Noctiva is a proprietary low-dose formulation of desmopressin acetate administered through a patent-protected intranasal delivery system. It is the first and only product approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of nocturia due to nocturnal polyuria.
Nocturia is a medical condition that affects approximately 40 million2 people in the United States, and represents a high unmet medical need. Nocturia results in frequent nighttime urination, which may prevent patients from experiencing a normal, restful sleep cycle.
Nocturia is associated with a number of co-morbidities and health-related consequences, including an increase in the risk of nighttime falls and fractures, loss of sleep, decreased work productivity, impaired daytime functioning and compromised quality of life3.
Mike Anderson, Avadel’s Chief Executive Officer, said, “Licensing Noctiva is an important step in our strategic growth plan and positions Avadel as a fully-integrated specialty pharmaceutical company, with a profitable base and a significant ongoing Phase III trial.
“Noctiva is the first and only FDA approved product to treat nocturia due to nocturnal polyuria, and aligns with our mission of offering patients unique and differentiated branded products. Noctiva has the potential to deliver significant value to Avadel, the large, underserved patient population who suffer from nocturia and our shareholders.”
Dr. Samuel Herschkowitz, Chief Executive Officer of Serenity, said, “Approximately $200 million has been invested in order to develop and gain FDA approval for Noctiva, which is the first drug therapy shown to be safe and effective for the treatment of nocturia.
“The clinical program for Noctiva included four Phase 3 studies and two long-term safety trials and demonstrated significant reductions in the mean number of nocturic episodes, and improved quality of life4. We believe Avadel is the right partner with the experience, capability and commitment to bring Noctiva to market for the benefit of patients, providers and payors.”
Terms of the final agreement, which can be found in detail on Avadel’s 8-K filed with the S.E.C. on September 5, 2017, include an upfront payment of $50 million, $20 million due at the earlier of full scale commercial launch or June 30, 2018, performance-based milestones tied to specific Noctiva net sales thresholds and a tiered royalty rate structure based upon achievement of annual net sales.
As a result of the licensing agreement, the Company expects an improvement in its effective tax rate, as expenses associated with the launch will partially offset U.S. taxable income.
Avadel’s strong balance sheet, with $173 million in cash and marketable securities and no bank debt at June 30, 2017, means the Company is able to self-fund the licensing acquisition of Noctiva and subsequent near-term commercialization plans.
The transaction is set to close upon expiration of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. T.R. Winston & Company, LLC, served as financial and strategic advisor to Serenity.