Business Wire

Pharnext Announces PXT3003 was Granted Priority Review by the China Food and Drug Administration

Del

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.

Contact information

Pharnext
René GoedKoop, +33 (0)1 41 09 22 30
Chief Medical Officer
medical@pharnext.com
or
Financial Communication (France)
Actifin
Stéphane Ruiz, +33 (0)1 56 88 11 15
sruiz@actifin.fr
or
Investor Relations (U.S.)
Stern Investor Relations, Inc.
Matthew Shinseki, +1-212-362-1200
matthew@sternir.com
or
Investor Relations (Europe)
MC Services AG
Anne Hennecke, +49 211 529252 22
anne.hennecke@mc-services.eu
or
Media Relations (Europe)
Ulysse Communication
Bruno Arabian, +33 (0)1 81 70 96 30
barabian@ulysse-communication.com
or
Media Relations (U.S.)
RooneyPartners
Kate L. Barrette, +1-212-223-0561
kbarrette@rooneyco.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

American Airlines Announces Nonstop Philadelphia (PHL) to Orlando Melbourne (MLB)21.9.2018 22:13Pressemelding

Glorious beaches by day and theme park fireworks by night just got more convenient for Philadelphia travelers. American Airlines announced today that it will begin nonstop flights to Orlando Melbourne International Airport (MLB) starting February 16, 2019. The Central Florida airport is conveniently located in the heart of the tourism region and is the closest airport to NASA rocket launches, Port Canaveral’s cruises and what critics call “some of the most beautiful beaches Florida has to offer.” The flights will depart Saturdays from Philadelphia at 8:05 a.m., arriving in Florida at 10:48 a.m. The Embraer 175 jet arrival time syncs perfectly with cruise ship noon early boarding. Melbourne Airport Express offers nonstop shuttle service to the port, and all major rental car companies are onsite. The return flight to PHL departs at 11:24 a.m. and arrives in PHL at 1:55 p.m., with enough time to connect to some of American’s largest international destinations, including recently announced

Amy Palladino Joins BCW as Executive Vice President, Managing Director, Corporate Practice21.9.2018 17:43Pressemelding

BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Amy Palladino has joined the agency as Executive Vice President, Managing Director in the agency’s U.S. Corporate Practice. Based in New York, Palladino will focus on senior client counsel and executive positioning for the agency’s largest corporate clients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005507/en/ Amy Palladino Joins BCW (Burson Cohn & Wolfe) “Amy is a talented and highly experienced communications executive with a track record of solving clients’ complex challenges and building business through smart, integrated communications approaches,” said Chris Foster, President, North America, BCW. “Her creativity and judgement will be enormously valuable to our current and prospective clients.” Palladino has more than 20 years of experience advising global clients across numerous industries, including technology, healthcar

Heidelberg Engineering Announces the CE-Marking of ANTERION21.9.2018 16:41Pressemelding

Heidelberg Engineering, the leader in diagnostic imaging known for the internationally-acclaimed SPECTRALIS ® retina and glaucoma platform, announces the CE-marking of ANTERION ® – an innovative platform designed to transform anterior segment diagnostics and workflow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005442/en/ The new Heidelberg Engineering ANTERION® provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. (Graphic: Business Wire) The new ANTERION provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. It is a single, workflow-efficient solution that brings together corneal topography and tomography, anterior segment metrics, axial length measurement and IOL calculation to transform the day-to-day routine of busy practices and clinics. Heidelberg Engineering has leveraged its core OCT technolo

Florian Winterstein Becomes New CEO of Jedox21.9.2018 15:46Pressemelding

The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it

Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 13:30Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+

Asda Selects HCL Technologies to Help Drive IT Transformation21.9.2018 12:16Pressemelding

HCL Technologies (HCL), a leading global technology company, today announced that it has been selected to help drive IT transformation at the UK’s third-largest grocery retailer, Asda. The three-year application services contract will see HCL transform Asda’s IT Application Services with a new DevOps delivery model to drive data and analytics and support back-office applications through the full lifecycle of development, testing and support. HCL will also build a central data management platform to enable Asda to improve its insight and analytics capabilities. Asda operates more than 600 stores across the UK, employing over 135,000 people. Asda wanted to adopt a more agile approach towards application development and testing. This would allow the company to respond faster to business requirements and reduce time to market, while driving better user experience and satisfaction. HCL was selected due to its extensive expertise in successfully delivering similar large scale IT transformati