TIDMIPO
IP Group PLC
11 July 2016
FOR RELEASE ON 11 July 2016
IP Group plc - Portfolio company Diurnal reports positive
headline data from European Infacort(R) Phase III pivotal study
IP Group plc (LSE: IPO) ("IP Group" or "the Group"), the
developer of intellectual property-based businesses, is pleased to
note that portfolio company Diurnal Group plc ("Diurnal" or "the
Company"), a specialty pharmaceutical company targeting patient
needs in chronic endocrine (hormonal) diseases, has announced
positive headline data from its European Phase III study for
Infacort(R) in the treatment of paediatric Adrenal Insufficiency
(AI), several months ahead of schedule.
Diurnal, a spin-out company from the University of Sheffield,
reported that initial analysis of the results confirms the trial
met its primary endpoint, demonstrating a statistically significant
(p<0.0001) increase in cortisol values following administration
of Infacort(R) compared to the pre-dose values. No serious adverse
events were reported. A full evaluation of the data is underway and
the results of this comprehensive analysis are expected later this
quarter.
IP Group is beneficially interested in 23,488,264 ordinary
shares in Diurnal, representing 45.0% of Diurnal's issued share
capital.
Sam Williams, Head of IP Group's Biotech division, said: "This
is an important milestone in Diurnal's development and validates
our decision to back the company from inception in 2004 all the way
to late-stage clinical studies and market authorisation, which the
Company now expects in 2017. That Diurnal achieved this milestone
several months ahead of schedule demonstrates management's ability
to continually meet and/or exceed expectations and we anticipate
that this will continue with the release of pivotal data in early
2018 for the Company's second Phase III product, Chronocort(R) ,
and the ramp up of sales for both products over the coming years.
IP Group's significant holding in Diurnal reflects our desire to
back a focussed portfolio of high-conviction biotech
companies."
AI is characterised by deficiency in cortisol, an essential
hormone in regulating metabolism and the response to stress. It is
identified as a rare disease in Europe where there are estimated to
be approximately 4,000 sufferers younger than the age of six.
Untreated, the disease is associated with precocious puberty,
virilisation in girls and chronic fatigue, leading to a poor
quality of life in adulthood and increased morbidity and mortality.
However, while adult AI is treated with hydrocortisone, the
synthetic version of cortisol, there is no approved formulation of
hydrocortisone available for young children with AI, with doctors
often reliant on unlicensed preparations of the drug. 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. Infacort(R)
represents the first of two late-stage products Diurnal is
developing for the treatment of AI and diseases of cortisol
deficiency, with Chronocort(R) for adult forms of the disease in a
Phase III study due to report in early 2018.
The full text of the announcement follows:
Diurnal reports positive headline data from European Infacort(R)
Phase III pivotal study
Primary endpoint met, with Infacort(R) treatment achieving
target cortisol levels in children aged less than six years
Major breakthrough in paediatric Adrenal Insufficiency, a
condition of high unmet medical need with no currently licensed
formulation for young children
European market authorisation anticipated in late 2017
Infacort(R) is the first Diurnal product candidate to complete a
registration study, a major milestone towards building a
proprietary endocrinology franchise
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical
company targeting patient needs in chronic endocrine (hormonal)
diseases, announces, ahead of schedule, positive headline data from
the pivotal study for Infacort(R) in Europe for paediatric Adrenal
Insufficiency (AI).
AI is characterised by deficiency in cortisol, an essential
hormone in regulating metabolism and the response to stress. It is
identified as a rare disease in Europe where there are estimated to
be approximately 4,000 sufferers younger than the age of six.
Untreated, the disease is associated with significant morbidity.
Currently there are no licensed hydrocortisone (the synthetic
version of cortisol) preparations in Europe specifically designed
to treat these young patients. Infacort(R) is on target to be the
first pharmaceutically defined dose and consistent formulation of
hydrocortisone designed specifically for children.
The Phase III trial was designed in agreement with the European
Medicines Agency (EMA) and conducted in a total of 24 subjects
before their sixth birthday, requiring replacement therapy for AI
due to Congenital Adrenal Hyperplasia (CAH), primary adrenal
failure or hypopituitarism.
Initial analysis of the results confirms that the study met its
primary endpoint, demonstrating a statistically significant
(p<0.0001) increase in cortisol values following administration
of Infacort(R) compared to the pre-dose values. No serious adverse
events were reported. A full evaluation of the data is underway and
the results of this comprehensive analysis are expected later this
quarter.
