Conference Call Scheduled for Today, Wednesday,
March 13, 2019 at 8:30 a.m. ET
KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company
engaged in the discovery and development of proprietary prodrugs,
today provided an update on formulary adoption of its FDA-approved
prodrug product, APADAZ® (benzhydrocodone and acetaminophen, or
APAP, tablets), which has been licensed to KVK-Tech, Inc. for
commercialization. According to Managed Markets Insights and
Technology (MMIT, www.formularylookup.com) estimates, the
authorized generic of APADAZ (benzhydrocodone/APAP, or AG-APADAZ)
currently has unrestricted formulary access for 91% of Commercial
lives and unrestricted access for 90% of state Medicaid lives.
In addition, MMIT estimates indicate that branded APADAZ
currently has unrestricted formulary access for 15% of Commercial
lives, generally at a Tier 3 or equivalent reimbursement status.
Based on 2018 utilization data for
hydrocodone/APAP (HC/APAP), the total market was nearly four
billion tablets, of which 41% was Commercial, 39% was Medicare, and
12% was Medicaid, with the majority of Commercial volumes flowing
through the top 6 pharmacy benefit managers (PBMs) (source: SHS
PHAST: 2018). Taken together and based on 2018 utilization
data, potential volume of approximately 1.2 billion tablets would
be addressable by AG-APADAZ among those PBMs alone.
Currently, APADAZ and AG-APADAZ are not yet covered by Medicare,
although formulary review is in progress and expected to be
completed within 90 days.
“Widespread formulary adoption for AG-APADAZ has
advanced much faster than we anticipated, though there remains work
to be done to gain an advantage over currently available generic
HC/APAP products. We believe this milestone indicates that
KemPharm’s strategy of offering an authorized generic of APADAZ at
prices comparable to generic HC/APAP may be an attractive
proposition. We continue to believe that the replacement of
current HC/APAP products with APADAZ and its authorized generic
will be a meaningful market opportunity based on this achievement
and prior discussions with payors,” said Travis C. Mickle, Ph.D.,
President and Chief Executive Officer of KemPharm. “APADAZ and its
authorized generic remain on track for commercial launch in the
second half of 2019.”
Conference Call
Information:
KemPharm will host a brief conference call and
live audio webcast with slide presentation today, Wednesday, March
13, 2019, at 8:30 a.m. ET. Interested participants and
investors may access the conference call by dialing either:
- (866) 395-2480 (U.S.)
- (678) 509-7538 (international)
- Conference ID: 8690988
An audio webcast with slide presentation will be
accessible via the Investor Relations section of the KemPharm
website www.investors.kempharm.com. An archive of the webcast and
presentation will remain available for 90 days beginning later
today, March 13, 2019, at approximately 9:30 a.m. ET.
About KemPharm:
KemPharm is a specialty pharmaceutical company
focused on the discovery and development of proprietary prodrugs to
treat serious medical conditions through its proprietary
LAT™ (Ligand Activated Therapy) technology. KemPharm
utilizes its proprietary LAT technology to generate improved
prodrug versions of FDA-approved drugs as well as to generate
prodrug versions of existing compounds that may have applications
for new disease indications. KemPharm’s prodrug product candidate
pipeline is focused on the high need areas of attention deficit
hyperactivity disorder, or ADHD, and stimulant use disorder.
KemPharm’s co-lead clinical development candidates for the
treatment of ADHD, KP415 and KP484, are both based on a prodrug of
d-methylphenidate, but have differing duration/effect profiles. In
addition, KemPharm has received FDA approval for APADAZ®, an
immediate-release combination product containing benzhydrocodone, a
prodrug of hydrocodone, and acetaminophen. For more information on
KemPharm and its pipeline of prodrug product candidates visit
www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook
and YouTube.
APADAZ®
APADAZ® was developed from KemPharm’s
proprietary LAT™ (Ligand Activated Therapy) platform technology and
is intended for the short-term (no more than 14 days)
management of acute pain severe enough to require an opioid
analgesic and for which alternative treatments are inadequate.
APADAZ is differentiated from other prescription opioids as it is
the first FDA-approved product to contain a prodrug of hydrocodone.
A prodrug is chemically inert, or inactive, on its own. When
ingested, enzymes in the gastrointestinal tract cleave the ligand
from the prodrug (benzhydrocodone) and release the parent drug
(hydrocodone), which can then exert its therapeutic effect.
The final approved product labeling for APADAZ includes these and
other data points but concludes that the overall results of the
clinical program did not demonstrate abuse-deterrence by current
measurement standards.
The approval of APADAZ via the 505(b)(2) pathway
was based in part on pharmacokinetic studies with Vicoprofen®,
Ultracet®, and Norco® in which APADAZ demonstrated exposure to
hydrocodone and acetaminophen (APAP) that is expected to result in
therapeutic effects equivalent to currently approved
immediate-release hydrocodone/APAP combination products when
administered orally as intended.
Indication:APADAZ® contains an
opioid agonist and acetaminophen and is indicated for the
short-term (no more than 14 days) management of acute pain
severe enough to require an opioid analgesic and for which
alternative treatments are inadequate.
Limitations of Use:Because of
the risks of addiction, abuse, and misuse with opioids, even at
recommended doses, reserve APADAZ® for use in patients for whom
alternative treatment options [e.g., non-opioid analgesics] have
not been or are not expected tolerated, or have not provided
adequate analgesia, or are not expected to provide adequate
analgesia.
Important Safety
Information:
APADAZ® is contraindicated in patients with:
significant respiratory depression; acute or severe bronchial
asthma in an unmonitored setting or in absence of resuscitative
equipment; known or suspected gastrointestinal obstruction,
including paralytic ileus; and hypersensitivity to hydrocodone or
acetaminophen.
APADAZ® contains benzhydrocodone, a Schedule II
controlled substance. APADAZ® can be abused and is subject to
misuse, addiction, and criminal diversion.
Potential risks associated with APADAZ® include
addiction, abuse, and misuse, life-threatening respiratory
depression, neonatal opioid withdrawal syndrome, risks of
concomitant use or discontinuation of cytochrome P450 CYP3A4
inhibitors and inducers, acetaminophen hepatotoxicity risks from
concomitant use with benzodiazepines or other central nervous
system (CNS) depressants, risk of life-threatening respiratory
depression in patients with chronic pulmonary disease or in
elderly, cachectic, or debilitated patients, adrenal insufficiency,
severe hypotension, serious skin reactions, risks of use in
patients with increased intracranial pressure, brain tumors, head
injury, or impaired consciousness, hypersensitivity/anaphylaxis,
risks of use in patients with gastrointestinal conditions, risk of
use in patients with seizure disorders, and withdrawal, risks of
driving and operating machinery.
Potential drug interactions with APADAZ®
include:
- Serotonergic Drugs: Concomitant use may result in serotonin
syndrome. Discontinue APADAZ® if serotonin syndrome is
suspected.
- Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:
Avoid use with APADAZ® because they may reduce analgesic effect of
APADAZ® or precipitate withdrawal symptoms.
- Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the
effects of hydrocodone. Avoid concomitant use in patients receiving
MAOIs or within 14 days of stopping treatment with an MAOI.
Most common adverse reactions (>5%) are
nausea, somnolence, vomiting, constipation, pruritus, dizziness,
and headache.
The Full Prescribing Information for APADAZ®
contains the following Boxed Warning:
WARNING: ADDICTION, ABUSE, AND MISUSE;
RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION;
HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES
OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and
Misuse:
APADAZ® exposes patients and other users to the
risks of opioid addiction, abuse, and misuse, which can lead to
overdose and death. Assess each patient’s risk prior to prescribing
APADAZ® and monitor all patients regularly for the development of
these behaviors and conditions.
