FDA APPROVES RECORDATI'S ISTURISA (osilodrostat) TO TREAT CUSHING'S DISEASE
by John G. Baresky on 03/09/20
Isturisa, Developed By Novartis, Scores FDA Approval And Orphan Drug Status
Recordati (BIT: REC) and Novartis have been issued FDA approval for Isturisa. In 2019 Recordati licensed the rights to the product from Novartis and the approval enables Recordati to start recouping its investment. Isturisa further benefits from the FDA approval as it was given Orphan Drug status that establishes 7 years of market exclusivity.
Isturisa is indicated for the treatment of Cushing’s
Disease
Cushing’s Disease is a rare condition in which a patient’s adrenal glands generate an excessive amount of cortisol. Cushing's disease is usually found in adults 30 to 50 years of age and is more prevalent in women. Cortisol affects all tissues and organs in the body; collectively the symptoms and the healthcare problems as a result of excess cortisol are referred to as “Cushing’s Syndrome”.
Osilodrostat is a steroidogenesis inhibitor of 11-Beta-hydroxylase, an enzyme that catalyses the last step of cortisol synthesis in the adrenal cortex. Isturisa is the first therapy that is FDA-approved that treats cortisol overproduction by blocking the 11-beta-hydroxylase enzyme that triggers it.
Isturisa (Type 1 New Molecular Entity) is a tablet which will be available in 1mg, 5mg and 10mg dosages that is taken orally. With its specific indication for Cushing's disease, Isturisa will be a welcome therapeutic option for endocrinologists and other clinicians treating this highly specialized patient care challenge.
Recordati focuses on developing treatments for rare diseases
Founded
in 1990 with origins dating back to 1926, Milan, Italy-based Recordati
has a unique portfolio of products of which only a few besides Isturisa are approved
by the FDA for patient treatment in the United States:
- Chemet (succimer)
capsules
- Cosmegen
(dactinomycin) injection
- Desoxyn CII
(methamphetamine hydrochloride) tablets
- NeoProfen (Ibuprofen
lysine) Injection
- Panhematin
(hemin) injection
- Peganone® (ethotoin)
tablets
- Tranxene
T-TAB (clorazepate dipotassium) tablets
Recordati has additional therapeutic agents approved in Europe, China and other markets.
Recordati's deal with Novartis included the Signifor brand franchise that is also used in the treatment of Cushing's disease
Recordati paid Novartis $390 million for Signifor and Signifor LAR (each indicated for Cushing’s disease and acromegaly in adults who have failed or cannot undergo surgery) plus Isturisa (osilodrostat). Isturisa was not approved by the FDA at the time of the transaction. In addition to the $390 million licensing transaction, Recordati will be providing Novartis with milestone and royalty payments associated with Signifor and Isturisa.
Novartis (NYSE: NVS) generates over $53 billion in annual sales. Presumably their strategy is to concentrate on therapies which produce larger sales numbers (margin and total revenue). The deal with Recordati (a smaller scale organization specializing in more niche market therapies) enables Novartis to generate revenue from products they develop which can be more effectively commercialized by another company.
