Clinuvel Pharmaceuticals Ltd
Overview
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 our unique expertise in understanding the interaction of light and human skin, we have 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), is in Phase II and III trials in the US and Europe, and is expected to be filed before the end of 2011 for review by the European Medicines Agency. Presently, there is no known effective treatment for EPP and SCENESSE® has been granted orphan drug status. Based in Melbourne, Australia, Clinuvel has operations in Europe and in the US, with 30 employees worldwide.
Number of employees: 30
Main business focus/
Listing by sector:
- Drug Discovery & Development
- Dermatology
- Oncology
- Haematology & Anaemia
- Drug Delivery
Competitive Advantages
Clinuvel's photoprotective drug, SCENESSE® (afamelanotide), is a 'first-in-class' preventative treatment for a range of light related skin disorders and as a repigmentation therapy for vitiligo. Clinuvel's lead indication for SCENESSE® is erythropoietic protoporphyria (EPP), a rare metabolic disorder causing absolute light intolerance.
There are no other companies in clinical trials in the area of melanogenisis (natural activation of melanin).
Clinuvel has licensed the exclusive worldwide rights to develop and commercialise SCENESSE® for melanogenisis.
Clinuvel has received an Orphan Drug Designation for SCENESSE® from the European Medicines Agency (EMA), Swissmedic and the US FDA for EPP.
In May 2010, the Italian medicines agency approved the prescription and reimbursement of SCENESSE® for patients diagnosed with EPP under Law 648/96. SCENESSE® is the first treatment to be recognised under this law prior to its formal approval anywhere in the world.
Clinuvel has completed Phase II and III trials of SCENESSE® and expects to file SCENESSE® with the European Medicines Agency for Marketing Authorisation Approval in early 2012.
Technology/IP
Clinuvel's drug, SCENESSE® (afamelanotide), is a peptide and an analogue of the naturally occurring hormone, alpha-MSH, with up to 1000 times greater potency.
Clinuvel has patents for compositions and methods of inducing melanogenisis across a range of indications.
Clinuvel has determined the optimal dosage and delivery vehicle (a controlled release formulation) for its proprietary photoprotective drug Scenesse.
For more information see http://www.scenesse.com
Partnering Opportunities
Clinuvel is pursuing partnering opportunities to expediate drug development and commercialisation programs.
Contact Details
| Contact person | Lachlan Hay |
|---|---|
| Job Title | Head of Global Network & Communications |
| Address | Level 14, 190 Queen St |
| City/Suburb | Melbourne |
| State | Victoria |
| investorrelations@clinuvel.com | |
| Phone | +61 3 9660 4900 |
| Fax | +61 3 9660 4999 |
| Website | http://www.clinuvel.com |
