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Ergomed Plc (ERGO)     

dreamcatcher - 18 May 2015 18:12



Founded in 1997, Ergomed plc is a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs. It operates globally in over 40 countries.

Ergomed plc has two complementary businesses:
(1) The Services Business – a well-established, clinical research business providing services to the pharmaceutical and biotechnology industry; and
(2) The Co-Development Business – a growing portfolio of partnerships with pharmaceutical and biotech companies, providing its drug development services in exchange for a carried interest in any revenues attributable to the drug asset, including outlicensing milestones as well as sales of the product

Since its formation, Ergomed plc has been providing expertise in clinical development / trial management from the largest pharmaceutical companies, as well as many small and mid-sized drug development companies. Ergomed plc successfully manages clinical development from Phase I through to late phase programmes.

Ergomed plc has a wide therapeutic focus, but has particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed plc believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed plc and the investigational sites involved in clinical trials. As well as providing high quality clinical development services, Ergomed plc is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed plc leverages its expertise and services in return for carried interest in the drugs under development.

The company has planned, managed, monitored, and reported clinical trials with a range of technologies that include small molecule drugs, monoclonal antibodies, tri-functional antibodies, soluble receptors and other targeted agents, cancer vaccines and immunotherapy, radioactive agents, and photodynamic therapies.

http://www.ergomedplc.com/


Chart.aspx?Provider=EODIntra&Code=ERGO&SChart.aspx?Provider=EODIntra&Code=ERGO&S

dreamcatcher - 26 Sep 2016 16:43 - 10 of 15

Half-year Report
RNS
RNS Number : 7528K
Ergomed plc
26 September 2016
 
PRESS RELEASE
 
Unaudited Interim results for the six months ended 30 June 2016
 
Strong first half financial performance - revenues up 21% and gross profit up 26%
£19 million new contracts signed resulting in a backlog of £60 million
Acquisitions of O+P and GASD strengthens service business
Acquisition of Haemostatix expands product pipeline potential significantly
Completion of £9.2 million fund raising
 
 
Guildford, UK - 26 September 2016: Ergomed plc, ('Ergomed', 'the Company', AIM: ERGO) a profitable UK-based company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, today announces its interim results for the six months ended 30 June 2016.
 
Commenting on the results, Miroslav Reljanovic M.D., Chief Executive Officer of Ergomed plc, said:
"Ergomed has delivered another set of excellent results for the first half of 2016. We made significant progress against our strategic goals through the continued strong trading performance of our profitable, growing service businesses where overall top-line growth of 21% was driven by revenue growth of 53% in our subsidiary company PrimeVigilance and through the completion of two targeted acquisitions.
 
The acquisitions of O+P and GASD augment the continuing growth of our services businesses, adding immediate significant, tangible value including an in-house Electronic Data Capture system, "OPVERDI" and biostatistics and data management capabilities. We have already won our first service contract together for a clinical study with a European biotech company underlining the benefits of the acquisition.
 
We continue to believe we can create significant value by investing in-kind through carefully selected co-development partnerships and we are expecting important clinical data readouts from Ferrer and Aeterna Zentaris around the end of 2016 and early 2017 respectively. The Haemostatix acquisition is an exciting evolution of the co-development model and has the potential to be transformational for Ergomed through the rapid development of its novel treatment for surgical bleeding.
 
Overall, we continue to believe that our hybrid model of a growing, profitable services business combined with managed risk drug development has the potential to deliver significant shareholder value over the next few years with some exciting newsflow in the next 12 months."
 
