Diurnal Limited (“Diurnal”), a Sheffield -based medical therapeutics Biofusion portfolio company, today announced it has received Orphan Medicinal Product designation for a modified release hydrocortisone tablet for the treatment of congenital adrenal hyperplasia. This product is being developed by Phoqus Pharmaceuticals Limited (“Phoqus”), a drug delivery company based in Kent, England. This follows the exclusive licencing by Phoqus of a Diurnal patent that relates to delayed and sustained release therapy.
Orphan Medicinal Product designation affords 10 years market exclusivity after the grant of a marketing authorisation in Europe. Other benefits include protocol assistance, access to the centralised procedure for the application for marketing authorisation and fee reductions. The Directors’ believe that the global market for this product is estimated to be worth £100m. The product is expected to enter human studies in Q4 2005.
The tablet formulation developed by Phoqus will allow for the controlled and sustained release of hydrocortisone, a steroid normally released from the adrenal gland, in a manner which mimics the normal physiological circadian rhythm. This marked rhythm, with high levels in the morning and low levels at night, is lost in patients with adrenal insufficiency. The Diurnal management believe that their product will offer a potential much needed improvement in steroid treatment for patients with congenital adrenal hyperplasia, a form of adrenal insufficiency. Current therapies cannot adequately control the condition and Diurnal anticipates that the new product will provide a more efficacious therapy with improved compliance from patients.
Diurnal also intends to explore additional opportunities in areas in which steroid levels may be implicated in other diseases such as inflammatory conditions.
Professor Richard Ross of Diurnal said: “Orphan Medicinal Product designation is a great boost for our development of modified released hydrocortisone and recognition of the potential of the product to benefit sufferers of this rare but serious condition.”
David Baynes, CEO of Biofusion, said: “This is excellent news for Diurnal allowing the company to push ahead with its development plan, which includes tests in humans by the end of this year. The company will benefit from guidance given by the EMEA in its development plan and we look forward to working with Diurnal and Phoqus in progressing this product to the market as quickly as possible.
“This is an exciting time for Biofusion as we are starting to see the value and potentialof Sheffield’s world class IP.”
Andy Jones, CEO of Phoqus, said: “This is an exciting opportunity to apply Phoqus’ innovative QtrolTM controlled release technology to develop a product that will benefit patients through simplified dosing regimens and reduced side effects.”