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Guildford, UK – 16th December 2015: Ergomed plc, (LSE: ERGO) a profitable UK-based company dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, provides an update on its current co-development partnerships. Ergomed’s four active partnerships have studies in late stage development with the potential to deliver significant Phase II and Phase III news flow with two studies scheduled to report results in 2016.
Ergomed’s growing portfolio of drug development partners range from single product university spinouts and US-listed biotech companies to mid-sized Pharma companies developing products in oncology, neurology and rare diseases. Under these agreements Ergomed is contributing to the total cost of the clinical trials and in return will receive a share of any proceeds generated from the commercialisation of the partnered drug asset. Ergomed is committed to building its portfolio of co-development assets and delivering significant clinical data and is targeting further partnerships in 2016 with the potential to create significant shareholder value in the next few years.
CEL-SCI (NYSE MKT:CVM):Ergomed and CEL-SCI are running one of the largest Phase III studies in head and neck cancer with the product Multikine. With more than 80 sites open and more than 600 patients enrolled out of a target of 880 the study is now in an advanced stage. This novel treatment aims to treat advanced primary head and neck cancer and if successful will be a significant advance in the treatment options available to patients. Ergomed and CEL-SCI are also collaborating on a Phase I study in peri-anal warts in HIV/HPV co-infected patients.
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ): The ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) pivotal study with Zoptrex™ (zoptarelin doxorubicin) in women with advanced, recurrent or metastatic endometrial cancer, is proceeding well. In June 2015, Ergomed reached the recruitment target of 500 patients ahead of schedule and in October 2015 the Data and Safety Monitoring Board recommended the continuation of the ZoptEC Phase III Trial in Advanced Endometrial Cancer. The ZoptEC study is being run in 115 centers from North America, Europe, Israel and other countries under a Special Protocol. Final results from the study are expected in 2016.
Ferrer: Ferrer is a privately-held Spanish pharmaceutical company. In 2014, together with Ildong Pharmaceuticals, Ergomed joined forces to develop Ferrer’s novel treatment for insomnia, Lorediplon. Recruitment in this 130 patient, Phase IIa study began as planned in July 2015 and is scheduled to complete by late 2016. To date more than 45 patients have been randomised. Lorediplon has demonstrated a potent hypnotic profile and extended systemic half-life in preclinical and clinical studies, properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. The Phase IIa study is being run at specialist sleep centres and aims to confirm the promising Phase I results and hopes to promote a longer duration of sleep throughout the night in patients with insomnia. Final results from the study are expected in 2016.
Dilaforette: Ergomed’s recent co-development partnership with Dilaforette is our first targeting an orphan drug indication. The partnership is exploring the potential of sevuparin as a novel treatment for Vaso-Occlusive Crisis (VOCs) in patients with sickle-cell disease (SCD). In October 2015, the companies announced the start of recruitment into a multi-centre, international, randomised Phase II study performed in Europe and the Middle East. Ergomed’s MENA infrastructure is well positioned to access patients in the Middle East, where SCD is a significant healthcare problem. In addition, Ergomed’s site management model supports the identification and management of SCD patients when they suffer a VOC and are in need of hospitalisation. Results from this Phase II trial with sevuparin are expected in the second half of 2016.
Ergomed is investing a proportion of its revenues from conducting this Phase II trial with sevuparin in return for an equity stake in Dilaforette. Dilaforette is a private Swedish biotech company and is part of the Karolinska Development AB (STO: KDEV) portfolio. Sevuparin was developed based on research from the Karolinska Institute and Uppsala University.
Synta Pharmaceuticals (NASDAQ:SNTA): Announced this year the early termination of its Phase III study of Ganetespib for advanced non-small cell lung cancer (NSCLC). Ganetespib has a number of trials ongoing under investigator sponsored studies and Synta will evaluate next steps after these report results. Ergomed’s carried interest remains in place but no further investment by Ergomed is planned.
Miroslav Reljanovic, CEO of Ergomed plc, commented: “Our growing pipeline of co-development partnerships is on track and we are looking forward to providing updates on two late stage clinical data readouts in 2016. As we continue to see opportunities in this sector and as the portfolio expands we will be in a strong position to place more emphasis on this division of our business.
