zu ihren Produkten und deren Vermarktung...
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C3 has committed resources to the commercialisation of CellSpray®, CellSpray XP® and ReCell® and as a result has separately incorporated two Research & Development companies for its future product pipeline ? EpiGrow Pty Ltd (for the treatment of chronic wounds) and Sterifast Pty Ltd (end point sterility testing service).
C3 does not plan to make significant direct expenditures on Research & Development. The funding for EpiGrow® and SteriFast® will be driven by a combination of government grants, external funding and joint venture alliances with other companies.
C3 recently signed two key supplier contracts to drive the internalisation and commercialisation of C3?s products.
US Company Ventrex Inc was contracted to manufacture autologous skin cell harvesting device, ReCell®, which will be the first medical device of its kind globally and is targeted at the fast growing plastic and cosmetic surgery markets. C3 is committed to having a market presence in Europe for ReCell® by 2004 and is currently in discussions with potential distributors.
The second contract involved a manufacturing agreement with a subsidiary of US company, Cambrex Corporation (NYSE: CBM) for the manufacture of CellSpray® and CellSpray® XP for the European market. C3 is focused on establishing a market presence in Europe for CellSpray® by the first quarter of 2004 and have already submitted product regulatory dossier to the Belgium authorities.
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European production facility for CellSpray® Regulatory process initiated for Europe
10 September, 2003 - PERTH, AUSTRALIA and EAST RUTHERFORD, NJ, USA:
Clinical Cell Culture Ltd (ASX: CCE), also known as C3 and Cambrex Bio Science Verviers Sprl, a subsidiary of Cambrex Corporation (NYSE: CBM) today announced that they have entered into a contract manufacturing agreement for the manufacture of CellSpray® and CellSpray® XP (CellSpray® products) for the European market.
CellSpray® products are cultured autologous (patient?s own cells) skin suspension for the treatment of major burns. The parties have also jointly submitted the regulatory dossier to the Belgium Ministry of Health for the cGMP production of CellSpray® products in the Cambrex facility in Verviers, Belgium.
These are the first two important steps towards the launch of CellSpray® products in the European market. Troels Jordansen, C3 Chief Executive Officer said; ?After several months of searching for the most appropriate partner, we are pleased to have teamed up with Cambrex. Cambrex obtained cGMP approval from the Belgium authorities earlier this year for their newly constructed tissue-engineering laboratory in Verviers.This partnership will allow C3 to have cost and time effective contract manufacturing of CellSpray® products in Europe without having to invest in a European laboratory and wait for its construction and validation. Over the coming months both parties will focus their attention on the technology transfer, ensuring that patients will be treated with the same quality as Australian patients have been treated for several years. C3 has already placed one CellSpray® products trained cell biologist in Europe, close to the Cambrex laboratory to support the technology transfer process.?
?In order to obtain marketing approval, the Belgian authorities will first have to approve the manufacturing process to cGMP standards. Country specific submissions will then take place. While the exact timing of the approval process is dependent on regulatory agencies, we expect to be treating European patients during the first quarter of 2004. By then we will have sales and customer service resources trained and ready to support hospitals in Germany, Austria and Switzerland, with a population of approx. 100 million and thirty burn centres,? said Troels Jordansen said
David Smith, Cambrex Cell Therapy Strategic Business Unit Director commented, ?We are very pleased that C3 has selected Cambrex as the European contract manufacturer of their innovative CellSpray® products. Our state of the art facilities, logistics and regulatory expertise, along with a strong commitment to patient safety, will allow us to meet the clinical timeline for C3. Cambrex is well positioned to support worldwide manufacturing of C3?s commercial tissue-engineered products with facilities in Europe and United States.?
C3 will participate in several burn related congresses over the next 12 months and expects to train 20-30 surgeons in CellSpray® products in the same period.
About C3 and CellSpray® products Clinical Cell Culture is a publicly listed (ASX:CCE) biomedical company, which develops and distributes tissue-engineered cellular products for autologous skin replacement. The Company?s lead products and product candidates are CellSpray®? cultured epithelial autograft spray suspension for the treatment of major burns, ReCell®? autologous cell harvesting device for the treatment of small burns, pigment loss and scars and EpiGrow®, autologous epidermal derived fluid for the treatment of chronic wounds. C3?s products have been used on more than 1,600 patients to date.
CellSpray® is a cultured autologous (patient?s own cells) skin (epithelia) suspension that can be sprayed onto wound surfaces. Cell expansion takes between 5 to 7 days. Cultured Epithelia Autografts (CEA) has generated significant interest globally being the only source of the patient?s own skin in major burns. CellSpray® XP is a rapid version of CellSpray®, but without cell expansion. Cells can then be used for patient care already 48 hours after biopsy has been taken. An estimated 30,000 burn patient pro annum require skin grafts (source: Wedbush and C3 management). For more information, please visit our website at www.clinicalcellculture.com.
