Wednesday, February 3, 2010

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

Medivation (MDVN) is approaching to release a formula of a Phase 3 clinical hearing of Dimebon in a not to distant future. Dimebon is written for a treatment of Alzheimer's disease.....By Bob DeMarco


Pfizer Medivation previously announced a Dimebon CONNECTION investigate formula would be expelled during a initial half of 2010.

There is great expectancy not usually in a Alzheimer's community but amongst investors.

Alzheimer's mildew effects some-more than 5 million people in a United States, as well as some-more than 30 million worldwide. These numbers have been approaching to three times by 2050.

As we look opposite a Internet we am noticing which multiform reputable investigate analysis have been forecasting annual sales of $1 to $1.5 billion if Dimebon is authorized by a Food as well as Drug Administrtion (FDA). Current sales of drug for Alzheimer's, together with Pfizer's (PFE) Aricept, already surpass $5 billion.

Judging by a series of Google searches for Dimebon, as well as a series of searches entrance to a Alzheimer's Reading Room via Google, we believe it is safe to contend which Dimebon is upon a minds of many of a Alzheimer's community. The series of searches for Dimebon exceeds a series of searches for all alternative initial drug right away in clinical trials as well as focused upon Alzheimer's disease. The same would be loyal of a emails we receive upon a Alzheimer's Reading Room.

Medivation's (MDVN) CONNECTION investigate is a center piece of a initial studies with Dimebon. CONNECTION is a six-month, confirmatory, main Phase 3 hearing of a investigational drug Dimebon in patients with mild-to-moderate Alzheimer's disease. The pass word here is: confirmatory.

Patients in a CONNECTION investigate have been not taking any alternative Alzheimer's drug. Dimebon's efficacy will be totalled by both a ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) as well as CIBIC-plus (Clinician's Interview-Based Impression of Change) tests. These have been ordinarily used measures of cognition, mental recall as well as overall clinical duty used to consider Alzheimer's patients. Over time, a ADAS-cog as well as CIBIC-plus scores of an Alzheimer studious decrease as a studious gradually loses memory, as well as loses a ability to do normal bland functions.

The purpose of a CONNECTION investigate is to determine if Dimebon can improve a patient's cognitive as well as overall duty for a duration to time, or during least delayed a progression of a Alzheimer's disease.

Here is a candid comparison. Aricept, a series one selling Alzheimer's drug, demonstrated a 3-point alleviation in ADAS-cog over remedy in a six-month main study.

In Medivation's main proviso dual study, a ADAS-cog great for Dimebon over remedy was 5.9 points during 9 months as well as 6.9 points during one year. Dimebon demonstrated statistically poignant improvements in memory, discernment behavior as well as overall function. Remarkable or as well great to be true? The formula were met with lots of skepticism in a systematic community.

We have been right away available a formula for six-month, confirmatory, main Phase 3 hearing of Dimebon.

It should be noted which a proviso dual Dimebon investigate formula were published in a prestigious British medical biography The Lancet in Jul 2008. This gives a initial commentary one some-more credibility. This added scrutiny of Dimebon should get your attention.

One issue which we will be looking during closely is how a patients upon a Placebo measure upon a tests. There is systematic justification which patients stay out of nursing homes longer when participating in clinical trials of initial drug -- even when a initial drug do not work. There is additionally justification which investigate participants great almost from a frequent, high-quality medical courtesy they receive as partial of a clinical trial. These commentary can be an issue in a formula of any clinical trial.

Pfizer Medivation has one some-more clinical trials with Dimebon going upon right now. The drug is being in tested in combination with Aricept; and, is additionally being tested separately in combination with Namenda.

It is at large well known which a Dimebon CONNECTION investigate is for Alzheimer's patients with mild-to-moderate Alzheimer's disease. we do not consider it is at large know which Dimebon is right away being tested in patients with moderate to severe Alzheimer's Disease. There is no exisitng drug which is written to work opposite a entire spectrum of Alzheimer's -- mild-moderate-severe Alzheimer's disease.

If Medivation's Dimebon proves out upon possibly front -- mild-moderate or moderate-severe this could spin into a blockbuster drug. Both fronts as well as a sky is a limit.

Caregivers with family members as well as spouses suffering from Alzheimer's mildew have been already impatiently waiting for a Dimebon clinical hearing test formula as well as a outcome from a FDA. If a drug gains approval, doctors will be inundated with telephone calls for appointments. The usually negative we can see for a Alzheimer's community is which this drug is going to be EXPENSIVE.

My theory is which this drug, by itself, will send older citizens into or nearby a Medicare donut hole by my birthday each year --August 12th. Ouch.

To review one some-more information about a CONNECTION investigate as well as about ongoing Dimebon clinical trials -- go here.

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FULL DISCLOSURE: This is not an suggest to buy or sell any stock, bond, or commodity. The writer is not a registered securities researcher or associated with any member firm. The essence of this article have been purely informational. All information was obtained from readily available open sources of information. The writer does not own Pfizer (PFE) or Medivation (MDVN) during a time this article is being published.

The mother of a author, Dorothy DeMarco, is right away enrolled in a proviso three clinical hearing 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 a editor of a Alzheimer's Reading Room as well as an Alzheimer's caregiver. Bob has written some-more than 1,200 articles with some-more than 9,000 links upon a Internet. Bob resides in Delray Beach, FL.


Original calm Bob DeMarco, a Alzheimer's Reading Room




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