Arbor Pharmaceuticals, LLC and Debiopharm International SA Announce Commercial Availability of Triptodur(TM), Triptorelin 6-month Formulation, for Treatment of Central Precocious Puberty (CPP)

PR70413

ATLANTA and LAUSANNE, Switzerland, Oct. 3, 2017/PRNewswire=KYODO JBN/ --

- Triptodur(TM), (triptorelin) extended release injectable suspension, has been

shown to arrest or reverse the clinical signs of puberty associated with CPP

via a once every six-month intramuscular (IM) injection.

    Arbor Pharmaceuticals, LLC, a U.S. based specialty pharmaceutical company,

and Debiopharm International SA, part of Debiopharm Group(TM), a Swiss-based

global biopharmaceutical company, announced today that Triptodur(TM)

[http://www.triptodur.com ] (triptorelin) is now commercially available in the

U.S. for the treatment of pediatric patients 2 years and older diagnosed with

central precocious puberty (CPP) - a rare condition that affects one in every

5,000 to 10,000 children.[1]

    "We are pleased to be providing this important new treatment option for

children diagnosed with CPP," said Ed Schutter, President and CEO of Arbor. "We

believe that many providers, patients and parents will appreciate the

convenience Triptodur(TM) offers through a once-every six-month dosing

schedule."

    CPP is a condition that occurs when a child shows signs of puberty earlier

than normal: before age 8 in girls and age 9 in boys.[2],[3] Without

appropriate treatment, children with CPP will be shorter in height than their

peers due to premature fusion of growth plates.[4] CPP has also been associated

with low self-esteem and higher anxiety, irritability or withdrawal.[5-7],[12]

    "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 may be returned

to a normal level, slowing the clinical signs of puberty until an age

appropriate time."

    Triptodur(TM) (triptorelin) is the first gonadotropin-releasing hormone

(GnRH) agonist administered through intramuscular injection (IM) to offer

once-every six-month dosing.[8] This treatment helps to return hormone levels

in children to a normal prepubertal level, pausing the clinical signs of

puberty until an age appropriate time. GnRH agonists are the primary treatment

for CPP and can help preserve time in childhood.[9]

    "We are very pleased to offer this well tolerated and efficacious

triptorelin formulation to children suffering from central precocious puberty,

for which no other 6-month GnRH agonist formulation is approved," said Eija

Lundstrom, Medical Director, Debiopharm International SA.[8]

    Triptodur(TM) (triptorelin) has been approved by the U.S. Food and Drug

Administration (FDA) for the treatment of children with CPP. In a phase III

clinical trial, Triptodur(TM) (triptorelin) demonstrated a return to

pre-pubertal luteinizing hormone (LH) levels in 93 percent of patients after 6

months of treatment, and in 98 percent of patients after 12 months.[10] The

most common adverse reactions in clinical studies were injection site

reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and

infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis

externa, pharyngitis, sinusitis, and upper respiratory tract infection). Please

see Important Safety Information below.

    Triptorelin extended release formulations were developed by Debiopharm and

are manufactured in Switzerland by Debiopharm Research & Manufacturing SA.

Arbor acquired exclusive U.S. commercial rights to Triptorelin 6-month for CPP

in November 2015 and it was approved by the U.S. FDA in June 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.[1]-[2] 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.[11]

    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.[3] 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.[10]

    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(TM)

    INDICATIONS

    TRIPTODUR(TM) is indicated for the treatment of pediatric patients 2 years

of age and older with central precocious puberty (CPP).

    IMPORTANT SAFETY INFORMATION

    Contraindications

    TRIPTODUR(TM) 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(TM) 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 advised of the potential risk to the fetus.

    Warnings and Precautions

    Initial Rise of Gonadotropins and Sex Steroid Levels - During the early

phase of therapy, gonadotropins 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 or after subsequent doses.

    Psychiatric Events - Psychiatric events have been reported in patients

taking GnRH agonists. Postmarketing 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(TM).

    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

    In clinical trials for TRIPTODUR(TM), the most common adverse reactions

(greater than or equal to4.5%) are injection site reactions, menstrual

(vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis,

gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis,

sinusitis, and upper respiratory tract infection).

    For additional safety information, consult the TRIPTODUR(TM) full

Prescribing Information:

http://arborpharma.com/docs/TriptodurFullProductInformation.pdf

    For More Information

    For additional news or information about Triptodur(TM) (triptorelin),

please visit www.Triptodur.com [http://www.Triptodur.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

[http://www.debiopharm.com].

    We are on Twitter. Follow us @DebiopharmNews at

http://twitter.com/DebiopharmNews.

    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 [http://www.arborpharma.com ] or send email inquiries to

info@arborpharma.com

    References

    1. Partsch CJ, Sippell WG. Treatment of central precocious puberty. Best

Pract Res Clin Endocrinol Metab.2002;16:165-189.

    2. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381.

    3. Carel JC, Leger J. Clinical practice. Precocious puberty. N Engl J Med.

2008;358(22) :2366-2377.

    4. Carel JC, Lahlou N, Roger M & Chaussain JL. Precocious puberty and

statural growth. Human Reproduction Update. 2004;10:135-147.

    5. Precocious puberty. Mayo Clinic Web site.

http://www.mayoclinic.org/diseases-conditions/precocious-puberty/symptoms-causes/dxc-20266

003. Accessed June 21, 2017.

    6. Mendle, J., et al. Detrimental Psychological Outcomes Associated with

Early Pubertal Timing in Adolescent Girls. Dev Rev. 2007; 27(2): 151-171.

    7. Johansson T & Ritzen EM. Very long-term follow-up of girls with early

and late menarche. Endocrine Development. 2005;8:126-136.

    8. Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC.

http://arborpharma.com/docs/TriptodurFullProductInformation.pdf

    9. Faqua JS. Treatment and outcomes of precocious puberty: an update. J

Clin Endocrinol Metab. 2013;98(6):2198-207.

    10. 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.

    11. Antoniazzi F, Zamboni G. Central precocious puberty: current treatment

options. Paediatr Drugs. 2004;6:211-231.

    12. Early Puberty. Lurie Children's Web site.  

https://www.luriechildrens.org/en-us/care-services/conditions-treatments/early-puberty/Pages/index.aspx

.  Accessed June 21, 2017.

    PP-TRIP-US-0056

    Arbor Pharmaceuticals, LLC Contact

   Melissa Bond

    Spectrum Science Communications

    mbond@spectrumscience.com

    Tel: +1-212-468-5340

    Debiopharm International SA Contact

    Christelle von Bueren

    Communication Coordinator

    christelle.vonburen@debiopharm.com

    Tel: +41(0)21-321-01-11

    Source: Debiopharm International SA