Dimebon Dimebolin Information Availability » Combination Therapy

Medivation – Dimebon Launch in 2012?

admin — Tue, 01 Nov 2011 08:02:04 +0000

Medivation Inc. (MDVN – Analyst Report) reported first quarter 2009 financial results following the market close on May 11, 2009. Revenue came in at $16.34 million, exactly where we had it modeled. Revenue consisted solely of collaboration revenue from Pfizer. EPS was ($0.19), significantly ahead of our forecast of ($0.34), due to substantially lower-than-expected operating expenses.

Pfizer makes quarterly true-up payments to Medivation as reimbursement for a significant portion of Dimebon-related development and commercialization expenses. In the first quarter 2009, Pfizer made a $5.8 million true-up payment to MDVN, which is reflected as a reduction in operating expenses – approximately $5.4 million of the true-up payment hit the R&D expense line-item.

In October 2008 Medivation received $225 million in collaboration revenue from Pfizer, which will be recognized on a straight-line basis through the first quarter of 2012. The company will likely not generate any other revenue or receive any development milestone payments in 2009.

We expect operating expenses to spike to near $120 million in 2009 (from $77 million in 2008), as the company funds larger clinical trials of both Dimebon and MDV3100. We model $65.4 million in collaboration revenue and EPS of ($1.65) in 2009.

An NDA filing for Dimebon for the treatment of Alzheimer’s is possible in 2010, depending on the success of the CONNECTION and safety studies. We more conservatively model a Dimebon Alzheimer’s filing in 2011, supported from all 5 of the phase III Alzheimer’s studies. We believe Dimebon could launch with a broad label, including for the treatment of mild-through-severe Alzheimer’s as a monotherapy as well as a combination therapy. We model a Dimebon launch in 2012 for both the Alzheimer’s and Huntington’s indications.

We view MDV3100 as more of a wild-card, but with significant upside depending on the outcome of phase III trials. Safety, most notably seizures, are a concern but appear to be possibly dose-related or related to background medication, and occurred in patients treated at doses greater than 240mg. The phase III trial will exclusively use the 240mg dose.

We also believe Medivation could be looking to partner MDV3100 in the near-term, potentially before phase III testing begins later this year. A partnership would reduce Medivations’ development costs, dilute the risk of failure of MDV3100 and potentially bolster the company’s cash position.

With cash-burn rates materially increasing in 2009 and 2010, a partnering deal for MDV3100 would also significantly reduce the need to raise additional capital before Dimebon launches.

We expect the company to remain unprofitable through at least 2010 and currently model EPS of $0.11 in 2011 as development milestones push the company towards positive earnings. We think this grows to $0.32 in 2012 on the heels of the Dimebon launch. EPS upside to our forecast could materialize with an earlier-than-expected NDA filing for Dimebon and/or a partnering deal for MDV3100.

Medivation shares currently trade at $22.41. We recommend that investors hold at the current price, and forecast an EPS loss of $1.65 in 2009. Our price target is $25.

http://www.zacks.com/stock/news/21612/Medivation

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Dimebon Dimebolin Information Availability

Medivation – Dimebon Launch in 2012?

admin — Tue, 23 Aug 2011 13:35:17 +0000

With cash-burn rates materially increasing in 2009 and 2010, a partnering deal for MDV3100 would also significantly reduce the need to raise additional capital before Dimebon launches.

Medivation shares currently trade at $22.41. We recommend that investors hold at the current price, and forecast an EPS loss of $1.65 in 2009. Our price target is $25.

http://www.zacks.com/stock/news/21612/Medivation

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Study Set To Provide Breakthrough In Treatment Of Alzheimer’s

admin — Tue, 18 Jan 2011 01:59:02 +0000

Study Set To Provide Breakthrough In Treatment Of Alzheimer’s

A ground-breaking clinical trial which could help halt the onset of advanced Alzheimer’s and dramatically improve the quality of life for patients and carers has been launched in the UK.

Glasgow Memory Clinic is now enrolling patients in the CONCERT trial, a one-year international study set up to test the effectiveness of a unique investigation drug, dimebon (also known by its proposed generic name of latrepirdine), in patients currently taking Aricept (donepezil HCI tablets), the leading medication for Alzheimer’s disease worldwide.

More than 1,000 patients from across western Europe, the United States, Australia and New Zealand will take part in the CONCERT trial and it is hoped that the combined medication will help stabilise the condition of those with Alzheimer’s by safely improving cognition (thinking and awareness), memory, daily functioning, behaviour and the ability to care for oneself.

