CAMBRIDGE, U.K., September 13, 2018 /PRNewswire-PRWeb/ -- Atlantic Healthcare plc ("Atlantic Healthcare" or "Company"),
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), have accepted Camligo™ as the proprietary brand name for alicaforsen enema, which is currently undergoing a pivotal Phase 3 trial in the treatment of orphan-designated pouchitis.
Pouchitis is a rare and serious form of Inflammatory Bowel Disease (IBD), which is believed to impact the lives of approximately 200,000 patients in the U.S and Europe. There is no approved treatment for pouchitis, hence there remains a significant unmet clinical need.
In May 2017 Atlantic Healthcare initiated the rolling submission of its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and filed its non-clinical package for alicaforsen to treat pouchitis.
John Temperato, U.S. President and COO at Atlantic Healthcare said: "We are acutely aware of the unmet needs of pouchitis patients and the debilitating effects the disease can have on their quality of life. Now this brand name has been agreed with the U.S. and European regulatory authorities, we have met another critical milestone towards Camligo™ (alicaforsen) enema being available as a treatment for these patients."
Toby Wilson Waterworth, CEO at Atlantic Healthcare said: "We look forward to announcing the results of the Phase 3 trial in the first quarter of 2019 and being able to complete regulatory submissions for Camligo™ with the FDA and EMA. Following approval Camligo™ would be the first and only approved treatment for pouchitis. In the meantime, we continue to broaden the commercial potential and develop the pipeline of alicaforsen products for the treatment of ulcerative colitis, Crohn's disease and other inflammatory diseases."
For more information about Camligo™ (alicaforsen) enema for pouchitis and the alicaforsen pipeline please see http://www.atlantichc.com/camligo.
For information please contact:Atlantic HealthcareToby Wilson Waterworth (CEO)+44 1799 512 055
Adam Michael (Head of Communications) +44 1799 512 055+44 777 588 1813adam.michael(at)atlantichc(dot)com
U.S. Investor Relations and MediaLazar PartnersFern Lazar / David Carey+1 212-867-1762atlantic.healthcare(at)lazarpartners(dot)com
European Investor Relations and MediaConsilium Strategic CommunicationsMary-Jane Elliott / Matthew Neal+44 20 3709 5700atlantichealthcare(at)consilium-comms(dot)com
NOTES TO EDITORSAbout Atlantic Healthcare plc (http://www.atlantichc.com)"Atlantic Healthcare" is a specialist pharmaceutical company focused on developing and commercializing gastrointestinal therapeutics, which address unmet patient needs and rare diseases. The Company owns the exclusive worldwide rights to alicaforsen, a promising new drug for the treatment of inflammation. Its most advanced development program – alicaforsen enema - is undergoing a pivotal Phase 3 trial for pouchitis. In addition, work is ongoing to develop and deepen the pipeline for alicaforsen with treatments for additional gastrointestinal (GI) indications.
Atlantic Healthcare has a highly committed investor base and is led by an experienced international Board and Leadership Team, with deep roots and a proven track record in the pharmaceutical industry. Fundraising to date includes Ł1.9m 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 PouchitisPouchitis is an inflammatory disease of the pouch. The pouch is an artificial rectum, which is created surgically following removal of the colon ("colectomy"). Indications for removal of the colon include ulcerative colitis, colon cancer and FAP ("familial adenomatous polyposis", a pre-cancerous condition). However, pouchitis is predominantly associated with pouches formed in patients with a prior diagnosis of ulcerative colitis. Like ulcerative colitis, pouchitis is a progressive disease characterised by inflammation, ulceration and increasingly uncontrolled, frequent and urgent emptying of the bowel (up to 10-20 times a day and night), with a corresponding reduction in quality of life. For information about prevalence, treatment and the unmet needs of pouchitis patients please see http://www.atlantichc.com/inflammatory-bowel-disease.
About Camligo™ (alicaforsen) enemaCamligo™ alicaforsen 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 centers across the U.S., Canada, Europe, and Israel, and is expected to report preliminary data in Q1 2019.
Trials have shown Camligo™ (alicaforsen) enema to be a safe, well tolerated and effective treatment, which delivers a durable response for pouchitis patients.
About the Camligo™ nameCommenting on the name, the US Food and Drug Association (FDA) "concluded that it is conditionally acceptable."
The European Medicine Agency (EMA) said: "The Name Review Group (NRG) and The Committee for Medicinal Products for Human Use (CHMP) have no objections to the invented name Camligo. It should be noted, the (invented) name review is valid, at the present point in time, which does not prohibit the possibility of objections being raised at any time prior or after the granting of the marketing authorization."
The Camligo™ trademark has been registered in the UK and is pending in Europe and the U.S..
About AlicaforsenAlicaforsen is a novel antisense drug. It is a pipeline in a drug, with the potential to establish a new class of therapy for the treatment of multiple inflammatory gastrointestinal disorders.
For further reading: http://www.atlantichc.com/published-papers
SOURCE Atlantic Healthcare
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