TIDMDNL
RNS Number : 1291J
Diurnal Group PLC
25 April 2022
25 April 2022
Diurnal Group plc
("Diurnal" or the "Company")
Efmody(R) distribution and marketing agreement signed with EffRx
for Switzerland
Extends Company's existing agreement with EffRx for Alkindi(R)
in Switzerland
EffRx to submit Market Authorisation Application for Efmody(R)
to Swissmedic in H2 2022
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces that it has extended its distribution and
marketing agreement with EffRx Pharmaceuticals ("EffRx") in
Switzerland to now include Efmody(R) (hydrocortisone
modified-release hard capsules). Under the agreement signed in
October 2020, EffRx already holds the exclusive rights to market
and distribute Alkindi(R) (hydrocortisone granules in capsules for
opening) in Switzerland. Alkindi(R) was approved by Swissmedic in
November 2021.
EffRx intends to submit a Market Authorisation Application (MAA)
to Swissmedic for the registration of Efmody(R) as treatment for
adolescent and adult patients (12 years and older) with the rare
condition congenital adrenal hyperplasia (CAH) in Switzerland
during the second half of 2022. The MAA submission to Swissmedic
for Efmody(R) will be based on the European regulatory dossier and
published clinical trial data, with EffRx expecting potential
market launch in Switzerland in 2024. Under the terms of the
agreement, EffRx will receive the exclusive rights to market and
sell Efmody(R) in Switzerland once registered. According to the
Company's estimates, there are approximately 450 patients in
Switzerland suffering from CAH.
Efmody(R) is a modified-release preparation of hydrocortisone
that has been specifically designed for the treatment of patients
with CAH, a rare condition caused by a genetic deficiency of
adrenal enzymes. In May 2021, Efmody(R) was granted marketing
authorisation in the European Union and was subsequently launched
by the Company in Germany, Austria and the UK in September
2021.
On successful approval in Switzerland, Diurnal will provide
Efmody(R) to EffRx for sale from its established European supply
chain.
Richard Bungay, Interim Chief Executive Officer of Diurnal,
commented:
"We are pleased to deepen our relationship with EffRx to include
the distribution and marketing of Efmody(R) in Switzerland. We have
been impressed by the progress EffRx has made with the regulatory
approval and reimbursement of Alkindi(R) and look forward to
continuing to work with them as they prepare to submit an MAA to
Swissmedic for Efmody(R) ."
Lorenzo Bosisio, Chief Executive Officer of EffRx,
commented:
"We are excited to sign this additional agreement with Diurnal,
enabling us to build on the momentum we have achieved with
Alkindi(R) in Switzerland following approval from Swissmedic in
November 2021. We believe the unique release profile of Efmody(R) ,
that mimics the body's natural cortisol circadian rhythm, could
have a genuine impact on CAH patients' symptoms. We are aligned
with Diurnal's strategy to address the unmet medical need in
patients suffering from diseases of cortisol deficiency and look
forward to working with the Diurnal team to bring Efmody(R) to
patients suffering from CAH in Switzerland."
This is a business press release containing financial
information and/or data for the benefit of shareholders and
potential investors. Data are included to allow informed investment
decisions.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please visit www.diurnal.co.uk or
contact:
+44 (0)20 3727
Diurnal Group plc 1000
Richard Bungay, Interim Chief Executive Officer
and Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser +44 (0)20 7886
and Joint Corporate Broker) 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: Rupert Dearden
Stifel Nicolaus Europe Limited (Joint Corporate +44 (0) 20 7710
Broker) 7600
Healthcare Investment Banking: Nicholas Moore,
Samira Essebiyea, William Palmer-Brown
Corporate Broking: Nick Adams, Nick Harland
+44 (0)20 3727
FTI Consulting (Media and Investor Relations) 1000
Simon Conway
Victoria Foster Mitchell
Alex Davis
Notes to Editors
About congenital adrenal hyperplasia
Congenital adrenal hyperplasia (CAH) is an orphan condition
caused by deficiency of adrenal enzymes, most commonly
21-hydroxylase. This enzyme is required to produce the adrenal
steroid hormone, cortisol. The block in the cortisol production
pathway causes the over-production of male steroid hormones
(androgens), which are precursors to cortisol. The condition is
congenital (inherited at birth) and affects both sexes. The
cortisol deficiency and over-production of male sex hormones can
lead to increased mortality, infertility and issues during sexual
development including ambiguous genitalia, premature (precocious)
sexual development and short stature. Sufferers, even if treated,
remain at risk of death through an adrenal crisis.
Current therapy for CAH uses a variety of generic glucocorticoid
(steroid) preparations including hydrocortisone, dexamethasone,
prednisolone and prednisone in the US, with no standard treatment
regimen. Approximately two-thirds of CAH patients are estimated to
have poor disease control, leading to elevated androgen levels. The
condition is estimated to affect a total of approximately 16,000
patients in the US, with over 400,000 in the rest of the world.
About Efmody(R) (hydrocortisone modified-release hard
capsules)
Efmody(R) is a preparation of hydrocortisone that has been
specifically designed to mimic the circadian rhythm of cortisol
when given in a twice-a-day "toothbrush" regimen (administered last
thing at night before sleep and first thing in the morning on
waking) to control androgen excess and chronic fatigue in patients
with diseases of cortisol deficiency. The first indication for
Efmody(R) is congenital adrenal hyperplasia (CAH) in adults and
adolescents (children older than 12 years of age). Efmody(R) has
been extensively studied in 239 human subjects including 138 CAH
patients who have taken part in clinical trials in Europe and the
US.
The MHRA and European Commission marketing authorisation
approval of Efmody(R) was based on a Phase 3 study conducted in a
total of 122 patients enrolled across 11 clinical sites, including
sites in Great Britain, the largest ever interventional clinical
trial completed in CAH. The Phase 3 data was supported by detailed
analysis of data from an open-label safety extension study for
patients completing treatment in the Phase 3 study, which is
assessing the impact of treatment with Efmody(R) over an extended
period, with a number of patients on this trial having been treated
for over five years. Summary of Product Characteristics (SmPC) for
UK (Northern Ireland) can be found here .
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty
pharmaceutical company dedicated to developing hormone therapeutics
to aid lifelong treatment for rare and chronic endocrine
conditions, including congenital adrenal hyperplasia, adrenal
insufficiency, hypogonadism and hypothyroidism. Its expertise and
innovative research activities focus on circadian-based
endocrinology to yield novel product candidates in the rare and
chronic endocrine disease arena.
For further information about Diurnal, please visit
www.diurnal.com
About EffRx Pharmaceuticals
EffRx Pharmaceuticals is a commercial-stage pharmaceutical
company focused on the late-stage development and commercialisation
of prescription medications for niche and orphan indications. The
business model is centred around providing superior clinical and
commercial value propositions for physicians, payers and patients.
EffRx pro-actively seeks in-licensing opportunities for Europe in
niche therapeutic areas, with a primary interest for rare diseases,
where EffRx has received an orphan drug designation (ODD) from the
US Food and Drug Administration (FDA).
For further information about EffRx Pharmaceuticals, please
visit www.effrx.com
Date of Preparation: April 2022 Code: CORP-EU-0034
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