Applied NeuroSolutions, Inc. (APNS) is a development stage biopharmaceutical company focused on diagnostics and therapeutics for the treatment of Alzheimer’s Disease (AD).
Applied NeuroSolutions’ has a long-term agreement with Albert Einstein College of Medicine (AECOM) that grants APNS the exclusive licensing rights to commercialize Dr. Peter Davies’ neurodegenerative disease related discoveries. The technologies are based on the presence of an abnormal form of a protein present in the brains and cerebrospinal fluid (CSF) of AD patients. A specific chemical change in this protein, known as tau, results in an abnormal protein called ptau-231 (tau protein phosphorylated on amino acid 231). The presence of the ptau-231 protein leads to the development of abnormal structures (paired helical filaments and neurofibrillary tangles – the hallmark of Alzheimer’s disease) that contribute to nerve cell death. The correlation between excess amounts of the ptau-231 protein and AD supports the development of diagnostic tests, in vitro drug discovery systems and therapeutics aimed at preventing the formation of this protein and the accompanying neuron-destroying structures. The Company’s technology originated from Dr. Peter Davies, the Judith and Burton P. Resnick Professor of Alzheimer’s Disease Research at the Albert Einstein College of Medicine, and APNS’ scientific founder.
AD Diagnostic Test
Increased amounts of the altered tau protein (ptau-231) in cerebrospinal fluid (CSF) distinguish AD patients from those with other forms of cognitive impairment, providing an early diagnostic test and a method for following disease progression. Applied NeuroSolutions has developed an antibody-based test measuring the protein in the CSF of AD patients and is working on a second-stage blood serum-based test that is expected to be easier to perform and less expensive.
Currently there are no approved diagnostic tests to detect AD and follow its progression. Confirmation of diagnosis is performed through a series of behavioral measurements and brain scans. Definitive diagnosis can be made only from examination of postmortem brain tissue samples. Applied NeuroSolutions’ test would provide a significant breakthrough in supporting definitive early diagnosis.
Alzheimer’s Drug Discovery Platforms
The Company is working on a therapeutic program developed by Dr. Peter Davies based on the common pathway leading to the development of abnormal, destructive brain structures characteristic of AD. This screen can be used to identify drugs that interfere with that pathway, thereby preventing disease development.
Mouse Model for AD
Dr. Davies and the Nathan Kline Institute (NKI) have developed a transgenic mouse model of AD that exhibits Alzheimer-like pathology including accumulation of the abnormal form of tau (p-tau 231) and extensive neuronal death. These mice can be used to test for candidate drugs. The Company and NKI intend to market these models and several drug development companies have expressed interest in them.
Agreements with Pfizer, Novartis
Several major pharmaceutical and biotechnology companies have utilized Applied NeuroSolutions tools and technology to enhance their efforts to develop more effective drugs for Alzheimer's. In January 2003, the Company announced a Research Agreement with Pfizer, Inc. In November 2003, the Company also announced a Research Agreement with Novartis Pharmaceuticals Corporation.
Basis of Research
All of the Company's products and research tools are based upon a distinctive view of the cause and progression of Alzheimer’s disease developed over the past 25 years by Dr. Peter Davies and his colleagues at the Albert Einstein College of Medicine, where Dr. Davies currently serves as the Burton P. and Judith Resnick Professor of Alzheimer's Disease Research.
Applied NeuroSolutions was created from a reverse merger of Molecular Geriatrics Corporation into the public company Hemoxymed, Inc. on September 10, 2002. The management team comes from Molecular Geriatrics and has worked together as a group since 1993. The Company changed its name to Applied NeuroSolutions in October 2003 to reflect its focus upon the diagnosis and treatment of AD. The Company’s stock currently trades on the Over-the-Counter Bulletin Board (OTCBB) under the symbol APNS.OB.
