Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty
pharmaceutical company, today announced that the U.S. Food and Drug
Administration granted final approval for TLANDO™ (testosterone
undecanoate), an oral treatment for testosterone replacement
therapy (“TRT”) indicated for conditions associated with a
deficiency or absence of endogenous testosterone, or hypogonadism
in adult males.
Robert F. Apple, President and Chief Executive
Officer of Antares Pharma, commented, “The FDA approval of TLANDO
brings to market an oral formulation of testosterone that we
believe will prove beneficial to physicians and their patients. We
have recently expanded our commercial organization to 108 sales
representatives and expect to leverage our relationships with
urologists and endocrinologists to drive adoption of TLANDO. This
approval also reinforces the opportunity for Antares to continue to
drive share gains in the TRT market with both TLANDO and XYOSTED
and support our future growth with an expanded commercial
portfolio. We look forward to launching TLANDO commercially, which
will provide a complementary treatment option to patients and
clinicians in the second quarter of this year.”
“We are excited with the opportunity to
commercialize TLANDO and reinforce our commitment to the TRT
market. Our existing commercial capabilities and presence in the
market with XYOSTED provide an important foundation for the
potential commercial success of TLANDO. With an expanded commercial
footprint, we expect to continue to foster our strong physician
relationships to support their patient-centric care and preference
for different treatment options. We believe TLANDO’s oral
formulation and convenient dosing, which requires no titration,
differentiates it from other treatment options. As we prepare for
the commercial launch, we look forward to our sales representatives
detailing a differentiated portfolio of products consisting of
XYOSTED, TLANDO and NOCDURNA that will continue to deliver
solutions for improved patient care,” added Joe Renda, Senior Vice
President, Commercial of Antares Pharma.
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Male hypogonadism, also known as testosterone
deficiency, is an endocrine disorder in which the body fails to
produce enough of the hormone. Hypogonadism is a common condition
in the male population, with a higher prevalence in older men,
obese men, and men with type 2 diabetes. It is estimated that
approximately 35% of men older than 45 years of age and 30-50% of
men with obesity or type 2 diabetes have hypogonadism1.
Hypogonadism can be treated with testosterone replacement
1 Endocrine Society
TLANDO™ (testosterone undecanoate) capsules, for oral
Initial U.S. Approval: 1953
WARNING: BLOOD PRESSURE
- TLANDO can cause blood
pressure (BP) increases that can increase the risk of major adverse
cardiovascular events (MACE), including non-fatal myocardial
infarction, non-fatal stroke and cardiovascular
- Before initiating TLANDO,
consider the patient’s baseline cardiovascular risk and ensure
blood pressure is adequately controlled.
- Periodically monitor for
and treat new-onset hypertension or exacerbations of pre-existing
hypertension and re-evaluate whether the benefits of TLANDO
outweigh its risks in patients who develop cardiovascular risk
factors or cardiovascular disease on treatment.
- Due to this risk, use
TLANDO only for the treatment of men with hypogonadal conditions
associated with structural or genetic etiologies.
TLANDO INDICATIONS AND
TLANDO (testosterone undecanoate) is indicated
for testosterone replacement therapy in adult males for conditions
associated with a deficiency or absence of endogenous
- Primary hypogonadism (congenital or
- Hypogonadotropic hypogonadism
(congenital or acquired)
LIMITATIONS OF USE
- Safety and efficacy of TLANDO in
males less than 18 years old have not been established
TLANDO is contraindicated in:
- Patients with carcinoma of the
breast or known or suspected carcinoma of the prostate.
- Women who are pregnant.
Testosterone can cause virilization of the female fetus when
administered to a pregnant woman.
- Known hypersensitivity to
testosterone undecanoate or any of TLANDO’s ingredients.
- Men with hypogonadal conditions,
such as “age-related hypogonadism”, that are not associated with
structural or genetic etiologies. The efficacy of TLANDO has not
been established for these conditions, and TLANDO can increase BP
that can increase the risk of MACE.
WARNINGS AND PRECAUTIONS
Increase in Blood Pressure: In
Study 18-001, TLANDO increased systolic BP after 4 months of
treatment by an average of 4.3 mmHg based on ambulatory blood
pressure monitoring (ABPM) and 4.8 mmHg from baseline based on
blood pressure cuff measurements.
These BP increases can increase the risk of
major adverse cardiovascular events (MACE), with greater risk in
patients with established cardiovascular disease or risk factors
for cardiovascular disease.
