SAN
DIEGO, June 7, 2022 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the
commercial launch of TLANDO™ (testosterone undecanoate), an oral
treatment indicated for testosterone replacement therapy in adult
males for conditions associated with a deficiency or absence of
endogenous testosterone (primary or hypogonadotropic hypogonadism).
TLANDO™ was approved by the U.S. Food and Drug Administration (FDA)
on March 28, 2022.
"We are delighted to announce the commercial availability of
TLANDO and provide patients with a convenient oral dosing
option for testosterone replacement therapy. The launch of TLANDO
represents our second testosterone replacement therapy product,
following the 2018 launch of XYOSTED, a weekly subcutaneous
auto-injector. The TLANDO approval and commercial launch
demonstrate our continued commitment to developing new drug
delivery options for patients," commented Dr. Helen Torley, president and chief executive
officer of Halozyme. "We look forward to expanding our market share
in this growing therapeutic category with both XYOSTED and TLANDO."
"Our sales organization is well positioned to leverage its
experience and physician relationships established through the
commercialization of XYOSTED," said Joe
Renda, senior vice president, commercial of Halozyme. "We
believe TLANDO's oral formulation and convenient dosing, which
requires no titration, are key benefits for physicians and
patients."
For full prescribing information, please
visit www.TLANDO.com.
About Hypogonadism
Male hypogonadism is an endocrine disorder in which the body
fails to produce enough testosterone. 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
therapy.
1 Endocrine Society
IMPORTANT SAFETY INFORMATION
TLANDO (testosterone undecanoate) capsules, for oral use,
CIII
Initial U.S. Approval: 1953
IMPORTANT SAFETY INFORMATION
WARNING: BLOOD PRESSURE INCREASES (See Boxed Warning
on Product Label for more information)
- 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 death with greater risk in patients with established
cardiovascular disease or risk factors for cardiovascular
disease.
- Before initiating TLANDO, consider the patient's baseline
cardiovascular risk and ensure blood pressure is adequately
controlled.
- Three weeks after initiating therapy monitor for and treat
new-onset hypertension or exacerbations of pre-existing
hypertension.
- 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
USAGE
TLANDO (testosterone undecanoate) is indicated for testosterone
replacement therapy in adult males for conditions associated with a
deficiency or absence of endogenous testosterone.
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
LIMITATIONS OF USE
- Safety and efficacy of TLANDO in males less than 18 years old
have not been established.
CONTRAINDICATIONS
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
[see Adverse Reactions (6.1)].
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 MACE.
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 events
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 with androgens
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 and
management
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 [see Adverse Reactions (6.1)].
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.
Hypercalcemia: Androgens, 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.
Decreased Thyroxine-binding 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.
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
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 requirements.
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 (see Data) 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 cancer.
Geriatric patients treated with androgens may also be at risk
for worsening of signs and symptoms of BPH and hypertension.
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
and aggression.
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 has not been
documented.
For more information, call 1-844-996-7833.
Please see full Prescribing Information, including Boxed Warning
and Medication Guide.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's
commercially-validated solution is used to facilitate the delivery
of injected drugs and fluids in order to reduce the treatment
burden to patients. Having touched more than 600,000 patient lives
in post-marketing use in five commercialized products across more
than 100 global markets, Halozyme has licensed its ENHANZE®
technology to leading pharmaceutical and biotechnology companies
including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers
Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and
Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, novel therapeutic products using its
advanced auto-injector technology 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 commercial portfolio of
proprietary products including XYOSTED®, TLANDO™ and NOCDURNA® and
partnered commercial products and ongoing product development
programs with industry leading pharmaceutical companies including
Teva Pharmaceutical, Covis Pharma, Pfizer and Idorsia
Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka
is also the site of its operations facility.
For more information visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
SAFE HARBOR STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
In addition to historical information, this press release
contains forward-looking statements within the meaning of the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements include,
without limitation, statements concerning the Company's
commercial launch of TLANDO™, the Company's potential expansion of
market share in the testosterone replacement therapeutic category
as well as the potential growth of this therapeutic category, and
the potential benefits TLANDO™ will provide for physicians and
patients. 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. Actual results could differ
materially from the expectations contained in forward-looking
statements as a result of several factors, including but not
limited to, unexpected results or delays in the commercial launch
of TLANDO™, including any potential delays caused by the current
COVID-19 global pandemic, unexpected market acceptance, payor
coverage or future prescriptions and revenue generated by TLANDO™,
unexpected actions by the FDA or other regulatory agencies with
respect to the Company's products, competitive conditions and
unexpected adverse events or patient outcomes from being treated
with TLANDO™. 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.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@antarespharma.com
Dawn Schottlandt / Claudia
Styslinger
Argot Partners
212-600-1902
Halozyme@argotpartners.com
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SOURCE Halozyme Therapeutics, Inc.