Glasgow Memory Clinic has already enrolled a number of patients onto the trial and still has spaces available for those who meet the eligibility criteria.

Dr Fraser Inglis, Consultant Physician and founder of the Glasgow Memory Clinic, is optimistic about the advances the trial may make in the treatment of Alzheimer’s disease.

“Alzheimer’s is a complex disease and while current medications may improve the symptoms for some patients for a time, often the disease continues to progress. Therefore, combination therapy may be the method to maximize clinical benefit,” said Dr Inglis.

“CONCERT is an important study because dimebon is thought to work differently to current medications and this study will evaluate whether adding it to one of the most commonly used Alzheimer’s medications will provide a more effective symptomatic treatment to patients, stabilising their condition and ultimately improving their quality of life.

“A cure for Alzheimer’s is still many years away, however treatments that provide lasting effects, more symptomatic benefits or slow disease progression would offer meaningful benefits for patients and their carers. For this reason, there is an urgent need for patients to participate in clinical trials such as CONCERT and help advance the understanding of how Alzheimer’s disease can be better treated.”

The Alzheimer’s Society estimates that as many as 417,000 people in the UK are living with Alzheimer’s, a devastating disease that hinders the patient’s ability to remember, learn, perform daily activities and relate to others. As the baby boomer population ages, the incidence of Alzheimer’s is expected to increase dramatically.

Mrs Balneaves, wife of an Alzheimer’s sufferer adds: “As the wife and carer of an Alzheimer’s patient, I understand fully how debilitating this disease is and how, in the majority of cases, it leaves sufferers requiring round-the-clock care and unable to interact fully with society.

“It causes untold suffering not only to the person with the disease, but also to their family and friends, and I can only welcome any research that can provide renewed hope of an improved quality of life for anyone touched by Alzheimer’s.”

The Glasgow Memory Clinic is based in a new £4m facility within the West of Scotland Science Park and is internationally recognized as a leading independent research organization dedicated to finding better treatments for those with Memory Impairment, Alzheimer’s disease and dementia.

Patients or caregivers interested in participating in the CONCERT trial are invited to contact the Glasgow Memory Clinic for information on eligibility and enrolment on 0141 948 0206 or http://www.glasgowmemoryclinic.com/. Further information is also available on the Concert study freephone number 0808 178 7959 or www.concertstudy.com.

About Concert

Concert (http://www.concertstudy.com/) is an international, randomised, double-blind, placebo-controlled study that will enrol approximately 1,050 patients with mild-to-moderate Alzheimer’s disease at approximately 100 sites in western Europe, the United States, Australia and New Zealand. Patients on a stable dose of Aricept will be randomised to one of three treatment groups: dimebon 20 mg three times per day, dimebon 5 mg three times or placebo.

The primary endpoints are the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS – ADL), a measure of self-care and daily function. The Concert study is sponsored by Pfizer and Medivation, Inc.

About Dimebon

Dimebon (latrepirdine) is an investigational drug currently in Phase 3 development for the treatment of Alzheimer’s disease and in clinical development for Huntington disease (HD). The comprehensive Phase 3 clinical development programme for Alzheimer’s disease is evaluating the potential for dimebon to be used in broad applications including use alone, in combination with existing medications and in patients at all stages of the disease.

Dimebon has a unique mechanism of action, distinct from currently available treatments. In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain survival, potentially stabilizing and improving mitochondrial function. Mitochondria are critical to brain cell functioning as they are the primary source of energy for cells. Drugs that protect mitochondria or restore their function could potentially be a valuable treatment approach in AD.

Issued by Beattie Communications (www.beattiegroup.com) on behalf of Glasgow Memory Clinic (http://www.glasgowmemoryclinic.com/)

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http://www.dimebonalzheimers.com/

Job Cuts at Medivation

admin — Fri, 18 Jun 2010 01:55:18 +0000

Medivation, Inc. (MDVN) recently announced that it intends to reduce its workforce by 20% or 23 people to save costs and focus its resources towards research and development activities related to dimebon and MDV3100.

Medivation also announced the departure of its senior vice president of clinical development and the vice president of commercial development. The company said that it is no longer looking for a new Chief Financial Officer (CFO) as this post will be filled by the current Chief Business Officer (CBO).

Medivation’s workforce reduction announcement comes on the heels of disappointing phase III results reported earlier this month on its lead pipeline candidate, dimebon. Dimebon, which is being developed for Alzheimer’s disease in collaboration with Pfizer, Inc. (PFE), failed to achieve both its primary and secondary endpoints in a phase III study (CONNECTION).

