Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates against validated molecular targets in indications of
high unmet medical need, today announced a partnership with Advanz
Pharma, a pharmaceutical company with a strategic focus on
commercialization of specialty, hospital, and rare disease
medicines, for commercialization of AT-007 (govorestat) in Europe.
“We believe Advanz Pharma is an ideal partner
for commercialization of AT-007 in Europe,” said Shoshana
Shendelman, PhD, Founder and CEO of Applied Therapeutics. “Advanz
Pharma’s commitment to improving the lives of patients alongside
their critical infrastructure and expertise in rare diseases
positions them well for commercial success. This partnership brings
us one step closer to making AT-007 available to patients with
Galactosemia and SORD Deficiency – both debilitating rare diseases
with no other therapies currently available – and strengthens
Applied Therapeutics’ capital position.”
“We are pleased to partner with Applied
Therapeutics,” said Susanna El-Armale, Chief Corporate Development
Officer of Advanz. “We believe that AT-007 represents a compelling
scientific opportunity to treat rare diseases, including
Galactosemia and SORD Deficiency. This partnership delivers on our
commitment to bring innovative products to market that serve an
unmet medical need and to build a strong product pipeline to drive
Advanz’s mid- and long-term growth.”
Under the terms of the agreement:
- Applied Therapeutics will receive
certain near-term development milestones upon clinical trial
completion and marketing authorization in Europe as well as
commercial sales milestones, which in the aggregate amount to over
€130 million, including €10 million upfront due upon signing.
- Applied Therapeutics will receive
royalties on any future net sales of AT-007 in Europe of 20%.
- Applied Therapeutics will continue
to be responsible for the development, manufacturing and supply of
AT-007, and Advanz Pharma will be responsible for packaging,
distribution and commercialization in Europe.
- Advanz Pharma receives exclusive
commercial rights in the European Economic Area, Switzerland, and
the UK for AT-007 in Galactosemia and SORD Deficiency, with certain
rights to future indications for AT-007 in Europe.
About AT-007
AT-007 is a central nervous system (CNS)
penetrant Aldose Reductase inhibitor (ARI) in development for the
treatment of several rare neurological diseases, including
Galactosemia, SORD Deficiency, and PMM2-CDG. In clinical trials,
AT-007 significantly reduced plasma galactitol levels vs. placebo
in adults and children with Galactosemia. AT-007 is currently being
studied in a Phase 3 clinical outcomes trial (ACTION-Galactosemia
Kids) in children ages 2-17 with Galactosemia, as well as a
long-term open-label study in adults with Galactosemia. In a pilot
study in adults with SORD Deficiency, AT-007 significantly reduced
blood sorbitol levels. AT-007 is currently being studied in a Phase
3 trial (INSPIRE) investigating biomarker efficacy and clinical
outcomes in adults and children 16 years and older with SORD
Deficiency. The drug has been generally safe and well tolerated in
all clinical studies to date.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage
biopharmaceutical company developing a pipeline of novel drug
candidates against validated molecular targets in indications of
high unmet medical need. The Company’s lead drug candidate, AT-007,
is a novel central nervous system penetrant Aldose Reductase
Inhibitor (ARI) for the treatment of CNS rare metabolic diseases,
including Galactosemia, SORD Deficiency, and PMM2-CDG. The Company
is also developing AT-001, a novel potent ARI, for the treatment of
Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart.
The preclinical pipeline also includes AT-003, an ARI designed to
cross through the back of the eye when dosed orally, for the
treatment of Diabetic retinopathy.
To learn more, please visit
www.appliedtherapeutics.com and follow the company on Twitter
@Applied_Tx.
About Advanz Pharma
ADVANZ PHARMA is a global pharmaceutical company
with a strategic focus on specialty, hospital, and rare disease
medicines in Europe and Canada. The company has commercial
affiliates in Europe, North America and Australia, and a Centre of
Excellence in Mumbai, India, as well as an established global
network of commercial partners throughout the rest of the world.
With an agile and experienced team, including direct sales,
marketing, and medical capabilities across Europe's major markets,
Canada, and Australia, ADVANZ PHARMA is committed to improving
lives of patients by providing and enhancing the specialty,
hospital, and rare disease medicines they depend on. The company
has a broad expertise in several therapeutic areas including
hepatology, gastroenterology, CNS, critical care, anti-infectives,
endocrinology, oncology, and more broadly rare disease medicines,
making ADVANZ PHARMA a partner of choice for the commercialization
of specialty, hospital, and rare disease medicines.
Forward-Looking Statements
This press release contains “forward-looking
statements” that involve substantial risks and uncertainties for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. Any statements, other than
statements of historical fact, included in this press release
regarding the strategy, future operations, prospects, plans and
objectives of management, including words such as “may,” “will,”
“expect,” “anticipate,” “plan,” “intend,” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) are forward-looking statements. These
include, without limitation, statements regarding (i) the
anticipated benefits of the Company’s partnership with Advanz
Pharma and (ii) the expected development milestone payments.
Forward-looking statements in this release involve substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by the forward-looking
statements, and we, therefore cannot assure you that our plans,
intentions, expectations or strategies will be attained or
achieved.
Such risks and uncertainties include, without
limitation, (i) our plans to develop, market and commercialize our
product candidates, (ii) the initiation, timing, progress and
results of our current and future preclinical studies and clinical
trials and our research and development programs, (iii) our ability
to take advantage of expedited regulatory pathways for any of our
product candidates, (iv) our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing,
(v) our ability to successfully acquire or license additional
product candidates on reasonable terms and advance product
candidates into, and successfully complete, clinical studies, (vi)
our ability to maintain and establish collaborations or obtain
additional funding, (vii) our ability to obtain and timing of
regulatory approval of our current and future product candidates,
(viii) the anticipated indications for our product candidates, if
approved, (ix) our expectations regarding the potential market size
and the rate and degree of market acceptance of such product
candidates, (x) our ability to fund our working capital
requirements and expectations regarding the sufficiency of our
capital resources, (xi) the implementation of our business model
and strategic plans for our business and product candidates, (xii)
our intellectual property position and the duration of our patent
rights, (xiii) developments or disputes concerning our intellectual
property or other proprietary rights, (xiv) our expectations
regarding government and third-party payor coverage and
reimbursement, (xv) our ability to compete in the markets we serve,
(xvi) the impact of government laws and regulations and liabilities
thereunder, (xvii) developments relating to our competitors and our
industry, (xvii) the impact of the COVID-19 pandemic on the timing
and progress of our ongoing clinical trials and our business in
general and (xiv) other factors that may impact our financial
results. In light of the significant uncertainties in these
forward-looking statements, you should not rely upon
forward-looking statements as predictions of future events.
Although we believe that we have a reasonable basis for each
forward-looking statement contained in this press release, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur at all.
Factors that may cause actual results to differ from those
expressed or implied in the forward-looking statements in this
press release are discussed in our filings with the U.S. Securities
and Exchange Commission, including the “Risk Factors” contained
therein. Except as otherwise required by law, we disclaim any
intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Contacts
Investors:
Maeve Conneighton (212) 600-1902
appliedtherapeutics@argotpartners.com
Media:
media@appliedtherapeutics.com
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