DJ Pharnext: Shareholder Letter
Pharnext
Pharnext: Shareholder Letter
29-Oct-2020 / 08:30 CET/CEST
Dissemination of a French Regulatory News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
PARIS, France, 08:30 a.m. CET, October 29, 2020 - Pharnext SA (FR0011191287 - ALPHA),
an advanced late-stage clinical biopharmaceutical company pioneering new approaches to
developing innovative drug combinations based on big genomics data and artificial
intelligence ("Company") using its PLEOTHERAPY platform, today published a Letter
to Shareholders from its Chief Executive Officer, Dr. David Horn Solomon.
Dear Fellow Shareholder,
2020 is a pivotal year for Pharnext's development, and we look forward to continued
growth and progress in the remainder of the year and ahead. Over the course of this
year, we have made several operational and clinical advances, including important
leadership appointments, addition of highly qualified independent directors to our
Board, and most importantly, we received guidance from the FDA on the development path
forward for our lead asset, PXT3003, for the treatment of Charcot-Marie-Tooth disease
type 1A (CTM1A), a rare and highly debilitating disease. We believe that we are
well-positioned to initiate and execute our second pivotal Phase III clinical trial for
our lead program, PXT3003, in CMT1A.
Our Focus on PXT3003 and Upcoming Pivotal Phase III Clinical Trial in CMT1A
We continue to focus most of our resources on developing PXT3003 for CMT1A with the
goal of obtaining marketing approval from FDA and EMA. PXT3003 is a novel combination
of naltrexone, baclofen and sorbitol, taken orally, and has Orphan Drug Designation
from both FDA and EMA. Currently, there are no approved therapies to treat CMT1A, and
PXT3003 is the most advanced pharmaceutical product candidate in development. Given
there are over 100,000 CMT1A patients across the US and EU5 markets with little
competition, we believe that the global annual commercial revenue opportunity for
PXT3003 exceeds $1 billion. Our Company has been transformed and is dedicated to
successfully bringing PXT3003 to the market to treat CMT1A patients, improving their
quality of life and reducing the burden on their families and caregivers.
Key Events in 2020:
Strengthened senior management with key hires
I joined the Pharnext team as the Chief Executive Officer in April 2020. Having spent
almost 30 years in the pharmaceutical industry and serving as the Chief Executive
Officer of Silence Therapeutics and Zealand Pharma previously, I have a tremendous
appreciation for Pharnext's vision and rich pipeline assets.
I am honored to have been given the opportunity to lead Pharnext through this next
phase of growth. Our PLEOTHERAPY platform, by leveraging genomic big data and
artificial intelligence, truly offers a novel and innovative approach to identifying
potential treatments for a variety of indications. I am grateful to Daniel Cohen who,
as a visionary founder, explored the opportunities to leverage the PLEOTHERAPY
platform to continue to build our pipeline.
In August 2020, Dr. Adrian Hepner joined Pharnext as Chief Medical Officer and Head of
R&D. Dr. Hepner has more than 30 years of industry experience in biomedical research,
clinical drug development and medical affairs. Prior to joining Pharnext, he held
executive positions at Eagle Pharmaceuticals, Avanir Pharmaceuticals, BioDelivery
Sciences International (BDSI) and UCB BioSciences, Inc. Dr. Hepner received an M.D. and
Ph.D. in Psychiatry and Neurology from the University of Buenos Aires. He also
completed a post-doctoral fellowship in Neuro-Psychopharmacology at the University of
Ottawa and additional training at Harvard University. Adrian's drive and passion for
drug development has led to 8 NDAs resulting in approved medicines.
The senior management team also includes Peter Collum, our Chief Financial and Business
Officer, who joined Pharnext in July 2019 after a 17-year career in life sciences
investment banking with both Bank of America and MTS Health Partners, as well as a
5-year career in the pharmaceutical industry with Roche as an engineer. Peter brings to
our company a remarkable knowledge of financial markets and the pharmaceutical
industry.
Together with the other talented members of management, we believe we now have a strong
and complete team of executives and employees with expertise and invaluable experience
to position the Company to meet our strategic objectives and ultimately develop
therapies for patients in need.