 
Financial highlights (unaudited)
 
·      Revenues up 21% to £17.6 million from £14.5 million in H1 2015
o  Including revenue growth of 53% to £5.5 million from £3.6 million in H1 2015 from PrimeVigilance
·      Gross profit up 26% to £5.3 million from £4.2 million in H1 2015
·      Adjusted EBITDA up 12% to £1.9 million from £1.7 million in H1 2015 excludes costs of £0.4 million relating to M&A activities and £0.1 million of R&D costs (note 11)
·      EBITDA before adjustments for share-based payment charge, M&A costs, exceptional items and R&D of £1.2 million compared with £1.4 million in H1 2015 (note 11)
·      Placing of 6.63 million new ordinary shares raised £9.2 million before expenses
·      Cash and cash equivalents of £9.9 million as of 30 June 2016 (30 June 2015: £4.9 million; 31 December 2015: £4.0 million)
·      Contribution in kind to co-development projects increased to £2.1 million in H1 2016 from £1.9 million in H1 2015
 
 
Operational highlights
 
·      Service contracts with a value of £19 million signed in H1 2016 (£15 million signed in H1 2015)
·      Strong backlog of awarded contracts of approximately £60 million at the end of July 2016
·      O+P and GASD, a contract research organisation with a proprietary electronic data capture system, OPVERDI, and a biostatistics and data management company respectively, were acquired on 13 June 2016 (note 8)
·      Opening of a new office in Boston, MA to support growth of PrimeVigilance in the US in June 2016
·      Five ongoing clinical studies with co-development partnerships proceeding to plan
·      Haemostatix, a UK company developing a proprietary platform to control surgical bleeding with two lead products, one of which is Phase IIb ready, was acquired on 24 May 2016 (note 7)

dreamcatcher - 26 Sep 2016 16:45 - 11 of 15

26 Sep
N+1 Singer
N/A
Buy

22 Sep
Stifel
271.00
Buy

2 Sep
Stifel
271.00
Buy

dreamcatcher - 04 Apr 2017 19:11 - 12 of 15

15:30 04/04/2017
Director Deals - Ergomed Plc (ERGO)
Peter George, Non Executive Director, bought 100,000 shares in the company on the 3rd April 2017 at a price of 190.00p. The Director now holds 100,000 shares. Story provided by StockMarketWire.com Director deals data provided by www.directorsholdings.com

dreamcatcher - 04 Apr 2017 19:12 - 13 of 15

4 Apr
Numis
300.00
Buy
4 Apr
Stifel
315.00
Buy

dreamcatcher - 23 Oct 2017 20:08 - 14 of 15

RNS
RNS Number : 2686U
Ergomed plc
23 October 2017
 
PRESS RELEASE
 
 
Ergomed's first-in-class haemostat, PeproStat™, reports positive top-line results and meets key endpoints in Phase II study
 
-     Highly innovative blood free haemostat met the primary efficacy endpoint of superiority over standard of care in time to haemostasis with statistical significance across all surgery types tested
 
-     PeproStat was seen to be safe with no treatment related SAEs reported and no re-bleeding
 
-     PeproStat™ demonstrated superiority in time to haemostasis at each time point during 10-minutes assessment over standard of care
 
-     PeproStat had a higher response rate, with more investigators finding the product good to excellent with respect to control of bleeding compared to standard of care and the "liquid and sponge" format easy/very easy to use
 
-     Results reinforce potential as a safe, blood-free, ready-to-use and cost-effective method of controlling bleeding during surgery
 
-     Phase II results ahead of original schedule; preparation for Phase III in 2018 and potential entry to $2.5 billion global market1
 
 
London, UK - 23 October 2017: Ergomed plc (LSE: ERGO) ('Ergomed' or the 'Company'), a specialised pharmaceutical services and drug development company, today announces positive top-line results from its Phase II clinical trial of PeproStat™, the Company's potential first-in-class coagulant, or 'haemostat', for intraoperative surgical bleeding. PeproStat is a novel, blood-free, ready-to-use, cost-effective, product based on a peptide which binds fibrinogen.
 
The Phase II clinical trial was carried out at 16 hospitals across five European countries and treated 169 patients undergoing three types of surgical procedure: liver/soft tissue; vascular and spinal. The trial was double blinded and compared PeproStat to standard of care (gelatin sponge). In the control arm, patient bleeds were treated by applying pressure with a gelatin sponge soaked in saline, which represents standard of care in Europe. In the treatment arm, the sponge was soaked with PeproStat. The safety profile of the product was good, with no treatment-related serious adverse events, and no re-bleeding after the observation period.
 
PeproStat reduced the time to haemostasis (TTH) by 1.55 minutes (p <0.0041) across all surgery types, demonstrating superiority compared to the standard of care, the primary efficacy endpoint of the trial, a statistically and clinically significant result and one which compares favourably with literature on comparative products. Notably, in 58.2% of patients the TTH was equal or less than 2 minutes (standard of care: 32.7%).
 
The absolute TTH of both PeproStat and standard of care were higher (4.2 minutes and 5.8 minutes respectively) than seen in the Phase I trial which may be due to the observation that there was a greater proportion of moderate (vs mild) levels of bleeding in this trial compared with the Phase I trial and seen in trials of competitor products.
 
80.9% of investigators in the trial rated the product as good to excellent, compared to 59.6% for standard of care with respect to controlling bleeding. In addition to improved efficacy, 93.5% of investigators rated the liquid plus sponge format as easy to very easy to use, confirming the product's design as a ready to use formulation.
 
Ergomed plans to submit detailed data, once a full analysis is complete, for presentation at upcoming scientific conferences.
 
Dr Dan Weng, Chief Executive Officer of Ergomed, said: ""We are delighted to report positive results from the Phase II study. We believe PeproStat is a first-in-class product which could enter the large and growing haemostat market as early as 2020. We have already completed our first commercial agreement for PeproStat and our other haemostat, ReadyFlow, with Boryung in September, and will now explore our options to bring this first-in-class haemostat to the market as soon as possible. Currently, we have a number of active licensing and partnering discussions to fund further development."
 
Dr Paul Hayes, Addenbrookes Hospital, Cambridge, UK, the Chief Investigator for the trial, said: "Surgical bleeding is a common problem that can be associated with significant blood loss, increasing patient morbidity and mortality. PeproStat works fast and has shown to reduce the non-responder rate by almost 50% compared to a current standard of care product. This provides surgeons with a huge and clinically relevant advantage in providing better control of excess bleeding during surgery and could be hugely beneficial to patients, reducing operation times, complications and preventing unnecessary returns to surgery. I am both impressed by Ergomed's ability to bring this innovative product through Phase II so efficiently, and really excited by the results we have seen, demonstrating the potential of PeproStat as an important new alternative."
 
The global haemostat market is estimated to be worth $2.5 billion1. Current products may be limited by a range of issues, including slow onset of action and long preparation time. PeproStat, based on a synthetic peptide which eliminates the risk of exposure to blood derived materials, is more stable allowing the formulation of ready-to-use preparations and has a fast mode of action. With these advantages, Ergomed expects the product will gain significant market share.
 
PeproStat is the lead product in Ergomed's Haemostatix portfolio, with ReadyFlowTM in mid-stage pre-clinical development. Ergomed believes that together these two products are estimated to have peak sales potential of more than $500 million2.
 
The Phase II study completed six months ahead of the original schedule, demonstrating both strong physician interest in this innovative haemostat, and Ergomed's ability as a specialist drug developer to efficiently recruit patients fit for study purpose.
 
Ergomed will hold a conference call for analysts at 08:30 BST. Dial-in details are: +44 (0) 1452 555 566. Conference ID: 9677908#. For a copy of the presentation, please email ergomed@consilium-comms.com.
 
1 Hemostats Market by Product Type (Thrombin, Oxidised Regenerated Cellulose, Combination, Gelatin, Collagen), and Geography (Americas, Europe, APAC, MEA) - Global Forecast to 2020. MarketsandMarkets, February 2016.
2 Company estimate
 
ENDS
 

dreamcatcher - 23 Oct 2017 20:09 - 15 of 15

12:20 23/10/2017
Broker Forecast - Numis issues a broker note on Ergomed Plc
Numis today reaffirms its buy investment rating on Ergomed Plc (LON:ERGO) and raised its price target to 300p (from 280p). Story provided by StockMarketWire.com
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