The EMA has already approved a Paediatric Investigation Plan
(PIP) for Infacort(R) , setting out the regulatory pathway to
market authorisation via the Paediatric Use Marketing Authorisation
(PUMA) route. Diurnal is on track to submit this regulatory dossier
to the EMA around the end of 2016. If approved, Infacort(R) has the
potential to be the first licensed treatment in Europe for AI
(including CAH) specifically designed for use in children. Diurnal
anticipates market authorisation in late 2017.
Martin Whitaker, CEO of Diurnal, commented:
"We are pleased to announce the completion of treatment in this
pivotal study and look forward to the announcement of the full
clinical data package shortly. The initial results of this pivotal
study are very exciting as Infacort(R) has the potential to address
a significant unmet need for children with Adrenal Insufficiency
who are not being treated satisfactorily. This marks a significant
developmental milestone for Diurnal as we move towards building a
proprietary endocrinology franchise based on Infacort(R) and our
second product, Chronocort(R) , which is in Phase III trials in
Europe for adult CAH. With Infacort(R) now ready for regulatory
filing later this year and anticipated market authorisation in late
2017, we have taken a major step towards realisation of our
vision."
Following US Food and Drug Administration (FDA) feedback,
Diurnal will be commencing the US registration programme for
Infacort(R) in 2016.
Infacort(R) is Diurnal's most clinically advanced product and is
the first preparation of hydrocortisone specifically designed for
use in children suffering from AI. The patented, immediate-release
oral product has been designed to meet the dosing needs of children
for whom no child-appropriate licensed products exist in Europe or
in the US. Infacort(R) is manufactured using commercially proven
technology in paediatric acceptable doses in order to give maximum
flexibility to clinicians in tailoring treatment to children as
they develop and grow. Currently, pharmacists often compound
(grind) hydrocortisone tablets to a fine powder and reconstitute it
in individual capsules or sachets to achieve the lower doses
required for children. Compounding can be highly variable and may
result in inaccurate dosing to patients.
It is Diurnal's ambition to develop an adrenal product franchise
that can treat patients with all forms of cortisol deficiency,
including AI and CAH, with the Company's second product,
Chronocort(R) , currently in Phase III clinical development in
Europe for adults with CAH. The Chronocort(R) trial is scheduled to
complete by Q1 2018. This implies a potential market authorisation
in Europe could be forthcoming around year end 2018.
Overview of Infacort(R) pivotal trial design
The pivotal phase III trial was an open-label study of
Infacort(R) in neonates and children up to <6 years of age with
adrenal insufficiency carried out at Charité-Universitätsmedizin,
Berlin Germany and consisted of three cohorts that were carried out
in series:
-- Cohort 1: 12 patients with adrenal insufficiency aged 2 - 6 years of age
-- Cohort 2: 6 patients with adrenal insufficiency aged 1 month to 2 years of age (infants)
-- Cohort 3: 6 patients with adrenal insufficiency aged 0 to 1 month of age (neonates)
The primary objective of the study was to measure peak and
four-hour cortisol levels after administration of a single dose of
Infacort(R) . The secondary objective was safety.
For more information, please contact:
IP Group plc www.ipgroupplc.com
Alan Aubrey, Chief Executive
Officer +44 (0) 20 7444 0050
Greg Smith, Chief Financial
Officer +44 (0) 20 7444 0062/+44
Liz Vaughan-Adams, Communications (0) 7979 853802
Charlotte Street Partners
Andrew Wilson +44 (0) 7810 636995
Notes for editors
About IP Group
IP Group is a leading intellectual property commercialisation
company which focuses on evolving great ideas, mainly from its
partner universities, into world-changing businesses. The Group has
pioneered a unique approach to developing these ideas and the
resulting businesses by providing access to business building
expertise, capital (through its 100%-owned FCA-authorised
subsidiary IP Capital), networks, recruitment and business support.
IP Group has a strong track record of success and its portfolio
comprises holdings in approximately 100 early-stage to mature
businesses across four main sectors -- Biotech, Cleantech,
Healthcare and Technology. The Company is listed on the Main Market
of the London Stock Exchange under the code IPO.
For more information, please visit our website at
www.ipgroupplc.com.
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 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. The European Medicines Agency
has already approved a Paediatric Investigation Plan
(EMEA-001283-PIP01-12) for Infacort(R) , which sets out the
regulatory pathway to market authorisation via the Paediatric Use
Marketing Authorisation (PUMA) route.
About Diurnal Group plc
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.
Please further information, please visit www.diurnal.co.uk
ENDS
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRAGLGDRDBBBGLB
(END) Dow Jones Newswires
July 11, 2016 02:13 ET (06:13 GMT)
Ip (LSE:IPO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ip (LSE:IPO)
Historical Stock Chart
From Apr 2023 to Apr 2024
