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Life Therapeutics

Life Therapeutics acquires commercial rights to manufacture rAnti-D from BPL

Life Therapeutics today announced it has signed a Licensing Agreement with leading UK-based blood fractionator Bio Products Laboratory (“BPL”) to acquire the global rights (excluding the UK) to develop and commercialise a therapeutic recombinant Anti-D antibody (rAnti-D) product.

The Agreement completes the MOU signed on 29 June this year as part of the Company’s 200 day plan.

Life Therapeutics Managing Director and CEO Dr Hari Nair said the Agreement was a critical step in the evolution of the company into a manufacturer of niche therapeutic products, as outlined in the original 200 day plan.

“Not only is rAnti-D Life Therapeutics’ first therapeutic product, but it is anticipated that it will be manufactured using our proprietary Gradiflow® technology, thereby fast tracking the validation of the technology,” said Dr Nair.

Under the Agreement, Life Therapeutics will license from BPL the patents, master cell banks and other intellectual property necessary for the development of rAnti-D as a recombinant replacement product for human plasma-derived Rh Immune Globulin (RHIG).

The Agreement also provides for Life Therapeutics to exclusively develop, test, and manufacture rAnti-D for the world market. Life Therapeutics expects to begin Phase II clinical trials in the US in 2005/2006.

Life Therapeutics CFO Mr John Manusu said that one of the reasons the company acquired the Life Sera business earlier this year was to enable Life Therapeutics to conduct US clinical trials of therapeutic products like rAnti D.

“Owning the Life Sera business will significantly reduce the cost of undertaking clinical trials,” said Mr Manusu.

BPL spokesman, Richard A’Court, PhD said that he is looking forward to working with Life Therapeutics on the commercial development of its prime recombinant product.

“With its novel, vertically integratable technology and its focus on commercialisation, I believe Life Therapeutics is the right partner to take rAnti-D to the rest of the world,” said Dr A’Court.

The background science to BPL’s rAnti-D was initiated by a team of scientists from Cambridge, Babraham and IBGRL, Bristol. BPL continued this development and completed successful clinical trials. The product is a recombinant antibody cocktail alternative to the human plasma derived RHIG that is distributed worldwide today. rAnti-D is more efficient to manufacturer and offers patients better protection from emerging infectious diseases than the human plasma-derived version, of which BPL is currently the UK’s largest manufacturer and supplier.

rAnti-D can be sold into the fast-growing recombinant product market, which is perceived as being safer and more efficient than traditional plasma-derived products.

The worldwide market for Anti-D products is estimated at US$200 million per year, with the United States accounting for US$100 million, Europe for US$65 million, and the rest of the world for US$35 million.

“Currently no recombinant product is available for use in this market. It is anticipated that, subject to US FDA approval, the Life Therapeutics recombinant product will achieve market share based on viral safety profile alone,” said Mr Manusu

“This exclusive Agreement with BPL gives both companies a very strong position in the Anti-D market globally. It also complements the plasma-derived Anti-D business of Life Sera,” Dr Nair said.

This Agreement was signed at the conclusion of the exclusive negotiation period with BPL that was previously announced on 29 June this year.

For more information, please contact:

Dr Hari Nair David Lumb or Andrew Sedger
Chief Executive Officer Porter Novelli
Life Therapeutics Ph: +61 2 9463 7600
Ph: +61 2 8977 9000

Editors note:

Anti-D, or human anti-D immunoglobulin, is given to women with a blood type known as rhesus or Rh negative and who are pregnant with a foetus that is Rh positive. Approximately 6% of pregnancies in the United States require Anti-D to prevent potentially fatal complications caused by blood group incompatibilities between mother and baby. It is also indicated to reduce platelet destruction in Rh-positive blood type patients suffering form Immune Thrombocytopenic Purpura (ITP), an autoimmune disease.

About Life Therapeutics

Life Therapeutics is the trading name of Gradipore Limited (ASX Code: GDP). Life Therapeutics is an Australian global biotechnology company which researches, develops, manufactures and markets haematological and separation technologies principally for the life science market throughout the world. For information on Life Therapeutics, visit the company’s corporate web site at Life Therapeutics

About BPL

BPL is a not-for-profit organisation, wholly owned by the British Government. Its research, development, manufacturing and marketing departments are all based at Elstree on the outskirts of London. BPL is committed to provide a continuous and competitive supply of high quality plasma-derived products, to a growing global market through investing in the latest research, technology and manufacturing methods. We will ensure on-going and responsive support to health professionals throughout the world. For information on BPL, visit the organisations web site at BPL

Thanks for the information re Anti-D alternative... I am having trouble finding out information about the alternative and where it is available.

has anyone else had any luck with this?

I contacted the TGA who said that the only anti-d shots on the medical register are the blood plasma types. I've sent an email to the distributor in the US, so I'll keep you posted, but if you know of anything else, I would really appreciate your help!

Many thanks

im in the same situation being rhesus negative and have had a lot of people in the medical industry here not understanding why i do not want anti-d and i am struggling to find information about a synthetic version.

Hi Lizzy

I hit dead ends wherever I went to find information relevant to Australian residents for an alternative. Basically, I was told nothing else was available and I would have to fly to New Zealand to receive an alternative shot!! And seeing as you need shots at 28, 34 weeks and one after the baby is born (if it is positive) then you would need to be seriously loaded to fly that many times!

My GP and the hospitals were no help with my searches. I ended up taking the anti-d drug which contains a fraction of plasma in it. I have had no side effects, but still, would be nice if we didnt need to have any fraction of blood AT ALL and have a synthetic version available.

Let me know if you find any more info!
Jane

Jane, did you try contacting Life Therapeutics since they are an Australian company?

yep! Rang few times and finally talked to an office person who was 'answering their phones for them' and said I had to email her my query. She then forwarded my query to an American part of the company and never heard back from them.. emailed a second time and rang and then gave up! After I spoke with the medical authority in Australia though, I gave up trying to find an alternative coz they said that none had been approved for being used here. Hope you can find an alternative, you'd think they would have something by now - anti D has been around since the 70's!! please let us know if you do, although after my experience in hospital (I posted a reply on your other blog about being a JW) I dont think I will be able to have any more children. But would be good if I knew for other people. thanks

thank you for all that research, i also had the anti-d after my first child but i refused to have it throughout the pregnancy and also after my miscarriage, i will keep up the endeavor to find a synthetic version.

try contacting BPL, based in the UK

ask if it could be shipped

Jane 1980, please can you pm me the email address

thanks