--FDA-approved product further expands Endo's Branded
Pharmaceutical Men's Health portfolio
-- Commercial launch planned for Q1
2015
DUBLIN, Dec. 9, 2014 /PRNewswire/ -- Endo
International plc (NASDAQ: ENDP) (TSX: ENL), announced today the
completion of the acquisition of rights to Natesto™
(testosterone nasal gel), the first and only testosterone
nasal gel for replacement therapy in adult males diagnosed with
hypogonadism, from Trimel BioPharma SRL, a wholly-owned subsidiary
of Trimel Pharmaceuticals Corporation (TSX: TRL) for $25 million including additional payments upon
the achievement of certain regulatory and sales milestones.
Endo will collaborate with Trimel on all regulatory and clinical
development activities regarding Natesto™, which was approved by
the U.S. Food and Drug Administration (FDA) in May of 2014. Endo
intends to launch the product, through its Endo Pharmaceuticals
subsidiary, in the first quarter of 2015.
About Natesto™ (testosterone) Nasal Gel
Indications and Usage
Natesto™ is an androgen indicated for replacement therapy in
males for conditions associated with a deficiency or absence of
endogenous testosterone including:
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
Limitations of Use
- Safety and efficacy of Natesto™ in males less than 18 years old
have not been established
Dosage
Natesto™ for intranasal use is available as a
metered-dose pump. One pump actuation delivers 5.5 mg of
testosterone. The recommended dose of Natesto™ is 11 mg of
testosterone (two pump actuations, one per nostril), applied
intranasally three times daily for a total daily dose of 33 mg.
Contraindications
- Men with carcinoma of the breast or known or suspected prostate
cancer
- Pregnant or breast-feeding women. Testosterone may cause fetal
harm
Warnings and Precautions
- Nasal adverse reactions: nasal signs and symptoms should
be monitored. Natesto™ is not recommended for use in patients
with chronic nasal conditions or alterations in nasal anatomy
- Monitor patients with benign prostatic hyperplasia (BPH) for
worsening of signs and symptoms of BPH
- Venous thromboembolism (VTE), including deep vein thrombosis
(DVT) and pulmonary embolism (PE) have been reported in patients
using testosterone products. Evaluate patients with signs or
symptoms consistent with DVT or PE
- Women and children should not use Natesto™
- Exogenous administration of androgens may lead to
azoospermia
- Edema with or without congestive heart failure (CHF) may be a
complication in patients with preexisting cardiac, renal, or
hepatic disease
- Sleep apnea may occur in those with risk factors
- Monitor serum testosterone, prostate-specific antigen (PSA),
hemoglobin, hematocrit, liver function tests, and lipid
concentrations periodically
Adverse Reactions
The most common adverse reactions (incidence >/=3%) to
Natesto™ observed in clinical trials were an increase in prostate
specific antigen (PSA), headache, rhinorrhea, epistaxis, nasal
discomfort, nasopharyngitis, bronchitis, upper respiratory tract
infection, sinusitis and nasal scab.
About Endo International plc
Endo International plc is a global specialty healthcare company
focused on improving patients' lives while creating shareholder
value. Endo develops, manufactures, markets, and distributes
quality branded pharmaceutical, generic pharmaceutical, over the
counter medications and medical device products through its
operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
About Trimel
Trimel is a specialty pharmaceutical company involved in the
sale, distribution, and development of products with a focus in
men's health, women's health, and respiratory medicine. NATESTO™, a
product utilizing Trimel's licensed nasal gel technology, has been
approved for sale in the United
States by the FDA and is licensed to an affiliate of Endo
International plc for commercialization. For more information,
please visit www.trimelpharmaceuticals.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and Canadian securities legislation. Statements
including words such as "believes," "expects," "anticipates,"
"intends," "estimates," "plan," "will," "may," "look forward,"
"intend," "guidance," "future" or similar expressions are
forward-looking statements. Because these statements
reflect Endo's current views, expectations and beliefs
concerning future events, these forward-looking statements involve
risks and uncertainties. Although Endo believes that
these forward- looking statements and information are based upon
reasonable assumptions and expectations, readers should not place
undue reliance on them, or any other forward- looking statements or
information in this news release. Investors should note that many
factors, as more fully described in the documents filed
by Endo with securities regulators in the United
States and Canada including under the caption "Risk
Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K
filings with the Securities and Exchange Commission and
with securities regulators in Canada on System for
Electronic Document Analysis and Retrieval ("SEDAR") and as
otherwise enumerated herein or therein, could
affect Endo's future financial results and could
cause Endo's actual results to differ materially from
those expressed in forward-looking statements contained
in Endo's Annual Report on Form 10-K. The forward-looking
statements in this press release are qualified by these risk
factors. These are factors that, individually or in the aggregate,
could cause Endo's actual results to differ materially
from expected and historical results. Endo assumes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future developments or
otherwise, except as may be required under applicable securities
law.