Endo Int\'l (ENDP) Acquires Natesto Gel Rights from Trimel BioPharma

November 24, 2014 7:02 AM EST

Endo Int\'l (NASDAQ: ENDP) 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. Natesto™ was approved by the U.S. Food and Drug Administration (FDA) in May of 2014.

Under the terms of the agreement Trimel will receive an upfront payment of $25 million and could receive additional payments upon the achievement of certain regulatory and sales milestones. Additionally, Trimel will be responsible for the manufacture and supply of Natesto™ and Endo will pay a tiered supply price for the product. Endo expects the transaction to close in early 2015.

"We are pleased to acquire the rights to Natesto™ to further enhance our branded pharmaceutical portfolio and look forward to leveraging our commercial expertise in the areas of men's health and urology to support this highly differentiated product," said Rajiv De Silva, President and CEO of Endo. "Natesto™ offers a unique intranasal delivery system which will expand options for appropriate patients seeking testosterone replacement therapy and we are focused on getting Natesto™ to market as expeditiously as possible."

Under the terms of the agreement, Endo receives sole and exclusive commercial rights to the Natesto™ product in the US and Mexico. In addition, Endo will collaborate on all regulatory and clinical development activities in coordination with Trimel.

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

DosageNatesto™ 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.



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