Avadel Pharma (NASDAQ:AVDL), "Avadel" or "the Company," today announced its 2018 corporate objectives and financial expectations, including the commercial launch of Noctiva™ and the anticipated filing of a New Drug Application (NDA) for both FT218, a once-nightly formulation of sodium oxybate using Micropump®, and its fourth Unapproved Marketed Drug (UMD) product, AV001.
For 2018, the Company has set forth the following expectations:
Implement a full-scale commercial launch for Noctiva during the second quarter
File the NDA for FT218 by the end of 2018
File the NDA for AV001, its fourth UMD product
Maintain market leading position across its portfolio of hospital products and improve the effectiveness and efficiency of its pediatric operations
Enhance portfolio development through selective M&A and advancement of internal pipeline
Generate total revenues between $110 - $130 million
Mike Anderson, Avadel’s Chief Executive Officer, remarked, "We are excited to enter 2018 with a set of strategic objectives that will be transformational for our company. Achievement of these objectives moves us towards our goal of becoming a fully integrated specialty pharmaceutical company with an exceptional long-term growth trajectory. We have built a strong base business that has provided and continues to provide us cash flow, and we have laid the groundwork to invest in our future."
Mr. Anderson continued, "We not only expect to successfully complete our Phase III REST-ON trial of FT218 for excessive daytime sleepiness and cataplexy, and subsequently file our NDA by year end, but we are also gearing up for a strong commercial launch for Noctiva™ in the second quarter. Both FT218 and Noctiva are proprietary products with enormous market potential. They will expand our commercial footprint into new therapeutic categories and create meaningful long-term value for shareholders."
Clinical Operations
Avadel is progressing in enrolling patients for its REST-ON Phase III clinical trial. REST-ON is a double-blind, randomized, placebo controlled study of 264 patients to assess the efficacy and safety of FT218, a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. FT218 uses the Company’s proprietary Micropump® drug delivery technology.
"Filing the NDA for FT218 by the end of 2018 is still our target, and strategies to drive enrollment through social media, clinical site incentive goals and identification of additional clinical sites have aided us in maintaining this objective. We recognize that enrollment is the most difficult aspect of this trial given the limited population of narcolepsy patients and the strict exclusion criteria agreed upon in our Special Protocol Assessment with FDA. The important thing is that we continue to make progress with patient enrollment and simultaneously prepare the nonclinical and CMC requirements for our NDA filing," said Mr. Anderson.
Mr. Anderson continued, "We maintain that FT218 is our most important clinical project in 2018. The opportunity to enter a possible blockbuster market with a potentially superior product is incredibly meaningful for our company. The current approved product to treat the condition generates well over $1 billion per year. Based on an independent claims analysis, there exists a large body of patients who ultimately choose not to remain on the approved twice-nightly version of sodium oxybate, with only 46% of new start patients persisting on treatment at twelve months1. The need and desire for a once-nightly product from the medical community and patients are strong, and we believe FT218 has the potential to meet these needs."
In addition to FT218, Avadel is also working to file an NDA for a fourth sterile injectable product, AV001, which is currently being marketed by another company without...
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