PR95479

MILAN, April 19, 2022, /PRNewswire=KYODO JBN/

NTC Srl, R&D driven pharmaceutical company with headquarters in Italy announces

the submission of the marketing authorisation application through the European

Decentralised Procedure (DCP) for its development product NTC015 (Kleerkol(R))

for bowel preparation for colonoscopy.

"Colonoscopy remains the standard for diagnosing and monitoring colorectal

cancer and for diagnosis and surveillance of inflammatory bowel disease", says

Maurizio Vecchi, Gastroenterology and Endoscopy Unit, Foundation IRCCS Ca'

Granda Ospedale Maggiore Policlinico, Milan, Italy. "The colon must be

completely emptied from stool for the procedure. All patients currently must

undergo a scheduled bowel preparation, sometimes lasting more than one day,

which includes dietary restrictions, and ingesting large amounts of fluid and

solutions for colon cleansing. An effective drug favouring a quick bowel

cleaning, palatable and easy to be taken by patients would represent a new and

attractive therapeutic option".

"Often bowel preparation before a colonoscopy is experienced as burdensome and,

if inadequate, it leads to suboptimal effectiveness, increasing the need to

repeat the procedure. Indeed, some patients decide not to undergo the test

because of disturbing bowel preparation" Peter Uebel, Practice for

gastroenterology and specialist internal medicine in the House of Health,

Ludwigshafen am Rhein, Germany states. "For this reason, it is important to

offer patients an effective, easy-to-use, fast-acting, simpler and palatable

preparation".

NTC015 was developed to respond to the unmet medical needs of being quick, easy

to take, and good tasting. For its approval, a controlled trial with an

adaptive study design was conducted. "We have recently concluded the

Satisfaction Trial, a large multicentre international study on Kleerkol (R).

Based on the study outcome, we submitted the marketing authorisation

application in the EU. Our goal is to make Kleerkol(R) available in Europe as

soon as possible. We are also expecting to register it beyond Europe, on a

global basis, in collaboration with our partners. Today, we have several

countries still available for partnering, to offer to patients and doctors this

innovative solution all over the world" Riccardo Carbucicchio, Chief Executive

Officer of NTC concludes.

About NTC

A pharmaceutical company headquartered in Milan - Italy, with distributors and

partners in more than 100 countries, engaged in research, development,

registration and commercialization of drugs, medical devices, and food

supplements in ophthalmology, and in other therapeutic areas including

pediatrics, gynecology and gastroenterology. NTC offers to more than 200

partners innovative and high quality standard pharmaceutical products. For more

information, please visit www.ntcpharma.com

Source: NTC s.r.l.