CellSeed and Orphan Australia Announce Licensing Agreement for the Regenerated Oral Mucosal Epithelial Cell-sheet for Limbal Stem Cell Deficiency of Cornea epithelium.

 

Tokyo, Japan, November 8, 2008 - CellSeed Inc., a privately owned regenerative medicine company based in Tokyo, Japan and Orphan Australia Pty Ltd., an Australian specialty pharmaceutical company, have signed a licensing agreement where CellSeed grants the exclusive right to Orphan Australia for manufacturing and marketing of the regenerated oral mucosal epithelial cell-sheet for transplant of defective cornea epithelium for the territories of Australia, New Zealand, Indonesia, Malaysia and Singapore. Under the agreement, CellSeed will transfer the technology to produce the cell-sheet to Orphan Australia, who will be responsible for registration, production and marketing of the product in the agreed territories.

 

This epithelial cell-sheet is currently under development for the treatment of Limbal Stem Cell Deficiency (LSCD, which results in persistent epithelial breakdown, superficial corneal vascularization, chronic discomfort and impaired vision caused by the migration of conjunctival epithelial cells and blood vessels onto the corneal surface. LSCD may be caused by various pathologies such as chemical burns, Stevens-Johnson syndrome, Saltzman syndrome, ocular cicatricial pemphigoid or aniridia.

 

This product is made from the patient’s own epithelial stem cells taken from their oral mucosa located in the back of the cheek and expanded using a unique regenerative medicine technique developed by CellSeed and its collaborator, the Tokyo Women’s Medical University called “Cell-sheet engineering” and thus avoids the problems of donor shortage, graft-versus-host disease and transplant rejection. This Cell-sheet engineering technique avoids the use of proteolytic enzymes typical of other techniques that damage the epithelial cell-sheet and thus avoids the need of sutures for engraftment.

 

The surgical technique is very simple and easy to perform and the average time required for surgery is less than 1 hour.

 

The regenerated oral mucosal epithelial cell-sheet is currently under clinical development in the EU. The product is expected to become commercially available for patients suffering from limbal stem cell deficiency (LSCD) of cornea from year 2011.

 

 

This product has the potential to offer a new bright future for the LSCD patient as there is no currently approved drug to cure the disease. The product is expected to reduce the inflammation and pain, and improve the visual acuity of the patient.

 

“We are pleased to enter into this partnership with Orphan Australia Pty Ltd., who shares the same vision to provide novel therapies for underserved patients. Orphan Australia is an expert in providing novel and highly specialized products to patients suffering from certain incurable disease in Australia, and no better partnership can be expected. CellSeed and Orphan Australia are committed to continue to collaborate intimately to deliver this novel therapy as quickly as possible to the patients in Australia, New Zealand, Indonesia, Malaysia and Singapore” said Dr. Yukio Hasegawa, CEO and the president of CellSeed.

 

“We enthusiastically embrace our new relationship with CellSeed and look forward to the successful completion of the clinical trial development. We look forward to making available to ophthalmologists a novel therapeutic for the treatment of an extremely debilitating condition and one from which patients are likely to benefit immensely” commented John Michailidis General Manager of Orphan Australia Pty Ltd.

 

Enquiries:

CellSeed Inc.

Masato Ishiwata, Business Development Manager  Tel: +81(3)5286 6231

 

Orphan Australia Pty Ltd.

Gennaro D’Alessandro, Manager, Business Development Tel. +61 3 9769 5744

 

 

Notes to Editors

 

About CellSeed Inc.

CellSeed Inc. is a Japan-based biotechnology innovator committed to development and commercialisation of highly differentiated tissue-engineered products for patients that are not sufficiently served by current medical technologies.

 

CellSeed owns novel cell-sheet engineering technology developed by Professor Teruo Okano at Tokyo Women's Medical University. The core technology is based on grafting any kind of synthetic polymers to organic materials covalently at nano-thickness level. When CellSeed's temperature-responsive polymers are grafted to the cell culture surface, the recovery of intact cells retaining important cell surface proteins becomes possible through temperature control. This process avoids the use of potentially damaging enzymatic treatment such as the use of trypsin when detaching cells from the cell culture surface. Cells cultured in this way can be collected in a form of contiguous cell-sheet rather than as isolated cells. This tissue requires no suture when grafted to patients and the cell-sheets can be piled together to create 3-dimensional tissue.

 

CellSeed's lead regenerative medicine product is autologous regenerated human oral mucosa epithelium cell-sheet, targeting corneal epithelial disorders of bilateral total stem-cell deficiency with severe loss of vision (<1/10).

 

Cellseed is also applying its core technology beyond tissue-regeneration. The Company is distributing its novel cell cultureware products, such as UpCell, RepCell and HydroCell, for the worldwide research market. The Company also launched its Aqua Way series, a novel HPLC column which separates small molecules, peptides and proteins using a temperature-controlled method.

 

Further information on CellSeed can be found at http://www.cellseed.com/index-e.html.

 

About Orphan Australia Pty Ltd.

Orphan Australia is a specialty pharmaceutical company and is a member of the Sigma Pharmaceuticals Group, and is based in Melbourne, providing hospital specialist products to Australia and New Zealand. Orphan Australia specializes in bringing to market novel compounds and therapies that treat serious or life-threatening diseases where treatment choices are limited or inadequate.

 

Further information on Orphan Australia can be found at http://www.orphan.com.au/.

 

 

 

This press release includes forward-looking statement regarding Orphan Australia and CellSeed’s distribution agreement and the regenerated living cell culture product for cornea disease. Any statement describing our goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as CellSeed’s clinical goals. 

Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing technology, in commercializing products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such products. Actual results could differ materially from those discussed in this press release. As a result, you are cautioned not to rely on these forward-looking statements.