“We believe that our hybrid model of a profitable, healthcare services business combined with managed investment in an exciting co-development portfolio has the potential to deliver significant value for investors while balancing the risks over the next few years.”
For further information, please contact:
Hume Brophy – for UK enquiries
Mary Clark, Supriya Mathur and Hollie Vile
Tel: + 44 203 440 5654
NOMAD/Broker to the Company
Jonathan Senior, Stewart Wallace and Ben Maddison
Tel: +44 207 710 7600
MC Services – for Continental European enquiries
Tel: +49 211 529252 22
About Ergomed plc
Founded in 1997, Ergomed plc is a profitable UK-based company, providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 40 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 60 clients ranging from top 10 pharmaceutical and generics companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has wide therapeutic expertise, with a particular focus in oncology, neurology and immunology and the development of orphan drugs. Ergomed’sapproach 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 and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies. Here Ergomed shares the risks and rewards of drug development, leveraging its expertise and services in return for carried interest in the drugs under development. – a low risk investment model for potential high returns. For further information, visit: https://www.ergomedplc.com.
Global pharmacovigilance and medical information services are provided through its group company PrimeVigilance. www.primevigilance.com
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomised, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, which could result in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while Phase 2 trials in ovarian and prostate cancer have been completed. Aeterna Zentaris owns the worldwide rights to this compound except in China (including Hong Kong and Macau) where rights have been out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list. On April 16, 2015, the Company announced the filing of a patent application intended to strengthen the exclusivity of zoptarelin doxorubicin through a unique modification of the manufacturing process resulting in significantly lower cost.
Lorediplon is a novel, longer acting non-BZD (benzodiazepine) hypnotic drug that modulates the GABAa receptor. Compared to other non-BZD receptor agonists (such as zolpidem) in preclinical and clinical studies, Lorediplon has demonstrated a potent hypnotic profile and extended systemic half-life; properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. A recent Phase I pharmacodynamic study with Lorediplon (in a phase advanced model of insomnia) demonstrated the orally available compound has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem, ref: Hum. Psychopharmacol Clin Exp 2014; 29: 266–273. Lorediplon was safe and well tolerated, with no residual effects observed up to fourteen hours after dosing.
Dilaforette’s sevuparin is an innovative, proprietary polysaccharide drug which has the potential to restore blood flow and prevent further microvascular obstructions caused by abnormal blood cells in SCD patients. With its anti-adhesive properties, sevuparin could offer treatment of the underlying cause of VOC in SCD patients, potentially facilitating earlier pain relief, shorter hospital stays, reduced need of opioids and improved quality of life. Resolving the microvascular obstructions with sevuparin may also affect long term outcomes by avoiding additional tissue and organ damage thereby reducing co-morbidities and possibly also mortality.
Forward Looking Statements
Certain statements contained within the announcement are forward looking statements and are based on current expectations, estimates and projections about the potential returns of Ergomed plc (“Ergomed”) and industry and markets in which Ergomed operates, the Directors’ beliefs and assumptions made by the Directors. Words such as “expects”, “anticipates”, “should”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “pipeline” and variations of such words and similar expressions are intended to identify such forward looking statements and expectations. These statements are not guarantees of future performance or the ability to identify and consummate investments and involve certain risks, uncertainties, outcomes of negotiations and due diligence and assumptions that are difficult to predict, qualify or quantify. Therefore, actual outcomes and results may differ materially from what is expressed in such forward looking statements or expectations. Among the factors that could cause actual results to differ materially are: the general economic climate, competition, interest rate levels, loss of key personnel, the result of legal and commercial due diligence the availability of financing on acceptable terms and changes in the legal or regulatory environment.
These forward-looking statements speak only as of the date of this announcement. Ergomed expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in Ergomed’s expectations with regard thereto, any new information or any change in events, conditions or circumstances on which any such statements are based, unless required to do so by law or any appropriate regulatory authority