The company's address is 50 Lakeview Parkway, Suite 111, Vernon Hills, Illinois, 60061. The telephone number is 847-573-8000 and the fax number is
Corporate Presentation http://www.appliedneurosolutions.com/pdf/APNS_Presentation_11_29_07.pdf
The Company’s management team and board of directors include experienced scientists from both academic and pharmaceutical settings as well as senior executives with considerable experience in the development, management and commercialization of biotech and pharmaceutical products. Dr Peter Davies, the Company’s founding scientist is world renowned as an Alzheimer’s disease researcher. The Directors, executive officers, and certain key scientists and advisors of the Company are as follows:
Ellen R. Hoffing, was appointed Chairman of the Board of Directors in December 2007 and has been President, Chief Executive Officer and a Director since August 29, 2006. Since 2005, she has been a consultant to healthcare focused companies. In 2005, Ms. Hoffing was Vice President, Strategic Planning at American Pharmaceutical Partners, a publicly traded specialty pharmaceutical company focused on injectable oncology, anti-infective and critical care products. From 2002 to 2005, Ms. Hoffing was Vice President, Renal Pharmaceuticals at Baxter Healthcare, a New York Stock Exchange listed company. From 2001 to 2002, she was Vice President, Strategy and Acquisitions, at Merisant (the maker of Equal®) and from 2000 to 2001, Ms. Hoffing was a strategy and management consultant to healthcare focused companies. Prior to 2000, Ms. Hoffing took on roles of increasing responsibility in her 17 years at the Searle division of Monsanto, which culminated in her position as Vice President, Global Analytics.
Robert S. Vaters, has been a Director of the Company since October 2005. Mr. Vaters was Chairman of the Board of Directors from July 2006 until December 2007. Mr. Vaters is currently a General partner in Med Opportunity Partners, a New York based private equity firm. Previously, Mr. Vaters was Executive Vice President, Strategy and Corporate Development of Inamed Corporation from November 2004 to March 2006 after serving as Inamed's Chief Financial Officer from August 20, 2002 to November 2004. From September 2001 to August 2002, Mr. Vaters worked on a variety of private merchant banking transactions. He was Executive Vice President and Chief Operating Officer at Arbinet Holdings, Inc., a leading telecom capacity exchange from January 2001 to July 2001. He served as Chief Financial Officer at Arbinet from January 2000 to December 2000. Prior to that he was at Premiere Technologies from July 1996 through January 2000, where he held a number of senior management positions, including Executive Vice President and Chief Financial Officer, Managing Director of the Asia Pacific business based in Sydney, Australia and Chief Financial Officer of Xpedite Systems Inc., formerly an independent public company that was purchased by Premiere. Additional experience includes Senior Vice President, Treasurer of Young and Rubicam Inc., a global communications firm with operations in 64 countries. From 1995 to 1998, Mr. Vaters was also an independent board member and chairman of the audit committee of Rockford Industries, a public company providing healthcare equipment financing..
Jay B. Langner, has been a Director of the Company since July 2005. Since 1985, Mr. Langner has served as the Chairman of the Board of Trustees of Montefiore Medical Center. Located in The Bronx, NY, Montefiore Medical Center is the University Hospital for the Albert Einstein College of Medicine (AECOM) and one of the largest health care systems in the United States. From 1961 to 2003, he served as Chairman and CEO of the Hudson General Corporation, which was sold to Luftansa Airlines in 1999. Mr. Langner began his career in 1954, serving as president of Langner Leasing Corporation.
Alan L. Heller, has been a Director of the Company since September 2006. Since March 2006, Mr. Heller has been an Operating Partner at a private equity firm, Water Street Healthcare Partners. Mr. Heller currently serves on the Board of Directors of two public companies: Savient Pharmaceuticals, Inc. (NasdaqGM: SVNT) and Northfield Laboratories Inc. (NasdaqGM: NFLD). From November 2004 to November 2005, Mr. Heller was President and Chief Executive Officer of American Pharmaceutical Partners, Inc., a company that develops, manufactures and markets branded and generic injectable pharmaceutical products. From January 2004 to November 2004 Mr. Heller served as an investment advisor on life science transactions to One Equity Partners, a private equity arm of JP Morgan Chase. From 2000 to 2004, Mr. Heller also served as Senior Vice President and President Global Renal operations at Baxter Healthcare Corporation (NYSE:BAX). Prior to joining Baxter, Mr. Heller spent 23 years at G.D. Searle. He served in several senior level positions including Co-President and Chief Operating Officer, with responsibility for all commercial operations worldwide, and Executive Vice President and President, Searle Operations.
David C. Tiemeier, Ph.D., has been a director of the Company since October 2007. He is currently serving as Deputy Director of UChicagoTech, the University of Chicago’s Office of Technology and Intellectual Property. Previously, Dr. Tiemeier pursued postdoctoral studies in molecular genetics at the National Institutes of Health before joining the faculty of the University of California, Irvine, Medical School. He joined Monsanto Co. (NYSE:MON) as the head of Molecular Genetics, and continued his career in Monsanto’s pharmaceutical division as Senior Director of Immunoinflammatory and Infectious Diseases and took on roles of increasing responsibility including General Manager of the Global New Business Franchise and Vice President of Global Business Development. He subsequently held senior positions in Pharmacia Corporation and Pfizer Inc. (NYSE:PFE). Following his retirement from Pfizer, Dr. Tiemeier held senior management positions with NeoPharm, Inc. (Nasdaq:NEOL), Immtech Pharmaceuticals, Inc. (Amex:IMM) and Kalypsys, Inc.
