IP Group PLC Diurnal positive advice from EMA for Chronocort
April 11 2019 - 2:12AM
RNS Non-Regulatory
TIDMIPO
IP Group PLC
11 April 2019
FOR RELEASE ON 11 April 2019
IP Group plc - Portfolio company Diurnal announces positive
scientific advice from European Medicines Agency for
Chronocort(R)
IP Group plc (LSE: IPO) ("IP Group" or "the Group"), the
developer of intellectual property-based businesses, notes the
announcement by its portfolio company Diurnal Group plc ("Diurnal")
that, following a positive meeting with the European Medicines
Agency (EMA) in March 2019, it has received formal Scientific
Advice from the EMA confirming the current clinical and regulatory
path for Chronocort(R) as a treatment for adults with congenital
adrenal hyperplasia (CAH).
Consequently, Diurnal intends to submit a Marketing
Authorisation Application (MAA) for Chronocort(R) (modified release
hydrocortisone) in Q4 2019 based upon the existing clinical data,
including data to support Orphan Drug Status in the treatment of
CAH. This positive outcome follows the submission of a regulatory
package requesting Scientific Advice to the EMA for Chronocort(R)
based on detailed analysis of data from its Phase 3 study, the
largest ever clinical trial programme in CAH, and the open-label
safety extension study.
IP Group currently holds a direct undiluted beneficial stake of
43.3% in Diurnal, a specialty pharmaceutical company targeting
patient needs in chronic endocrine (hormonal) diseases.
Dr Sam Williams, IP Group Managing Partner, Life Sciences, said:
"This positive development means that the EMA has not requested a
further clinical study of Chronocort, despite the recent Phase 3
not meeting its primary endpoint, and is consistent with Diurnal's
intention to file its marketing application this year based on the
existing data. This supports IP Group's view that the chances of
approval of Chronocort in Europe are very good and, moreover, that
there remains the potential for Orphan status, which would give
Chronocort significant advantages over existing treatments for
CAH."
CAH is an orphan condition caused by a block in cortisol
production, an essential adrenal steroid hormone required for
healthy life. A lack of cortisol in turn causes the over-production
of male steroid hormones (androgens). 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. Sufferers, even if
treated, remain at risk of death through an adrenal crisis. The
condition is estimated to affect a total of approximately 47,000
patients in Europe, with over 400,000 in the rest of the world.
For more information, please contact:
IP Group plc www.ipgroupplc.com
+44 (0) 20 7444 0050
Alan Aubrey, Chief Executive Officer
Greg Smith, Chief Financial Officer +44 (0) 20 7444 0062/+44 (0)
Liz Vaughan-Adams, Communications 7979 853802
Charlotte Street Partners
Andrew Wilson +44 (0) 7810 636995
David Gaffney +44 (0) 7854 609998
Tom Gillingham +44 (0) 7741 659021
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
subsidiaries IP Capital and Parkwalk Advisors), networks,
recruitment and business support. IP Group has a strong track
record of success and its portfolio comprises holdings in
early-stage to mature businesses across life sciences and
technology. IP Group is listed on the Main Market of the London
Stock Exchange under the code IPO.
Group holdings in portfolio companies reflect the undiluted
beneficial equity interest excluding debt, unless otherwise
explicitly stated.
For more information, please visit our website at
www.ipgroupplc.com.
ENDS
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END
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