Living Cell Technologies Limited
ACN: 104 028 042
ASX: LCT
OTCQX: LVCLY
ASX ANNOUNCEMENT
26 June 2015 - Sydney, Australia & Auckland, New Zealand - Living Cell Technologies' 50% owned joint venture, Diatranz Otsuka Limited (DOL), is to concentrate its research and development activities on supporting the development of DIABECELL® in the United States. As a consequence, research, development and manufacturing of DIABECELL in New Zealand will cease and there will be a reduction of staff at DOL's headquarters in Auckland.
Otsuka Pharmaceutical Factory, Inc. (OPF), DOL's other 50% shareholder, is full sponsor and funder of the US program, operating under an exclusive licence from DOL for US development and commercialisation of DIABECELL. Since securing the licence, OPF has made positive progress, establishing a solid partnership framework for the US development.
DOL's know-how, research to date and clinical experience in pig islet transplantation will be actively combined with OPF's global drug development expertise and these partnerships to further strengthen and expedite the US development program.
This alignment of DOL's expertise with the US program is part of DOL's previously announced commitment to focus on the US development and FDA approval of DIABECELL. Once registered in the US, DOL retains a royalty free right to commercialise the FDA approved product in the rest of world.
LCT will continue research and manufacturing of NTCELL® from DOL's Auckland facilities using Auckland Island pigs. A Phase IIb study of the clinical efficacy of NTCELL in Parkinson's disease is planned to commence in late 2015.
- Ends -
For further information: www.lctglobal.com
| For DOL: Andrea Grant Chief Executive Tel: +64 9 276 2690 Mobile: +64 21 0785421 agrant@dolglobal.com |
For LCT: Ken Taylor Chief Executive Tel: +64 9 276 2690 Mobile: +64 21 796 000 ktaylor@lctglobal.com |
Media enquires: Rachael Joel Botica Butler Raudon Partners Tel: +64 9 303 3862 Mobile: +64 21 403 504 rachaelj@botica.co.nz |
About Living Cell Technologies
Living Cell Technologies Limited (LCT) is an Australasian biotechnology company improving the wellbeing of people with serious diseases worldwide by discovering, developing and commercializing regenerative treatments which restore function using naturally occurring cells.
LCT's lead product NTCELL® is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells. After transplantation NTCELL functions as a biological factory producing factors to promote new central nervous system growth and repair disease induced nerve degeneration.
The results of the Phase I/IIa clinical trial of NTCELL in New Zealand as an advanced therapy for the treatment of Parkinson's disease were presented at the International Congress of Movement Disorders and Parkinson's disease, San Diego, USA in June 2015.
NTCELL has the potential to be used in a number of other central nervous system indications such as Huntington's, Alzheimer's and motor neurone diseases.
LCT's proprietary encapsulation technology, IMMUPEL™, allows cell therapies to be used without the need for co-treatment with drugs that suppress the immune system.
LCT holds a 50% interest in Diatranz Otsuka Limited which is developing a cell therapy for type 1 diabetes.
LCT is listed on the Australian (ASX: LCT) and US (OTCQX: LVCLY) stock exchanges. The company is incorporated in Australia, with its operations based in New Zealand.
For more information visit www.lctglobal.com or follow @lctglobal on Twitter
LCT disclaimer
This document contains certain forward-looking statements, relating to LCT's business, which can be identified by the use of forward-looking terminology such as "promising," "plans," "anticipated," "will," "project," "believe," "forecast," "expected," "estimated," "targeting," "aiming," "set to," "potential", "seeking to," "goal," "could provide," "intends," "is being developed," "could be," "on track," or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other health authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. LCT is providing this information and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
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