation of CEO





Plethora Solutions Holdings plc (AIM: PLE) announces that it has agreed with Ronald Openshaw that he will step down from the board and resign as Chief Executive Officer on 30 November 2013. Ronald has concluded that he wishes to devote his time to his consulting firm Lucia Capital LLP.



Ronald commenced his involvement with Plethora in early 2009 when he became interim CFO. In 2009 he led the Company's efforts to restructure its debt obligations which concluded with the Termination and Release Agreement with Paul Capital and the full repayment of the loans to ETV Capital.



At the beginning of 2011, Ronald was appointed the Company's CEO following the serious illness of the previous CEO.



In 2011, Ronald negotiated the first agreement to return economic and operational control in Europe and the Rest of the World (excluding certain territories) to PSD502, the Company's treatment for premature ejaculation, from Shionogi. Concurrent with that transaction a fundraising was completed which was corner-stoned by Jim Mellon, now the Company's Chairman. That agreement paved the way for the submission of the European dossier to the European Medicines Agency for the centralised approval of PSD502. On 19 November 2013, the Company announced that the European Commission had granted a marketing authorisation for PSD502 under the name 'Prilocaine Lidocaine Plethora'.



In August 2013, Ronald concluded the agreement with Shionogi for the return of the economic and operational control for the remaining rights to PSD502 in North America, South America, Japan, Korea, Taiwan and China. This will lead to the submission in 2014 of a New Drug Application to the US Food and Drug Administration. Following this and the CHMP opinion Ronald co-ordinated a financing to raise £4.4 million which was announced in October 2013.



Following Mr Openhaw's resignation, the board has asked Mike Collis to act as Chief Financial Officer on a part time basis with effect from 1 December 2013. Mr Collis was appointed to the board on 9 September 2013 as a non-executive director. In addition, Romero Tayong will be appointed as Company Secretary. Mr Tayong is the Company's Financial Controller and has worked with the Company since 2008. He is a Certified Accountant.



Jim Mellon, Chairman of Plethora said:



"The Company is indebted to Ronald who has led the financial restructuring of the business, the return of the global rights to PSD502 and the European approval of the product. Through his efforts, Plethora has been restructured and is now well financed to deliver upon its objectives of commercialising PSD502 on an international basis. We thank Ronald for his efforts and achievements and wish him well in his next ventures. In due course, the Company intends to further strengthen the management team and a further announcement will be made when appropriate."

Award of LTIPs & Issue of Ordinary Shares

RNS


RNS Number : 2242U

Plethora Solutions Holdings PLC

29 November 2013










29 November 2013



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Award of LTIPs & Issue of Ordinary Shares





Plethora (AIM: PLE) announces it has awarded shares in relation to the Company's Long Term Incentive Plan ("LTIP") and has issued new ordinary shares in Plethora in relation to a number of agreements.



LTIP Award to Prof Wyllie



Plethora has today made an award of 16.5 million new ordinary shares to Prof Mike Wyllie, the Company's Chief Scientific Officer, under the Company's LTIP established in 2009. The award is subject to the achievement of certain performance conditions in relation to the regulatory approval process of PSD502 in the US, the signature of licensing transactions, and the establishment of new or the extension of further intellectual property over PSD502. In addition, the award is subject to the continued employment or directorship of Prof Wyllie for the next three years.





Issuance of shares



Plethora also announces that it has allotted 6,279,407 new ordinary shares of 1p each ("New Shares"), fully paid conditional only upon admission, to trading on AIM in relation to:



(i) the issuance of 1,355,975 New Shares in connection with awards made in 2010 which have now matured under the Company's LTIP;



(ii) the issuance of 923,432 New Shares in settlement of directors fees due in relation to Jim Mellon and Mike Collis; and



(iii) the issuance of 4,000,000 New Shares as an award to Ronald Openshaw that would otherwise have accrued under the company's LTIP.



Application will be made for the 6,279,407 New Shares to be admitted to trading on AIM ("Admission") and it is expected that Admission will take place on 4 December 2013.



Following Admission, the Company will have 415,274,582 ordinary shares in issue. The Company does not hold any ordinary shares in treasury. Therefore the total number of ordinary shares in the Company with voting rights is 415,274,582.



The above figure may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the Financial Conduct Authority's Disclosure and Transparency Rules.







-Ends-

Plethora Solutions welcomes Jamie Gibson as new CEO

By Giles Gwinnett

December 20 2013, 3:51pm
He has spent most of his professional career working with Plethora chairman Jim Mellon at Regent Pacific Group specialising in corporate finance and direct equity investments



Jamie Gibson has been appointed the new chief executive at Plethora Solutions (LON:PLE) starting January 1.

Gibson, 47, is tasked with driving the commercialisation of the firm's treatment for premature ejaculation PSD502 and leading initiatives on manufacturing strategy.

He has spent most of his professional career working with Plethora chairman Jim Mellon at Regent Pacific Group specialising in corporate finance and direct equity investments.

Mellon said: "We welcome Jamie whom I have worked with at Regent Pacific for over 17 years; we wish him every success in his new role.

"We are extremely pleased to have such an experienced team lead our business development activities, which is part of the company's disciplined approach to increasing shareholder value through the successful commercialisation of PSD502."

Reading Shares - For a company Plethora's size the potential of its product is a crucial factor for investors when deciding to back the stock. The company has an offering larger companies would pay to own in their search to replace lost income.

Company update

RNS


RNS Number : 9983B

Plethora Solutions Holdings PLC

11 March 2014










11 March 2014



Plethora Solutions Holdings PLC

("Plethora" or the "Company")

Company update



Plethora (AIM: PLE) is pleased to inform shareholders that our recent meeting during Q1 2014 with the United States Food and Drug Administration ("FDA") has now unambiguously defined the path to a successful submission of the New Drug Application for PSD 502. Appropriate actions are well underway with the Company's various consultants. Importantly, the FDA has confirmed that premature ejaculation is an area of high medical need with a requirement for effective therapy and recognises the importance of the initiatives that Plethora has made towards this goal.

The Company sees a significant potential market opportunity for PSD 502 both in the United States and EU. Based on the Company's internal modeling and pricing input from its US marketing consultant, the Company forecasts in excess of US$1 billion per annum peak prescription sales. It therefore sees significant value in PSD 502 for the Company's shareholders and correspondingly, management is to looking to unlock that value as quickly as possible through bringing to closure negotiations with potential marketing partners. In this respect, the Company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories. Negotiations are at a more advanced stage with a number of potential marketing partners and the Company is hopeful that an announcement will be made in this regard over the coming months. However, shareholders should please note that given the nature of licensing talks, it is not possible to determine with accuracy the timing of completing such agreements, nor to give guidance on the terms thereof.

The Company is also making excellent progress with its preferred manufacturing partner and is hopeful that an announcement will be made within the next month.

Plethora Solutions eyeing US$1bn a year in sales

By Giles Gwinnett

March 11 2014, 8:46am
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales


Plethora Solutions (LON:PLE) shares raced up Tuesday as it reported positive progress in the USA for its lead product, PSD 502 for premature ejaculation.

The firm's recent meeting with the United States Food and Drug Administration (FDA) has now "unambiguously defined the path" to a successful submission for making a drug application for 502, said the company, which now forecasts more than US$1 billion per annum peak prescription sales.

Investors hailed the brief statement, sending shares up over 22% to 11 pence each.

The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant means it now forecasts more than US$1 billion per annum peak prescription sales.

The firm said it's looking to unlock value as quickly as possible through bringing to closure negotiations with potential marketing partners for PSD 502.

"In this respect, the company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories," it said.

Negotiations are at a more advanced stage with a number of potential marketing partners and Plethora said it was hopeful that an announcement will be made over the coming months.

"The company is also making excellent progress with its preferred manufacturing partner and is hopeful that an announcement will be made within the next month."
--------------------------------------------------------------------------------------------

UPDATE - Plethora Solutions eyeing US$1bn a year in sales

By Giles Gwinnett

March 11 2014, 5:46pm
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales
The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant, mean it now forecasts more than US$1 billion per annum peak prescription sales


--ADDS BROKER COMMENT--

Plethora Solutions (LON:PLE) shares soared on Tuesday as it reported positive progress in the USA for its lead product for premature ejaculation.

The firm's recent meeting with the United States Food and Drug Administration (FDA) has now "unambiguously defined the path" to a successful submission for making a drug application for PSD 502.

The AIM-listed company saw its shares jump 24% to 11.1p on the news.

The US is the world's biggest drug market and Plethora's internal modelling and input from its US marketing consultant means it now forecasts more than US$1 billion a year in peak prescription sales.

The firm said it is looking to unlock value as quickly as possible by bringing to a close negotiations with potential marketing partners for PSD 502.

“In this respect, the company has received several expressions of interest for out-licensing PSD 502 in the US, EU and other territories,” it said.

Negotiations are at a more advanced stage with a number of potential marketing partners.

“The company is also making excellent progress with its preferred manufacturing partner and is hopeful that an announcement will be made within the next month,” it added.

The shares have put on 550% since trading at just 2p a year ago amid funding issues.

Daniel Stewart lifted its target price on the stock from 18.9p to 25.6p on Tuesday, reducing its discount rate from 19% to 15% in its DCF (discounted cash flow) model now that the treatment is closer to being awarded US approval.

“We continue to see significant scope for reducing our conservative discount rate, and hence increasing our target price, as PSD502 further progresses through to US approval and commercial launch,” analyst Vadim Alexandre said.

Plethora Solutions: Daniel Stewart moves shifts target price from 18.9p to 25.6p and keeps a buy recommendation.

Another 10% today

UPDATE - Plethora Solutions secures manufacturing development partner for PSD502

By Giles Gwinnett

March 26 2014, 3:30pm
PSNW will generate data to vary the EU licence variation and complete work for the initial submission of the New Drug Application (NDA) with the United States Food and Drug Administration (FDA)
PSNW will generate data to vary the EU licence variation and complete work for the initial submission of the New Drug Application (NDA) with the United States Food and Drug Administration (FDA)


---ADDS BROKER COMMENT AND SHARE PRICE---

Plethora Solutions (LON:PLE) reached a further milestone in its commercialisation of its lead product - by securing a supply chain and manufacturing development partner.

Pharmaserve North West Limited (PSNW) will carry out the manufacturing for the new six dose canister of PSD502 for premature ejaculation.

PSNW will generate data to vary the EU licence variation and complete work for the initial submission of the New Drug Application (NDA) with the United States Food and Drug Administration (FDA).

Plethora reckons it will spend around £1mln on the manufacturing, including the supply of raw materials, to the end of 2014.

Chairman Jim Mellon told investors: "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."

PSNW is a leading manufacturing organisation, which specialises in the development and manufacture of metered dose inhalers (MDI's), dry powder inhalers (DPI's) and other pharmaceutical aerosols.

Following the announcement, house broker Daniel Stewart gave a 'buy' rating on the shares and repeated its target price of 25.6p.

On Wednesday, Plethora shares eased 0.94% to stand at 13.125p.

A good recovery rise of 17%

Stick with it folks!... and top up when you can! (imho & dyor)

Tally bally ho Huzzah and hoooorahhhhh!!

onwards and upwards north of 10p today

great news ;