SAN DIEGO, June 8, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company
developing novel, clinical-stage therapies for sickle cell disease
and heart failure, today announced that the United States Patent
and Trademark Office (USPTO) has issued a notice of allowance for
its patent application entitled, "Poloxamer Composition Free of
Long Circulating Material and Methods for Production and Uses
Thereof" (U. S. Patent Application No. 14/793,670). Upon
issuance, the patent will provide key intellectual property
protection for the Company's vepoloxamer programs that is expected
to expire no earlier than July 2035.
The allowed claims cover composition of matter, methods of use,
and methods of making certain purified forms of poloxamer 188,
including vepoloxamer. The notice of allowance concludes
substantive examination of the patent application, which is
expected to issue as a patent once the issue fee is paid and the
USPTO concludes administrative procedures. Mast also has filed
corresponding patent applications that will allow the Company to
seek similar patent protection for vepoloxamer in key markets
throughout the world, including Europe and Japan.
"This milestone is an important contribution to our intellectual
property strategy," stated Brian M.
Culley, Chief Executive Officer of Mast
Therapeutics. "We believe this patent not only will provide
protection for vepoloxamer in sickle cell disease beyond the
seven-year orphan market exclusivity period anticipated in the
U.S., but also strengthen the commercial opportunities for
development of vepoloxamer in non-orphan indications such as heart
failure and stroke."
Martin Emanuele, Ph.D., Senior
Vice President, Development of Mast Therapeutics and primary
inventor, commented, "We are gratified that the USPTO has
recognized the novelty and uniqueness of vepoloxamer. We plan
to continue to strengthen our intellectual property protection for
vepoloxamer to further enhance its potential value as a therapeutic
intervention in a wide range of diseases and conditions
characterized by impaired microvascular blood flow and/or damaged
cell membranes."
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The Company
is developing two clinical-stage investigational new drugs for
serious or life-threatening diseases and conditions. Vepoloxamer,
the Company's lead product candidate, is in Phase 3 clinical
development for the treatment of vaso-occlusive crisis in patients
with sickle cell disease and in Phase 2 clinical development for
the treatment of patients with heart failure. Enrollment in
the Company's 388-patient Phase 3 study of vepoloxamer in patients
with sickle cell disease, known as the EPIC study, was completed in
February 2016. Enrollment in the Company's Phase 2 study of
vepoloxamer in patients with chronic heart failure is
ongoing. AIR001, the Company's second product candidate, is
in Phase 2 clinical development for the treatment of patients with
heart failure with preserved ejection fraction (HFpEF). Enrollment
in a Phase 2a study of AIR001 in patients with HFpEF is ongoing and
AIR001 was recently selected by the Heart Failure Clinical Research
Network for evaluation in a 100-patient, multicenter, randomized,
double-blind, placebo-controlled, Phase 2 study in patients with
HFpEF. More information can be found on the Company's web
site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast
Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions
you that statements included in this press release that are not a
description of historical facts are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995 that are based on the Company's current expectations and
assumptions. Such forward-looking statements may be identified by
the use of forward-looking words such as "intend," "plan,"
"anticipate," "believe," "expect," among others, and include, but
are not limited to, statements relating to prospects for successful
development and commercialization of vepoloxamer for the treatment
of vaso-occlusive crisis of sickle cell disease, heart failure and
other serious or life-threatening diseases and market exclusivity
for vepoloxamer. There are a number of factors that could
cause or contribute to material differences between actual events
or results and the expectations indicated by the forward-looking
statements. These factors include, but are not limited to:
the inherent uncertainty of outcomes in ongoing and future studies
of the vepoloxamer and the risk that vepoloxamer may not
demonstrate adequate safety, efficacy or tolerability in one or
more such studies, including vepoloxamer in EPIC; the risk that,
even if current and planned clinical studies are successful, the
FDA or other regulatory agencies may determine they are not
sufficient to support a new drug application; the potential that,
even if clinical studies of a product candidate in one indication
are successful, clinical studies in another indication may not be
successful; risks associated with the Company's ability to manage
operating expenses and obtain additional capital as needed; the
Company's potential inability to continue as a going concern if it
does not raise additional capital as needed; uncertainty related to
the Company's ability to remain in compliance with the terms and
restrictions under its debt facility and the potential that it may
be required to repay outstanding debt obligations on an accelerated
basis and/or at a time that could be detrimental to the Company's
financial condition, operations and/or business strategy, including
the prepayment of $10 million of the
principal balance if results from the EPIC study are not positive
and/or not available on or before July 31,
2016; the potential for the Company to significantly delay,
reduce or discontinue current and/or planned development and
commercial-readiness activities or sell or license its assets at
inopportune times if it is unable to raise sufficient additional
capital as needed; the Company's dependence on third parties to
assist with important aspects of development of its product
candidates, including conduct of its clinical studies and supply
and manufacture of clinical trial material, and, if approved,
commercial product, and the risk that such third parties may fail
to perform as expected, leading to delays in product candidate
development or approval or inability to meet market demand for
approved products, if any; the risk that, even if the Company
successfully develops a product candidate in one or more
indications, it may not realize commercial success and may never
achieve profitability; the risk that the Company is not able to
obtain and maintain effective patent coverage or other market
exclusivity protections for its products, if approved, without
infringing the proprietary rights of others; and other risks and
uncertainties more fully described in the Company's press releases
and periodic filings with the Securities and Exchange Commission.
The Company's public filings with the Securities and Exchange
Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date when made. Mast
Therapeutics does not intend to revise or update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date hereof,
except as may be required by law.
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SOURCE Mast Therapeutics, Inc.