Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented
biopharmaceutical company committed to improving patient lives by
developing and commercializing innovative products across a range
of therapies, today announced that the Food and Drug Administration
(FDA) granted its subsidiary Xeris Pharmaceuticals, Inc.,
orphan-drug exclusivity (ODE) for Recorlev® (levoketoconazole) for
the treatment of adult patients with endogenous Cushing’s syndrome
for whom surgery is not an option or has not been curative.
As the first approval of levoketoconazole (Recorlev) for
Cushing’s syndrome, Xeris is entitled to seven years of orphan-drug
market exclusivity from its FDA approval date of December 30, 2021.
The FDA's Orphan Drug Designation program is designed to advance
the development of drugs that treat a condition affecting 200,000
or fewer U.S. patients annually. This regulatory exclusivity is in
addition to the patent exclusivity under Xeris’ U.S. patents
covering Recorlev and its therapeutic use, which extends to at
least March 2040.
“Cushing’s syndrome is a rare disease that can be physically and
emotionally devastating to the patient. Most patients endure years
of symptoms prior to obtaining a diagnosis and are then faced with
limited effective treatment options," said Paul R. Edick, Xeris’
Chairman and CEO. “We are excited to receive this important
orphan-drug exclusivity approval for Recorlev on a new therapeutic
option that can address symptoms while treating the root cause of
the disease for this underserved Cushing’s patient community.”
Mr. Edick continued, “Recorlev is an important and welcome
therapeutic option for clinicians to help manage patients with
endogenous Cushing's syndrome, a severe, potentially
life-threatening rare disease. The approval of Recorlev was based
upon data from two positive Phase 3 studies that evaluated a
combined study population of 166 patients and was shown to be
effective for reducing and normalizing cortisol.”
In order to serve and support this community, Xeris is committed
to ensuring everyone who needs access to their therapies will
receive it. Xeris has created Xeris CareConnection™ to provide a
comprehensive program for patients and their caregivers throughout
the treatment journey, including financial assistance, one-on-one
support, and educational resources. Xeris CareConnection also
supports healthcare professionals and their teams through education
on access and reimbursement. For more information visit our website
(www.recorlev.com) or contact Xeris CareConnection (available
Monday–Friday from 8 a.m–7 p.m ET) at 1-844-444-RCLV (7258).
About Cushing’s Syndrome
Endogenous Cushing’s syndrome is a rare, serious, and
potentially fatal endocrine disease caused by chronic elevated
cortisol exposure—often the result of a benign tumor of the
pituitary gland. This benign tumor tells the body to overproduce
high levels of cortisol for a sustained period of time, which often
results in characteristic physical signs and symptoms that are
distressing to patients. The disease is most common among adults
between the ages of 30–50, and it affects women three times more
often than men. Women with Cushing's syndrome may experience a
variety of health issues, including menstrual problems, difficulty
becoming pregnant, excess male hormones (androgens), primarily
testosterone, which can cause hirsutism (growth of coarse body hair
in a male pattern), oily skin, and acne.3
Additionally, the multisystem complications of the disease are
potentially life threatening. These include metabolic changes such
as high blood sugar or diabetes, high blood pressure, high
cholesterol, fragility of various tissues, including blood vessels,
skin, muscle, and bone, and psychological disturbances such as
depression, anxiety, and insomnia.3 Untreated, the five-year
survival rate is only approximately 50%.4
About Recorlev®
Recorlev® (levoketoconazole) is a cortisol synthesis inhibitor
for the treatment of endogenous hypercortisolemia in adult patients
with Cushing’s syndrome for whom surgery is not an option or has
not been curative.1 Endogenous Cushing’s syndrome is a rare but
serious and potentially fatal endocrine disease caused by chronic
elevated cortisol exposure.2 Recorlev is the pure 2S,4R enantiomer
of ketoconazole, a steroidogenesis inhibitor.1 Recorlev has
demonstrated in two successful Phase 3 studies to significantly
reduce mean urinary free cortisol.1
The Phase 3 program for Recorlev included LOGICS and SONICS, two
multinational studies designed to evaluate the safety and efficacy
of Recorlev when used to treat endogenous Cushing’s syndrome.
LOGICS, a double-blind, placebo-controlled, randomized-withdrawal
study met its key endpoint of normalizing and maintaining
therapeutic response compared with placebo.1 The supportive SONICS
study met its primary and secondary endpoints, significantly
reducing and normalizing mean urinary free cortisol concentrations
without a dose increase.1,2 The ongoing open-label OPTICS study
will gather further useful information related to the long-term use
of Recorlev.
