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March 2008
 
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Welcome to the twenty-first edition of Spruson & Ferguson's Biotech E-news – a bi-monthly breakdown of important IP issues in the Australian biotech industry including expert analysis and practical advice to advance your business.

It is our intention that this e-Newsletter will provide useful news and information for our clients and associates. Please feel free to send us your feedback, particularly suggestions for topics you would like to see addressed in future issues to BiotechEnews@sprusons.com.au

NEWS IN BRIEF
Spruson & Ferguson shortlisted for IP award

We are delighted to announce that the international magazine Managing Intellectual Property has shortlisted Spruson & Ferguson for their annual ‘Australian Firm of the Year’ awards. The shortlist was compiled based on research undertaken by the magazine over the past six months which included telephone interviews with peers and clients as well as emailed questionnaires.

In another recent survey published by Managing Intellectual Property, Spruson & Ferguson was placed in the first tier for patent and trade mark prosecution services in Australia.

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Motor Neuron disease: Linked to a poisonous protein

Researchers from the ANZAC Research Institute in Sydney have found a causative link to motor neuron diseases (MNDs), a group of progressive neurological disorders that destroy motor neurons, the cells that control essential voluntary muscle activity such as speaking, walking, breathing, and swallowing.

Lead by Professor Garth Nicholson, this research group discovered that patients with MND possess an abnormal protein. This discovery was made after assessing these patients over a 10 year period.

Professor Garth Nicholson says that "Many people have thought for many years that motor neuron disease might be a poison of some sort, in the environment". Now, the research group is indicating that this poison comes from the body itself (i.e. the abnormal protein), not the environment, and that this protein is destroying motor neurons. Professor Nicholson further states that "the proof of it is that we found patients who have this abnormality with the disease in families and people who didn't get the disease didn't have this abnormality”.

Professor Nicholson is of the view that this finding may assist in finding new treatments for MNDs.

Source: http://www.abc.net.au/news/stories/2008/02/29/2175859.htm and http://www.anzac.edu.au

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Australian-based company initiates US Clinical Trial for retinoic acid

Phosphagenics Limited (“Phosphagenics”), a Melbourne-based biotechnology company, has recently announced the commencement of a human clinical trial in the US for its lead dermatological product, retinoic acid, a form of vitamin A.

Phosphagenics’ R&D program mainly focuses on the discovery of new and cost effective ways to enhance the bioavailability, activity, safety and delivery of proven pharmaceutical and nutraceutical products. One way in which Phosphagenics does this (as indicated in the company’s name) is to add a phosphate group to the drug.

Retinoic acid is the most prescribed drug for the topical treatment of acne. However, retinoic acid is known to irritate and dry the skin, and in some cases, cause liver damage if a large amount of the drug enters the circulatory system. It has been reported by The American Dermatological Association Inc. that half of patients who prematurely terminate retinoic acid treatment do so because of irritation. As such, practitioners prefer to prescribe retinoic acid in small quantities to ameliorate the side effects.

Phosphagenics has found that the application of their proprietary drug delivery platform to retinoic acid increases dermal absorption and significantly reduces irritation scores. The US clinical trial with retinoic acid is a double blinded study that will involve 90 subjects and is expected to be completed by the end of the second quarter, 2008. They hope that this new formulation will provide practitioners with greater flexibility in prescribing the product by reducing the side effects and thus achieving improved efficacy.

Source: http://www.phosphagenics.com/main/Release_19-02-2008.htm

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Review of National Innovation System

The Minister for Innovation, Industry, Science and Research, the Honourable Senator Kim Carr, announced on 22 January 2008 a “wide ranging” review of Australia's national innovation system based on the Rudd Government's commitment to fostering innovation across the economy. This review will be conducted by an expert panel chaired by Dr Terry Cutler.

The panel review will also consider the Cooperative Research Centres (CRC) Program such as the overall strategic direction of CRCs with particular focus on governance and program design matters, the level and length of funding needed to support the program's objectives, as well as its overall scope and effectiveness. The panel is expected to issue a Green Paper by the end of July 2008 which will be followed by a White Paper response from the Government.

For more information on the National Innovation System Review go to: http://www.innovation.gov.au/innovationreview or http://www.ipaustralia.gov.au.

AusBiotech has indicated that it will make a submission to the review on behalf of its members and is planning high-level meetings over the next months in Victoria and NSW to ensure that members’ views are well represented in the organisation’s submissions. Please visit the official AusBiotech website for the most current developments (see http://www.ausbiotech.org/)

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Change of guard at the Australian Patent Office

IP Australia has recently announced the appointment of Mr Philip Noonan as its new Director General.

Mr Noonan replaces Dr Ian Heath who recently retired after eight years in that position. To learn more about Mr Noonan, please visit the official IP website shown below in which Mr Noonan posted a greeting on the website dated 31 January 2008.

