CAMBRIDGE, England, Aug. 2, 2018 /PRNewswire-PRWeb/ -- Atlantic Healthcare plc (Atlantic Healthcare), a specialist gastrointestinal
Atlantic Healthcare is developing alicaforsen for the treatment of inflammatory bowel disease (IBD). Results of the fully-funded Phase 3 trial for alicaforsen enema in the treatment of orphan-designated IBD pouchitis are expected in Q1 2019. Pouchitis is a rare and serious form of IBD for which there is no approved therapy and limited treatment options.
Subject to positive results from the trial and subsequent regulatory approval, Atlantic Healthcare will commercialise alicaforsen enema as the first and only approved treatment for pouchitis. Work is also ongoing to develop the pipeline for alicaforsen in additional indications, including distinct and novel tablet formulations to treat Crohn's disease and ulcerative colitis (UC).
John has a wealth of experience in pharmaceutical sales and marketing. He joins Atlantic Healthcare from Melinta Therapeutics, where he was President and Chief Operating Officer / Chief Commercial Officer responsible for the commercialisation strategy and building the Company's product portfolio. Prior to Melinta, he headed sales and marketing at Salix Pharmaceuticals (now part of Valeant Pharmaceuticals, where he successfully launched numerous products, helping to grow revenue from $119 million in 2004 to $2 billion in 2015. John has also held positions at Celltech Pharmaceuticals, Medeva Pharmaceuticals and Adams Laboratories.
John Temperato, U.S. President and COO at Atlantic Healthcare said: "I am delighted to join Atlantic Healthcare at what is an extremely exciting time. The highly experienced team has deep roots in pharmaceuticals, alicaforsen enema is in the final stages of clinical trials and a promising pipeline is being developed for alicaforsen tablets in additional GI indications."
Toby Wilson Waterworth, CEO at Atlantic Healthcare said: "This appointment is an important step in the growth and development of Atlantic Healthcare. John's experience of taking pharmaceuticals to market will inform our approach to commercialising alicaforsen enema, which will target gastroenterologists in hospitals and specialist care centres in Europe and the U.S., with first commercial revenues anticipated in H1 2020."
Notes to editors About Atlantic Healthcare plc (http://www.atlantichc.com) "Atlantic Healthcare" is a gastrointestinal (GI) focused pharmaceutical company, developing treatments for orphan diseases and unmet needs. The Company's lead product, alicaforsen enema, is in a pivotal Phase 3 trial for pouchitis, and in preparation for Phase 3 clinical development in ulcerative colitis (UC). The Company is also developing two tablet formulations of alicaforsen, to treat Crohn's disease and UC. Atlantic Healthcare has a highly committed investor base, and an experienced international leadership team. Atlantic Healthcare's fundraising to date includes £1.9m through SBRI funding awarded by Innovate UK, the UK Government's innovation agency (http://www.innovateuk.gov.uk). In Q1 2016 the Company closed a $24m round led by LDC (the private equity division of Lloyd's Banking Group) with new and existing investors.
About Pouchitis Patients who have failed drug treatment options for ulcerative colitis often progress to having their diseased colon being removed, a new rectum created and the bowel reconnected with a procedure called pouch surgery (ileal pouch-anal anastomosis – IPAA). Surgeons use the end of the small intestine (ileum) to create a pouch to act as a new rectum, typically shaped like the letter J. The pouch is attached internally to the area just above the anus to hold faeces before being evacuated.
Pouchitis is the return of inflammatory disease in the pouch. It occurs in approximately half of the people who have the IPAA procedure. Signs and symptoms of pouchitis can include inflammation and ulceration, diarrhoea, abdominal pain, cramps, fever, an increased number of bowel movements, night-time faecal seepage, faecal incontinence, and a strong urge to have a bowel movement.
About Alicaforsen Alicaforsen is being developed as a locally active, topical treatment with the potential to establish a new class of therapy, with clear differentiating features, for the treatment of multiple inflammatory GI disorders.
Alicaforsen is in development for the treatment of IBD. An enema formulation is currently in a pivotal Phase 3 trial agreed with U.S., Canadian and European regulatory agencies in patients with active pouchitis. The trial has completed enrollment of 138 patients to approximately 40 trial centres across the U.S., Canada, Europe, and Israel, and is expected to report preliminary data in Q1 2019.
There is currently no approved treatment for pouchitis in the U.S. or Europe and there are limited treatment options for UC and Crohn's disease.
Under a rolling submission agreement with the FDA, Atlantic Healthcare has filed the nonclinical data package of its New Drug Application (NDA) for alicaforsen to treat pouchitis with the regulator. Alicaforsen has also been granted FDA Fast-Track designation, plus U.S. and European Orphan Drug designations for this indication.
Alicaforsen enema has shown, in five Phase 2 clinical trials involving 377 patients with UC and pouchitis, to reduce inflammation and promote mucosal healing with good tolerability and a durable effect. Alicaforsen also has a good safety profile based on data from more than 1,000 patients (enema, parenteral, and IV delivery).
Alicaforsen is an antisense oligonucleotide, which has been designed to interact and down regulate mRNA for ICAM-1, a well-recognised cell-surface protein that is involved in the inflammatory response of both the adaptive and innate components of the immune system, and is over-expressed in patients with IBD.1 Research at Atlantic Healthcare has also provided evidence that alicaforsen can interact with TLR-9, an intracellular receptor involved in TLR-9 signaling pathways that activate cells of the innate immune system involved in inflammatory responses.2
Atlantic Healthcare has supplied more than 300 courses of alicaforsen enema to patients in Europe through unsolicited requests via Named Patient Supply regulations. This has provided further evidence of efficacy and safety in the pouchitis3 and UC indications.4-6
References: 1. Inflammatory Bowel Disease. Imre Szabo. ISBN 978-953-51-0879-5 2. Toll-like receptors: the swiss army knife of immunity and vaccine development Jennifer K Dowling and Ashley Mansell. Clinical & Translational Immunology (2016) 5, e85; doi:10.1038/cti.2016.22 3. Alicaforsen, an antisense inhibitor of ICAM-1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series. Thomas Greuter, Luc Biedermann, Gerhard Rogler, Bernhard Sauter and Frank Seibold. UEG Journal (2015) DOI: 10.1177/2050640615593681 4. Alicaforsen Retention Enema Induces Long-Term Remission in Patients with Ulcerative Colitis. Zaid Heetun, David Gibson, Denise Keegan, Kathryn Byrne, Hugh E Mulcahy, Garret Cullen, Glen A Doherty. Irish Soc Gastroenterol Nov 2014 5. Alicaforsen, ICAM-1 enema as a treatment option when treating distal ulcerative colitis. LA. Bark 1 , I. Löfberg 1 , B. Håkansson 1 , U. Sjöqvist 1 (http://www.atlantichc.com/la-bark-abstract-pdf) 6. Alicaforsen, an antisense inhibitor of Intercellular Adhesion Molecule-1, in the treatment for left-sided ulcerative colitis and ulcerative proctitis. Thomas Greuter, Stephan Vavricka, Luc Biedermann, Julia Pilz, Jan Borovicka, Frank Seibold, Bernard Sauter, Gerhard Rogler. Dig Dis (2017) DOI: 10.1159/000484979
For more information please contact: Atlantic Healthcare Toby Wilson Waterworth (CEO) +44 1799 512 055
Adam Michael (Head of Communications) Media Contact +44 1799 512 055 +44 777 588 1813 adam.michael(at)atlantichc.com
U.S. Investor Relations and Media Lazar Partners Fern Lazar / David Carey +1 212-867-1762 atlantic.healthcare(at)lazarpartners.com
European Investor Relations and Media Consilium Strategic Communications Mary-Jane Elliott / Matthew Neal +44 20 3709 5700 atlantichealthcare(at)consilium-comms.com
SOURCE Atlantic Healthcare
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