Dimebon was the most advanced pipeline candidate at Medivation, which has no marketed products in its portfolio. The successful development of dimebon would have been a major boost for the company. In addition to the Alzheimer’s indication, Medivation is also studying dimebon for Huntington’s disease.

Going forward, Medivation intends to focus on the further analysis of the CONNECTION data, which will help determine future development plans for the candidate. Dimebon is currently being studied in combination with Pfizer’s Aricept for the treatment of mild-to-moderate Alzheimer’s. Positive results from this study could allow the companies to push for approval of the product as a combination therapy.

Dimebon is also in another study which is being conducted in Huntington disease patients.

We currently have a Neutral recommendation on Medivation. The high profile phase III failure was a major setback for the company. Medivation could suffer another blow if Pfizer decides to pull out from the collaboration agreement for dimebon.

We note that Pfizer already has another Alzheimer’s candidate, bapineuzumab, in its portfolio that is being developed with Elan Corp (ELN) and Johnson & Johnson (JNJ). As such, Pfizer may decide to focus its efforts towards the development of bapineuzumab.

http://www.dimebonalzheimers.com/

Donepezil

admin — Mon, 20 Apr 2009 18:03:22 +0000

Donepezil (Aricept) is a drug derived from components of actual black pepper. It is the most widely prescribed drug for patients who have Alzheimer’s disease . It works by preventing the breakdown of the chemical neurotransmitter acetylcholine in the brain. The tablet is taken once daily , which helps with regular pill taking ( compliance). It seems that for all the studies that have been done in an effort to improve the taking of pills and medications on a regular basis – that is compliance – that lack of compliance is generally estimated at a full 50 %. The only things that seem to enhance and improve compliance levels with medications are 1) to reduce the frequency of dosage and 2) tie in the pill taking to a regime involving a daily habit — 0ften meals. To make matters perhaps more amusing and even worse it seems that patients often improve their regular pill taking and compliance of medications when they become more ill and are reminded of their symptoms. The poor health care providers are often at a loss to explain symptoms and side effects that often and usually were not present before and are the direct result of patients now taking their pills and medications on a regular and proper basis. On top of that multi-drug side effects and interactions may now emerge since the patient may well be finally taking the drugs they had forgot to or had chosen not to take before in their treatment plan and plans.

Forteo, Enbrel, Methotrexate, Folic Acid, Donepezil Hcl … – Large, long term drug study: Forteo, Enbrel, Methotrexate, Folic Acid, Donepezil Hcl, Hydrocodone Bitartrate And Acetaminophen, Acetylsalicylic Acid Srt drug interactions and effectivenesses for females and males at all ages (2742948)

Phase 3 study of Dimebon and donepezil combination therapy for … – Pfizer and Medivation, Inc announced the initiation of a 12-month, Phase 3 trial of the investigational drug Dimebon in combination with donepezil HCl for the treatment of mild-to-moderate Alzheimer’s disease (AD).

Alzheimer’s Reading Room: Dimebon Added to Donepezil in Patients … – The study builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated. CONCERT is designed to complement previous and ongoing studies by further …

Pfizer and Medivation Initiate Phase 3 Trial of Dimebon Added to … – New 12-month study broadens Phase 3 clinical program to further eval… …NEW YORK and SAN FRANCISCO April 15 /- Pfizer … …,Pfizer,and,Medivation,Initiate,Phase,3,Trial,of,Dimebon,Added,to,Donepezil,in,Patients,with,Alzheimer’s …

Drug interactions analysis of Zyprexa, Venlafaxine Hcl … – Real world drug safety study: Drug interactions analysis of Zyprexa, Venlafaxine Hcl, Risperidone, Quetiapine, Donepezil Hcl (2704001) … Donepezil Hcl. ^Back to Content. 2 related incidents are studied for males aged 75 (±5): …

Donepezil – Welcome to donepezil WebLog donepezil BUY ONLINE! Related Posts: {RELATED}. EPIX Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly …

Donepezil – Darkover has butorphanol opiate withdrawal features once crooning under heal children fulvicin always said smoke from trigger breathing relenza market share gsk hat about with all too was aricept donepezil hydrochloride omilla and …

Donepezil Hcl side effects and drug interactions analysis (ID … – Drug(s): Donepezil Hcl Date: Aug, 28, 2008 Patient demographics: unspecified year(s) old Male who has Cognitive Disorder.

The Donepezil comes in tablet form. The typical daily dose id 10 mg. It is generally well tolerated. Often the dose is started low at 5 mg per a day and then “bumped” up to the 10 mg dose. