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
Editor Note: As a result of the Connection Study clinical trial results for Alzheimer's disease, all but the Concert Study have been canceled. See Pfizer Medivation Dimebon Connection Study Results
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.
As I look across the Internet I am noticing that several reputable research analysis are forecasting annual sales of $1 to $1.5 billion if Dimebon is approved by the Food and Drug Administrtion (FDA). Current sales of drugs for Alzheimer's, including Pfizer's (PFE) Aricept, already exceed $5 billion.
Judging by the number of Google searches for Dimebon, and the number of searches coming to the Alzheimer's Reading Room via Google, I believe it is safe to say that Dimebon is on the minds of most of the Alzheimer's community. The number of searches for Dimebon exceeds the number of searches for all other experimental drugs currently in clinical trials and focused on Alzheimer's disease. The same would be true of the emails I receive on the Alzheimer's Reading Room.
Medivation's (MDVN) CONNECTION study is the center piece of its experimental studies with Dimebon. CONNECTION is a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug Dimebon in patients with mild-to-moderate Alzheimer's disease. The key word here is: confirmatory.
Patients in the CONNECTION study are not taking any other Alzheimer's drug. Dimebon's effectiveness will be measured by both the ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) and CIBIC-plus (Clinician's Interview-Based Impression of Change) tests. These are commonly used measures of cognition, memory and overall clinical function used to assess Alzheimer's patients. Over time, the ADAS-cog and CIBIC-plus scores of an Alzheimer patient decline as the patient gradually loses memory, and loses the ability to do normal everyday functions.
The purpose of the CONNECTION study is to determine if Dimebon can improve a patient's cognitive and overall function for a period to time, or at least slow the progression of the Alzheimer's disease.
Here is a straightforward comparison. Aricept, the number one selling Alzheimer's drug, demonstrated a 3-point improvement in ADAS-cog over placebo in its six-month pivotal study.
In Medivation's pivotal phase two study, the ADAS-cog benefit for Dimebon over placebo was 5.9 points at 9 months and 6.9 points at one year. Dimebon demonstrated statistically significant improvements in memory, cognition behavior and overall function. Remarkable or too good to be true? The results were met with lots of skepticism in the scientific community.
We are now awaiting the results for six-month, confirmatory, pivotal Phase 3 trial of Dimebon.
It should be noted that the phase two Dimebon study results were published in the prestigious British medical journal The Lancet in July 2008. This gives the experimental findings additional credibility. This added scrutiny of Dimebon should get your attention.
One issue that I will be looking at closely is how the patients on the Placebo score on the tests. There is scientific evidence that patients stay out of nursing homes longer when participating in clinical trials of experimental drugs -- even when the experimental drugs don't work. There is also evidence that study participants benefit substantially from the frequent, high-quality medical attention they receive as part of a clinical trial. These findings can be an issue in the results of any clinical trial.
Pfizer Medivation has additional clinical trials with Dimebon going on right now. The drug is being in tested in combination with Aricept; and, is also being tested separately in combination with Namenda.
It is widely known that the Dimebon CONNECTION study is for Alzheimer's patients with mild-to-moderate Alzheimer's disease. I don't think it is widely know that Dimebon is now being tested in patients with moderate to severe Alzheimer's Disease. There is no exisitng drug that is designed to work across the entire spectrum of Alzheimer's -- mild-moderate-severe Alzheimer's disease.
If Medivation's Dimebon proves out on either front -- mild-moderate or moderate-severe this could turn into a blockbuster drug. Both fronts and the sky is the limit.
Caregivers with family members and spouses suffering from Alzheimer's disease are already impatiently waiting for the Dimebon clinical trial test results and the verdict from the FDA. If the drug gains approval, doctors will be inundated with telephone calls for appointments. The only negative I can see for the Alzheimer's community is that this drug is going to be EXPENSIVE.
My guess is that this drug, by itself, will send older citizens into or near the Medicare donut hole by my birthday each year --August 12th. Ouch.
To read additional information about the CONNECTION study and about ongoing Dimebon clinical trials -- go here.
FULL DISCLOSURE: This is not an offer to buy or sell any stock, bond, or commodity. The author is not a registered securities analyst or associated with any member firm. The contents of this article are purely informational. All information was obtained from readily available public sources of information. The author does not own Pfizer (PFE) or Medivation (MDVN) at the time this article is being published.
The mother of the author, Dorothy DeMarco, is currently enrolled in a phase three clinical trial for Dimebon -- A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease.
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Bob DeMarco is the editor of the Alzheimer's Reading Room and an Alzheimer's caregiver. Bob has written more than 1,200 articles with more than 9,000 links on the Internet. Bob resides in Delray Beach, FL.
Original content Bob DeMarco, the Alzheimer's Reading Room