Avadel Pharmaceuticals enters into exclusive negotiations with Serenity Pharmaceuticals for Noctiva.
Avadel Pharmaceuticals plc announced that it has entered into an agreement for the right to exclusively negotiate with Serenity Pharmaceuticals, LLC for the sole rights to commercialize and further develop Noctiva in the United States and Canada.
Noctiva is a proprietary low-dose formulation of, and delivery system for, the drug desmopressin acetate. It was specifically developed to meet the needs of nocturia patients and was approved by the U.S. Food and Drug Administration (FDA) on March 3, 2017. Noctiva is the first and only drug approved for the treatment of nocturia due to nocturnal polyuria in adults ages 18 and over who awaken two or more times per night to void.
Nocturia is a condition that affects as many as 40 million adults in the United States1. Noctiva is a metered dose intranasal formulation administered as a single spray in one nostril 30 minutes before bedtime and is approved in two dose forms of 0.83 mcg and 1.66 mcg.
The exclusive negotiation period is expected to close on or before September 7, 2017. If Avadel terminates negotiations without cause, Avadel must pay $10 million to Serenity; and if Serenity terminates negotiations without cause, Serenity must pay $10 million to Avadel.
Avadel is a specialty pharmaceutical company headquartered in Dublin, Ireland with operations in St. Louis, MO and Lyon, France.
1 Sources: (1) US census data 2016 estimates (2) Lee, L. K., et al. “Potential benefits of diagnosis and treatment…” International journal of clinical practice 70.1 (2016): 66-81.