Debiopharm International SA and Arbor Pharmaceuticals, LLC Announce U.S. FDA Approval for Triptodur(TM), Triptorelin 6-month Formulation, in the Treatment of Central Precocious Puberty (CPP)

Lausanne, Switzerland and Atlanta, GA (ots) - Triptodur (TM),
(triptorelin) for extended release injectable suspension, has been
shown to arrest or reverse the clinical signs of puberty with once
every six-month intramuscular injection (IM) dosing for children with
CPP

Approval brings new CPP treatment formulation to U.S. children for
the first time in six years

Debiopharm International SA, part of Debiopharm Group(TM), a
Swiss-based global biopharmaceutical company, and Arbor
Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA) has
approved Triptodur(TM) for the treatment of pediatric patients 2
years and older with central precocious puberty (CPP). CPP occurs
when a child shows signs of puberty sooner than normal - before age 8
in girls and age 9 in boys.

"We are extremely pleased to provide this pediatric population
with the option of the triptorelin six-month formulation", said Eija
Lundstrom, Medical Director, Debiopharm International SA. "This will
allow children to benefit from an effective and well tolerated
treatment with only two injections per year."

Triptodur(TM), a gonadotropin-releasing hormone (GnRH) agonist
administered through intramuscular injection (IM), is the first GnRH
agonist to offer once-every six-month dosing approved for the
treatment of CPP in the U.S. In a phase III clinical trial,
Triptodur(TM) demonstrated a return to pre-pubertal luteinizing
hormone (LH) levels in 93 percent of patients, with pre-pubertal LH
suppression maintained at 12 months by 98 percent of patients.1 The
most common adverse reactions are injection site reactions and
menstrual (vaginal) bleeding.

"Early puberty in a child can pose significant physical and
emotional challenges throughout their life, including shorter adult
stature, social, psychological and emotional effects," said Karen
Klein, M.D., Pediatric Endocrinologist, University of California San
Diego and Rady Children's Hospital. "With treatment, hormone levels
in children with CPP are returned to a normal level, slowing the
clinical signs of puberty until an age appropriate time."

"We are excited to be bringing Triptodur(TM), a new treatment
option for children impacted by the disruptive effects of CPP, to the
U.S. market," said Ed Schutter, President and CEO of Arbor.
"Triptodur(TM) adds to our growing portfolio of approved medications
that may help to improve the lives of our patients."

Triptorelin was developed by Debiopharm and will be manufactured
in Switzerland by Debiopharm Research & Manufacturing SA. Arbor
acquired exclusive U.S. commercial rights to Triptorelin 6-month for
CPP in November 2015. Triptodur(TM) is expected to be available in
the fourth quarter of 2017.

About Central Precocious Puberty (CPP)

GnRH-dependent CPP is defined by pubertal development occurring
before the age of 8 years in girls and 9 years in boys. 2,3 It is
characterized by early pubertal changes such as breast development
and start of menses in girls and increased testicular and penile
growth in boys, appearance of pubic hair, as well as acceleration of
growth velocity and bone maturation and tall stature during
childhood, which often results in reduced adult height due to
premature fusion of the growth plates.4

Reliable epidemiological data on CPP worldwide is not available.
The condition is a rare disease occurring in about 1 out of every
5,000 to 10,000 children.5 Central precocious puberty is more common
in girls than in boys, with a female: male ratio estimated to be
between 3:1 and 23:1. 3

About Triptorelin

Triptorelin is an agonist analogue of the natural
gonadotropin-releasing hormone (GnRH). Debiopharm has developed three
sustained-release formulations (1, 3 and 6 months) of triptorelin
pamoate. The 1-, 3- and 6-month formulations have been registered in
numerous countries for several indications.

Triptorelin was first registered in France in 1986 and is
currently marketed in more than 80 countries for various indications
including CPP.

About TRIPTODUR

INDICATIONS

TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist
indicated for the treatment of pediatric patients 2 years and older
with central precocious puberty.

IMPORTANT SAFETY INFORMATION

Contraindications

TRIPTODUR is contraindicated in:

- Individuals with a known hypersensitivity to triptorelin or any
other component of the product, or other GnRH agonists or GnRH.

- Women who are or may become pregnant. Expected hormonal changes
that occur with TRIPTODUR treatment increase the risk for pregnancy
loss and fetal harm when administered to a pregnant woman. If this
drug is used during pregnancy, or if the patient becomes pregnant
while taking this drug, the patient should be apprised of the
potential hazard to the fetus.

Warnings and Precautions

Initial Rise of Gonadotropins and Sex Steroid Levels - During the
early phase of therapy, gonadotrophins and sex steroids rise above
baseline because of the initial stimulatory effect of the drug.
Therefore, a transient increase in clinical signs and symptoms of
puberty, including vaginal bleeding, may be observed during the first
weeks of therapy.

Psychiatric Events - Psychiatric events have been reported in
patients taking GnRH agonists. Post-marketing reports with this class
of drugs include symptoms of emotional lability, such as crying,
irritability, impatience, anger, and aggression. Monitor for
development or worsening of psychiatric symptoms during treatment
with TRIPTODUR.

Convulsions - Post-marketing reports of convulsions have been
observed in patients receiving GnRH agonists, including triptorelin.
These included patients with a history of seizures, epilepsy,
cerebrovascular disorders, central nervous system anomalies or
tumors, and patients on concomitant medications that have been
associated with convulsions such as bupropion and SSRIs. Convulsions
have also been reported in patients in the absence of any of the
conditions mentioned above.

Adverse Reactions

The most common adverse reactions are injection site pain,
menstrual disorder and vaginal bleeding. For additional safety
information, consult the TRIPTODUR full Prescribing Information
http://arborpharma.com/docs/TriptodurFullProductInformation.pdf

About Arbor Pharmaceuticals LLC

Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a
specialty pharmaceutical company currently focused on the
cardiovascular, neurology, hospital and pediatric markets as well as
generics through its Wilshire division. The company has approximately
750 employees, with over 625 sales professionals that promote its
products to hospitals and physicians. In addition to its extensive
pipeline, the company continues to actively pursue growth through
acquisition or licensing of marketed or late-stage development
products. Arbor currently markets twenty-two approved NDA and ANDA
products, and, along with Wilshire, has over forty products in
development. For more information regarding Arbor Pharmaceuticals or
any of its products, visit www.arborpharma.com or send email
inquiries to info@arborpharma.com.

About Debiopharm International SA

Part of Debiopharm Group(TM) - a Swiss-headquartered global
biopharmaceutical group including five companies active in the life
science areas of drug development, GMP manufacturing of proprietary
drugs, diagnostic tools and investment management - Debiopharm
International SA is focused on the development of prescription drugs
that target unmet medical needs. The company in-licenses and develops
promising drug candidates. The products are commercialized by
pharmaceutical out-licensing partners to give access to the largest
number of patients worldwide. For more information, please visit
www.debiopharm.com.

We are on Twitter. Follow us @DebiopharmNews at
http://twitter.com/DebiopharmNews.

1 Klein K, et al. Efficacy and safety of triptorelin 6-month
formulation in patients with central precocious puberty. J Pediatr
Endocrinol Metab. 2016;29(11):1241-1248.
2 Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381.
3 Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J
Med. 2008;358(22):2366-2377.
4 Antoniazzi F, Zamboni G. Central precocious puberty: current
treatment options. Paediatr Drugs. 2004;6:211-231.
5 Partsch CJ, Sippell WG. Treatment of central precocious puberty.
Best Pract Res Clin Endocrinol Metab.2002;16:165-189.

PP-TRIP-US-0014

Pressekontakt:
Debiopharm International SA Contact
Christelle Tur
Communication Coordinator
christelle.tur@debiopharm.com
Tel: +41 (0)21 321 01 11

Arbor Pharmaceuticals, LLC Contact
Amanda Sellers
Spectrum Science Communications
asellers@spectrumscience.com
Tel: +1 404-865-3597

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell