DGAP-News: Neovacs S.A. / Key word(s): Study
NEOVACS OBTAINS SOUTH KOREA HEALTH AUTHORITY APPROVAL FOR IND APPLICATION
WITH INFα KINOID IN LUPUS
14.04.2016 / 09:45
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
NEOVACS OBTAINS SOUTH KOREA HEALTH AUTHORITY APPROVAL FOR IND APPLICATION
WITH INFα KINOID IN LUPUS
Paris, April 14th, 2016 - NEOVACS (Alternext Paris: ALNEV), a leader in
active immunotherapies for the treatment of autoimmune diseases, today
announced that South Korea health authority approved Neovacs's
Investigational New Drug application for IFNα Kinoid in phase IIb
development in Lupus.
Miguel Sieler, CEO of NEOVACS commented about this trial, now including
South Korea: "The examination of our trial has been particularly detailed
and has therefore taken into consideration the innovative character of our
technology in the frame of the development of a new therapeutic approach
for a rare disease. Indeed the Korean health authorities were very
demanding and wanted to analyze and understand clearly the mechanism of
action and the preclinical and clinical data obtained so far as well as the
different steps of production. This result is now an expression of
confidence which is encouraging for the future."
Neovacs has indeed signed a licensing and partnering agreement with the
Korean company Chong Kun Dan Pharmaceuticals (CKD), leader in South Korea
in the field of immunosuppressive drugs. This country is the only one of
the OECD where Lupus disease fulfills the requirements to obtain the Orphan
disease status. Within this agreement Neovacs will file in a near future
for "Orphan Drug Designation". In case of success of its Phase IIb trial
the registration of the product and its launch in the Korean market could
as consequence take place without a previous Phase III trial.
Based on these elements having received this IND is of strategic importance
for Neovacs and for CKD in order to launch IFNα Kinoid in the Korean
market.
This actually running Phase IIb trial, randomized, versus placebo and
concerning 166 patients, covers more than 100 investigation centers in the
world, including now 5 in South Korea. The results of this trial are
expected for summer 2017.
About Neovacs
Created in 1993, Neovacs is today a leading biotechnology company focused
on an active immunotherapy technology platform (Kinoids) with applications
in autoimmune and/or inflammatory diseases. On the basis of the company's
proprietary technology for inducing a polyclonal immune response (covered
by five patent families that potentially run until 2032) Neovacs is
focusing its clinical development efforts on IFNα Kinoid, an immunotherapy
being developed for the indication of lupus. Neovacs is also conducting
preclinical development works on other therapeutic vaccines in the fields
of auto-immune diseases, oncology and allergies. The goal of the Kinoid
approach is to enable patients to have access to safe treatments with
efficacy that is sustained in these life-long diseases.
All information about Neovacs is available on the website: www.neovacs.fr
Contacts
Neovacs/ Charlène Masson
+33 (0)1 53 10 93 00
cmasson@neovacs.com
New Cap /Valentine Brouchot / Pierre Laurent
+33 (0)1 44 71 94 94
neovacs@newcap.eu
Investor Relations / Financial Communications Germany - MC Services
Raimund Gabriel
+49-89-21-02-28-30
raimund.gabriel@mc-services.eu
Press / U.S. Inquiries - The Ruth Group
Joanna Zimmerman / Joseph Green
+1-646-536-7012 / 7013
jzimmerman@theruthgroup.com / jgreen@theruthgroup.com
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14.04.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Neovacs S.A.
3-5, Impasse Reille
75014 Paris
France
Phone: +33 (0)1 53 10 93 00
Fax: +33 (0)1 53 10 93 03
E-mail: www.neovacs.fr
Internet: info@neovacs.fr
ISIN: FR0004032746
WKN: A1CVKR
Listed: Regulated Unofficial Market in Stuttgart; Open Market in
Frankfurt
End of News DGAP News Service
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454249 14.04.2016
DGAP-News: NEOVACS OBTAINS SOUTH KOREA HEALTH AUTHORITY APPROVAL FOR IND APPLICATION WITH INFα KINOID IN LUPUS
| Source: EQS Group AG