MENLO PARK, Calif.,
March 20, 2018 /PRNewswire/
-- BioPharmX Corporation (NYSE American: BPMX), a specialty
pharmaceutical company developing products for the dermatology
market, today announced the U.S. Patent and Trademark Office has
granted the first in what the company expects will be a new family
of patents protecting its novel topical gel delivery system that
allows for greater bioavailability of an active pharmaceutical
ingredient (API) .
The patent (U.S. Patent No. 9,918,998), entitled "Pharmaceutical
Tetracycline Composition For Dermatological Use," covers a topical
composition comprised of minocycline or another tetracycline-class
drug and a method for making such compositions. The patent also
covers treatments of dermatological inflammation or infection using
a minocycline composition. Current formulations protected by the
patent include BPX-01 for the treatment of acne and BPX-04 for the
treatment of rosacea.
This is the fourth U.S. patent issuance BioPharmX has received.
Three earlier-issued U.S. patents protect the company's
encapsulation delivery system, which can isolate the API. The most
recent of these patents, U.S. Patent No. 9,901,586, entitled
"Dosage Form Comprising an Active Ingredient and a Plurality of
Solid Porous Microcarriers," was granted Feb. 27.
The US 9,918,998 patent protects tetracycline-class products
carried by BioPharmX's innovative delivery system, which for the
first time stabilizes and fully solubilizes these drugs to make
them effective in a topical formulation. This includes products
that use other tetracycline-class drugs as well as combination
products that combine antibiotics with other drugs, for example
retinoids.
"This patent protection is a significant milestone for
BioPharmX," said President and Co-founder Anja Krammer. "It recognizes that our
development of a topical tetracycline-class drug, something that
has eluded the pharmaceutical industry since minocycline was first
commercially used in the 1970s, is truly unique."
"And, like the other patents we hold, it will protect our
valuable intellectual property for a substantial length of time,"
she said. "It recognizes the innovative research and development
that BioPharmX has successfully completed and ensures that our
company and investors will benefit from it as we commercialize our
products."
Oral minocycline has been widely used since the 1970s, however
oral antibiotics tend to flood the body with medicine and are
commonly associated with adverse effects that range from nausea to
diarrhea. Also, there is growing concern over the rise in
antibiotic-resistant bacteria.
In response, the pharmaceutical industry has spent years
unsuccessfully trying to develop a stable, soluble topical
formulation of minocycline, which produces less resistance than
other tetracycline-class antibiotics. BioPharmX is the first
company to develop a topical gel formulation of minocycline that
reaches targeted areas of the skin, where acne and other conditions
develop. By applying minocycline topically, a patient may reduce
the systemic uptake of minocycline and focus the drug's beneficial
effects at the skin where they are most needed.
BioPharmX has successfully completed a phase 2b trial for BPX-01 for acne and is in phase 3
readiness. The company has reported positive interim results from a
feasibility study for BPX-04 for rosacea and is preparing for a
phase 2 trial.
In addition to the four patents it has been awarded on two drug
delivery systems, the company has more than a dozen patents pending
and in process.
About BPX-01 and BPX-04
BPX-011 and BPX-041 are hydrophilic
(non-oil-based) topical gels with fully solubilized minocycline
that have been shown to penetrate the skin to deliver the
antibiotic to its target. Following positive results from its
previously announced phase 2b
dose-ranging study of BPX-01 in acne, BioPharmX continues with
phase 3 clinical study plans for BPX-01 for the treatment of
inflammatory lesions of acne.
About BioPharmX Corporation
BioPharmX Corporation (NYSE American: BPMX) is a Silicon
Valley-based specialty pharmaceutical company, which seeks to
provide products through proprietary platform technologies for
prescription, over-the-counter (OTC), and supplement applications
in the health and wellness markets, including dermatology and
women's health. To learn more about BioPharmX,
visit www.BioPharmX.com.
Forward-Looking Statements
The information in this press release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the "safe harbor" created by those sections. This press release
contains forward-looking statements about the company's
expectations, plans, intentions, and strategies, including, but not
limited to, statements regarding strategic partnering alternatives,
the safety and medical effects of BPX-01 and BPX-04, the effect
BPX-01 and BPX-04 may have on the treatment of acne and rosacea,
the commencement and results of future trials of BPX-01 and BPX-04
and the size of such trials, continued and consistent results in
future tests of BPX-01 and BPX-04, absence of side effects of
future use of BPX-01 and BPX-04 and ability to advance BPX-01 and
BPX-04 through a successful NDA submission and commercialization.
These forward-looking statements may be identified by words such as
"plan," "expect," "anticipate," "believe" or similar expressions
that are intended to identify such forward-looking statements.
These forward-looking statements involve risks and
uncertainties, as well as assumptions, which, if they do not fully
materialize or prove incorrect, could cause our results to differ
materially from those expressed or implied by such forward-looking
statements. The risks and uncertainties include those described in
the company's filings with the Securities and Exchange Commission,
including our annual report on Form 10-K for the period
ended Jan. 31, 2017 and our quarterly report on Form 10-Q for
the period ended July 31, 2017. Given
these risks and uncertainties, you are cautioned not to place undue
reliance on such forward-looking statements. The forward-looking
statements included in this news release are made only as of the
date hereof, and the company undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
may be required under applicable securities law.
1 Caution: BPX-01 and BPX-04 are new drugs limited by
U.S. law to investigational use.
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SOURCE BioPharmX Corporation