TIDMCLIN
Clinigen Group plc
21 July 2021
21 July 2021
Clinigen and ORPHELIA Pharma sign an exclusive agreement to
supply Kigabeq(R) (vigabatrin)
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical Products and Services company, and ORPHELIA Pharma,
a pharmaceutical company specialised in orphan and paediatric
medicines, announce that they have signed an exclusive agreement to
manage the supply and distribution of Kigabeq(R) into unlicensed
markets.
Kigabeq(R) was granted a European Paediatric Use Marketing
Authorization (PUMA) in September 2018 and is currently approved
for the treatment of infantile spasms (West Syndrome) and
pharmaco-resistant focal-onset seizures (partial seizures).
Under the terms of the agreement, Clinigen will provide access
to Kigabeq(R) 500 mg and 100 mg soluble tablets into markets where
Kigabeq(R) is not commercially available. Clinigen will manage all
elements of the supply including healthcare practitioner enquiry
management, regulatory oversight, logistics and access management.
The agreement currently covers all global territories except for
USA, China, EU, UK and Bangladesh.
Sam Herbert, Chief Operating Officer and Head of Products
Division, Clinigen, said: "We are pleased to be partnering with
ORPHELIA Pharma and to be supplying Kigabeq(R) through our product
lifecycle platform. This agreement will offer healthcare
professionals another option to treat difficult-to-manage types of
epilepsy. This is a great example of how Clinigen's lifecycle
platform can help patients gain access to medicines which are not
otherwise available."
Hugues Bienaymé, General Manager of ORPHELIA Pharma added :
" We are delighted to have entered into this collaboration with
Clinigen. With this agreement, our ambition to make Kigabeq(R)
available worldwide, will be fulfilled."
Healthcare professionals can obtain details about the products
by calling the Clinigen customer service team at +44 (0) 1932
824100, emailing MedicineAccess@clinigengroup.com or going online
at
www.clinigendirect.com .
Patients seeking medical information should contact their
physician.
- Ends -
Contact details
Clinigen Group plc +44 (0) 1283 495010
Sam Herbert investors@clinigengroup.com
Group Chief Operating Officer & Head of Products
Division
Consilium Strategic Communications
Mary-Jane Elliott / Matthew Cole / Jessica Tel: +44 (0) 20 3709
Hodgson 5700 Clinigen@consilium-comms.com
ORPHELIA Pharma Tel: +33 (0)1 42 77
Séverine MARTIN 08 18
orphelia@orphelia-pharma.eu
Notes to Editors
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global, specialist
pharmaceutical services and products platform focused on providing
ethical access to medicines. Its mission is to deliver the right
medicine to the right patient at the right time. The Group operates
from sites in North America, Europe, Africa and the Asia
Pacific.
Clinigen has more than 1,000 employees across five continents in
16 countries, with supply and distribution hubs and operational
centres of excellence in key long-term growth regions. The Group
works with 34 of the top 50 pharmaceutical companies; interacting
with over 5,000 hospitals across more than 115 countries.
For more information on Clinigen, please visit
http://www.clinigen.com
About ORPHELIA Pharma
ORPHELIA Pharma is a biopharmaceutical company based in Paris
and Lyon that develops and markets drugs for the treatment of
paediatric and orphan diseases. Its mission is to provide patients
with essential hospital products in the fields of epilepsy and
oncology, with formulations that are suited to the paediatric
population. ORPHELIA's first product, Kigabeq(R), which was
approved during the latter part of 2018 for the treatment of West
Syndrome in particular, has been launched in several European
countries. Its second product, Ivozall(R), obtained a European
marketing authorization at the end of 2019 for the treatment of
acute lymphoblastic leukaemia. ORPHELIA Pharma also conducts
research projects through academic and industrial partnerships.
For further information, please go to www.orphelia-pharma.eu
About Kigabeq(R)
Kigabeq is indicated in infants and children from 1 month to
less than 7 years of age for:
Treatment in monotherapy of infantile spasms (West's
syndrome).
Treatment in combination with other antiepileptic medicinal
products for patients with resistant partial epilepsy (focal onset
seizures) with or without secondary generalisation, that is where
all other appropriate medicinal product combinations have proved
inadequate or have not been tolerated.
https://www.ema.europa.eu/en/documents/product-information/kigabeq-epar-product-information_en.pdf
About infantile spasms
West syndrome, or infantile spasms, is an extremely serious
epileptic encephalopathy in infants that combines epileptic spasms,
psychomotor deterioration and a hypsarrhythmic type
electroencephalogram. It is a rare disease, with an estimated
incidence of 5 per 10,000 births. It can occur in an infant with
previously normal development or with a pre-existing delay; in all
cases, infantile spasms severely hamper the psychomotor
development. Pharmacological treatment should be started quickly to
allow the spasms to stop and to improve the prognosis.
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