Recorlev received orphan drug designation from the FDA and the
European Medicines Agency for the treatment of endogenous Cushing's
syndrome.
Indication & Important Safety Information for
Recorlev®
BOXED WARNING: HEPATOTOXICITY AND QT PROLONGATION
HEPATOTOXICITY
Cases of hepatotoxicity with fatal outcome or requiring liver
transplantation have been reported with oral ketoconazole. Some
patients had no obvious risk factors for liver disease. Recorlev is
associated with serious hepatotoxicity. Evaluate liver enzymes
prior to and during treatment.
QT PROLONGATION
Recorlev is associated with dose-related QT interval
prolongation. QT interval prolongation may result in
life-threatening ventricular dysrhythmias such as torsades de
pointes. Perform ECG and correct hypokalemia and hypomagnesemia
prior to and during treatment.
INDICATION
Recorlev is a cortisol synthesis inhibitor indicated for the
treatment of endogenous hypercortisolemia in adult patients with
Cushing’s syndrome for whom surgery is not an option or has not
been curative.
Limitations of Use
Recorlev is not approved for the treatment of fungal
infections.
CONTRAINDICATIONS
- Cirrhosis, acute liver disease or poorly controlled chronic
liver disease, baseline AST or ALT > 3 times the upper limit of
normal, recurrent symptomatic cholelithiasis, a prior history of
drug induced liver injury due to ketoconazole or any azole
antifungal therapy that required discontinuation of treatment, or
extensive metastatic liver disease.
- Taking drugs that cause QT prolongation associated with
ventricular arrhythmias, including torsades de pointes.
- Prolonged QTcF interval > 470 msec at baseline, history of
torsades de pointes, ventricular tachycardia, ventricular
fibrillation, or prolonged QT syndrome.
- Known hypersensitivity to levoketoconazole, ketoconazole or any
excipient in Recorlev.
- Taking certain drugs that are sensitive substrates of CYP3A4 or
CYP3A4 and P-gp.
WARNINGS AND PRECAUTIONS
Hepatotoxicity
Serious hepatotoxicity has been reported in patients receiving
Recorlev, irrespective of the dosages used or the treatment
duration. Drug-induced liver injury (peak ALT or AST greater than 3
times upper limit of normal) occurred in patients using Recorlev.
Avoid concomitant use of Recorlev with hepatotoxic drugs. Advise
patient to avoid excessive alcohol consumption while on treatment
with Recorlev. Routinely monitor liver enzymes and bilirubin during
treatment.
QT Prolongation
Use Recorlev with caution in patients with other risk factors
for QT prolongation, such as congestive heart failure,
bradyarrhythmias, and uncorrected electrolyte abnormalities, with
more frequent ECG monitoring considered. Routinely monitor ECG and
blood potassium and magnesium levels during treatment.
Hypocortisolism
Recorlev lowers cortisol levels and may lead to hypocortisolism
with a potential for life-threatening adrenal insufficiency.
Lowering of cortisol levels can cause nausea, vomiting, fatigue,
abdominal pain, loss of appetite, and dizziness. Significant
lowering of serum cortisol levels may result in adrenal
insufficiency that can be manifested by hypotension, abnormal
electrolyte levels, and hypoglycemia. Routinely monitor 24-hour
urine free cortisol, morning serum or plasma cortisol, and
patient’s signs and symptoms for hypocortisolism during
treatment.
Hypersensitivity Reactions
Hypersensitivity to Recorlev has been reported. Anaphylaxis and
other hypersensitivity reactions including urticaria have been
reported with oral ketoconazole.
Risks Related to Decreased
Testosterone
Recorlev may lower serum testosterone in men and women.
Potential clinical manifestations of decreased testosterone
concentrations in men may include gynecomastia, impotence, and
oligospermia. Potential clinical manifestations of decreased
testosterone concentrations in women include decreased libido and
mood changes.
ADVERSE REACTIONS
Most common adverse reactions (incidence > 20%) are
nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic
hypertension, headache, hepatic injury, abnormal uterine bleeding,
erythema, fatigue, abdominal pain/dyspepsia, arthritis, upper
respiratory infection, myalgia, arrhythmia, back pain,
insomnia/sleep disturbances, and peripheral edema.
DRUG INTERACTIONS
- Consult approved product labeling for drugs that are substrates
of CYP3A4, P-gp, OCT2, and MATE prior to initiating Recorlev.
- Sensitive CYP3A4 or CYP3A4 and P-gp
Substrates: Concomitant use of Recorlev with these
substrates is contraindicated or not recommended.
- Atorvastatin: Use lowest
atorvastatin dose possible and monitor for adverse reactions for
dosages exceeding 20 mg daily.
