MDVN » Topics » About Alzheimers Disease

This excerpt taken from the MDVN 8-K filed Nov 3, 2009.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as delusions, hallucinations, anxiety, and agitation.

This excerpt taken from the MDVN 8-K filed Jun 11, 2009.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.

This excerpt taken from the MDVN 10-K filed Mar 16, 2009.

Alzheimer’s Disease

Alzheimer’s disease, the leading cause of dementia, is characterized by the progressive loss of memory, thinking and ability to perform activities of daily living (bathing, feeding, self-care, etc.), as well as significant behavioral disturbances (agitation, aggression, delusions, hallucinations, etc). There is currently no cure. According to the Alzheimer’s Association and the American Health Assistance Foundation:

 

   

Alzheimer’s disease currently affects approximately 5.2 million people in the U.S., including as many as 13% of people aged 65 and older and approximately 50% of those aged 85 and older.

 

   

Worldwide, Alzheimer’s disease affects 26 million people, and that number is expected to reach 106 million by 2050.

 

   

There are approximately 400,000 new diagnoses of Alzheimer’s disease, and approximately 72,000 Alzheimer’s disease deaths, per year in the U.S.

 

   

Following initial diagnosis, patients live four to six years on average, but may live up to 20 years with the disease.

 

   

Total annual expenditures on Alzheimer’s disease in the U.S. exceed $148 billion annually, and the average lifetime cost per Alzheimer’s disease patient is $174,000.

There are only four commonly-used drugs that the FDA has approved for the treatment of Alzheimer’s disease. Although the precise mechanism of action of these four drugs is unknown, three of them are believed to inhibit cholinesterase, and one is believed to inhibit the NMDA-receptor. These four drugs and their respective

 

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Table of Contents

marketers, FDA approval dates (as listed in the FDA’s on-line edition of its Orange Book) and postulated mechanisms of action (as appearing in the package inserts for these drugs) are set forth in the following table.

 

Drug (Trade Name/Generic)

  Marketed by   FDA Approval Date   Postulated Mechanism

Aricept® (donepezil)

  Pfizer Inc./Eisai Co., Ltd.   November 25, 1996   Cholinesterase inhibition

Exelon® (rivastigmine)

  Novartis AG   April 21, 2000   Cholinesterase inhibition

Razadyne® (galantamine)

  Johnson & Johnson   February 28, 2001   Cholinesterase inhibition

Namenda® (memantine)

  Forest Laboratories, Inc.   October 16, 2003   NMDA-receptor inhibition

According to IMS Health, the worldwide market for Alzheimer’s disease therapies currently exceeds $5 billion, with the largest selling cholinesterase inhibitor, Aricept, generating more than half of those sales, followed by Forest Laboratories, Inc.’s NMDA-receptor antagonist Namenda. In 2008, the first generic equivalent, galantamine, entered the market. Further generic entrants are expected as the remaining branded drugs lose patent protection in the United States and Europe between 2010 and 2015.

This excerpt taken from the MDVN 8-K filed Aug 11, 2008.

Alzheimer’s Disease

 

   

Initiated dosing of patients in a second pivotal Phase 3 trial of the investigational drug Dimebon in patients with mild-to-moderate Alzheimer’s disease. This international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon, known as the CONNECTION study, will enroll approximately 525 patients at 60 to 80 clinical sites in the U.S., Europe and South America.


   

Published results of the first pivotal clinical trial of Dimebon in the July 19, 2008 issue of The Lancet. The article highlighted that patients with mild-to-moderate Alzheimer’s disease treated with Dimebon experienced statistically significant improvements compared to placebo on all of the key aspects of the disease—memory and thinking, activities of daily living, behavior and overall function—over a 12-month period.

 

   

Presented new Dimebon data at three presentations at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD):

 

   

Presented results from a six-month open-label extension of the 12-month placebo-controlled study showing that Dimebon continued to improve the clinical course of the disease. After 18 months of treatment, Dimebon preserved function in patients at or near their original levels upon entering the trial across all key aspects of Alzheimer’s disease. Dimebon remained well tolerated throughout the 18-month treatment period.

