Allon Granted Key Japanese Patent for Davunetide
VANCOUVER, B.C. — February 10, 2011 — Allon Therapeutics Inc. (TSX: NPC) announced today that an important Japanese patent has been issued covering the composition of matter of the company’s lead product davunetide and other peptides in its neuroprotection drug platform.
Davunetide is now being evaluated in a pivotal Phase 2/3 clinical trial as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease which is often misdiagnosed as Parkinson’s or Alzheimer’s disease.
Alistair Stewart, Allon’s Vice President of Commercial Research, said the Japanese patent expands the commercial market potential of davunetide beyond North America and Europe.
“Japan is the third largest pharmaceutical market and this patent means that we now have consistent core protection for davunetide in all the three major markets of the world for several brain degenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and PSP,” Stewart said.
“This is important because davunetide’s clinical development has reached the stage where its commercialization is on the horizon and the patent portfolio becomes critical to our efforts in attracting pharma companies that might become our commercialization partners abroad.”
The patent granted by the Japan Patent Office covers the polypeptide and nucleotide composition of matter for davunetide, its parent protein ADNP and other derivatives of ADNP.
Allon also reported that it has been granted a patent in the United States covering the treatment of fetal alcohol syndrome developed as a result of in-utero exposure to alcohol with davunetide or derivatives and combinations of all other compounds in the company’s neuroprotection drug platform.
Allon is enrolling patients in a pivotal Phase 2/3 clinical trial evaluating davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal movement disorder with dementia which is often misdiagnosed as Parkinson’s or Alzheimer’s disease. Allon has agreement with the FDA on a Special Protocol Assessment allowing data from the trial to be used for drug registration and approval. Davunetide for the treatment of PSP has been granted Orphan Drug and Fast Track Status in the U.S. Similarly, Allon has Orphan Status for davunetide in the EU for the treatment of PSP.
Davunetide is a fragment of a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon’s human clinical and pre-clinical data suggest that davunetide works on microtubules, structures in the brain critical to communication between cells, and central to the tau pathway. In human trials, davunetide has shown statistically significant impacts on memory, activities of daily living, and a biomarker of brain cell function and integrity. Allon has extensive intellectual property protecting davunetide.
About Allon’s neuroprotective platforms
Allon’s two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF).
Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer’s disease, cognitive impairment associated with schizophrenia, and progressive supranuclear palsy (PSP). AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on developing the first drugs that impact the progression of neurodegenerative diseases. Allon’s lead drug davunetide, is proceeding in a Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under an SPA with the FDA. This pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data. The Company is listed on the Toronto Stock Exchange under the trading symbol “NPC” (Neuro Protection Company™) and based in Vancouver. For additional information please visit the Company’s website: www.allontherapeutics.com.
Forward Looking Statements
Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as “believes”, “may”, “plans”, “will”, “estimate”, “continue”, “anticipates”, “intends”, “expects”, and similar expressions. While forward-looking statements represent management’s outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon’s early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon’s dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon’s public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements.