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18.05.2010
Clinuvel Pharmaceuticals Ltd.: Clinuvel unveils SCENESSE® following European brand approval
Clinuvel Pharmaceuticals Ltd.: Clinuvel unveils SCENESSE® following European brand approval
EMA assignment of SCENESSE® trade name for afamelanotide
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the European Medicines Agency (EMA) Name Review Group (NRG) and the Agency’s Committee for Human Medicinal Products (CHMP) has approved the company’s proposed trade name – SCENESSE® (pronounced “sen-esse”) – for its proprietary first-in-class medicinal photoprotective drug.
SCENESSE, a registered trademark, is owned by Clinuvel and will be used throughout the centralised drug approval process with the EMA, covering all 27 member states, Switzerland, Norway and Iceland. From today onwards, Clinuvel will adopt SCENESSE in all references to the drug in its further global clinical development.
The announcement comes a day after SCENESSE was included by the Italian Medicines Agency (AIFA) on the list of drugs eligible for reimbursement by the Italian National Health System (Sistema Sanitario Nazionale, SSN), specifically for the treatment of erythropoietic protoporphyria (EPP), a rare intolerance to UV and light.
SCENESSE – a linear analogue of alpha-MSH – provides photoprotection to the skin of patients most at risk of UV and light damage. The drug elicits a physiological pigmentary response without exposing the skin to UV, whereby increased levels of skin pigmentation appear a few days after administration of SCENESSE, lasting up to 60 days. SCENESSE also assists the skin in maintaining a biological balance between rate of rejection of old, and regeneration of new, skin cells. In various UV and light related skin diseases regulation of programmed cell death (apoptosis) and cell survival (senescence) plays an important role.
“We searched long for a novel and relevant, yet appealing name which would best express the drug’s unique mechanism of action,” Clinuvel’s CEO, Dr Philippe Wolgen, said. “Analyses of the global pharmaceutical market in skin care showed an opportunity to establish a brand which would reflect the drug’s differential properties.”
SCENESSE is a first-in-class therapeutic being developed exclusively by Clinuvel. Administered subcutaneously as a controlled-release injectable, SCENESSE is being clinically trialled for use in erythropoietic protoporphyria (EPP), skin cancer in organ transplant recipients (OTR) and polymorphic light eruption (PMLE or PLE). To date the drug has been shown to safely and effectively reduce and prevent the onset of symptoms in specific light related skin disorders. Over 600 individuals have been included in the trials globally. No significant safety concerns have been identified with SCENESSE to date.
Pending confirmation of safety and efficacy in on-going clinical trials, Clinuvel plans to file a marketing authorisation application for SCENESSE in the European Union in 2010, followed by filings in Switzerland, Australia and the US.
“Association and identification with the drug is essential to patients globally who suffer from UV and light related disorders and who have not had access to an effective therapy. In SCENESSE we have captured the pharmacology which plays a role in skin protection.” Dr Wolgen said.
- 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, SCENESSE is a linear peptide which activates the skin to activate eumelanin, the dark pigment which is known to have photoprotective properties (providing 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.
Scenesse® is a registered trademark of Clinuvel Pharmaceuticals Ltd.
About Clinuvel Pharmaceuticals Limited
Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified five groups of patients with a clinical need for photoprotection. Currently, Clinuvel is in its final stages to complete testing of SCENESSE in Phase II and III trials in Australia and Europe. Clinuvel’s ongoing focus is to demonstrate the safety and efficacy of SCENESSE. Pending positive clinical results, Clinuvel aims to file SCENESSE for its first market approval for the orphan indication porphyria (EPP).
Clinuvel is currently testing SCENESSE in five clinical indications:
http://www.irw-press.com/dokumente/Clinuvel_170510_EN.pdf
Phase I and II human clinical trials using SCENESSE have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date.
Following successful conclusion of the development program, Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE.
For more information contact:
Australia
Lachlan Hay
Head of Global Network and Communications Clinuvel Pharmaceuticals Limited
T: +61 3 9660 4900
E: investorrelations@clinuvel.com
Europe
Daniela Schaefer
Head of Business Operations Europe
Clinuvel Pharmaceuticals Limited
T: +41 44 253 75 00
Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, afamelanotide for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:
• actual results may and often will differ materially from these forward-looking statements;
• no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for afamelanotide can or will be achieved;
• no assurances can be given by Clinuvel that, even if its development programme for afamelanotide is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place
Level 11 / 330 Collins Street
Melbourne, Victoria 3000
Australien
T +61 3 9660 4900
F +61 3 9660 4999
www.clinuvel.com
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EMA assignment of SCENESSE® trade name for afamelanotide
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the European Medicines Agency (EMA) Name Review Group (NRG) and the Agency’s Committee for Human Medicinal Products (CHMP) has approved the company’s proposed trade name – SCENESSE® (pronounced “sen-esse”) – for its proprietary first-in-class medicinal photoprotective drug.
SCENESSE, a registered trademark, is owned by Clinuvel and will be used throughout the centralised drug approval process with the EMA, covering all 27 member states, Switzerland, Norway and Iceland. From today onwards, Clinuvel will adopt SCENESSE in all references to the drug in its further global clinical development.
The announcement comes a day after SCENESSE was included by the Italian Medicines Agency (AIFA) on the list of drugs eligible for reimbursement by the Italian National Health System (Sistema Sanitario Nazionale, SSN), specifically for the treatment of erythropoietic protoporphyria (EPP), a rare intolerance to UV and light.
SCENESSE – a linear analogue of alpha-MSH – provides photoprotection to the skin of patients most at risk of UV and light damage. The drug elicits a physiological pigmentary response without exposing the skin to UV, whereby increased levels of skin pigmentation appear a few days after administration of SCENESSE, lasting up to 60 days. SCENESSE also assists the skin in maintaining a biological balance between rate of rejection of old, and regeneration of new, skin cells. In various UV and light related skin diseases regulation of programmed cell death (apoptosis) and cell survival (senescence) plays an important role.
“We searched long for a novel and relevant, yet appealing name which would best express the drug’s unique mechanism of action,” Clinuvel’s CEO, Dr Philippe Wolgen, said. “Analyses of the global pharmaceutical market in skin care showed an opportunity to establish a brand which would reflect the drug’s differential properties.”
SCENESSE is a first-in-class therapeutic being developed exclusively by Clinuvel. Administered subcutaneously as a controlled-release injectable, SCENESSE is being clinically trialled for use in erythropoietic protoporphyria (EPP), skin cancer in organ transplant recipients (OTR) and polymorphic light eruption (PMLE or PLE). To date the drug has been shown to safely and effectively reduce and prevent the onset of symptoms in specific light related skin disorders. Over 600 individuals have been included in the trials globally. No significant safety concerns have been identified with SCENESSE to date.
Pending confirmation of safety and efficacy in on-going clinical trials, Clinuvel plans to file a marketing authorisation application for SCENESSE in the European Union in 2010, followed by filings in Switzerland, Australia and the US.
“Association and identification with the drug is essential to patients globally who suffer from UV and light related disorders and who have not had access to an effective therapy. In SCENESSE we have captured the pharmacology which plays a role in skin protection.” Dr Wolgen said.
- 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, SCENESSE is a linear peptide which activates the skin to activate eumelanin, the dark pigment which is known to have photoprotective properties (providing 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.
Scenesse® is a registered trademark of Clinuvel Pharmaceuticals Ltd.
About Clinuvel Pharmaceuticals Limited
Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified five groups of patients with a clinical need for photoprotection. Currently, Clinuvel is in its final stages to complete testing of SCENESSE in Phase II and III trials in Australia and Europe. Clinuvel’s ongoing focus is to demonstrate the safety and efficacy of SCENESSE. Pending positive clinical results, Clinuvel aims to file SCENESSE for its first market approval for the orphan indication porphyria (EPP).
Clinuvel is currently testing SCENESSE in five clinical indications:
http://www.irw-press.com/dokumente/Clinuvel_170510_EN.pdf
Phase I and II human clinical trials using SCENESSE have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date.
Following successful conclusion of the development program, Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE.
For more information contact:
Australia
Lachlan Hay
Head of Global Network and Communications Clinuvel Pharmaceuticals Limited
T: +61 3 9660 4900
E: investorrelations@clinuvel.com
Europe
Daniela Schaefer
Head of Business Operations Europe
Clinuvel Pharmaceuticals Limited
T: +41 44 253 75 00
Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, afamelanotide for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:
• actual results may and often will differ materially from these forward-looking statements;
• no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for afamelanotide can or will be achieved;
• no assurances can be given by Clinuvel that, even if its development programme for afamelanotide is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place
Level 11 / 330 Collins Street
Melbourne, Victoria 3000
Australien
T +61 3 9660 4900
F +61 3 9660 4999
www.clinuvel.com
NEWSLETTER REGISTRIERUNG:
Aktuelle Pressemeldungen dieses Unternehmens direkt in Ihr Postfach:
<a href="http://www.irw-press.com/alert_subscription.php?lang=en&isin=AU000000CUV3">http://www.irw-press.com/alert_subscription.php?lang=en&isin=AU000000CUV3</a>
Mitteilung übermittelt durch IRW-Press.com. Für den Inhalt ist der Aussender
verantwortlich.
Kostenloser Abdruck mit Quellenangabe erlaubt.