Interaction with the U.S. Food and Drug Administration ("FDA")
In June 2020, we had a productive meeting with the FDA to discuss the regulatory path
forward for PXT3003 and appreciate the agency's continued collaborative approach in our
clinical advancement of PXT3003. Based on FDA guidance, Pharnext is preparing to
conduct an additional pivotal Phase III trial for which the FDA has recommended that
the primary endpoint be the Overall Neuropathy Limitations Scale ("ONLS"). This study
will have two arms to compare high dose and placebo. I would like to point out that in
our original Phase III study, the high dose patients showed encouraging responses using
the same primary endpoint, ONLS. We expect to launch this trial before the end of Q1
2021. In the meantime, we are running an open label study for patients enrolled in the
original Phase III trial.
We submitted a Special Protocol Assessment (SPA) to the FDA on September 15 in order to
further define the new Phase III study protocol.
If successful, the data results from the upcoming Phase III trial will be used to
support the New Drug Application ("NDA") for PXT3003 in CMT1A.
Appointment of new directors to the Board
As part of our 2020 Annual General Meeting, the Company proposed a transformation of
the Board consistent with the Company's vision of developing and commercializing
PXT3003 in the U.S. and Europe for CMT1A. The newly appointed directors have strong
biopharmaceutical and business expertise focused on clinical development, neurology,
strategy, transactions, value creation and governance. The newly appointed directors
include:
· Alexandre Berda - Managing Director of CB Lux, Pharnext's largest shareholder.
· Dr. Jean Combalbert - Founder and CEO of Epics Therapeutics SA, Chairman of the
Board of Syndesi Therapeutics SA.
· Dr. Elisabeth Svanberg - Chief Development Officer at Ixaltis SA, Board-certified
general surgeon and Associate Professor of Surgery.
· Joshua Schafer - Chief Strategy and Business Development Officer of Mallinckrodt
Pharmaceuticals and Board member of Shuttle Pharmaceuticals.
· Dr. David Horn Solomon - Chief Executive Officer of Pharnext SA, Chairman of the
Board for Advicenne Pharma (PARIS: ADV) and Rexgenero in London.
· Dr. Lawrence Steinman - Zimmerman Professor of Neurology and Neurological Sciences,
Pediatrics and Genetics at Stanford University.
In addition to the newly appointed directors, the Pharnext Board of Directors also
includes Michel de Rosen (Chairman), Pierre Bastid, Kenneth Lee and Dr. Philippe
Pouletty. Full biographies of Board Members can be found on Pharnext's website at
https://pharnext.com/about [1]. We truly believe we have the right Board in place to
oversee our value creation opportunity and effectively execute under their expertise.
Entered a Research Collaboration with Charcot-Marie-Tooth Association
In September, we signed a research collaboration with the Charcot-Marie-Tooth
Association (CMTA), a United States patient advocacy group, to investigate novel
biomarkers associated with CMT1A.
The primary objective of this collaboration is to identify and validate potential
treatment responsive CMT1A biomarkers that could be further explored in future clinical
studies, in particular the upcoming Phase III study of PXT3003. Notably, this
collaboration will evaluate the potential of TMPRSS5, a recently identified Schwann
cell-specific biomarker in CMT1A patients, to confirm if it can be used to assess
treatment response in future clinical trials. We are very excited about this
collaboration and look forward to conducting research that will potentially bring
valuable insights for further development of PXT3003.
The Future for Pharnext
2020 has been a very productive and event-driven year for Pharnext. Our plan is to
build on this momentum by advancing drug candidates from our PLEOTHERAPY pipeline
through clinical development and, subject to regulatory approval, ultimately bring them
to the market to fulfil the significant unmet medical need in our target patient
population. Pharnext estimates that the funding requirements to complete our Phase III
trial in CMT1A are approximately &euro70 million. Pharnext intends to fund its internal
clinical development efforts through one or more equity raises, anticipated to be
targeted in whole or in part at US and European institutional life science investors,
at times and on terms that will be subject to prevailing market conditions. Pharnext
expects to also benefit from the participation of existing shareholders in these equity
raises further evidencing their support of the Company's strategy and future
development path.
With Best Regards,
David Horn Solomon
Chief Executive Officer
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 completed an international Phase III trial with positive
topline results 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
encouraging Phase II results in Alzheimer's disease and will be advanced through
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