(PLE) Plethora Solutions Hldgs
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| 23-01-12 | RNS |
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RNS Number : 9689V Plethora Solutions Holdings PLC 23 January 2012 23 January 2012
Plethora Solutions Holdings PLC ("Plethora" or the "Company")
Pre-Close Trading statement
Plethora announces a pre-close trading update for the year ended 31 December 2011.
Over the course of 2011, the Company has made very significant progress on a number of fronts towards meeting its strategic objective of becoming a leading urology and sexual health speciality pharmaceutical company.
Set out below are the key highlights of the year.
Strengthened balance sheet § Plethora completed two financing rounds in April and October 2011 raising £0.86 million and £2.05 million respectively. Also in October 2011, loan note holders converted £1.66m of convertible loan notes, resulting in a reduction in the company's borrowings from £3.46 million to £2.65 million during the course of the year.
Regained control of PSD502 for the treatment of premature ejaculation § In September 2011, the Company announced that it had entered into an agreement with Shionogi to regain operational and economic control of PSD502. Under this agreement, Plethora now controls the commercialisation of PSD502 in Europe and the Rest of the World (excluding the USA, Japan and certain Asian territories). Plethora has committed to execute the regulatory filing of PSD502 with the European Medicines Agency for centralised approval. § In December 2011, the Company announced that the European Medicines Agency had appointed the regulatory agencies of Spain and the United Kingdom as Rapporteur and Co-Rapporteur to review the regulatory dossier. In the same announcement, Plethora confirmed that the Company was on-track to achieve regulatory filing of the full dossier for approval in the first half of 2012.
Multiple product acquisitions for The Urology Co § Striant SR - in March 2011, Plethora announced that it had entered into an agreement with Columbia Laboratories to expand its relationship from being the UK distributor of Striant SR to licensing it for all European territories. Striant SR is a testosterone replacement product and has a unique patent protected (2019) delivery system. This agreement permanently embeds the value of this product into the Company and gives substantial scope for the geographic expansion of the business into continental Europe. § BioClin MultiGyn & MultiMam - in June 2011, the Company announced that it had become the UK exclusive distributor for the MultiGyn and MultiMam product ranges. The MultiGyn range treats a number of conditions causing vaginal discomfort and the MultiMam range treats discomfort experienced by the breast feeding mother. These products were previously launched in the UK and The Urology Co was chosen to grow UK sales. The Company took over distribution effective 1 September 2011. § Gepan-Instill - on 20 January 2012, the Company announced that The Urology Co had become the UK exclusive distributor for Gepan-Instill, a GAG-repair product for the treatment of chronic pelvic pain conditions including interstitial cystitis, painful bladder syndrome, radiation cystitis, and chronic recurrent cystitis.
Board Changes § In January 2011, the Company announced that it had appointed Richard Horsman as a non-executive and senior independent director of the Company. Mr Horsman was previously CEO of Cybit Holdings plc a company he grew and eventually sold in an MBI. § In January 2012, Plethora announced that Ronald Openshaw had been appointed CEO of the Company on a permanent basis. This follows his appointment as Interim CEO in February 2011 following the illness and subsequent departure of Dr Steven Powell. § In January 2012, the Company announced that it had appointed Jim Mellon as a non-executive director of the Company. It was also announced that Mr Mellon had an indirect interest in 10% of the capital of the Company. Mr Mellon is a renowned fund manager and is co-founder of Regent Pacific Group and Charlemagne Capital Limited.
Financial Trading Update
Revenues from The Urology Co for the year ended 31 December 2011 are expected to be in excess of £180,000 (unaudited) (H1 2011: £21,000 (unaudited), FY 2010: £33,000 (audited)). In the interim results statement, the Company highlighted that revenues had been slower to develop than had been anticipated. Revenues increased substantially in the fourth quarter of 2011, particularly in response to the distribution agreements for MultiGyn, MultiMam and Gepan-Instill and were approximately £120,000.
At 31 December 2011, the Company had cash resources of approximately £0.99m (H1 2011 £0.36k (unaudited), FY 2010: £0.76m audited). At 31 December 2011, the principal sum of total borrowings was £2.65m (H1 2011 £3.46m (unaudited), FY 2010: £3.46m audited).
The Company expects to announce its audited results for the year ended 31 December 2011 in March 2012.
Outlook
The Company's strategy has been to build a leading urology and sexual health focussed speciality pharmaceutical company. This business will generate revenue from products developed in house and licensed to third parties and from the sales of products via its subsidiary The Urology Co.
Work on the preparation for the filing of the dossier for PSD502 is now underway and the Company expects to submit this to the European Medicines Agency in the first half of this year. Our objective will then be to secure a major pharmaceutical company to lead the launch of the product in our territories and the focus will be to secure such a deal as soon as practicable.
The Urology Co's strategy has been to seek to launch products from its own R&D (i.e. Urolieve) or to acquire third party products either as a licensee or a distributor, particularly those with existing revenues in the UK market. The Company believes that the growth in revenue demonstrates that this strategy is now delivering results. Revenues for all products are showing growth and we look forward to seeing trading continue to increase. Over the course of 2012 our business development will continue to seek to secure additional products to drive revenue growth and in due course profitability.
Ronald Openshaw, Chief Executive Officer, said:
"2011 was a significant challenge for the Company and we are grateful to all shareholders who supported the Company in the fund raisings.
"Following the agreement with Shionogi in September 2011, we are delighted to report that the process for filing PSD502 with the EMA this year remains firmly on-track.
"Finally, we believe that the doubling in the trading revenue in the fourth quarter, compared to the first 9 months, demonstrates the strategy that Plethora can create a sustainable speciality sales and marketing business to drive the profitability of the group. Whilst only a few weeks in, we are encouraged that revenues continue to grow in 2012."
Enquiries:
About Plethora: Plethora is focussed on the development and marketing of products for the treatment of urological disorders. The Company isfocussed on: (i) driving the development of its speciality sales and marketing business, The Urology Company; and (ii) seeking to increase the value of its development assetsthe most advanced of which is PSD502 for the treatment of premature ejaculation.
Plethora's subsidiary, The Urology Company Limited, established in 2009, markets and distributes a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions. Its products fall into two categories (i) Professional - where a physician, nurse or other healthcare professional makes a prescribing decision and include Striant® SR, Urolieve®, Hyalofemme® and Dianatal®; and (ii) Consumer - where the consumer/patient makes a buying decision and include Hyalofemme®, Multi-Gyn®, Multi-Mam® and hI-Cran®.
The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk and www.theurologyco.com
This information is provided by RNS The company news service from the London Stock Exchange More |
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| 20-01-12 | RNS |
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RNS Number : 8851V Plethora Solutions Holdings PLC 20 January 2012 20 January 2012
Plethora Solutions Holdings PLC
Gepan® instill - New Product Acquisition
Plethora announces that its subsidiary The Urology Company Limited entered into an agreement with G. Pohl-Boskamp GmbH & Co. KG ("Pohl-Boskamp") to become the UK exclusive distributor of Gepan® instill.
Gepan® instill is a product to treat several chronic forms of cystitis including: · interstitial cystitis · overactive bladder · radiation cystitis and · chronically-recurring cystitis
Gepan® instill comprises an 80mg dose of chondroitin sulphate as a 0.2% solution in a 40ml pre-filled syringe. The solution is introduced into the bladder via a catheter and acts to repair the glycosaminoglycan (GAG) layer of the lining of the bladder. Gepan® instill is the only GAG replenishment product to be presented as a pre-filled syringe saving nursing time and increasing convenience.
It is estimated that up to 1.6 million patients in the UK currently suffer from interstitial cystitis, overactive bladder, radiation cystitis and chronically-recurring cystitis. These conditions have a major impact on a patients' quality of life and persist for many years. At present many of these patients are misdiagnosed or underdiagnosed and therefore do not receive adequate control of their symptoms and management of their conditions. It is estimated that on average a patient uses between 6 and 12 treatments for these various conditions, per annum.
In 2008, Nordling and van Ophoven published data from a multi-national, multi-centre, prospective observational trial regarding GAG replenishment therapy. They showed that after a course of three months 82% of patients gave a positive statement to the treatment with Gepan® instill(1) This cohort of patients is the largest studied to date in intravesical GAG replenishment therapy and provides compelling evidence for efficacy and safety.
The Urology Company has exclusive distribution rights for Gepan® instill. The product will be distributed through the channels built up by The Urology Company since its inception.
Ronald Openshaw, CEO of Plethora Solutions commented: "We are delighted to have secured the distributorship for Gepan® instill in the UK. This is an important product for the management of a serious condition with a significant unmet need. In the last few months we have seen growing interest and have expanded the usage of the product in the UK. "
Bodo Heibrock, Director of International Sales at Pohl-Boskamp said: "We have every confidence in the appointment of The Urology Company to meet patients needs in this distressing condition. We were convinced that their specialist focus in urology and their dedicated salesforce and the complementary nature of this product in their portfolio would help us to expand the population of patients treated with Gepan® instill."
