Clinuvel selects leading US manufacturing partner for SCENESSE®
(firmenpresse) - Clinuvel selects leading US manufacturing partner for SCENESSE®
- SurModics, Inc selected to manufacture SCENESSE® final commercial product at scale
8th July 2010 - Melbourne, Australia - Australia’s Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced it had entered a long term manufacturing agreement with SurModics, Inc. (Nasdaq: SRDX), a leading provider of proprietary drug delivery technologies to the healthcare industry, for the manufacture of the novel and patented injectable formulation, SCENESSE® (afamelanotide).
Under this exclusive arrangement, SurModics will commercially manufacture and supply Clinuvel with proprietary product SCENESSE® for an indefinite period. SCENESSE® will be manufactured by SurModics at its recently opened, FDA certified facilities in Birmingham, Alabama. During the past eight years, Clinuvel and SurModics have been fully committed to the development of this particular formulation resulting in SurModics being selected as its lead manufacturer.
SurModics is a provider of a broad range of technology solutions to the pharmaceutical and biotech industries worldwide with a key component of the business focused on manufacture. Central to their activities is the development of extended-release products that systemically or locally deliver active pharmaceutical ingredients for days to months. SurModics is a global provider of its expertise and proven supply of polymer technologies in life sciences.
SCENESSE®, Clinuvel’s proprietary first-in-class photoprotective drug, is currently in late stage clinical trials in Europe, Australia and USA. The innovative product is injected as a controlled-release subcutaneous formulation, a dissolvable implant the size of a grain of rice, delivering afamelanotide (16mg) that activates skin pigment, (eu)melanin, and provides photoprotection for up to 60 days. The drug has been safely administered to over 500 patients in global clinical trials. To date, SCENESSE® has been shown in Phase II and III clinical trials to safely provide skin protection in patients with severe UV and light related skin conditions.
Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said:
“We are very pleased to have finalised the first manufacturing arrangements for the SCENESSE® implant as part of our commercialisation strategy for the drug. Following a decade of refinement of the afamelanotide molecule and development of SCENESSE®, we now have signed with confidence our agreement with SurModics for the manufacture of our commercial product.
“Importantly, as part of our technological evolution we have arrived at a solution to deliver Clinuvel’s proprietary molecule in a controlled manner and at the necessary doses over a defined period of time for optimum biological response.”
SurModics Chief Scientific Officer, Dr Arthur J Tipton commented:
“Today’s announcement represents a natural progression of our relationship with Clinuvel. Together, our teams have solved numerous scientific and technical challenges over the years.
“Clinuvel’s product provides a novel way to treat serious skin disorders. We are excited about the commercial prospects and the opportunity to continue supporting Clinuvel in its clinical programs”
Clinuvel’s CEO, Dr Philippe Wolgen said:
“Today’s agreement between Clinuvel and SurModics is part of a logical sequence in our lengthy development. Of particular relevance is that this agreement follows Clinuvel’s right of first commercial supply of SCENESSE® in Italy, as made public last month.
“With SurModics as our elected manufacturing partner, we are confident in our ability to manage scale-ability associated with both ongoing trials and commercial supplies. For severely UV-affected patients worldwide, the signing of this partnership marks the beginning of providing a bespoke and innovative solution to serious disease.”
- 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 release 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. For more information see www.scenesse.com.
About SurModics
SurModics’ vision is to extend and improve the lives of patients through technology innovation. The Company partners with the world’s foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved diagnosis and treatment for patients. Core offerings include: drug delivery technologies (coatings, microparticles, nanoparticles, and implants). SurModics is headquartered in Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the Company, see www.surmodics.com.
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, Europe and the United States. 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 see www.clinuvel.com.
For more information contact:
Australia
Lachlan Hay
Head of Global Network and Communications
Clinuvel Pharmaceuticals Limited
T: +61 3 9660 4900
E: investorrelations(at)clinuvel.com
Europe
Daniela Schaefer
Head of Business Operations Europe
Clinuvel AG
T: +41 44 253 75 00
Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE (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 SCENESSE can or will be achieved;
•no assurances can be given by Clinuvel that, even if its development programme for SCENESSE 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
Australia
T +61 3 9660 4900
F +61 3 9660 4999
www.clinuvel.com
Leseranfragen:
CLINUVEL PHARMA
Clinuvel Pharmaceuticals Limited,
Level 11,
330 Collins Street,
Melbourne
VIC 3000
Australia
Tel: +61 3 9660 4900
Fax:+61 3 9660 4999
" alt="Mindoro Awarded Commendation by Philippines Government for Coastal Management ProgramDatum: 08.07.2010 - 10:19 Uhr
Sprache: Deutsch
News-ID 23624
Anzahl Zeichen: 0
contact information:
Town:
Wien
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 276 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Clinuvel selects leading US manufacturing partner for SCENESSE®
"
steht unter der journalistisch-redaktionellen Verantwortung von
CLINUVEL PHARMA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
