We are issuing a corrected version of the KemPharm release
originally issued this morning at 7:30 am ET. The corrected release
follows.
KemPharm, Inc. (NasdaqGS: KMPH) (“KemPharm,” or
the “Company”), announced today that it changed its name to Zevra
Therapeutics, Inc. (“Zevra”). This name change reflects the
Company’s intensified focus and dedication to developing
transformational, patient-focused therapies for rare diseases with
limited or no treatment options. In conjunction with the name
change, the Company will begin trading under the new ticker symbol
“ZVRA” on The Nasdaq Global Market on or about March 1, 2023.
“The adoption of the name Zevra, the Greek word
for zebra, is an important step in our journey to become a leading
rare disease company since the zebra is the recognized symbol of
the rare disease community around the world,” said Richard W.
Pascoe, Chief Executive Officer of Zevra. “With the launch of our
new company name in anticipation of Rare Disease Day next week, we
renew our unwavering commitment to stand with this important
community as we pursue our primary mission to deliver life-changing
treatments to people with rare conditions, their families and
caregivers who desperately need better options.”
In May 2022, Zevra, then KemPharm, acquired
arimoclomol, an orally-delivered, first-in-class investigational
product candidate for the treatment of Niemann-Pick type C disease
(“NPC”), from Orphazyme A/S as part of the Company’s long-term
vision to evolve into a commercially-driven rare disease
therapeutics company. Through the acquisition, Zevra welcomed key
new team members with years of valuable rare disease therapeutic
research and development experience, maintained the ongoing early
access programs and relationships with treatment centers in the
U.S. and Europe, and continues to build upon longstanding
partnerships within the NPC patient community. NPC, a rare disease
with no currently approved treatments in the U.S., primarily
affects children and is often fatal, causing progressive loss of
brain, nerve, liver, spleen, bone marrow, and lung functions. The
U.S. Food and Drug Administration (“FDA”) has granted arimoclomol
orphan drug designation, Fast Track designation, and rare pediatric
disease designation for treating NPC.
In addition to arimoclomol, Zevra is advancing
KP1077, a product candidate based on Zevra’s prodrug of
d-methylphenidate, serdexmethylphenidate (“SDX”), which is
currently being evaluated in a Phase 2 trial for the treatment of
idiopathic hypersomnia (“IH”), a rare sleep disorder. Pending the
results from that trial, the Company plans to conduct a pivotal
phase 3 study in IH, with the potential to study an expanded
indication in narcolepsy.
“The launch of the Zevra brand today marks the
next key step in our evolution into a commercially-focused rare
disease therapeutics company. People with rare diseases are
desperately awaiting treatments, and even one drug that doesn’t
reach them is one drug too many,” said Matthew R. Plooster,
Chairman of the Zevra Board of Directors. “The Zevra team is
actively leveraging their deep scientific and clinical expertise
and strategic approach to overcome drug development and regulatory
barriers to advance much-needed solutions to the people who need
them. Moreover, we have the leadership team and financial resources
to get our promising rare disease drug candidates over the
regulatory approval finish line and into the U.S. market, which the
Board firmly believes will be a key value-driver for patients and
shareholders alike.”
Zevra looks ahead to key milestones in 2023,
including the resubmission of arimoclomol New Drug Application
(“NDA”) to the FDA as early as Q3 2023, an interim and final data
readout for KP1077 in IH, and the potential achievement of certain
commercial sales milestones for our partnered asset, AZSTARYS®.
Along with the new name, the Company has a new
logo and website. Visit 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 type C (“NPC”), has been granted orphan drug
designation, Fast Track designation and rare pediatric disease
designation for NPC by the U.S. Food and Drug Administration
(“FDA”) and 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 U.S. 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
Statements:This 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: the
promise and potential impact of our preclinical or clinical trial
data, including without limitation the initiation, timing, and
results of any clinical trials or readouts, the timing or results
of any Investigational New Drug (“IND”) applications and New Drug
Application (“NDA”) submissions for arimoclomol, KP1077, or any
other product candidates for any specific disease indication or at
any dosage, 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. They are
subject to several 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) Annual Report on Form 10-K for the year
ended December 31, 2021, as updated by Zevra’s (formerly KemPharm)
Quarterly Report on Form 10-Q for the three months ended September
30, 2022, and Zevra’s (formerly KemPharm) 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 cannot assure that such expectations will prove
correct. These forward-looking statements should not be relied upon
as representing our views as of any date after 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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