In some patients, the increase in BP with TLANDO
may be too small to detect but can still increase the risk for
Before initiating TLANDO, consider the patient’s
baseline cardiovascular risk and ensure blood pressure is
adequately controlled. Check BP approximately 3 weeks after
initiating TLANDO and periodically thereafter. Treat new-onset
hypertension or exacerbations of pre-existing hypertension.
Re-evaluate whether the benefits of continued treatment with TLANDO
outweigh its risks in patients who develop cardiovascular risk
factors or cardiovascular disease.
Polycythemia: Increases in
hematocrit levels, reflective of increases in red blood cell mass,
may require discontinuation of TLANDO. Check hematocrit prior to
initiating TLANDO. Evaluate hematocrit approximately every 3 months
during the first year of treatment, and then every 6 months
thereafter while the patient is taking TLANDO. If hematocrit
becomes elevated, stop TLANDO until hematocrit decreases to an
acceptable concentration. If TLANDO is restarted and again causes
hematocrit to become elevated, stop TLANDO permanently. An increase
in red blood cell mass may increase the risk of thromboembolic
Cardiovascular Risk: Long term
clinical safety trials have not been conducted to assess the
cardiovascular outcomes of testosterone replacement therapy in men.
To date, epidemiologic studies and randomized controlled trials
have been inconclusive for determining the risk of major adverse
cardiovascular events (MACE), such as non-fatal myocardial
infarction, non-fatal stroke, and cardiovascular death, with the
use of testosterone compared to non-use. Some studies, but not all,
have reported an increased risk of MACE in association with use of
testosterone replacement therapy in men. TLANDO can cause BP
increases that can increase the risk of MACE. Patients should
be informed of this possible risk when deciding whether to use or
to continue to use TLANDO.
Worsening of Benign Prostatic
Hyperplasia (BPH) and Potential Risk of Prostate Cancer:
Patients with BPH treated with androgens are at an increased risk
for worsening of signs and symptoms of BPH. Monitor patients with
BPH for worsening signs and symptoms. Patients treated with
androgens may be at increased risk for prostate cancer. Evaluate
patients for prostate cancer, including measurement of prostate
specific antigen (PSA), prior to initiating and during treatment
Venous Thromboembolism: There
have been post marketing reports of venous thromboembolic events,
including deep vein thrombosis (DVT) and pulmonary embolism (PE),
in patients using testosterone replacement products such as TLANDO.
Evaluate patients who report symptoms of pain, edema, warmth, and
erythema in the lower extremity for DVT and those who present with
acute shortness of breath for PE. If a venous thromboembolic event
is suspected, discontinue TLANDO and initiate appropriate workup
Abuse of Testosterone and Monitoring of
Serum Testosterone Concentrations: Testosterone has been
subject to abuse, typically at doses higher than recommended for
the approved indication and in combination with other anabolic
androgenic steroids. Anabolic androgenic steroid abuse can lead to
serious cardiovascular and psychiatric adverse reactions.
If testosterone abuse is suspected, check serum
testosterone concentrations to ensure they are within therapeutic
range. However, testosterone levels may be in the normal or
subnormal range in men abusing synthetic testosterone derivatives.
Counsel patients concerning the serious adverse reactions
associated with abuse of testosterone and anabolic androgenic
steroids. Conversely, consider the possibility of testosterone and
anabolic androgenic steroid abuse in suspected patients who present
with serious cardiovascular or psychiatric adverse events.
Not for Use in Women: Due to
lack of controlled studies in women and the potential for
virilizing effects, TLANDO is not indicated for use in women.
Potential for Adverse Effects on
Spermatogenesis: With large doses of exogenous androgens,
including TLANDO, spermatogenesis may be suppressed through
feedback inhibition of pituitary follicle-stimulating hormone (FSH)
possibly leading to adverse effects on semen parameters including
sperm count. Patients should be informed of this possible risk when
deciding whether to use or to continue to use TLANDO.
Hepatic Adverse Effects:
Prolonged use of high doses of orally active 17-alpha-alkyl
androgens (e.g., methyltestosterone) has been associated with
serious hepatic adverse effects (peliosis hepatis, hepatic
neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis
can be a life-threatening or fatal complication. Long-term therapy
with intramuscular testosterone enanthate has produced multiple
hepatic adenomas. TLANDO is not a 17 alpha-alkyl androgen and is
not known to produce hepatic adverse effects associated with
17-alpha-alkyl androgens. Nonetheless, patients should be
instructed to report any signs or symptoms of hepatic dysfunction
(e.g., jaundice). If these occur, promptly discontinue TLANDO while
the cause is evaluated.
Edema: Androgens, including
TLANDO, may promote retention of sodium and water. Edema, with or
without congestive heart failure, may be a serious complication in
patients with preexisting cardiac, renal, or hepatic disease. In
addition to discontinuation of the drug, appropriate work up and
management of edema may be required.
Sleep Apnea: The treatment of
hypogonadal men with testosterone products may potentiate sleep
apnea in some patients, especially those with risk factors such as
obesity or chronic lung diseases.
Gynecomastia: Gynecomastia may
develop and persist in patients being treated for hypogonadism.
Lipid Changes: Changes in serum
lipid profile may require dose adjustment of lipid lowering drugs
or discontinuation of testosterone therapy. Monitor the lipid
profile periodically after starting testosterone therapy.
including TLANDO, should be used with caution in cancer patients at
risk of hypercalcemia (and associated hypercalciuria). Monitor
serum calcium concentrations periodically in these patients.
Globulin: Androgens, including TLANDO, may decrease
concentrations of thyroxin-binding globulins, resulting in
decreased total T4 serum concentrations and increased resin uptake
of triiodothyronine (T3) and thyroxine (T4). Free thyroid hormone
concentrations remain unchanged, however, and there is no clinical
evidence of thyroid dysfunction.
Increases in Prolactin:
Increases in serum prolactin have been reported in patients treated
with TLANDO in clinical trials. Evaluate serum prolactin levels
prior to initiating treatment with TLANDO. Re-evaluate serum
prolactin levels 3 to 4 months after starting treatment. If serum
prolactin remains elevated, discontinue TLANDO.
The safety of TLANDO was evaluated in 2 clinical
studies in a total of 233 men.
Study 18-001: 138 hypogonadal males were treated
with TLANDO 225 mg twice daily with morning and evening meals for
approximately 4 months.
Study 16-002: 95 hypogonadal males were treated
with TLANDO 225 mg twice daily with morning and evening meals for
approximately 24 days.
The most commonly reported adverse reactions (≥
2%) were: increased blood prolactin, hypertension, increased
hematocrit, upper respiratory tract infection, weight increased,
headache, and musculoskeletal pain.
Insulin: Changes in insulin
sensitivity or glycemic control may occur in patients treated with
androgens. In diabetic patients, the metabolic effects of androgens
may decrease blood glucose and, therefore, insulin
Oral Anticoagulants: Changes in
anticoagulant activity may be seen with androgens. Frequent
monitoring of INR and prothrombin time may be necessary in patients
taking anticoagulants, especially at the initiation and termination
of androgen therapy.
Corticosteroids: The concurrent
use of testosterone with corticosteroids may result in increased
fluid retention and should be monitored cautiously, particularly in
patients with cardiac, renal or hepatic disease.
Drugs that May Also Increase Blood
Pressure: Some prescription drugs and nonprescription
analgesic and cold medications can increase blood pressure.
Concomitant administration of these medications with TLANDO may
lead to additional increases in blood pressure.
USE IN SPECIFIC POPULATIONS
Pregnancy: TLANDO is
contraindicated in pregnant women and not indicated for use in
females. Testosterone is teratogenic and may cause fetal harm when
administered to a pregnant woman based on data from animal studies
and its mechanism of action. Exposure of a female fetus to
androgens may result in varying degrees of virilization. In animal
developmental studies, exposure to testosterone in utero resulted
in hormonal and behavioral changes in offspring and structural
impairments of reproductive tissues in female and male offspring.
These studies did not meet current standards for nonclinical
development toxicity studies.
Lactation: TLANDO is not
indicated for use in females.
Females and Males of Reproductive
Potential: During treatment with large doses of exogenous
androgens, including TLANDO, spermatogenesis may be suppressed
through feedback inhibition of the
hypothalamic-pituitary-testicular axis. Reduced fertility is
observed in some men taking testosterone replacement therapy. The
impact on fertility may be irreversible. Testicular atrophy,
subfertility, and infertility have also been reported in men who
abuse anabolic androgenic steroids.
Pediatric Use: The safety and
effectiveness of TLANDO in pediatric patients less than 18 years
old have not been established. Improper use may result in
acceleration of bone age and premature closure of epiphyses.
Geriatric Use: There have not
been sufficient numbers of geriatric patients in controlled
clinical studies with TLANDO to determine whether efficacy or
safety in those over 65 years of age differs from younger subjects.
Of the 95 patients enrolled in Study 16-002, the 24-day major
safety and effectiveness study utilizing TLANDO, 16 (16.8%) were
over 65 years of age. Additionally, there is insufficient long-term
safety data in geriatric patients utilizing TLANDO to assess the
potentially increased risk of cardiovascular disease and prostate
Geriatric patients treated with androgens may
also be at risk for worsening of signs and symptoms of BPH and
DRUG ABUSE AND DEPENDENCE
TLANDO contains testosterone undecanoate, a
Schedule III controlled substance.
Abuse and misuse of testosterone are seen in
male and female adults and adolescents. Testosterone, often in
combination with other anabolic androgenic steroids, may be abused
by athletes and bodybuilders.
Serious adverse reactions have been reported in
individuals who abuse anabolic androgenic steroids and include
cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy,
congestive heart failure, cerebrovascular accident, hepatotoxicity,
and serious psychiatric manifestations, including major depression,
mania, paranoia, psychosis, delusions, hallucinations, hostility
The following adverse reactions have also been
reported in men: transient ischemic attacks, convulsions,
hypomania, irritability, dyslipidemias, testicular atrophy,
subfertility, and infertility.
The following additional adverse reactions have
been reported in women: hirsutism, virilization, deepening of
voice, clitoral enlargement, breast atrophy, male-pattern baldness,
and menstrual irregularities.
The following adverse reactions have been
reported in male and female adolescents: premature closure of bony
epiphyses with termination of growth, and precocious puberty.
Withdrawal symptoms can be experienced upon
abrupt discontinuation in patients with addiction. Withdrawal
symptoms include depressed mood, major depression, fatigue,
craving, restlessness, irritability, anorexia, insomnia, decreased
libido, and hypogonadotropic hypogonadism. Drug dependence in
individuals using approved doses for approved indications have not
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical company focused primarily on the development and
commercialization of pharmaceutical products and technologies that
address patient needs in targeted therapeutic areas. The Company
develops, manufactures and commercializes, for itself or with
partners, novel therapeutic products using its advanced drug
delivery systems that are designed to provide commercial or
functional advantages such as improved safety and efficacy,
convenience, improved tolerability, and enhanced patient comfort
and adherence. The Company has a portfolio of proprietary and
partnered commercial products and ongoing product development
programs in various stages of development. The Company has formed
partnership arrangements with several different industry leading
SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to: successful commercial launch,
market acceptance, payor coverage and future prescriptions and
revenue for TLANDO™; the Company’s ability to achieve the 2022
revenue guidance; the uncertainty regarding the ongoing COVID-19
pandemic, including new strains of the virus, and the mitigation
measures and other restrictions implemented in response to the same
and the impact on demand for our products, new patients and
prescriptions, future revenue, product supply, clinical trials, and
our overall business, operating results and financial condition;
the timing and results of the Company’s or its partners’ research
projects or clinical trials of product candidates in development;
actions by the FDA or other regulatory agencies with respect to the
Company’s products or product candidates of its partners;
commercial success of the Company’s products or partner products
and continued growth in product, development, licensing and royalty
revenue; the Company’s ability to obtain financial and other
resources for its research, development, clinical, and commercial
activities and other statements regarding matters that are not
historical facts, and involve predictions. These statements involve
known and unknown risks, uncertainties and other factors that may
cause actual results, performance, achievements or prospects to be
materially different from any future results, performance,
achievements or prospects expressed in or implied by such
forward-looking statements. In some cases you can identify
forward-looking statements by terminology such as ''may'',
''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'',
''potential'', ''seem'', ''seek'', ''future'', ''continue'', or
''appear'' or the negative of these terms or similar expressions,
although not all forward-looking statements contain these
identifying words. Additional information concerning these and
other factors that may cause actual results to differ materially
from those anticipated in the forward-looking statements is
contained in the "Risk Factors" section of the Company's Annual
Report on Form 10-K, and in the Company's other periodic reports
and filings with the Securities and Exchange Commission. The
Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. All
forward-looking statements are based on information currently
available to the Company on the date hereof, and the Company
undertakes no obligation to revise or update these forward-looking
statements to reflect events or circumstances after the date of
this press release, except as required by law.
Contact:Tram BuiVice President,
Corporate Communications and Investor
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