 

   

Presented new 12-month data from subgroup analyses by disease severity of the first pivotal trial showing that Dimebon benefited both mild and moderate patients, resulting in significant benefit on the study’s primary endpoint, the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog). The drug-placebo difference in moderate patients was 9.7 ADAS-cog points after 12 months of Dimebon treatment.

 

   

Presented new preclinical data at podium presentation on Dimebon’s novel mechanism of action, showing that Dimebon improves mitochondrial function in the setting of cellular stress with very high potency. Mitochondria, which generate energy for cells and play important roles in mediating cell function and survival, have been associated with both Alzheimer’s and Huntington’s diseases in the published literature.

 

   

Successfully completed a thorough QTc cardiac safety study of Dimebon. In this study, Dimebon was well tolerated and did not produce any cardiac safety issues. The U.S. Food and Drug Administration requires thorough QTc studies for all new drugs undergoing regulatory approval.

This excerpt taken from the MDVN 8-K filed Jul 30, 2008.

ALZHEIMER’S DISEASE

SAN FRANCISCO (July 30, 2008) – Medivation, Inc. (NASDAQ: MDVN) today announced new data showing that its investigational drug Dimebon continues to produce broad, clinically meaningful benefits in Alzheimer’s disease patients after long-term dosing, and appears to operate through a novel mechanism of action. These data were presented today in a podium session and two poster sessions at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) in Chicago. The presentations are highlighted below.

This excerpt taken from the MDVN 8-K filed Jul 18, 2008.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive, neurodegenerative disease that destroys brain cells and affects areas of the brain involved in memory, cognition, judgment, language and behavior, eventually leading to severe impairments in cognition and function. The most common form of dementia, Alzheimer’s disease affects as many as 5 million Americans.

This excerpt taken from the MDVN 8-K filed May 1, 2008.

Alzheimer’s Disease

 

   

Held successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration, which recognized our previously completed trial of Dimebon™ in patients with mild-to-moderate Alzheimer’s disease (AD) as pivotal, as long as a significant portion of sites in our confirmatory Phase 3 trial are located in the United States.

 

   

Presented neuropsychiatric data from first pivotal trial of Dimebon in AD at the annual meeting of the American Association for Geriatric Psychiatry showing that Dimebon stabilized behavioral symptoms in patients with mild-to-moderate AD over a one-year period, resulting in significantly decreased caregiver distress.

 

   

Presented data from the first pivotal trial at two sessions of the 60th Annual Meeting of the American Academy of Neurology (AAN). Investigators presented data showing that one year of Dimebon treatment produced significant improvements over placebo in eating, toilet use, phone use, conversation, preparing meals, traveling, keeping appointments, reading and using household appliances. These benefits allowed caregivers to save an average of nearly one hour each day caring for patients.


   

Also at AAN, investigators presented data showing that Dimebon-treated patients showed significant improvements over placebo in all aspects of cognitive function (i.e., memory, orientation, language, praxis or the process of getting an idea, and initiating and completing a new motor task) after one year of treatment.

 

   

Began patient dosing in a Phase 1 safety and tolerability study of Dimebon in AD patients when dosed in combination with Aricept.

 

   

Will be presenting 18-month open-label extension data from our first pivotal AD trial at a medical meeting in the third quarter.

This excerpt taken from the MDVN 8-K filed Feb 19, 2008.

Alzheimer’s Disease

 

   

Completed a double-blinded, placebo-controlled twelve month extension of our first pivotal Alzheimer’s disease (AD) trial, in which patients continued to show statistically significant benefits on all five clinical endpoints studied;

 

   

Completed a comprehensive Phase 1 clinical development program in the U.S., which continued to show Dimebon to be safe and well tolerated;

 

   

Completed a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration, which recognized our previously completed AD trial as pivotal and allowed us to proceed to a confirmatory pivotal Phase 3 trial;

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