Pharnext Announces PXT3003 was Granted Priority Review by the China Food and Drug Administration
June 14 2018 - 1:30AM
Business Wire
Regulatory News:
Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA),
a biopharmaceutical company pioneering a new approach to the
development of innovative drug combinations based on big genomic
data and artificial intelligence, today announced that PXT3003 was
granted priority review for Charcot-Marie-Tooth Type 1A disease
(CMT1A) by the China Food and Drug Administration (CFDA).
Pharnext’s first-in-class PLEODRUG™ PXT3003 is currently in a
Phase 3 clinical trial in Europe and the United States, with
results expected before the end of 2018. PXT3003, developed using
Pharnext’s R&D platform PLEOTHERAPY™, is a novel oral fixed-low
dose combination of baclofen, naltrexone and sorbitol, with EMA and
U.S. FDA Orphan Drug Designation.
GeneNet Co, Ltd, a joint venture between Tasly and Pharnext,
owns the commercialization rights for PXT3003 for CMT1A in Greater
China (Mainland China, Hong Kong, Taiwan, and Macau), as well as
exclusive license rights to all PXT3003 patents applied for and
authorized in Greater China.
In December 2017, GeneNet applied for clinical approval for
PXT3003 to be registered as an imported pharmaceutical in China.
PXT3003’s inclusion in the priority review process will greatly
shorten the waiting time for clinical approval and also expedite
registration as an imported pharmaceutical.
“We are pleased that PXT3003 has been identified as a priority
by the CFDA, and that its fast-track status will decrease the
waiting time for the drug’s approval,” said Prof. Daniel Cohen,
M.D., Ph.D., Pharnext’s Co-Founder and CEO.
About Pharnext
Pharnext is an advanced clinical-stage biopharmaceutical company
developing novel therapeutics for orphan and common
neurodegenerative diseases that currently lack curative and/or
disease-modifying treatments. Pharnext has two lead products in
clinical development. PXT3003 is currently in an international
Phase 3 trial for the treatment of Charcot-Marie-Tooth Type 1A
disease and benefits from orphan drug status in Europe and the
United States. The results of this trial are expected in the second
half of 2018. PXT864 has generated positive Phase 2 results in
Alzheimer’s disease. Pharnext has developed a new drug discovery
paradigm based on big data genomics and artificial intelligence:
PLEOTHERAPY™. The Company identifies and develops synergic
combinations of drugs called PLEODRUG™ offering several key
advantages: efficacy, safety and robust intellectual property. The
Company was founded by renowned scientists and entrepreneurs
including Professor Daniel Cohen, a pioneer in modern genomics, and
is supported by a world-class scientific team.
Pharnext is listed on Euronext Growth Stock Exchange in Paris
(ISIN code: FR0011191287).
For more information, visit www.pharnext.com.
About Tasly
Tasly Pharmaceutical Group Co., Ltd. was listed on the Shanghai
Stock Exchange in August 2002 (Stock Code 600535). The company
concept is "To share the joy of health with all” and the company
mission “To improve human life and quality of life.” Tasly is
committed to promoting the integration of Traditional Chinese
Medicine (TCM) with modern medical and pharmaceutical technologies.
It is also committed to building the first international brand of
modernized TCM. “To become the global innovation leader of modern
TCM and the scientific standard maker of modern TCM” is our target.
To achieve this goal, Tasly will strive to bring modernized TCM to
international pharmaceutical standards. To support its development
strategy of “Comprehensive Internationalization,” Tasly has set up
a complete manufacturing chain which respects international
guidelines and exploits intelligent manufacturing systems. Based on
its “Two Wheels of Innovation and Capitalization” strategy, Tasly
has developed several core competitive advantages, such as its
R&D model, a multi-level product system, a multi-dimensional
patent protection system and a commercial and marketing
network.
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PharnextRené GoedKoop, +33 (0)1 41 09 22 30Chief Medical
Officermedical@pharnext.comorFinancial Communication
(France)ActifinStéphane Ruiz, +33 (0)1 56 88 11
15sruiz@actifin.frorInvestor Relations (U.S.)Stern Investor
Relations, Inc.Matthew Shinseki,
+1-212-362-1200matthew@sternir.comorInvestor Relations
(Europe)MC Services AGAnne Hennecke, +49 211 529252
22anne.hennecke@mc-services.euorMedia Relations
(Europe)Ulysse CommunicationBruno Arabian, +33 (0)1 81 70 96
30barabian@ulysse-communication.comorMedia
Relations (U.S.)RooneyPartnersKate L. Barrette,
+1-212-223-0561kbarrette@rooneyco.com
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