Optinose, Inc. Provides Update on Hikma Manufacturing Agreement
March 14, 2024 at 04:27 pm EDT
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OptiNose, Inc. and Hikma Pharmaceuticals USA, Inc. (Hikma) are parties to a Manufacturing and Supply Agreement, dated December 11, 2020 (the Manufacturing Agreement) pursuant to which, following FDA approval of Hikma as an alternative manufacturing site (which occurred on March 9, 2024), Hikma will manufacture and supply finished XHANCE units. Optinose will provide rolling forecasts to Hikma for orders of XHANCE units, of which a certain portion of such forecasts are binding. Optinose is required to have purchased a specified minimum number of XHANCE units over an annual period or it will be required to pay a specified fee to Hikma based on the number of XHANCE units not purchased. The Manufacturing Agreement also contains representations, warranties, indemnification and other obligations of Optinose and Hikma. The term of the Manufacturing Agreement expires on December 31, 2026 subject to earlier termination or extension in accordance with the terms of the agreement. Either Optinose or Hikma may terminate the Manufacturing Agreement prior to that date by mutual consent or for uncured material breach by or insolvency of the other party. Optinose may also terminate the Manufacturing Agreement if, among other things, any intellectual property of any third party is reasonably alleged by a third party to be infringed, misappropriated or otherwise violated by the manufacture, import, use, sale or distribution of XHANCE or if any regulatory authority requires us to cease production of the sale of XHANCE. Hikma may also terminate the Manufacturing Agreement if, among other things, Hikma is named in a third party claim which alleges Hikma?s performance of its obligations under the agreement infringe, misappropriate, or otherwise violate the intellectual property of any third party.
On March 9, 2024, the U.S. Food and Drug Administration (?FDA?) approved Hikma Pharmaceuticals USA Inc.?s affiliate West-Ward Columbus Inc. (?Hikma?), as an additional manufacturing site for finished XHANCE units for commercial sale and sampling. As a result, there are now two sites approved by the FDA for the manufacturer of finished XHANCE units for commercial sale and sampling ? Hikma and Contract Pharmaceuticals Limited Canada.
OptiNose, Inc. is a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists. The Company's product, XHANCE (fluticasone propionate) nasal spray, 93 microgram (mcg), is a therapeutic utilizing its Exhalation Delivery System (EDS) that delivers a topically-acting corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps and chronic rhinosinusitis without nasal polyps (also known as chronic sinusitis). XHANCE combines the EDS with a liquid formulation of fluticasone propionate, a well-characterized, second-generation corticosteroid. XHANCE is designed to deliver medication into the high and deep regions of the nasal passages where both nasal polyps and inflamed and swollen membranes can obstruct normal sinus ventilation and drainage. The Company has developed both a liquid delivery EDS and a powder delivery EDS utilizing natural functional behaviors of the upper nasal airways intended to offer better drug deposition.