- Metformin: Monitor glycemia,
kidney function, and vitamin B12 and adjust metformin dosage as
needed.
- Strong CYP3A4 Inhibitors or
Inducers: Avoid use of these drugs 2 weeks before and during
Recorlev treatment.
- Gastric Acid Modulators: See Full
Prescribing Information for recommendations regarding concomitant
use with Recorlev.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed
during treatment and for one day after final dose.
To report SUSPECTED ADVERSE REACTIONS, contact Xeris
Pharmaceuticals, Inc. at 1-877-937-4737 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Please see Full Prescribing Information,
including Boxed Warning.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical
company committed to improving patients’ lives by developing and
commercializing innovative products across a range of therapies.
Xeris has three commercially available products; Gvoke®, a
ready-to-use liquid glucagon for the treatment of severe
hypoglycemia, Keveyis®, the first FDA-approved therapy for primary
periodic paralysis, and Recorlev® for the treatment of endogenous
Cushing’s syndrome. Xeris also has an increasingly diverse pipeline
of development and partnered programs using its proprietary
formulation technology platforms, XeriSol™ and XeriJect™, bringing
new products forward for the company as well as its partners
Xeris Biopharma Holdings is headquartered in Chicago, IL. For
more information, visit www.xerispharma.com, or follow us on
Twitter, LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Biopharma Holdings, Inc. including
statements regarding the market and therapeutic potential of
Recorlev, the market and therapeutic potential of its products and
product candidates, expectations regarding clinical data or results
from planned clinical trials, the timing of clinical trials, the
timing or likelihood of regulatory approval and commercialization
of its product candidates, the potential utility of its formulation
technology platforms and its ability to bring new products forward
for the company and its partners, and other statements containing
the words “will,” “would,” “continue,” “expect,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on numerous assumptions
and assessments made in light of Xeris’ experience and perception
of historical trends, current conditions, business strategies,
operating environment, future developments, geopolitical factors
and other factors it believes appropriate. By their nature,
forward-looking statements involve known and unknown risks and
uncertainties because they relate to events and depend on
circumstances that will occur in the future. Various factors could
cause Xeris’ actual results, performance or achievements, industry
results and developments to differ materially from those expressed
in or implied by such forward-looking statements, including the
impact of COVID-19 on our business operations and clinical
activities, our financial position and need for financing,
including to fund our product development programs or
commercialization efforts, whether our products will achieve and
maintain market acceptance, our reliance on third-party suppliers,
including single-source suppliers, our reliance on third parties to
conduct clinical trials, the ability of our product candidates to
compete successfully with existing and new drugs, and our and
collaborators’ ability to protect our intellectual property and
proprietary technology. No assurance can be given that our
expectations will be realized and persons reading this
communication are, therefore, cautioned not to place undue reliance
on these forward-looking statements. Additional information about
potential impacts of COVID-19, financial, operational, economic,
competitive, regulatory, governmental, technological, and other
factors that may affect Xeris is set forth in the "Risk Factors"
section of our most recently filed Quarterly Report on Form 10-Q
filed with the Securities and Exchange Commission, the contents of
which are not incorporated by reference into, nor do they form part
of, this communication. Forward-looking statements in this
communication are based upon information available to Xeris, as of
the date of this communication and, while believed to be
reasonable, actual results may differ materially. Subject to any
obligations under applicable law, Xeris does not undertake any
obligation to update any forward-looking statement whether as a
result of new information, future developments or otherwise, or to
conform any forward-looking statement to actual results, future
events, or to changes in expectations.
312-736-1237
1. Recorlev [prescribing information]. Chicago, IL: Xeris
Pharmaceuticals, Inc.; 2021. 2. Fleseriu M, et al. Lancet Diabetes
Endocrinol. 2019;7(11):855-865. 3. Pivonello R et al. Lancet
Diabetes Endocrinol. 2016; 4: 611-29. 4. Plotz CM, et al. Am J Med.
1952 November;13(5):597-614.
Recorlev®, Xeris Pharmaceuticals®, Xeris CareConnectionTM,
Keveyis®, Gvoke®, and Ogluo® are trademarks owned by or licensed to
Xeris Pharmaceuticals, Inc. PANTHERx Rare Pharmacy is a service
mark of PANTHERx Rare, LLC. All other trademarks referenced herein
are the property of their respective owners. Copyright © 2022 Xeris
BioPharma Holdings, Inc. All rights reserved. US-PR-22-00001v2
3/22
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version on businesswire.com: https://www.businesswire.com/news/home/20230130005152/en/
Investor Contact Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com
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