Timber Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for Lead Asset TMB-001
December 15 2020 - 8:00AM
via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the
“Company”) (NYSE American: TMBR), a biopharmaceutical company
focused on the development and commercialization of treatments for
rare and orphan dermatologic diseases, today announced that it has
received a formal notice of allowance from the U.S. Patent and
Trademark Office (USPTO) for the Company’s patent application
covering its pharmaceutical isotretinoin composition (U.S. Patent
Application No.: 15/772,456).
Timber’s investigational therapy, TMB-001
(topical isotretinoin), is being developed for the treatment of
moderate to severe subtypes of congenital ichthyosis (CI), a group
of rare genetic keratinization disorders that lead to dry,
thickened, and scaling skin. People living with CI may have limited
range of motion, chronic itching, an inability to sweat normally,
high risk of secondary infections, and impaired eyesight or
hearing. The management of CI is a life-long endeavor, which
remains largely symptomatic and commonly focused on reducing
scaling and/or skin lubrication with both systemic and topical
treatments. Many dermatologists are familiar with oral
isotretinoin, which was originally launched as Accutane®. By
formulating isotretinoin into a proprietary topical formulation, it
may be possible to reduce systemic absorption, potentially allowing
for chronic use over larger areas of the body.
“We are pleased to announce that our lead
product candidate will now have patent protection in addition to
potential orphan drug exclusivity pending regulatory approval as we
move forward with our clinical development program for this rare
dermatologic condition,” said John Koconis, Chief Executive Officer
of Timber. “We believe there is an opportunity to deliver a topical
composition of isotretinoin that may present many advantages over
the oral systemic delivery that is in use today and help patients
and families affected by CI in the years ahead.”
In 2018, the FDA awarded $1.5 million to support
Phase 2a and Phase 2b clinical trials evaluating TMB-001 through
its Orphan Products Clinical Trials Grant program. Timber
previously announced that all 11 sites across the U.S. and
Australia participating in the Phase 2b CONTROL study evaluating
TMB-001 are now initiated and patients with moderate to severe CI
are actively enrolling. It is a randomized, double-blind,
vehicle-controlled study to investigate the safety and efficacy of
two concentrations of TMB-001.
About Timber Pharmaceuticals,
Inc.
Timber Pharmaceuticals, Inc. is a
biopharmaceutical company focused on the development and
commercialization of treatments for rare and orphan dermatologic
diseases. The Company's investigational therapies have proven
mechanisms-of-action backed by decades of clinical experience and
well-established CMC (chemistry, manufacturing and control) and
safety profiles. The Company is initially focused on developing
non-systemic treatments for rare dermatologic diseases including
congenital ichthyosis (CI), facial angiofibromas (FAs) in tuberous
sclerosis complex (TSC), and localized scleroderma. For more
information, visit www.timberpharma.com.
Forward-Looking Statements
This press release contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and Private Securities Litigation Reform Act, as
amended, including those relating to the Company's product
development, clinical and regulatory timelines, market opportunity,
competitive position, intellectual property rights, possible or
assumed future results of operations, business strategies,
potential growth opportunities and other statements that are
predictive in nature. These forward-looking statements are based on
current expectations, estimates, forecasts and projections about
the industry and markets in which we operate and management's
current beliefs and assumptions.
These statements may be identified by the use of
forward-looking expressions, including, but not limited to,
"expect," "anticipate," "intend," "plan," "believe," "estimate,"
"potential, "predict," "project," "should," "would" and similar
expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve
known and unknown risks, uncertainties, and other factors which may
cause actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such
factors include those set forth in the Company's Form 10-Q filed on
August 18, 2020 and its other filings with the Securities and
Exchange Commission. Prospective investors are cautioned not to
place undue reliance on such forward-looking statements, which
speak only as of the date of this press release. The Company
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information, contact:
Timber Pharmaceuticals, Inc. John Koconis Chief
Executive Officer jkoconis@timberpharma.com
Investor Relations: Stephanie Prince PCG Advisory (646) 762-4518
sprince@pcgadvisory.com
Media Relations: Adam Daley Berry & Company Public Relations
(212) 253-8881adaley@berrypr.com
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