References: (1) Nordling J, van Ophoven A. Intravesical glycosaminoglycan replenishment with chondroitin sulphate in chronic forms of cystitis. A multi-national, multi-centre, prospective observational clinical trial. Arzneimittelforschung. 2008;58(7):328-35.
-Ends-
Enquiries:
About Plethora: Plethora is focussed on the development and marketing of products for the treatment of urological disorders. The Company isfocussed on: (i) driving the development of its speciality sales and marketing business, The Urology Company; and (ii) seeking to increase the value of its development assetsthe most advanced of which is PSD502 for the treatment of premature ejaculation.
Plethora's subsidiary, The Urology Company Limited, established in 2009, markets and distributes a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions. Its products fall into two categories (i) Professional - where a physician, nurse or other healthcare professional makes a prescribing decision and include Striant® SR, Urolieve®, Hyalofemme® and Dianatal®; and (ii) Consumer - where the consumer/patient makes a buying decision and include Hyalofemme®, Multi-Gyn®, Multi-Mam® and hI-Cran®.
The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk and www.theurologyco.com
This information is provided by RNS The company news service from the London Stock Exchange More |
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| 06-01-12 | RNS |
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RNS Number : 0992V Plethora Solutions Holdings PLC 06 January 2012
6 January 2012
Plethora Solutions Holdings plc ("Plethora" or "the Company")
Board Appointment
The Company announces that James (Jim) Mellon has been appointed as a Non-Executive Director with immediate effect.
Jim Mellon, based in the Isle of Man, is a renowned fund manager. He began his career with GT Management in the US and in Hong Kong and later became the co-founder and managing director of Thornton Management (Asia) Limited, based in Hong Kong. He is co-founder of Regent Pacific Group and Charlemagne Capital Limited. He is currently chairman of Manx Financial Group Plc, Speymill Plc and Rivington Street Holdings plc, co-chairman of Regent Pacific Group Ltd and West African Minerals Corporation (formerly Emerging Metals Limited), a director of Charlemagne Capital Limited, Webis Holdings plc, Polo Resources Limited, Burnbrae Group Limited and various other investment companies. Mr Mellon holds a Master's Degree in Philosophy, Politics and Economics from Oxford University.
Mr. Mellon has an indirect beneficial interest in 20,000,000 ordinary shares of the Company, representing approximately 10% of the issued share capital.
The Company also announces that Ronald Openshaw has been appointed as Chief Executive on a permanent basis. It was announced earlier this year that following the departure of the previous CEO due to illness that Mr Openshaw would serve in the role of interim CEO & CFO. Mr Openshaw will continue to fulfill the role of CFO for the foreseeable future.
Bill Robinson, Chairman, Plethora said: "We are delighted that Jim has agreed to join the board as a non-executive director. His support during the last financing round was pivotal to its success and we look forward to his input at the board with his considerable experience as a global investor."
-Ends-
Enquiries:
Additional information Save as set out below, there are no further details in relation to the above appointment which require disclosure under paragraph (g) of Schedule 2 to the AIM Rules. The Directorships and past Directorships of Jim Mellon, aged 54, are listed below:
Further disclosures: Mr James Mellon is also a Non-Executive Co-Chairman of Regent Pacific Group Ltd, a company listed on the Hong Kong Stock Exchange. The Company has been informed by Mr Mellon that there is an arrest warrant in his name which was originally issued by the South Korean prosecutor's office on 19 December 2000 and subsequently reissued on 14 January 2004. The warrant was due to remain valid and effective until 12 March 2010. The arrest warrant pertains to Mr Mellon's alleged involvement in a conspiracy with Seung-Hyun Jin (''Mr Jin'') and Chang-Kon Koh to manipulate the share price of Regent Securities Co., Ltd ("Regent") and a failure to make adequate investigations in connection with the provision of certain loans by one of Regent's subsidiaries to Mr Jin. Mr Mellon has informed the Company that he denies these allegations which are without substance. On 3 January 2008, Bigsave Holdings plc, a company of which Jim Mellon was a director, entered into a voluntary liquidation. There were no unsatisfied creditors. On 8 April 2003, Regent Pacific Fund, a company of which Jim Mellon was a director, entered into a voluntary liquidation. There were no unsatisfied creditors. On 9 December 2005 Undervalued Assets Fund - Series One, a company of which Jim Mellon was a director, entered into a voluntary liquidation. There were no unsatisfied creditors. Asian Opportunity Fund 1998 - Series I commenced voluntary liquidation on 5 February 2008 pursuant to its Articles and Association. Jim Mellon was a director within the 12 month periods preceding such date. There were no unsatisfied creditors. Jim Mellon was also previously a director of Regent Global Fund and Undervalued Assets Greater China Fund Series III, both of which went into voluntary liquidation. These two funds were liquidated with the consent of shareholders as the directors recommended that due to a decline in the size of the funds, they were uneconomic. There were no unsatisfied creditors.
About Plethora: Plethora is focussed on the development and marketing of products for the treatment of urological disorders. The Company isfocussed on: (i) driving the development of its speciality sales and marketing business, The Urology Company; and (ii) seeking to increase the value of its development assetsthe most advanced of which is PSD502 for the treatment of premature ejaculation.
Plethora's subsidiary, The Urology Company Limited, established in 2009, markets and distributes a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions. Its products fall into two categories (i) Professional - where a physician, nurse or other healthcare professional makes a prescribing decision and include Striant® SR, Urolieve®, Hyalofemme® and Dianatal®; and (ii) Consumer - where the consumer/patient makes a buying decision and include Hyalofemme®, Multi-Gyn®, Multi-Mam® and hI-Cran®.
The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk and www.theurologyco.com
This information is provided by RNS The company news service from the London Stock Exchange More |
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| 19-12-11 | RNS |
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RNS Number : 1991U Plethora Solutions Holdings PLC 19 December 2011
19 December 2011
Plethora Solutions Holdings plc ("Plethora" or "the Company")
Product Update PSD502 Appointment of Rapporteur & Co-Rapporteur - regulatory filing on track
The Company announces that, following a submission to the European Medicines Agency (the "EMA"), the EMA has appointed the pharmaceutical regulatory agencies of Spain as Rapporteur and the United Kingdom as Co-Rapporteur to review the planned dossier for the approval of PSD502, Plethora's proprietary new drug for the treatment of premature ejaculation.
In September 2011, the Company announced that it had secured operational control of PSD502 in Europe and certain other territories in the rest of the world. Further, the Company set out that its objective was to prepare a regulatory submission for the filing and approval of PSD502 in Europe. Plethora intends to file for approval on a Centralised basis which, when approved, would permit the marketing of PSD502 in all EU member states and certain Asian countries.
The appointment of the Rapporteur and Co-Rapporteur is the first step in the filing of the regulatory submission. It is the Rapporteur and Co-Rapporteur which will review the regulatory dossier and subsequent submissions and then provide recommendations to the EMA and member states for the approval of new pharmaceuticals.
Plethora has now engaged in a dialogue with these regulatory agencies prior to an intended submission of a dossier in 2012.
Ronald Openshaw, Chief Executive, Plethora said: "In September 2011, we agreed to take control of PSD502 and we raised money from investors partially to fund our regulatory development. I am pleased to report that this project is on schedule to meet the objectives we set ourselves at that time. Alongside this, we have commenced the process of seeking a partner to assist Plethora in the commercialisation of this important new product in our territories."
Mike Wyllie, Chief Scientific Officer, Plethora said: "The appointment of the Rapporteur and Co-Rapporteur is a key step in the registration of PSD502 and we are looking forward to continuing to work with the Spanish and UK agencies. Work on the preparation of the full dossier has commenced in earnest and we expect to submit the dossier on schedule next year. We believe there is no product on the market which meets patients' needs and consider that PSD502 represents an important treatment for men suffering from premature ejaculation."
-Ends-
Enquiries:
About Plethora: Plethora is focussed on the development and marketing of products for the treatment of urological disorders. The Company is focussed on: (i) driving the development of its speciality sales and marketing business, The Urology Company; and (ii) seeking to increase the value of its development assetsthe most advanced of which is PSD502 for the treatment of premature ejaculation.
Plethora's subsidiary, The Urology Company Limited, established in 2009, markets and distributes a range of branded and generic pharmaceutical products, pharmaceutical specials, medical devices and nutritional supplements for the treatment of urology, andrology and obstetric conditions. Its products fall into two categories (i) Professional - where a physician, nurse or other healthcare professional makes a prescribing decision and include Striant® SR, Urolieve®, Hyalofemme® and Dianatal®; and (ii) Consumer - where the consumer/patient makes a buying decision and include Hyalofemme®, Multi-Gyn®, Multi-Mam® and hI-Cran®.
The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM: PLE.L). Further information is available at www.plethorasolutions.co.uk and www.theurologyco.com
This information is provided by RNS The company news service from the London Stock Exchange More |
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