Clinuvel Files European Marketing Authorisation Application for SCENESSE® (afamelanotide)
February 06 2012 - 2:47AM
Business Wire
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX:
UR9; ADR: CLVLY) today announced that it has submitted a
marketing authorisation application (MAA) for its first-in-class
drug SCENESSE® (afamelanotide 16mg implant) to the European
Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a
prophylactic treatment in adult patients with erythropoietic
protoporphyria (EPP), a rare disease which causes absolute
intolerance of patients’ skin to light.
SCENESSE®, which received an orphan drug designation for
EPP in 2008, will be reviewed under the EMA’s Centralised
Procedure. An approval under this scheme will allow Clinuvel to
market SCENESSE® in all 27 European Union member states as well as
Norway, Iceland and Liechtenstein.
“We are confident that we have provided sufficient data to
demonstrate that SCENESSE® is a safe and clinically meaningful
treatment for EPP,” Clinuvel’s Chief Scientific Officer, Dr Hank
Agersborg said. “We firmly believe that our application will
withstand the rigor of the regulatory review.”
“This filing is an important milestone in the evolution of
Clinuvel, and is another landmark among the innovative therapies
developed by the biotech sector, as afamelanotide is the first ever
melanocortin filed for marketing approval,” Clinuvel’s CEO, Dr
Philippe Wolgen said. “In the coming months we will continue our
constructive dialogue with the regulatory authorities in order to
bring this much-needed therapy to the EPP community across
Europe.”
Erythropoietic protoporphyria (EPP)
EPP is a rare genetic disease found mainly in fair-skinned
people. It is characterised by severe phototoxicity (intolerance to
light) of the skin resulting in intolerable pain, swelling and
scarring, usually of exposed areas such as the face, hands and
feet. Symptoms can vary from mild to extreme lasting pain requiring
hospitalisation. Patients often lead an indoors and sheltered life,
avoiding light and UV exposure to prevent symptoms. Presently there
is no known effective treatment for EPP, which affects
approximately 10,000 people globally, an estimated 4,000 in
Europe.
During the Phase II and III studies in Europe, the US and
Australia, SCENESSE® has been shown to enable EPP patients to
expose themselves to (sun)light without incurring characteristic
burns (phototoxicity). Pivotal trials (CUV029 and CUV030) showed
SCENESSE® could reduce the severity of EPP symptoms and enable
patients to lead more normal lives. A marked improvement in Quality
of Life was also reported. Thus far no serious safety concerns have
been identified from the use of afamelanotide in more than 650
patients involved in trials, including more than 250 EPP patients.
SCENESSE® is being proposed as the first effective treatment to
prevent phototoxicity in EPP.
Afamelanotide 16mg controlled-release formulation
(SCENESSE®)
Afamelanotide, the active ingredient in SCENESSE®, is a
linear peptide which activates eumelanin, the dark pigment, in
skin. Eumelanin protects skin from light and UV radiation
(photoprotection). SCENESSE® is administered underneath the skin as
a dissolvable implant, approximately the size of a grain of rice,
which activates eumelanin for a period of two months.
– End –
About SCENESSE® (afamelanotide)
SCENESSE® is a first-in-class therapeutic being developed
by Clinuvel, with the generic name (or INN) afamelanotide. An
analogue of α-MSH, afamelanotide is a linear peptide which
activates eumelanin of the skin, the dark pigment which is known to
provide photoprotective properties (offering skin protection
against light and UV radiation). SCENESSE® is administered
underneath the skin as a dissolvable implant approximately the size
of a grain of rice. For more information on SCENESSE® go to
http://www.clinuvel.com/en/scenesse.
SCENESSE® is a registered trademark of Clinuvel
Pharmaceuticals Ltd.
About Clinuvel Pharmaceuticals Limited
Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9;
ADR: CLVLY) is a global biopharmaceutical company focused on
developing drugs for the treatment of a range of severe skin
disorders. With its unique expertise in understanding the
interaction of light and human skin, the company has identified
three groups of patients with a clinical need for photoprotection
and another group with a need for repigmentation. These patient
groups range in size from 10,000 to 45 million. Clinuvel’s lead
compound, SCENESSE® (afamelanotide), a first-in-class drug
targeting erythropoietic protoporphyria (EPP), has completed Phase
II and III trials in the US and Europe, and has been filed for
review by the European Medicines Agency. Based in Melbourne,
Australia, Clinuvel has operations in Europe and the US. For
further information please visit
www.clinuvel.com
For more information on EPP go to
http://www.clinuvel.com/en/erythropoietic-protoporphyria/
Please see Clinuvel's website for more information on forward
looking statements.
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