Zevra Therapeutics Reiterates Commitment to Rare Disease Community as New Corporate Council Member of the National Organization for Rare Disorders (NORD)
28 Febbraio 2023 - 2:00PM
Zevra Therapeutics, Inc. (NasdaqGS: KMPH) (“Zevra” or the “Company”
and formerly KemPharm, Inc.), a rare disease therapeutics company,
today announced that it has become a Corporate Council member of
the National Organization for Rare Disorders (NORD) and reiterated
its commitment to the rare disease community by celebrating Rare
Disease Day 2023.
A rare disease is a condition that impacts fewer
than 200,000 people in the United States, with over 7,000 known
rare diseases nationally affecting nearly 1 in 10 people. NORD is
dedicated to promoting research and access to therapies for the
more than 300 million people worldwide with rare diseases, as well
as raising awareness of this important community. As a company
focused on advancing therapies for rare diseases, Zevra stands with
NORD and the rare disease community today and every day.
“Zevra’s dedication to the rare disease
community is critical as we all work to bring much-needed therapies
and relief to people affected by a rare condition without
treatment options," said Peter L. Saltonstall, President and Chief
Executive Officer of NORD. “We enthusiastically welcome Zevra as an
important partner for our community and appreciate the symbolism of
its new name inspired by the zebra – the international symbol
of the rare disease community."
On February 22, 2023, Zevra announced its new
corporate name to embody the Company’s mission of innovating new
therapies for people with rare conditions and the highest unmet
needs. Zevra is Greek for zebra, the symbol of rare diseases.
"Rare Disease Day is both a reminder of the
strides the rare disease community has made over the last four
decades with the support of NORD's leadership, as well as a call to
action to continue making meaningful progress in rare disease
therapies," said Richard W. Pascoe, Chief Executive Officer of
Zevra. “Zevra is proud to partner with NORD as we redouble our
efforts to bring accessible treatments to patients with
Niemann-Pick disease type C and idiopathic hypersomnia."
Visit Zevra’s new corporate website at
www.zevra.com to learn more.
About ZevraZevra Therapeutics
is a rare disease company melding science, data, and patient need
to create transformational therapies for diseases with limited or
no treatment options. With unique, data-driven clinical,
regulatory, and commercialization strategies, the Company is
overcoming complex drug development challenges to bring much-needed
therapies to patients.
Arimoclomol, Zevra’s orally-delivered,
first-in-class investigational product candidate for the treatment
of Neimann-Pick disease type C ("NPC"), has been granted orphan
drug designation, Fast Track designation and rare pediatric disease
designation for the treatment of NPC by the US Food and Drug
Administration ("FDA"), and orphan medicinal product designation
for the treatment of NPC by the European Medicines Agency
("EMA").
KP1077 is Zevra’s lead clinical candidate being
developed to treat idiopathic hypersomnia ("IH") and narcolepsy.
KP1077 is comprised solely of serdexmethylphenidate (“SDX”),
Zevra’s proprietary prodrug of d-methylphenidate (“d-MPH”). The FDA
has granted KP1077 orphan drug designation for the treatment of IH,
and the US Drug Enforcement Agency ("DEA") has classified SDX as a
Schedule IV controlled substance based on evidence suggesting SDX
has a lower potential for abuse when compared to d-MPH, a Schedule
II controlled substance.
Early access programs are made available by
Zevra Therapeutics, Inc. and its affiliates and are subject to the
Company's Early Access Program ("EAP") policy as published on its
website at zevra.com. Participation in these programs is subject to
the laws and regulations of each jurisdiction under which each
respective program is operated. Eligibility for participation in
any such program is at the treating physician's discretion.
Caution Concerning Forward Looking
StatementsThis press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements include all
statements that do not relate solely to historical or current
facts, including without limitation and which can be identified by
the use of words such as "may," "will," "expect," "project,"
"estimate," "anticipate," "plan," "believe," "potential," "should,"
"continue," "could," "intend," "target," "predict," or the negative
versions of those words or other comparable words or expressions,
although not all forward-looking statements contain these
identifying words or expressions. Forward-looking statements are
not guarantees of future actions or performance. These
forward-looking statements include statements regarding our efforts
to bring accessible treatments to patients with Niemann-Pick
disease type C disease and idiopathic hypersomnia, and our
strategic and product development objectives. These forward-looking
statements are based on information currently available to Zevra
and its current plans or expectations and are subject to a number
of known and unknown uncertainties, risks and other important
factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These and other important factors are
described in detail in the "Risk Factors" section of Zevra’s
(formerly KemPharm’s) Annual Report on Form 10-K for the year ended
December 31, 2021, as updated by Zevra’s (formerly KemPharm’s)
Quarterly Report on Form 10-Q for the three months ended September
30, 2022, and Zevra’s (formerly KemPharm’s) other filings with the
Securities and Exchange Commission. While we may elect to update
such forward-looking statements at some point in the future, except
as required by law, we disclaim any obligation to do so, even if
subsequent events cause our views to change. Although we believe
the expectations reflected in such forward-looking statements are
reasonable, we can give no assurance that such expectations will
prove to be correct. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
Contacts:
Nichol Ochsner+1 (732) 754-2545nochsner@zevra.com
Jennifer Arcure +1 (917)
603-0681Jennifer.arcure@evokegroup.com
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