Arbor Pharmaceuticals to commercialize triptorelin in sustained-release formulation for the orphan indication central precocious puberty
Lausanne, Switzerland and Atlanta, GA USA – January 11, 2016 – Debiopharm International SA (Debiopharm), part of Debiopharm Group™, a Swiss-based global biopharmaceutical company, and Arbor Pharmaceuticals, LCC (Arbor), a U.S.-based specialty pharmaceutical company, jointly announce the execution of a distribution agreement for the commercialization and promotion of triptorelin 22.5 mg in the United States for central precocious puberty (CPP).
Under the terms of the agreement, Arbor acquires exclusive commercial rights for triptorelin 22.5 mg in the U.S., for the CPP indication. The product will be exported from Debiopharm Research and Manufacturing SA to Arbor. Once approved, triptorelin 22.5 mg will be made available primarily to pediatricians and pediatric endocrinologists.
“We are delighted to be partnering with an excellent research based company like Debiopharm to bring this important product to pediatric patients in the United States” said Ed Schutter, President and CEO of Arbor. “We are looking forward to working with them to file this unique dosage form of sustained-release triptorelin with the FDA in the near future.”
“We are happy to have found a good partner to commercialize our product in this orphan indication” said Thierry Mauvernay, Co-President & Delegate of the Board of Debiopharm Group. “It is important to us to make this treatment option with its 6-monthly administration available to these young patients.”
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. 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, which often results in reduced adult height and disproportioned body appearance due to premature fusion of the growth plates. Reliable epidemiological data on CPP worldwide are not available. The condition occurs in about 1 out of every 5,000 to 10,000 children (leading to an estimated prevalence of 10,000 to 20,000 children in the USA). These numbers show that CPP is a rare disease. 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.
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 in several indications.
About Debiopharm Group™
Debiopharm Group™ is a Swiss-based global biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, 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 on Debiopharm Group™, please visit: www.debiopharm.com.
About Arbor Pharmaceuticals, LLC
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets as well as generics through its Wilshire division. The company has approximately 600 employees, with over 500 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 eighteen 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 firstname.lastname@example.org.