TIDMCLIN
Clinigen Group plc
16 March 2017
16 March 2017
RNS Reach
Clinigen and Diurnal partner for European Managed Access
programme
for Infacort(R) and Chronocort(R)
Clinigen Group plc's (AIM: CLIN, 'Clinigen' or the 'Group') Idis
Managed Access (MA) division and Diurnal Group plc (AIM: DNL,
'Diurnal'), have partnered to launch a Managed Access programme in
Europe for Infacort(R) to treat paediatric patients with adrenal
insufficiency (AI) and Chronocort(R) to treat patients with
congenital adrenal hyperplasia (CAH).
CAH is the most common inherited hormone disorder affecting both
men and women. It is caused by genetic mutations of the enzymes in
the adrenal gland that synthesise steroid hormones. Patients with
CAH have a deficiency of the stress hormone, cortisol. Their body's
response to this is for the adrenal glands to produce more of the
male steroid hormones (androgens), which, in excess levels, are
harmful to patients.
Cortisol deficiency and over-production of androgens can lead to
increased mortality, infertility and severe development defects,
including ambiguous genitalia, precocious puberty and short
stature.
Approximately two thirds of CAH patients are estimated to have
poor disease control, leading to elevated androgen levels. The
condition is estimated to affect approximately 51,000 patients in
Europe.
Infacort(R) has been specifically designed for use in children
suffering from AI and has the potential to help young patients less
than six years of age with cortisol deficiency including AI and
CAH. Diurnal submitted a Paediatric Use Marketing Authorisation
(PUMA) application for Infacort(R) to the European Medicines Agency
(EMA) in late 2016.
Chronocort(R) has orphan drug designation in Europe and the US
for the treatment of CAH and AI in adult patients. Chronocort(R) is
currently in Phase III clinical development and therefore not yet
commercially available.
Run by Idis MA, the Managed Access programme will enable
physicians in the European Union to access Infacort(R) and
Chronocort(R) as unlicensed medicines on an individual named
patient basis for patients who have no other treatment options,
ahead of European approval and commercial launch.
Steve Glass, Chief Commercial Officer, North America and Europe
of Clinigen said:
"The effective treatment of patients with CAH and paediatric AI
represents a significant unmet need. As the global leader in
providing Managed Access programmes, we can leverage our
international reach to support these patients by enabling their
physicians to access these therapies safely, ethically and quickly,
ahead of approval and launch."
Martin Whitaker, Chief Executive Officer of Diurnal said:
"Our first product, Infacort(R), is currently undergoing
regulatory review with the EMA. Whilst this is ongoing, we are
focused on putting in place the appropriate infrastructure to
ensure that patients with cortisol deficiency but no other
treatment options can access this medicine as efficiently as
possible. As a global leader in providing unlicensed medicines to
patients on a Named Patient basis, Clinigen is well placed to help
us make Infacort(R) and Chronocort(R) accessible to patients ahead
of their potential approval."
Healthcare Professionals can obtain details about the
Infacort(R) and Chronocort(R) Managed Access programme by calling
+44 (0) 1283 495 010, or emailing
customer.services@clinigengroup.com.
- Ends -
Clinigen Group plc Tel: +44 (0) 1283 495 010
Shaun Chilton, Group Chief Executive
Officer
Steve Glass, Chief Commercial Officer
(North America and Europe)
Numis Securities Limited Tel: +44 (0) 20 7260 1000
Michael Meade / Freddie Barnfield
(Nominated Adviser)
James Black / Tom Ballard (Corporate
Broking)
RBC Capital Markets - Joint Broker Tel: +44 (0) 20 7653 4000
Marcus Jackson / Elliot Thomas / Jack
Wood
Instinctif Partners (media relations Tel: +44 (0) 20 7457 2020
- Clinigen)
Melanie Toyne-Sewell / Alex Shaw Email: clinigen@instinctif.com
Diurnal Group plc Tel: +44 (0) 20 3727 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Notes to Editors
About Adrenal Insufficiency
Adrenal Insufficiency (AI) is a condition characterised by
deficiency in cortisol, an essential hormone in regulating
metabolism and the response to stress. AI has been identified as a
rare disease in Europe where there are estimated to be
approximately 4,000 sufferers younger than the age of six.
