Adial Pharmaceuticals, Inc. (NASDAQ:ADIL;ADILW)
www.adialpharma.com, a clinical-stage biopharmaceutical
company focused on the development of medicines for addiction,
today announced a partnership with Catalent Pharma Solutions, a
leading global provider of advanced delivery technologies and
development solutions for drugs, biologics and consumer health
products, to advance clinical activities related to AD04, Adial’s
genetically targeted, lead investigational new drug product for the
treatment of alcohol use disorder (“AUD”). This partnership brings
together critical capabilities to allow the commencement of Adial’s
planned initial Phase 3 trial, with Catalent providing packaging
and distribution.
Based on the clinical experience to date and
publicly available databases, Adial believes the genetic prevalence
of genotype-positive AUD patients in the United States is about
33%, or about 11 million people, and that the prevalence in
Scandinavia and in certain areas of Eastern Europe may be even
higher, with possibly more than 50% being genetically positive for
treatment with AD04. The U.S. Food and Drug Administration (FDA)
has agreed that the Phase 3 trials of AD04 can proceed with
enrolling patients that are genotype positive for this Phase 3
trial.
“The FDA’s agreement to allow Adial to structure
our Phase 3 trial of AD04 by inclusion of only genotype-positive
patients significantly reduces the cost, time and risk as compared
with having to enroll patients in the study that are
genotype-negative for potential treatment with AD04,” commented
William Stilley, CEO of Adial Pharmaceuticals.
Adial plans to commence the initial Phase 3
trial of AD04 in Scandinavia and Eastern Europe during the first
half of 2019. Adial selected these geographic areas premised on the
expected higher prevalence of genotype positive patients, which
will help to reduce the cost, time and risk to achieve Phase 3
results.
Catalent has a robust, global network, with the
presence in Europe and the U.S. to provide flexible, integrated
clinical supply services for investigational medicinal products.
Catalent will be responsible for packaging and distributing AD04 to
clinical sites. With additional facilities in the Asia/Pacific
region and in Latin America, Catalent provides capabilities that
should also be important in the future development of AD04, and for
the eventual commercial launch of the product, once approved.
“We look forward to continuing our long-term
relationship with Catalent, which will provide critical
distribution and logistics support for AD04 in our upcoming Phase 3
trial,” added Mr. Stilley. “With facilities and personnel servicing
Scandinavia and Eastern Europe, Catalent is an ideal partner; we
believe that its packaging and logistics expertise and GMP
facilities are well equipped to support our planned clinical sites.
In addition, Catalent brings broad capabilities in the U.S. and
globally, which should be important as we seek to expand our
clinical development activities and initiate commercialization
promptly upon approval.”
“Catalent is pleased to enter this partnership
and we look forward to working with Adial as it drives to bring
this new drug product to patients for the treatment of alcohol use
disorder,” said Paul Hegwood, Catalent’s President of Clinical
Supply Services.
About Catalent
Catalent is the leading global provider of
advanced delivery technologies and development solutions for drugs,
biologics and consumer health products. With more than 85 years
serving the industry, Catalent has proven expertise in bringing
more customer products to market faster, enhancing product
performance and ensuring reliable clinical and commercial product
supply. Catalent employs over 11,000 people, including over 1,800
scientists, at more than 30 facilities across five continents, and
in fiscal 2018 generated approximately $2.5 billion in annual
revenue. Catalent is headquartered in Somerset, New Jersey. For
more information, visit www.catalent.com.
More products. Better treatments.
Reliably supplied.™
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage
biopharmaceutical company focused on the development of treatments
for addictions. The Company’s lead investigational new drug
product, AD04, is a genetically targeted therapeutic agent for the
treatment of alcohol use disorder (“AUD”). A Phase 2b clinical
trial of AD04 for the treatment of AUD showed promising results in
reducing frequency of drinking, quantity of drinking and heavy
drinking (all with statistical significance), and no overt safety
concerns (there were no statistically significant serious adverse
events reported). The Company plans to commence a Phase 3 clinical
trial using AD04 for the potential treatment of AUD in subjects
with certain target genotypes, which are to be identified using the
Company’s proprietary companion diagnostic genetic test. AD04 is
also believed to have the potential to treat other addictive
disorders such as opioid use disorder, gambling, and obesity.
www.adialpharma.com
Forward Looking Statements
This communication contains certain
“forward-looking statements” within the meaning of the U.S. federal
securities laws. Such statements are based upon various facts and
derived utilizing numerous important assumptions and are subject to
known and unknown risks, uncertainties and other factors that may
cause actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Statements
preceded by, followed by or that otherwise include the words
“believes,” “expects,” “anticipates,” “intends,” “projects,”
“estimates,” “plans” and similar expressions or future or
conditional verbs such as “will,” “should,” “would,” “may” and
“could” are generally forward-looking in nature and not historical
facts, although not all forward-looking statements include the
foregoing. These statements are based upon current beliefs,
expectations and assumptions and include statements regarding
commencing a Phase 3 clinical trial in the first half of 2019, the
expected reduction of cost, time and risk by conducting the Phase 3
trial in Scandinavia and Eastern Europe, the size of the market,
the expected benefit AD04 will bring to patients and the expected
contribution of Catalent. Any forward-looking statements included
herein reflect our current views, and they involve certain risks
and uncertainties, including, among others, our ability commence
the Phase 3 clinical trials in the first half of 2019, our ability
to reduce the cost, time and risk to achieve Phase 3 results, the
expected contribution of Catalent to helping us expand our clinical
development activities and seek to initiate commercialization, the
ability of AD04 therapy to perform as designed, to demonstrate
safety and efficacy, as well as results that are consistent with
prior results, the ability to enroll patients and complete the
clinical trials on time and achieve desired results and benefits,
our ability to obtain regulatory approvals for commercialization of
product candidates or to comply with ongoing regulatory
requirements, regulatory limitations relating to our ability to
promote or commercialize our product candidates for specific
indications, acceptance of its product candidates in the
marketplace and the successful development, marketing or sale of
products, our ability to maintain our license agreements, the
continued maintenance and growth of our patent estate, our ability
to establish and maintain collaborations, our ability to obtain or
maintain the capital or grants necessary to fund its research and
development activities, and our ability to retain our key employees
or maintain our Nasdaq listing. These risks should not be construed
as exhaustive and should be read together with the other cautionary
statement included in our annual report on Form 10-K that we have
filed with the SEC. Any forward-looking statement speaks only as of
the date on which it was initially made. We undertake no obligation
to publicly update or revise any forward-looking statement, whether
as a result of new information, future events, changed
circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC David Waldman Tel: +1 212-671-1021
Email: dwaldman@crescendo-ir.com |
Catalent Pharma Solutions
Chris Halling+44 (0)7580 041073 chris.halling@catalent.com
Richard Kerns+44 (0)161 728 5880richard@nepr.eu |
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