Peter Davies, Ph.D., has been involved with the Company since 1992 as the founding scientist of the Company's core Alzheimer’s technology. Dr. Davies joined the faculty of the Department of Pathology at the Albert Einstein College of Medicine in 1977, three years after beginning his research on Alzheimer's disease. A decade later, he was named the college's Judith and Burton P. Resnick Professor of Alzheimer’s Disease Research. His research has guided APNS in their activities directed toward development of solutions for neurodegenerative diseases. Dr. Davies has co-authored well over 100 scientific papers in the field of Alzheimer’s research where he is a world-renowned leader. His contributions to AD research have been at the forefront of understanding the pathological mechanisms involved in the formation of neurofibrillary tangles; one of the two hallmark pathologies of AD. The relationship between activation of mitotic mechanisms, tangle formation and neuronal death is a major focus of his current work. Currently Dr. Davies is focusing his expertise and vast knowledge in the AD field towards developing new therapeutics to treat, and better diagnostics for early detection of Alzheimer’s disease.
David Ellison, CPA, has been Chief Financial Officer of the Company since May 1996 and Corporate Secretary since August 1999. He had been Chief Financial Officer of a long-term care facility specializing in Alzheimer’s care and prior to that he was a senior manager in a Chicago-area public accounting firm.
John F. DeBernardis, Ph.D., has been Chief Scientific Officer since September 2006 and was previously the President and Chief Executive Officer of the Company since August 1999. He joined the Company in August 1993, as Director of Chemistry and Pharmacology, was promoted to Vice President of Discovery, and Senior Vice President, Research and Development. He was Secretary of the Company from April 1995 to August 1999, and was appointed a director of the Company in November 1995. Prior to joining the Company, Dr. DeBernardis spent sixteen years at Abbott Laboratories, where he began his career as a research chemist and progressively earned several promotions, ending with his position as the Area Head of Cardiovascular Research within the Pharmaceutical Products Division supervising an 85 person staff. During his tenure, a number of IND candidates were identified. Dr. DeBernardis received his Ph.D. degree from the University of Pittsburgh in 1974 and worked two years as an NIH postdoctoral fellow in the Department of Chemistry at MIT. He is co-author on 70 scientific publications and holds 35 U.S. patents.
For Further Information, Contact:
|Ellen Hoffing, President and CEO ||Applied NeuroSolutions, Inc. |
|Email: ||firstname.lastname@example.org |
|Telephone: ||(847) 573-8000 |
|Fax: ||(847) 573-8030 |
|Mailing Address: ||50 Lakeview Pkwy, Suite 111 |
Vernon Hills, IL 60061
|David Ellison, CFO ||Applied NeuroSolutions, Inc. |
|Email: ||email@example.com |
|Telephone: ||(847) 573-8000 |
|Fax: ||(847) 573-8030 |
|Mailing Address: ||50 Lakeview Pkwy, Suite 111 |
Vernon Hills, IL 60061
Alzheimer’s disease (AD) is an intractable, chronic and progressively incapacitating disease characterized by the degeneration and death of several types of neurons in certain regions of the brain. Patients affected by the disease initially suffer loss of memory, then a decline of intellectual abilities severe enough to interfere with work and activities of daily living, followed by severe dementia and, finally, death. This illness, currently affecting an estimated 4.5 million people in the United States, and approximately ten million people worldwide, is a leading cause of death behind cardiovascular disease and cancer. While the disease is most common in the elderly, affecting nearly 10% of people age 65 and older and up to 50% of people age 85 and older, it has been diagnosed in patients in their 40’s and 50’s.*
Alzheimer’s disease was first described in 1907 by Dr. Alois Alzheimer, a German psychiatrist who discovered large numbers of unusual microscopic deposits in the brain of a demented patient upon autopsy. These deposits, called amyloid plaques and neurofibrillary tangles, are highly insoluble protein aggregates that form in the brains of AD patients in particular regions, including those involved with memory and cognition. Generally, amyloid plaque is deposited on the surface of neurons, whereas neurofibrillary tangles are formed within neurons. The plaques and tangles are associated with degeneration and loss of neurons. The actual loss of neurons, as well as the impaired function of surviving neurons, is generally believed to be the key neuropathological contributors to the memory loss and dementia that characterizes Alzheimer’s disease.
