Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

ALGORAE PHARMACEUTICALS LIMITED AGM Information 2011

Nov 27, 2011

64249_rns_2011-11-27_4481d6d8-caa0-4421-8f26-0cbd05aa5be9.pdf

AGM Information

Open in viewer

Opens in your device viewer

==> picture [121 x 70] intentionally omitted <==

Chairman’s address AGM 28 November 2011

Let’s move on to the Chairman’s address, and it is my pleasure to report to you at my first AGM as your chairman.

As you will be aware there have been some key developments for LCT over the past year and I am pleased to have this opportunity to talk to you about what we have achieved – including a significant company changing opportunity which was announced recently.

Last month we were pleased to announce that LCT entered into a joint venture agreement with Otsuka Pharmaceutical Factory, Inc. to commercialise our DIABECELL® product. This is a relationship that your Board believes is crucial to the development of DIABECELL®, as well as LCT’s development of our other products, NTCELL and IMMUPEL™.

Otsuka Pharmaceutical Factory has invested $A25m cash while LCT has transferred its DIABECELL assets for $A25m into a new joint venture company, Diatranz Otsuka Limited, which is owned 50/50 by both Otsuka Pharmaceutical and LCT. The joint venture offers two key advantages for LCT: Firstly, it ensures that we have sufficient funding to take DIABECELL® forward through to registration over the next 3 years, and secondly, it ensures that once we are ready to go to market we have the global presence to take full advantage of commercial opportunities.

Otsuka Pharmaceutical is a major Japanese pharmaceutical company, with a significant presence in over 20 countries. We are fortunate to have them as a partner and are encouraged by their optimism over what can be done with DIABECELL® – both in terms of therapeutic value and commercial value.

Bringing a new experimental treatment to market is a time consuming and expensive process. Due to the continued market turmoil – both on local stock markets and throughout the global economy - it has become increasingly difficult for small companies like LCT to generate sufficient funding to see product development programs through to completion.

It was therefore desirable to find a partner who shared our vision, was willing to commit significant financing and resources, and one with a global distribution network that can fully maximize DIABECELL®’s opportunities. It is therefore a perfect partner.

We are pleased to report that the development of DIABECELL® has progressed over the past year. We have started Phase II trials in Argentina – with that country becoming our third jurisdiction to be trialling our product. The body of evidence to support the safety and efficacy of DIABECELL® for the treatment of Type 1 diabetes

is growing - with the completion of implants in the New Zealand trial adding to the results from the pilot Russian study.

The new company, Diatranz Otsuka Limited, has sufficient funding to carry out, over the next 3 years, the planned dose finding clinical trials, further refinement of DIABECELL®, conduct pivotal trials and obtain product registration.

Through Diatranz Otsuka Limited, both Otsuka Pharmaceutical and LCT remain firmly focused on delivering new therapeutic options for suffers of Type 1 Diabetes.

By ensuring that DIABECELL® has sufficient resources, LCT is enabled to focus attention on further development of some of our other assets – such as NTCELL and IMMUPEL™. To some extent the development of these products has been limited by the focus on ensuring funding for DIABECELL.

As you are aware our technology has applications beyond diabetes and we are excited by the opportunity to further expand this area of the Company. LCT can now focus on its plans and funding options to further develop these initiatives. In particular, as I said in our recent newsletter we are excited about our new product NTCELL, which is showing high pre-clinical promise for the treatment of Parkinson’s disease. Animal studies have been promising and the next step will be for LCT to apply for a small clinical trial of NTCELL with Parkinson’s patients.

With the changing market conditions, and changes to the structure of LCT, we have also had some changes to the management of the Company.

During the year Ross MacDonald resigned CEO. Fortunately, LCT founder Professor Bob Elliott was able to step into the position as acting CEO. Now that LCT’s future is clearer and more focussed, we have redefined the role of the CEO and the need to advance NTCELL and IMMUPEL™, we are now in the process of filling this position.

We were fortunate to have attracted two new directors to your Board, Dr Bernie Tuch and Robert Willcocks. Dr Tuch, currently with the CSIRO, brings his extensive experience in cell transplantation and Robert Willcocks will support us through his extensive corporate leadership experience.

The Board recognises that it has been a challenging period for investors in the Company. However, we believe the changes we have recently made put us in a much more stable position from which to develop our technologies.

We are developing unique technologies, we are a technical leader in cell implantation and importantly we offer the potential for DIABECELL® and NTCELL to provide paradigm-changing treatments for some of the world’s most common chronic diseases.

On behalf of the Board of Directors I would like to thank Prof. Elliott for his ongoing leadership of our Company during this challenging year.

I also would also like to thank our dedicated staff and collaborators, and you our investors, who continue to believe in our ultimate goal of providing improved treatments for diseases which continue to have a devastating impact on the lives of millions of people around the world.

We will now move to today’s formal business proceeding with the voting on resolutions.

– Ends –

For further information: www.lctglobal.com

At the company:Living Cell Technologies LimitedRoy Austin, ChairmanTel:+64 9 9134605Mobile: +64 21 656400[email protected] Bob Elliott, Medical DirectorTel: +64 9 2762690Mobile: +64 272924177[email protected] Media and analyst enquiries:Symbol Strategic CommunicationsPatrick Sinclair/Robert LuttrellTel: +61 2 8079 2969Mobile: +61 403 708 431[email protected]Robert Luttrell +61 419 185 652[email protected]

About Living Cell Technologies - www.lctglobal.com

Living Cell Technologies (LCT) is developing cell-based products to treat life threatening human diseases. The Company holds 50% of Diatranz Otsuka Limited which owns a biocertified pig herd that it uses as a source of cells for treating diabetes and neurological disorders. For patients with Type 1 diabetes, microencapsulated islet cells are implanted so that near-normal blood glucose levels may be achieved without the need for administration of insulin or at significantly reduced levels. The Company entered clinical trials for its diabetes product in 2007. For the treatment of Parkinson’s disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells that deliver beneficial proteins and neurotrophic factors to the brain. LCT’s technology enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressive drugs to prevent rejection. LCT also offers encapsulation services and medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.

About Otsuka Pharmaceutical Factory - www.otsukakj.jp/en/

Otsuka Pharmaceutical Factory, Inc., the first company in the group companies of Otsuka Holdings Co., Ltd. (TSE:4578), was established by Busaburo Otsuka in 1921. Originally, the company manufactured and distributed industrial and pharmaceutical chemicals. It began manufacturing intravenous solutions such as large volume parenterals in 1946. Since that time, Otsuka Pharmaceutical Factory has extended its operations into a wide variety of areas such as the development of new drugs, innovative packaging, and intravenous delivery systems. It has over 2000 employees and is headquartered in Naruto City, Tokushima, Japan.

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 forwardlooking statements contained in this document as a result of new information, future events or developments or otherwise.