Source: http://www.ipaustralia.gov.au/resources/news_new.shtml#5

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X marks the spot for autoimmune/anti-inflammatory treatment

CBio Limited, a Brisbane-based biopharmaceutical company, has announced the successful completion of Phase IIa clinical trials with XToll™ in Rheumatoid Arthritis, Psoriasis and Multiple Sclerosis. CBio believes that these trials confirm the high potential of XToll™ in treating various autoimmune and inflammatory diseases.

According to CBio, XToll™ is a heat shock protein that plays a key role in down regulating the innate immune response. XToll™ is CBio’s lead product in its R&D programme which capitalises on its proprietary innate immune modulation technology in the development of therapeutic drugs.

CBio is now commencing an expanded Phase IIa subcutaneous dosing Rheumatoid Arthritis trial with XToll™.

Source: http://www.cbio.com.au

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GETTING TO KNOW

Dr Dean J. Naylor

Head of Intellectual Property Development, CBio Ltd
Adjunct Senior Lecturer in the School of Pharmacy, University of Queensland

What is your particular area of expertise?

I have 16 years of experience in the field of molecular chaperones (or heat shock proteins), specifically the chaperonin 10 kDa (Cpn10) and chaperonin 60 kDa (Cpn60) proteins. As the name suggests, chaperones are best known and characterised for their roles in folding and assembly of numerous proteins. As a junior group leader at the Max Planck Institute for Biochemistry, Munich, my team investigated the mechanism by which molecular chaperones function in the context of a living organism. These efforts led to the exciting discoveries that enclosure of non-native protein in the unique Cpn10 and Cpn60 cage-like complex is essential for protein folding to proceed unimpaired by aggregation. Furthermore, confinement of unfolded protein in the chaperonin cage smoothes the energy landscape for folding of some proteins, effectively accelerating their attainment of the native state (Brinker et al., 2001 Cell). In addition, we identified and thoroughly characterised the in vivo substrate proteome (~300 proteins) of Cpn10 + Cpn60 (Naylor et al., 2005 Cell). This study was a major milestone in the field of chaperone research allowing for the first time the use of native substrates to help unravel the complex mechanisms by which molecular chaperones fold proteins.

Emerging data has implicated molecular chaperones in the regulation of the immune response. For the last 5 years I have worked at the biopharmaceutical company CBio Ltd. I am responsible for leading the research and development of immuno-modulatory drugs for clinical trial evaluation and the expansion/protection of the intellectual property portfolio. These efforts have led to the generation of several potential therapeutics, the most advanced being the human Cpn10 protein. We have established that Cpn10 is a natural regulator of the immune system which limits potentially hazardous inflammatory responses (Johnson et al., J.Biol.Chem. 2005). This observation suggests that Cpn10 may be useful as a therapeutic for diseases associated with inflammation (eg rheumatoid arthritis, psoriasis and multiple sclerosis). Indeed we have recently established that Cpn10 is safe and efficacious in rheumatoid arthritis patients (Vanags 2006, Lancet 368: 855-863).

What has been your career path to date?

I commenced a PhD in biochemistry at La Trobe Uni and completed my studies at Adelaide Uni in 1998. I undertook a brief post-doctoral stint in the same lab before moving to Munich, Germany in 1999. I was awarded an EMBO fellowship to work as a junior group leader at the Max Planck Institute for Biochemistry, Munich before I eventually returned to Australia in 2002. I am now a leader of Research & Development at CBio Ltd.

What have you been working on in the last three months?

IP protection of newly developed Cpn10-based therapeutics that potentially target specific inflammatory diseases and have significantly improved activity.

What do you find the most interesting aspect of your work?

There is a lot of satisfaction in taking a drug from the lab and establishing efficacy in the treatment of a human disease, especially within an Australian biotech company. I also enjoy the interaction with experts from all aspects of drug commercialisation, from academic discovery science, to IP protection, GMP drug production, preclinical toxicology and animal efficacy studies, human clinical trials and big pharma investors.

What practical advice would you give to innovators?

Ensure that you have adequate IP protection around your technology, and remember that the value of your technology is governed by the remaining patent protection lifetime once the technology reaches the market place, so get advice from the right people and be prepared to move quickly.

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FEEDBACK ASK US
We are interested in your feedback. Email biotechenews@sprusons.com.au to let us know if Biotech eNews is of interest or to give your suggestions for future issues. Please also let us know if you have a colleague who would like to be added to our circulation list.

We are here to be of service to you. If you have any questions about how to best protect your IP or if you wish to discuss the patentability of your ideas, we would be happy to arrange a meeting. Our principals and associates are also available to present seminars and information sessions to your staff. Please call Dr Martin O'Brien or Dr Andrew Blattman on (02) 9393 0100 or email martin.obrien@sprusons.com.au or andrew.blattman@sprusons.com.au

CONTACT US

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© Spruson & Ferguson 2008. This Newsletter is for the general information of our clients. Its contents are not a complete statement of the law on any subject. Professional advice should be sought before any course of action is pursued.

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