Business Wire

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

Jaa

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

SCG Chemicals Company chooses gPROMS modelling for digital design and operations22.3.2019 18:55:00 EETTiedote

Process Systems Enterprise (PSE), the Advanced Process Modelling company, today announced that it has signed a long-term agreement with SCG, one of the largest integrated petrochemical companies in South East Asia, to standardise on PSE’s gPROMS® modelling technology for digital design and operations. SCG applies advanced process models within digital design initiatives to explore the process decision space rapidly and effectively, in order to reduce uncertainty and make better, faster and safer design and operating decisions. This help them to accelerate innovation and optimise the design and operation of their process plants. Dr Suracha Udomsak, SCG’s Emerging Business Director and R&D Director, says, “at SCG Chemicals, advanced process modelling (APM) is a key element in our Digital Manufacturing platform. APM accelerates innovation by making the development workflow ‘faster, cheaper & safer’, which are key considerations for us. It is a core technology building block that enables u

Logicor Announces Results for Year Ended 31 December 201822.3.2019 17:29:00 EETTiedote

Logicor announces strong financial performance for the year ended 31 December Net Operating Income (NOI): €639 million, which represents year on year growth of 2.5%, reflecting our strategic focus on increasing occupancy and capturing market rental growth. Over 60% of NOI is generated in the key markets of the UK (26%), Northern Europe1 (21%) and France (15%). Gross Asset Value: €12.5 billion, a 3.3% increase in valuation, which reflects the strong performance of our portfolio, in particular in Northern Europe. EPRA Occupancy: 94.4%, with physical occupancy up 70 bps over the year, underpinned by strong growth in each of our three largest regions of the UK (+120 bps), Northern Europe (+110 bps) and France (+220 bps). LTV: 51%, down from 52% at year end 2017 following increases in property values. At year end, our debt to EBITDA ratio was 11.3x. Capital Structure In 2018 Logicor (rated BBB (Stable) by S&P) established a Euro Medium Term Note (‘EMTN’) programme and raised €1.8 billion of

Delticom AG/Mytyres.co.uk: Buying Great Value Tyres Online Doesn’t Mean Missing out on Professional Fitting22.3.2019 17:15:00 EETTiedote

Spring is just around the corner, and it’s time for drivers to start thinking about changing to summer tyres. However, a tyre check may show that your current summer tyres are getting old, worn out, or have visible damage, such as cracks or bumps. If this is the case, then it's time for a new set of tyres. The legal minimum tread depth is 1.6 mm, however experts recommend significantly more – summer tyres should be replaced even if the tread depth is 3 mm. Regardless of mileage, you should change your tyres at least every eight to ten years. This is because the rubber starts to harden, the tyres lose grip on the road, and driving performance is affected. Of course, a set of four new tyres is a significant investment – authorised workshops can often charge between 250 and 350 pounds. If you want to save money, consider the alternatives: the result is an increasing number of customers turning to online shops such as Mytyres.co.uk to buy new tyres. The market share of tyres sold online ha

Trueman Man Clinic Achieves 10000 Surgery Milestone with Its SWITCH Operation22.3.2019 16:00:00 EETTiedote

Trueman Man Clinic Network announced that the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation), has been successfully completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190322005013/en/ Trueman Man Clinic Network has been successfully completed the 10,000th surgery utilizing its SWITCH Premature Ejaculation Surgery (Nerve Conservation). The SWITCH Premature Ejaculation Surgery (SWITCH operation) developed in 2010 by Dr. Yang, the chief director of the Trueman Man Clinic Network, can reduce the side effects of penile neurectomy and maintain the stable reduction of the glans sensation. The Trueman Man Clinic Network is the leading hospitals for male enhancement surgeries in Korea consists of 11 clinics, with 16 doctors working. As of 2019, more than 43,000 man clinic surgeries have been performed. (Photo: Business Wire) The Trueman Man Clinic Network is the leading hospitals for m

Janssen Seeks Expanded Use of DARZALEX®▼ (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible22.3.2019 14:22:00 EETTiedote

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for DARZALEX®▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). “Today’s submission brings us one step closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. “We are incredibly grateful to the patients and investigators who participated in the MAIA clinical trial programme and look forward to working closely with the regulatory authorities to secure approval of this new combination.” The submission is supported by data from the Phase 3 MAIA (MMY3008) study, which were presented at the 60th Annual Meeting of the American

Bartek Ingredients Expands Leadership Team22.3.2019 01:35:00 EETTiedote

Bartek Ingredients Inc. recently completed a 4,000 ton/year capacity expansion for its malic and food-grade fumaric acid production facility, and today it announces the expansion of its leadership team, with the hiring of Jeff Billig as Vice President of Marketing & Business Development and Heinrich G. Schaefer as International Sales Director. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190321005785/en/ The global leader in malic and fumaric acid ingredients expands its leadership team. (Photo: Business Wire) Bartek’s investment in both its team and facilities reinforces its position as the leader in malic and fumaric acid globally and aligns with its mission to facilitate growth and increase global reach to better serve existing customers and markets while opening up new ones. Bartek’s addition of Billig and Schaefer lays the foundation for additional resource investment in the near future while rapidly increasing its sa

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme