Navigation Links
Atlantic Healthcare Secures Acceptance of Brand Name Camligo™ for Alicaforsen Enema to Treat Pouchitis
Date:9/13/2018

Atlantic Healthcare plc (“Atlantic Healthcare” or “Company”), a specialist pharmaceutical company focused on developing and commercializing gastrointestinal therapeutics, has secured acceptance of Camligo™ as the name for the Company’s first candidate product.

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 Healthcare
Toby Wilson Waterworth (CEO)
+44 1799 512 055

Adam Michael (Head of Communications)
+44 1799 512 055
+44 777 588 1813
adam.michael(at)atlantichc(dot)com

U.S. Investor Relations and Media
Lazar Partners
Fern Lazar / David Carey
+1 212-867-1762
atlantic.healthcare(at)lazarpartners(dot)com

European Investor Relations and Media
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Neal
+44 20 3709 5700
atlantichealthcare(at)consilium-comms(dot)com

NOTES TO EDITORS
About 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 £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
Pouchitis 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) enema
Camligo™ 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™ name
Commenting 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 Alicaforsen
Alicaforsen 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

Read the full story at https://www.prweb.com/releases/atlantic_healthcare_secures_acceptance_of_brand_name_camligo_for_alicaforsen_enema_to_treat_pouchitis/prweb15756862.htm.


'/>"/>
Source: PRWeb
Copyright©2018 Vocus, Inc.
All rights reserved


Related medicine technology :

1. Atlantic Pharmaceuticals President Named Health Care Hero Finalist in Atlanta Business Chronicle for Drug Abuse Deterrent Technology
2. Mid-Atlantic Biotech Leaders Featured On BioSpace Map
3. Millennium HealthCare Signs Exclusive Distribution Agreement with eWellness Corporation for Northeast and Mid-Atlantic Regions
4. AtlantiCare Heart Heroes group donates Cardiac Science AED to Atlantic City public access defibrillation program
5. Atlantic General Hospital Boosts Patient Safety with Expanded Use of Capnography
6. Alpha Imaging Acquires Tristar Midatlantic Imaging
7. Atlantic Canadians to Save $560-Million Through Unprecedented Three-Year Pan-Canadian Agreement on Generic Prescription Medicines
8. Atlantic.Net "Secures" Healthcare Industry With HIPAA Compliant Hosting For Medical Companies
9. ISPE Carolina-South Atlantic Chapter to Host 23nd Annual Life Sciences Technology Conference
10. ISPE Carolina-South Atlantic Chapter Life Sciences Technology Conference Announces Featured Charity for March 31 Conference
11. Atlantic Street Capital Portfolio Company Lombart Acquires INNOVA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/16/2018)... ... November 16, 2018 , ... Florida Hospital, Championship Level ... the Title Sponsor of the 18th Annual Florida Hospital Bolt Run, Saturday, November 17, ... with the first-ever finisher’s circle inside AMALIE Arena just a few feet away from ...
(Date:11/16/2018)... ... 2018 , ... Mytonomy, a leader in virtual digital health ... the usability of and satisfaction with Mytonomy’s video-based microlearning platform among people living ... the 18th Annual Diabetes Technology Society Meeting, showed that patients were highly satisfied ...
(Date:11/16/2018)... ... November 16, 2018 , ... ... is thrilled to announce the launch of its newly redesigned website. , ... the company's mission and products. The newly redesigned website will be regularly updated ...
Breaking Medicine Technology:
(Date:11/16/2018)... ... ... AP was selected in the Health Care 2 ($10-$30M) Category and will be ... Hyatt Regency Downtown Dallas along with other companies who have illustrated exceptional qualities during ... Annual Excellence in Construction National Level Competition through Associated Builders and Contractors, Inc (ABC). ...
(Date:11/16/2018)... , ... November 16, 2018 , ... Nutrex Research ... skin care product called Lipo-6 Defining Gel . Utilizing TopiSorbTM Technology, this gel ... Stubborn cellulite and fatty deposits have met their match. , Maximizing fat loss ...
(Date:11/16/2018)... NEW YORK (PRWEB) , ... November 16, 2018 ... ... academic medical center, announced today a historic agreement with Taikang Healthcare in China ... for Taikang’s Xianlin Drum Tower Hospital in Nanjing, the capital of Jiangsu Province ...
(Date:11/16/2018)... ... November 16, 2018 , ... The ... China Resources Microelectronics Limited (CR Micro) and China Resources Life Science Industry ... establishing two joint research centres for novel micro-electronic devices and precision medicine. ...
(Date:11/15/2018)... ... November 15, 2018 , ... ... investment from Winnebago Seed Fund and additional investors including Wind River Financial, a ... forge a strategic partnership with Wind River to provide a range of solutions ...
Breaking Medicine News(10 mins):