Currently there are no licensed hydrocortisone preparations in
Europe specifically designed to treat these young patients. These
children are often administered compounded adult tablets or other
unlicensed products. Poor control of disease can result in
precocious puberty in young children, virilisation in girls and
chronic fatigue leading to a poor quality of life in adulthood
resulting in increased morbidity and mortality.
About Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia ("CAH") is an orphan condition
usually caused by deficiency of the enzyme 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 severe development defects including
ambiguous genitalia, premature (precocious) sexual development and
short stature. Sufferers, even if treated, remain at risk of death
through an adrenal crisis.
Approximately two thirds of CAH patients are estimated to have
poor disease control, leading to elevated androgen levels. The
condition is estimated to affect approximately 71,000 patients in
Europe (51,000) and the US (20,000), with approximately 405,000 in
the rest of the world.
Current therapy for CAH uses a combination of generic steroids
(hydrocortisone, dexamethasone and prednisolone) and, at best,
these adequately treat approximately one third of CAH patients.
Other therapies being developed are at an early stage of
development and not expected to receive approval in the
short-term.
About Infacort(R)
Infacort(R) represents the first preparation of hydrocortisone
specifically designed for use in children suffering from AI. It is
a patented, immediate-release, oral, paediatric formulation of
hydrocortisone that allows for age-appropriate dosing in children.
This therapeutic approach has the potential to help young patients
less than six year of age suffering from diseases due to cortisol
deficiency including adrenal insufficiency and congenital adrenal
hyperplasia. AI requires life-long treatment and Diurnal's novel
approach to product development has the potential to significantly
improve these young patients' lives. Diurnal has already submitted
for market authorisation to the European Medicines Agency via the
Paediatric Use Marketing Authorisation (PUMA) route in late
2016.
About Chronocort(R)
Chronocort(R) is a modified release hydrocortisone preparation
that has been designed to mimic the natural circadian rhythm of
cortisol when given in a twice-a-day "toothbrush" regimen (last
thing at night before sleep and first thing in the morning on
waking). Chronocort(R) has been granted orphan drug designations in
Europe and the US in the treatment of Congenital Adrenal
Hyperplasia ("CAH") and Adrenal Insufficiency ("AI"). The first
planned indication for Chronocort(R) is CAH. Chronocort(R) has
completed three Phase I trials in 2011, 2012 and 2015 (food effects
study) and a Phase II trial in CAH patients in 2014, and is
currently in Phase III trials in Europe.
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and
services company with a unique combination of businesses focused on
providing access to medicines. Its mission is to deliver the right
medicine to the right patient at the right time.
The Group consists of five synergistic businesses focused in
three areas of global medicine supply; clinical trial, unlicensed
and licensed medicines.
Clinigen Clinical Trial Services is the global market leader in
the management and supply of commercial medicines for clinical
trials.
The Group is also the trusted global leader in ethically
sourcing and supplying unlicensed medicines to hospital pharmacists
and physicians for patients with a high unmet need, through three
of its divisions: Idis Managed Access runs early access programmes
for innovative new medicines. Idis Global Access and Link
Healthcare work directly with healthcare professionals to enable
compliant access to unlicensed medicines on a global basis and
niche essential licensed and generic medicines across Australasia,
Africa and Asia (AAA region).
Clinigen Specialty Pharmaceuticals acquires global rights,
revitalises and markets its own portfolio of niche hospital
medicines.
For more information, please visit www.clinigengroup.com
About Diurnal
Founded in 2004, Diurnal is a UK-based specialty pharma company
developing high quality products for the global market for the
life-long treatment of chronic endocrine conditions, including
Congenital Adrenal Hyperplasia and Adrenal Insufficiency. 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.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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