About Cambrex Cambrex (NYSE: CBM), located in East Rutherford, New Jersey, USA, is a global, diversified life sciences company dedicated to providing high quality products and services to accelerate drug discovery, development, and manufacturing processes for customers focused on health and the prevention of disease. The Company employs approximately 2,200 worldwide. For more information, please visit our website at www.cambrex.com.
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C3 signs up ReCell® Contract Manufacturers Strategic outlook for ReCell®
30th July 2003, PERTH, AUSTRALIA: Clinical Cell Culture Ltd (C3, ASX:CCE) today announced that Ventrex, Inc., CA, USA, has been contracted to manufacture C3?s ReCell®. This is the first of five important steps towards the global commercial launch of ReCell®.
ReCell® is an autologous skin cell harvesting device. It will be the first medical device of its kind globally and is targeted at the fast growing plastic and cosmetic surgery markets. Surgeons will be able to treat an area of skin equivalent to the size of one A-4 sheet within approx. 30 minutes of taking a biopsy from the patient.
C3 Chief Executive Officer, Mr Troels Jordansen, said the release of ReCell® would relieve C3 from relying solely on burns related treatment as its business base.
?With ReCell®, C3 will enter some of the fastest growing surgical specialities and will reduce C3?s exposure to the seasonal variations in the occurrence of burns. ReCell® represents a significantly larger market opportunity for C3 than the burn market?, Mr Jordansen said.
Indications for ReCell® include scar revision, small burns, vitiligo and other epithelial defects affecting small areas (up to 2% adult body surface area, 4% in children). Vitiligo, a pigment loss disorder, is an indication that reportedly affects 1-2% of the global population alone.
Ventrex has been contracted to carry out some of the manufacturing and the final assembly of the ReCell® kit. Ventrex has approvals to manufacture medical devices from all major regulatory bodies throughout the world. It has extensive experience in the manufacture of sterile devices under its own brand and on behalf of several other major medical device manufacturers. Ventrex was selected following a detailed evaluation of several medical device manufacturers in the USA, Europe and Australasia.
Mr Jordansen stated, ?This agreement is a very positive result of many months of focused and dedicated product development work by C3 personnel. ReCell® is a complicated device, containing electrical, biological and pharmaceutical components and has required input from more than 15 companies during its development. Now we will have one company coordinating the global production of the finished product, despite receiving parts from several contract manufactures, substantially simplifying our sourcing activities?.
Mr Jordansen said C3 had received design registration for ReCell® in Australia and has two patents pending in Europe and USA. This together with extensive product verification data, C3 proprietary information and substantial experience with cell biology and clinical applications makes the technology well protected.
In order to bring ReCell® to Australian and European plastic and cosmetic surgeons by 2004, C3 now needs to:
1. Complete the technology transfer to Ventrex and manufacture launch stocks of ReCell®.
2. Complete component validations and submit for regulatory approval with the Australian Therapeutic Goods Administration (TGA) and European CE mark authorities.
3. Set-up a distributor network to cover markets of interest.
4. Receive marketing authorisation for Australia from TGA and obtain CE mark for European markets.
Mr Jordansen said the company is committed to having a market presence in Europe by 2004 and is currently in discussions with potential distributors
?We are currently training European staff to service between 10 and 15 distributors who already visit plastic and cosmetic surgeons. This may also have benefits for CellSpray®, which is expected to be launched late 2003 in Europe.?
?During a recent three week visit to Europe I had the personal experience of speaking to several potential distributors and the level of interest was as solid and large as we had expected.?
Mr Jordansen said the US Food and Drug Administration (FDA) has informed C3 that ReCell® will be regulated as a device under the jurisdiction of The Centre for Biological Evaluation and Research (CBER). He said C3 expects to meet with the FDA in late 2003 to lock in the detailed requirements for obtaining marketing approvals in the USA.
About C3 Clinical Cell Culture is a publicly listed biomedical company, which develops and distributes tissue-engineered cellular products for autologous skin replacement. The Company?s lead products and product candidates are CellSpray®? cultured epithelial autograft spray suspension for the treatment of major burns, ReCell®? autologous cell harvesting kit for the treatment of small burns, pigment loss and scars and EpiGrow®, autologous epidermal derived fluid for the treatment of chronic wounds. C3?s products have been used on more than 1,600 patients to date.
Established in 1999, C3 was formed to commercialise products under licence from the McComb Foundation to advance the research undertaken by Fiona Wood and Marie Stoner into skin culture technologies. C3 is based in Perth, Western Australia and provides a worldwide service from its dedicated skin culture laboratory.
www.clinicalcellculture.com
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demnach gibt es noch keine Zulassung in Europa oder USA und keine Vermarktungsverträge... nur die Produktionskapazitäten sind gesichert...
was ist von der Aussage zu halten, dass die Opfer von Bali mit diesen Mitteln behandelt wurden... ist das glaubwürdig und war es auch erfolgreich?
mfg ipollit :-)
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