Avadel Announces Sale of Hospital Sterile Injectable Drug Portfolio for $42 Million
Avadel Pharmaceuticals plc recently announced the sale of its portfolio of sterile injectable drugs used in the hospital setting, including three commercial products, Bloxiverz, Vazculep, and Akovaz, as well as Nouress, which is approved by the US FDA, to Exela Sterile Medicines LLC for a total of $42 million.
“The sale of the sterile injectable drug portfolio is a significant milestone for the company, as it further reflects our commitment to strategically focus on advancing FT218 through the regulatory review process and, if approved, bringing our once-nightly formulation of sodium oxybate to patients,” said Greg Divis, Chief Executive Officer of Avadel. “By divesting our portfolio of sterile injectable drugs, we are now singularly focused on supporting the regulatory approval process, market planning and maximizing shareholder value for FT218.”
Under the terms of the agreement, Avadel will receive $14.5 million upfront and the remaining $27.5 million will be paid out to Avadel over the next 13 months. The transaction closed on June 30, 2020.
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is an emerging biopharmaceutical company. The company’s primary focus is the development and potential FDA approval of FT218, which has completed a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. For more information, visit www.avadel.com.
FT218 is an investigational, once-nightly formulation of Micropump controlled-release sodium oxybate. The company recently completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the US FDA for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.
Total Page Views: 1235