Applied NeuroSolutions’s core technology in the AD field is based on the work of its founding scientist Dr. Peter Davies and his colleagues at the Albert Einstein College of Medicine. Much of Dr. Davies’ AD research has been involved within an abnormal form of a protein called tau that normally serves to stabilize microtubules, the transit system in nerve cells that directs molecules to their destinations. Excessive phosphorylation of tau prevents it from stabilizing microtubules. This internal neuronal damage leads to the development of the paired helical filaments and neurofibrillary tangles, which are contributing factors to the eventual death of the neurons related to Alzheimer’s disease, and is one of the hallmark pathologies associated with AD. There is a high correlation among the presence of neurofibrillary tangles and cognitive decline in AD.
* Alzheimer’s Association, February 2006
Alzheimer’s disease, at present, can be conclusively diagnosed only by histological examination of the brain by biopsy or autopsy. The diagnosis of patients suspected of having AD is therefore typically made through a process of elimination, by conducting neurological and psychiatric examinations, extensive laboratory tests and a brain scan to rule out other conditions (such as stroke, brain tumor, or depression) with similar symptoms. The definitive AD predictive accuracy of such exams is generally in the range of 75-80%. Costs to patients for such testing currently runs anywhere from $1,000 - $4,000. A simple, predictive, accurate and cost effective diagnostic assay would therefore meet a tremendous medical need.
Applied NeuroSolutions has completed the development of a diagnostic assay utilizing cerebrospinal fluid (CSF). To date, the Company has completed numerous studies comprising in excess of 2,500 CSF samples utilizing this assay. These studies were designed to test the assay’s ability to differentiate patients diagnosed with AD from patients diagnosed with other forms of dementia and relevant neurological diseases, including major depression, as well as healthy controls. These studies have shown the ability of the assay to correctly identify the patients diagnosed with AD with an overall sensitivity and specificity in the 85% to 95% range. The studies have been published in peer reviewed scientific journals such as Neuroscience Letters, Archives of Neurology, Annals of Neurology, Archives of General Psychiatry, Journal of Internal Medicine, Neurobiology of Aging, Neurology, and American Journal of Psychiatry.
These data suggest that the phosphotau may represent an excellent biochemical marker for AD. It detects a characteristic feature of pathophysiology, may allow one to track disease progression and accurately discriminates between AD patients and neurological controls. Several pharmaceutical companies have utilized the Company’s CSF phosphotau assay as a biomarker in the clinical development of therapeutics to treat AD.
The Company’s long-range goal is to discover and develop novel therapeutics to treat AD. Work is being conducted utilizing an in-vitro screen Dr. Davies has developed that could lead to the discovery of a therapeutic to stop the progression of Alzheimer’s disease. The basis for this screen is the discovery of a common pathway that leads to the development of both the neurofibrillary tangles and amyloid plaques.
The market potential for a drug to effectively treat Alzheimer’s disease is extremely large. Currently there are only five drugs approved in the U.S. to treat AD. Four of these drugs are cholinesterase inhibitors and one is an NMDA receptor antagonist. These drugs have limited beneficial effects in treating symptoms associated with AD and are not able to arrest the progression of the disease.
Transgenic Mice Model
To date, no accepted animal model for AD has been developed. However, recently Dr. Peter Davies, through collaboration with a researcher at Nathan Klein Institute (“NKI”), has produced a transgenic mouse that develops neurofibrillary tangles, one of the two hallmark pathologies of Alzheimer’s disease. The pathology in these mice is Alzheimer-like, with hyperphosphorylated tau accumulating in cell bodies and dendrites leading to the production of neurofibrillary tangles. In addition, these transgenic mice have exhibited extensive neuronal death, which accompanies the tau pathology. These new transgenic mice could be used for testing the efficacy of therapeutic compounds. Several pharmaceutical and biotechnology companies have expressed interest in acquiring access to these transgenic mice for testing their therapeutics. The Company and NKI are currently marketing these mice to researchers.
|Shares Outstanding: ||130.19M |
|Float: ||N/A |
|% Held by Insiders: ||30.19% |
|% Held by Institutions: ||1.40% |
|Total Cash Per Share (mrq): ||0.02 |
|Total Debt (mrq): ||0 |
|Total Debt/Equity (mrq): ||N/A |
|Current Ratio (mrq): ||3.042 |
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