TIDMCLIN
Clinigen Group plc
10 March 2017
10 March 2017
RNS Reach
First-in-class Fycompa(R) (perampanel) approved in South Africa
for partial-onset seizures
Partnership with Clinigen to provide perampanel in the
region
Eisai is pleased to announce that perampanel has been approved
in South Africa for the adjunctive treatment of partial-onset
seizures, with or without secondarily generalised seizures in
patients with epilepsy aged 12 years and older.(1) Perampanel is
the first anti-epileptic drug to be approved in South Africa in
recent years.
Perampanel is the only licensed anti-epileptic drug to
selectively and non-competitively target AMPA* receptors. These
receptors play a critical role in the onset and spread of
seizures.(2)
Epilepsy affects one in every 100 people in South Africa, which
amounts to an estimated half a million people living with the
condition in the country.(3) In addition, 20-40 per cent of people
with newly-diagnosed epilepsy can become refractory to currently
available treatments, which require further adjunctive
medication.(4)
Dr Dave Anderson, Specialist Adult Neurologist, Wits Donald
Gordon Medical Centre, said:
"Many epileptic patients have poorly controlled seizures despite
the plethora of treatments available. It is exciting to see the
approval of a new treatment such as perampanel in South Africa. It
will be a welcome addition to the clinician's arsenal of treatments
and patients could benefit from its unique mode of action."
The approval of perampanel is based on three pivotal Phase III
studies (304, 305 and 306)(5,6,7) and an open extension study
307,(8) which show consistent results in the efficacy and
tolerability of perampanel as an adjunctive therapy in patients
with partial-onset seizures, with or without secondary
generalisation. The most commonly reported adverse events were
dizziness, somnolence, fatigue, headache, falls, irritability and
ataxia.(8)
To ensure access of perampanel to patients with epilepsy in
South Africa, Eisai is collaborating with its regional partner
Clinigen.
Johann Willemse, Chief Commercial Officer, Rest of World,
Clinigen, said:
"Perampanel is the second product we are working on together
with Eisai in South Africa. We have forged a strong partnership,
based on Eisai's innovative products and our ability to leverage
our extensive distribution network in the region and local
expertise. Together, we can enable access to perampanel where it is
needed most."
Neil West, Vice President Global Neurology Business Group,
Eisai, said:
"Eisai is committed to the therapeutic area of neurology and to
addressing the unmet medical needs of people with neurological
conditions and their families. Ensuring patient access to new
treatments underlines Eisai's human health care mission, the
company's commitment to innovative solutions in disease prevention,
cure and care for the health and wellbeing of people
worldwide."
*AMPA =
alpha-amino-3-hydroxy-5-methyl-4-isoxazole-propionate
- Ends -
Contact details
Clinigen Group plc Tel: +44 (0) 1283
495010
Shaun Chilton, Chief Executive
Officer
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 Tel: +44 (0) 20 7653
Broker 4000
Marcus Jackson / Elliot Thomas
/ Jack Wood
Instinctif Partners (media Tel: +44 (0) 20 7457
- Clinigen) 2020
Melanie Toyne-Sewell / Alex
Shaw Email: clinigen@instinctif.com
Eisai Europe Ltd Tel: +44 (0) 7507
309 895
Helena Symeou Email: helena_symeou@eisai.net
Tonic Life Communications Tel: +44 (0) 7817
(media - Eisai) 227 954
Hannah Macgregor / Chrissie Tel: +44 (0) 7772
Hannah 534 646
Email: hannah.macgregor@toniclc.com
Email: chrissie.hannah@toniclc.com
Notes to Editors
About Fycompa(R) (perampanel)
Perampanel is a first-in-class, non-competitive AMPA
(alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)
glutamate receptor antagonist on post-synaptic neurons.(1) AMPA
receptors, widely present in almost all excitatory neurons,
transmit signals stimulated by the excitatory neurotransmitter
glutamate within the brain, and are believed to play a role in
central nervous system diseases characterised by excess
neuroexcitatory signaling, including epilepsy.(9) Since launch,
approximately 52,000 people living with epilepsy have been treated
with perampanel.(10)
About Epilepsy
Epilepsy is one of the most common neurological conditions in
the world, affecting an estimated 50 million people worldwide.(11)
Epilepsy is a chronic disorder of the brain that affects people of
all ages. It is characterised by abnormal discharges of neuronal
activity which causes seizures. Seizures can vary in nature and
severity, from brief lapses of attention or jerking of muscles, to
severe and prolonged convulsions. Depending on the seizure type,
seizures may be limited to one part of the body, or may involve the
whole body. Seizures can also vary in frequency from less than one
per year, to several per day. Epilepsy has many possible causes but
often the cause is unknown.
About Eisai EMEA in Epilepsy
Eisai is committed to developing and delivering highly
beneficial new treatments to help improve the lives of people with
epilepsy. The development of anti-epileptic drugs is a major
strategic area for Eisai in Europe, the Middle East, Africa, Russia
and Oceania (EMEA).
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 and is 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 programs
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 Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and
development-based pharmaceutical company headquartered in Japan. We
define our corporate mission as "giving first thought to patients
and their families and to increasing the benefits health care
provides," which we call our human health care (hhc) philosophy.
With over 10,000 employees working across our global network of
R&D facilities, manufacturing sites and marketing subsidiaries,
we strive to realise our hhc philosophy by delivering innovative
products in multiple therapeutic areas with high unmet medical
needs, including Oncology and Neurology.
1 Fycompa South Africa MCC Approved Package Insert, dated 17
February 2017
2 Rogawski MA. Revisiting AMPA receptors as an antiepileptic
drug target. Epilepsy Currents 2011;11:56-63
3 Epilepsy South Africa. Facts About Epilepsy. Available at:
http://epilepsy.org.za/new/uploads/files/Facts_about_Epilepsy_Brochure_A4.pdf
Last accessed March 2017
4 French JA. Refractory Epilepsy; Clinical Overview. Epilepsia
2007: 48 (Suppl1) 3-7
5 French JA et al. Adjunctive perampanel for refractory
partial-onset seizures: randomized phase III study 304.
Neurology 2012:79(6):589-596
6 French JA et al. Evaluation of adjunctive perampanel in
patients with refractory partial-onset seizures: Results of
randomized global phase III study 305. Epilepsia
2013:54(1):117-125
7 Krauss GM et al. Randomized phase III study 306: Adjunctive
perampanel for refractory partial-onset seizures.
Neurology 2012:78(18):1408-1415
8 Krauss GL et al. Long-term safety of perampanel and seizure
outcomes in refractory partial-onset seizures and
secondarily generalised seizures: Results from Phase III
extension study 307. Epilepsia 2014:55(7):1058-1068
9 Lee K et al. AMPA Receptors as Therapeutic Targets for
Neurological Disorders. Adv Protein Chem Struct Biol.
2016;103:203-261
10 Eisai. Data on File 2016. DOF PER112
11 Epilepsy in the WHO European Region: Fostering Epilepsy Care
in Europe. Available at:
http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf
Last accessed March 2017
This information is provided by RNS
The company news service from the London Stock Exchange
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