Prana Biotechnology Limited operates as a development stage company that engages in the research and development of therapeutic drugs designed to treat the underlying cause of degeneration of the brain focusing on Alzheimer’s disease, Huntington disease, Parkinson’s disease and other neurological 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. PBT2, the company's Alzheimer’s and Huntington disease metal protein attenuating compounds (MPAC) product candidate, and PBT434, its candidate primary compound for Parkinsonian movement disorders, were selected from the MPAC library on the basis of rational drug design. Both compounds have been built ‘from the ground up’ to fulfill specific criteria, such as oral bioavailability and ability to cross the blood-brain barrier, and have demonstrated effectiveness in pre-clinical in vitro and in vivo testing. As of June 30, 2016, the company's primary MPAC in Parkinsonian movement disorders, PBT434, which had previously progressed through extensive modelling in Parkinson’s disease, 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. Patent Portfolio A total of six national phase patent case families protect the company's core MPAC technology. The first case is directed to the 8-hydroxyquinoline chemical class, which covers PBT2 and other 8-hydroxyquinoline compounds. The other five cases are directed to various ‘Follow Up’ or MPAC chemical classes, which comprise MPAC scaffolds that are an alternative to the 8-hydroxyquinoline chemical scaffold. In October 2015, the company achieved Allowance of patent claims in the USA covering the use of PBT2 for the treatment of Huntington’s disease. These claims provide a second level of protection, in addition to the successfully Granted composition of matter claims to PBT2 in a related application. In August 2015, the company filed a second Continuation Application in the USA, with claims seeking coverage of the use of 8-hydroxyquinoline compounds, other than PBT2 for the treatment of Huntington disease. This case is in active prosecution with the U.S. Patent and Trademark Office (USPTO). In September 2015, the company received Notice of Grant from the United States patent office in relation to the patent family entitled ‘Quinazolinone compounds’, which covers selected novel chemical drug candidates related to PBT434. In August 2015, the company filed a Continuation Application, with claims directed to the use of Quinazolinone compounds for the treatment of neurological diseases. This case is also in prosecution with the USPTO. In December 2015, the company filed a PCT application directed to 4H-Pyrido (1,2-a) Pyrimidin-4-one compounds, which are primary MPAC compounds for the treatment of neurodegenerative diseases. In March 2016, the company re-filed two Australian provisional patent applications directed to novel methods of synthesizing 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’. The company has a license under the agreement with GHC for the patent ‘Neurotoxic Oligomers’. Manufacturing The company’s primary compound in Huntington and Alzheimer’s disease, PBT2, has been manufactured by Dr. Reddy’s Laboratories Limited. 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. 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 (PBN:Stuttgart)
369 Royal Parade
Parkville, VIC 3052
Phone: 61 3 9349 4906
Fax: 61 3 9348 0377www.pranabio.com
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