Prana Biotechnology Limited, a development stage company, develops therapeutic drugs designed to treat the underlying causes of degeneration of the brain as the aging process progresses, focusing on Alzheimer’s disease, Huntington’s disease and Parkinson’s disease and other movement disorders. Other potential applications for the company’s therapies include certain cancers, age-related macular degeneration, Motor Neuron disease, Creutzfeldt-Jakob disease (the human variant of Mad Cow disease) and various orphan neurodegenerative disorders. The company’s platform technology addresses the causes of a spectrum of neurodegenerative and age-related diseases based on the interrelationship of metals and proteins. PBT2, the company’s Alzheimer’s and Huntington disease primary metal protein attenuating compounds (MPACs) product candidate, and PBT434, its candidate primary compound for Parkinson’s disease and movement disorders, were selected from the MPAC library on the basis of rational drug design. The company’s discovery research has established Structure Function Relationships within chemical moieties that guide its chemists towards novel therapeutic MPAC based treatments for neurodegenerative disorders. The discovery phase also includes preliminary bioavailability and pharmacokinetic characterization of its MPACS. The second tier comprises ‘translational’ animal modeling programs to test and validate new candidate MPACs as potential development leads. The company’s primary MPAC in movement disorders, PBT434 has progressed through the Translational Research program and has demonstrated evidence of efficacy in various models of Atypical Parkinsonian disorders, including Multiple System Atrophy, Corticobasal Degeneration, and Progressive Supranuclear Palsy. In April 2015, the company received Notice of Grant from the Israeli Patent Office for its key patent protecting PBT519. The patent, which is entitled, ‘Method of treatment and prophylaxis and agents useful for same’ covers the composition of matter of selected pyridopyrimidine compounds, including PBT519. The company has also Validated the European patent of this case in 16 major jurisdictions. In April 2015, the company received Notice of Grant from the Japanese and United States patent offices in relation to the patent family entitled ‘Quinazolinone compounds’, which covers selected novel chemical drug candidates related to PBT434 and their uses for neurological conditions, particularly Parkinson’s disease. In March 2015, the company filed two Australian provisional patent applications directed to novel methods of synthesising compounds, including the candidate PBT434 and compounds of similar structure. These patents are titled ‘A method of the production of 2-substituted-3H-quinazolin-4-ones-I’ and ‘A method of the production of 2-substituted-3H-quinazolin-4-ones-II‘. Regulatory Considerations The company’s ongoing research and development activities are, and the production and marketing of its pharmaceutical product candidates derived from those activities would be, subject to regulation by human research ethics committees and institutional research boards, as well as various governmental authorities in Australia, principally the Therapeutics Goods Administration, the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency in Europe. Manufacturing The company’s primary compound, PBT2, is manufactured by Dr. Reddy’s Laboratories Limited. History Prana Biotechnology Limited was founded in 1997. The company was incorporated under the laws of the Commonwealth of Australia in 1997.
prana biotechnology ltd-adr
369 Royal Parade
Parkville, VIC 3052
Phone: 61 3 9349 4906
Fax: 61 3 9348 0377www.pranabio.com
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