SAN DIEGO, Aug. 3, 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 the issuance of United States
Patent No. 9,403,941 for "Poloxamer Composition Free of Long
Circulating Material and Methods for Production and Uses Thereof"
(the "'941 patent") by the United States Patent and Trademark
Office (USPTO). The patent includes claims covering
composition of matter, methods of use, and methods of making
certain purified forms of poloxamer 188, including vepoloxamer, and
should provide key intellectual property protection in the U.S. for
the Company's vepoloxamer programs. The '941 patent will
expire no earlier than July 2035. The Company also has filed
corresponding patent applications that will allow it to seek
similar patent protection for vepoloxamer in key markets throughout
the world, including Europe and
Japan.
The Company believes that the '941 patent will be eligible for
listing in the U.S. Food and Drug Administration's (FDA) Approved
Drug Products with Therapeutic Equivalence Evaluations, commonly
known as the Orange Book, should vepoloxamer receive FDA approval
for the treatment of patients with sickle cell disease or heart
failure.
"The issuance of this patent is an important development
relating to maintaining exclusivity for vepoloxamer," 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, "The issuance of this patent by the USPTO is a
key milestone for our vepoloxamer programs and is encouraging for
the corresponding applications pending in other economically
important territories around the world."
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
earlier this year. 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 Phase 2 studies of AIR001 in patients with HFpEF are ongoing,
including a 100-patient, multicenter, randomized, double-blind,
placebo-controlled, Phase 2 study in patients with HFpEF being
conducted by the Heart Failure Clinical Research Network.
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 "believe," "intend," "expect,"
"plan," "anticipate," among others, and include, but are not
limited to, statements relating to prospects for successful
development and commercialization of vepoloxamer for the treatment
of patients with sickle cell disease, heart failure and other
serious or life-threatening diseases and market exclusivity for
vepoloxamer in the U.S. and foreign territories. 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 risk that the validity and/or
enforceability of the '941 patent may be challenged and that such a
challenge may be successful, resulting in loss of the patent or
loss or reduction in the scope of one or more of the claims of the
patent; the potential for competitors to design around the '941
patent in which case a competitor's product may not infringe on the
'941 patent, allowing the competitor to compete with the Company's
products before the '941 patent expires; the potential that key
claims in corresponding patent applications filed in other
territories will not be allowed; the inherent uncertainty of
outcomes in ongoing and future studies of vepoloxamer and the risk
that vepoloxamer may not demonstrate adequate safety, efficacy or
tolerability in one or more such studies, including in the EPIC
study; the risk that, even if EPIC study results are positive, the
FDA may require a second Phase 3 study or other clinical or
nonclinical studies to demonstrate substantial evidence of
vepoloxamer's effectiveness for sickle cell patients or to provide
additional safety and tolerability data or that the FDA may require
changes to manufacturing controls or processes that could delay
filing of 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 sufficient 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 its 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
October 14, 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.