Risk Evaluation and Mitigation Strategy
(REMS):
To ensure that the benefits of opioid analgesics
outweigh the risks of addiction, abuse, and misuse, the Food and
Drug Administration (FDA) has required a REMS for these products.
Under the requirements of the REMS, drug companies with approved
opioid analgesic products must make REMS-compliant education
programs available to healthcare providers. Healthcare providers
are strongly encouraged to
- complete a REMS-compliant education program,
- counsel patients and/or their caregivers, with every
prescription, on safe use, serious risks, storage, and disposal of
these products,
- emphasize to patients and their caregivers the importance of
reading the Medication Guide every time it is provided by their
pharmacist, and
- consider other tools to improve patient, household, and
community safety.
Life-Threatening Respiratory
Depression:
Serious, life-threatening, or fatal respiratory
depression may occur with use of APADAZ®. Monitor for
respiratory depression, especially during initiation of APADAZ® or
following a dose increase.
Accidental Ingestion:
Accidental ingestion of even one dose of
APADAZ®, especially by children, can result in a fatal overdose of
hydrocodone.
Neonatal Opioid Withdrawal
Syndrome:
Prolonged use of APADAZ® during pregnancy can
result in neonatal opioid withdrawal syndrome, which may be
life-threatening if not recognized and treated, and requires
management according to protocols developed by neonatology
experts. If prolonged opioid use is required in a pregnant
woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be
available.
Cytochrome P450 3A4
Interaction:
The concomitant use of APADAZ® with all
cytochrome P450 3A4 inhibitors may result in an increase in
hydrocodone plasma concentrations, which could increase or prolong
adverse reactions and may cause potentially fatal respiratory
depression. In addition, discontinuation of a concomitantly used
cytochrome P450 3A4 inducer may result in an increase in
hydrocodone plasma concentration. Monitor patients receiving
APADAZ® and any CYP3A4 inhibitor or inducer.
Hepatotoxicity:
APADAZ® contains acetaminophen. Acetaminophen
has been associated with cases of acute liver failure, at times
resulting in liver transplant and death. Most of the cases of liver
injury are associated with the use of acetaminophen at doses that
exceed 4000 milligrams per day, and often involve more than
one acetaminophen-containing product.
Risks From Concomitant Use With
Benzodiazepines Or Other CNS Depressants:
Concomitant use of opioids with benzodiazepines
or other CNS depressants, including alcohol, may result in profound
sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of APADAZ® and benzodiazepines
or other CNS depressants for use in patients for whom alternative
treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory
depression and sedation.
For Important Safety Information including full
prescribing information, visit: www.kempharm.com
Caution Concerning Forward Looking
Statements:
This press release may contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include all statements that do not
relate solely to historical or current facts, including without
limitation our proposed development and commercial timelines, and
can be identified by the use of words such as “may,” “will,”
“expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,”
“potential,” “should,” “continue” or the negative versions of those
words or other comparable words. Forward-looking statements are not
guarantees of future actions or performance. These forward-looking
statements, including the estimate of the addressable market and
launch timeline for APADAZ®, are based on information
currently available to KemPharm and its current plans or
expectations and are subject to a number of uncertainties and risks
that could significantly affect current plans. Risks concerning
KemPharm’s business are described in detail in KemPharm’s Annual
Report on Form 10-K for the year ended December 31, 2018, and
KemPharm’s other Periodic and Current Reports filed with the
Securities and Exchange Commission. KemPharm is under no
obligation to (and expressly disclaims any such obligation to)
update or alter its forward-looking statements, whether as a result
of new information, future events or otherwise.
KemPharm Contacts: |
Jason
Rando / Joshua Drumm, Ph.D.Tiberend Strategic Advisors,
Inc.212-375-2665 / 2664jrando@tiberend.comjdrumm@tiberend.com |
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