Pfizer Bapineuzumab Fails, All Clinical Trials Discontinued

The clinical findings and the decision to discontinue the bapineuzumab IV program in patients with mild-to-moderate Alzheimer’s disease is another setback for the Alzheimer's Community.

Alzheimer's Reading Room

Pfizer Inc. and Johnson & Johnson (JNJ) said Monday they are ending development of a drug to treat Alzheimer’s disease after the treatment failed in two late-stage clinical trials.

The companies said bapineuzumab intravenousdid not work better than placebo in the two late-stage clinical trials of patients who had mild to moderate Alzheimer’s disease.

"We are obviously very disappointed in the outcomes of this trial. We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild-to-moderate Alzheimer's disease and their caregivers," Steven Romano, head of Pfizer's Medicines Development Group, said in a statement.

Continued on the Next Page

Aricept Price Drops 90 Percent

You can buy generic Aricept, Donepezil, for $110 a year from a reputable retailer like Costco.

Less than a year ago the average retail price for a year was more than $2500.

Pfizer (PFE) is still selling branded generic Aricept at a higher price through its subsidiary Greenstone.

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Is Medivation's Dimebon a $1.5 Billion Blockbuster Drug ?

Medivation (MDVN) is expected to release the results of its Phase 3 clinical trial of Dimebon in the not to distant future. Dimebon is designed for the treatment of Alzheimer's disease.....

By Bob DeMarco

Pfizer Medivation previously announced the Dimebon CONNECTION study results would be released during the first half of 2010.

There is great expectation not only in the Alzheimer's community but amongst investors.

Alzheimer's disease effects more than 5 million people in the United States, and more than 30 million worldwide. These numbers are expected to triple by 2050.

Medivation Starts New Clinical Trials for Alzheimer's -- Dimebon

I wanted to bring this into you awareness

Full disclosure: I am in the process of determining if my mother is a candidate for the Dimebon with Namenda clinical trial. Protocol Number: B1451006

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe Alzheimer's disease who are receiving existing background therapy with memantine (namenda).

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MDVN Starts New Alzheimer’s Trials

Earlier this month, Medivation, Inc. (MDVN - Analyst Report) and Pfizer, Inc. (PFE - Analyst Report) initiated two phase III studies, CONTACT and CONSTELLATION, with Dimebon in patients with moderate-to-severe Alzheimer's disease (AD). Dimebon is being developed in collaboration with Pfizer for the treatment of Alzheimer’s and Huntington diseases.

The CONTACT study will assess the potential benefits of adding Dimebon to ongoing treatment with Pfizer’s Aricept on neuropsychiatric symptoms and activities of daily living. Meanwhile, the CONSTELLATION study will evaluate the effects of adding Dimebon to Forest Lab’s (FRX - Analyst Report) Namenda, another standard of care, on cognition, memory and activities of daily living.

Preclinical studies indicate that Dimebon has the potential to protect brain cells from damage and enhance brain cell survival, by stabilizing and improving mitochondrial function. Dimebon’s mechanism is distinct from currently available Alzheimer’s medications.

Dimebon is currently in seven studies which are evaluating the safety and efficacy of the candidate across all stages of Alzheimer's disease, both as monotherapy as well as in combination with currently available Alzheimer's treatments, and in Huntington disease.

Dimebon’s unique mechanism of action and efficacy seen in clinical trials could make it a significant player in the worldwide Alzheimer’s market, which represents huge commercial potential. It is estimated that the market is currently worth about $5 billion.

Dimebon has successfully completed the first of two pivotal trials required to gain marketing approval in the U.S. for mild-to-moderate Alzheimer’s disease. A second confirmatory phase III study, CONNECTION, is currently ongoing. We expect to see top-line results from this study in the first half of 2010. Positive results should allow Medivation to go ahead with the filing of the new drug application (NDA) for the Alzheimer’s indication in 2011.

We currently have a Neutral recommendation on Medivation.

All of the above investment information is from Zacks investment research. It does not represent any opinion on our part.

To read more about Medivation and Dimebon -- go here.

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Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. The Alzheimer's Reading Room is the number one website on the Internet for news, advice, and insight into Alzheimer's disease. Bob has written more than 950 articles with more than 8,000 links on the Internet. Bob resides in Delray Beach, FL.

Original content Bob DeMarco, Alzheimer's Reading Room