Business Wire

European Medicines Agency Agrees with Pharnext’s Pediatric Investigation Plan for PXT3003

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 the European Medicines Agency (EMA) has agreed with its pediatric investigation plan (PIP) for PXT3003 in Charcot-Marie-Tooth disease type 1A (CMT1A).

“The EMA agreement with our PIP represents a significant step forward in our efforts to bring PXT3003 to patients in Europe,” said Prof. Daniel Cohen, M.D., Ph.D., Co-Founder and Chief Executive Officer of Pharnext. “Given that much of the progression of CMT1A occurs in the first two decades of patients’ lives, we believe that by intervening in childhood, we can have a greater impact on patients’ disease trajectory. In our Phase 2 study, PXT3003 was observed to stablilize and slow the progression of CMT1A, and also demonstrated clinical improvement in patients. We are dedicated to providing the estimated 14,000 children in Europe living with CMT1A a safe therapeutic option that may offer significant long-term relief.”

As part of the regulatory process for registering new medicines with the EMA, pharmaceutical companies are required to provide a PIP that outlines the clinical development strategy for studying the investigational product in children. EMA agreement with the PIP is required before a company can file a marketing authorization application (MAA) for any new medicinal product in Europe.

PXT3003 is being evaluated in an international pivotal Phase 3 clinical trial in adults with CMT1A, with top-line results expected by October 2018. The clinical study investigating the safety and efficacy of PXT3003 for CMT1A in children will be conducted in Europe, Canada and the United States.

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 disease type 1A and benefits from orphan drug status in Europe and the United States. PXT864 has generated positive Phase 2 results in Alzheimer’s disease. Pharnext has developed a new drug discovery paradigm based on big genomic data 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 http://www.pharnext.com/

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

Dimension Data Global Delivery Centre (GDC) in Prague wins the ABSL 2018 Diamond Award for Business Innovation16.11.2018 08:00Pressemelding

Dimension Data, the USD 8 billion global technology integrator and managed services provider, today announced that its Global Delivery Centre (GDC) in Prague has won the 2018 ABSL Diamond award for Business Innovation. The main purpose of this centre is to provide innovative, global service delivery capabilities and deep technical expertise to support our clients. The ABSL Diamond awards recognise companies that implement innovative projects, enhancing their business and strengthening the position of the business services sector. Every year, the aim is to identify successful activities in this sector and promote best practices, ultimately encouraging and inspiring others to follow suit. The ABSL celebrates initiatives that push business services forward and stand out as exemplary projects. Bill Padfield, Group Chief Operating Officer for Transformation and Services at Dimension Data, said: “Winning another award for our Support Services is a fantastic achievement. This time the ABSL Di

FCC Grants LeoSat U.S. Market Access16.11.2018 06:00Pressemelding

LeoSat Enterprises, the dynamic young company which is launching a unique new data network comprised of a constellation of up to 108 low-earth-orbit communications satellites, has been awarded the authority by the U.S. Federal Communications Commission (FCC) to provide NGSO (non-geostationary satellite orbit) services in the United States. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181115005890/en/ LeoSat's Global Business Backbone in Space (Graphic: Business Wire) The increasing demand for business connectivity and with it, the need to move large quantities of data quickly and securely around the world, is fast outpacing the infrastructure in place to carry it. Existing networks are already carrying more than 1 Zeta Byte of traffic globally and this is set to grow exponentially. The FCC market access grant will allow LeoSat to address currently unmet demand for high-bandwidth, low-latency, high-security data transmissio

German Court Rules Huawei, ZTE Products Infringe AVC Patents16.11.2018 05:01Pressemelding

MPEG LA announced today that the District Court in Düsseldorf, Germany (“Landgericht Düsseldorf”) has ruled that Huawei Technologies Deutschland GmbH (“Huawei”) and ZTE Deutschland GmbH (“ZTE”) infringed patents of two patent holders in MPEG LA’s AVC Patent Portfolio License (“AVC License”) by using their technologies in mobile phones that implement the AVC/H.264 (MPEG-4 Part 10) Standard. The court also found that the license offered by the patent holders under those patents through the AVC License is fair, reasonable and nondiscriminatory. “The Landgericht Düsseldorf’s decision confirms the importance of respect for intellectual property, and offering everyone easy and affordable access to essential AVC technology under a single license is a cornerstone of the MPEG LA AVC License’s wide acceptance making that possible,” said Larry Horn, President and CEO of MPEG LA. “We continue to welcome Huawei and ZTE to join the nearly 2,000 Licensees who have entered into our AVC License.” Verdi

IFF-LMR Naturals Leads Industry with 90 Certified Vegan Natural Extracts15.11.2018 21:15Pressemelding

Regulatory News: IFF-LMR, a subsidiary of International Flavors & Fragrances Inc (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) announced their industry-leading position of 90 natural extracts in their portfolio certified vegan by the EVE (Expertise Vegan Europe) VEGAN standards. The certified extracts include Rose EssentialTM, Rose UltimateTM, Blackcurrant Buds Absolute, Ylang Oil Complete, Vetiver Oil Haiti, Patchouli Oil Indonesia, and Geranium Heart Oil, among many others. Bertrand de Preville, General Manager, IFF-LMR said, “Our people are passionate about creating the finest ingredients and together, we are committed to delivering premium, 100% pure and natural extracts. We believe in transparency, environmental management and sustainable development.” Mr. de Preville continued, “This certification of 90 extracts is in line with IFF-LMR’s continuous dedication to our planet, people, plants and animals.” The EVE VEGAN label was selected because it is considered one of the most rigor

Rimini Street Expands Investment and Operations in Asia-Pacific15.11.2018 20:00Pressemelding

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced that it has expanded its operations in the Asia-Pacific region with the launch of its new subsidiary, Rimini Street New Zealand Limited, and the opening of its new office in Auckland to address the growing demand for Rimini Street’s premium, ultra-responsive support services in New Zealand. Rimini Street’s expansion was announced at a gala event held at The Northern Club in Auckland, where clients, local IT leaders and the special guest of honor, Ambassador Scott P. Brown, the U.S. Ambassador to New Zealand, were hosted by Rimini Street’s general manager for Asia-Pacific, Andrew Powell, and Rimini Street corporate senior executives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181115005037/en/ Rimini Street launches subsidiary

Sartorius Stedim Biotech and Lonza Modify Relationship for Supply of Cell Culture Media15.11.2018 18:15Pressemelding

Sartorius Stedim Biotech (SSB) (Paris:DIM), a leading international supplier of the biopharmaceutical industry, and Lonza announced today that they have modified their current agreement for supply of cell culture media by mutual accord. The agreement, signed in 2012, gave SSB exclusive sales and marketing rights for certain cell culture media and buffers developed and manufactured by Lonza for use in biopharmaceutical manufacturing processes. Lonza retained sales for research-based products, among others. Under agreements signed today, SSB will continue to offer current and future Lonza media and buffers on a non-exclusive basis as part of its extensive portfolio of products for cell-based development and manufacturing. Lonza Pharma & Biotech resumes sales and marketing of all its media products for both manufacturing and research. Customers of both companies will continue to be able to source media products for their specific needs. “We have a long-standing and productive partnership