Intellectual Property

Patents

3D image of octreotide, an 8-amino acid octapeptide
WO2022159593 … the present disclosure provides methods for treating idiopathic intracranial hypertension (IIH) or cluster headache (CH) in a subject in need thereof, comprising administering to the subject an effective intranasal amount of a somatostatin mimetic formulated for intranasal administration. In some embodiments, the intranasal administration is direct nose-to-brain administration.

WO2022182779 … a method is provided for treating idiopathic intracranial hypertension (IIH) or cluster headache (CH) in a subject in need thereof, comprising administering to the subject a therapeutically effective combination of: (a) an intranasal dosing regimen of a somatostatin mimetic, wherein the dosing regimen of the somatostatin mimetic provides a dose level or exposure that is less than the therapeutically effective dosing regimen when administered alone by a non-nasal route of administration; and (b) a dosing regimen of a carbonic anhydrase inhibitor, wherein the dosing regimen of the carbonic anhydrase inhibitor provides a dose level or exposure that is less than the therapeutically effective dose when administered alone. In some embodiments, the intranasal dosing regimen of the somatostatin mimetic is direct nose-to-brain administration.

Both patents have been accepted in Australia.

Orphan Drug

US FDA “Pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), your orphan-drug designation request of octreotide is granted for treatment of idiopathic intracranial hypertension.” July 19, 2021
EU EMA “The medicinal product ‘Octreotide acetate’ is designated as an orphan medicinal product for the indication: Treatment of idiopathic intracranial hypertension. This medicinal product will be entered in the Community Register of Orphan Medicinal Products under number EU/3/21/2554.” December 10, 2021
Upon drug approval, Orphan Exclusivity lasts for 7 years in the U.S. and 10 years in the EU.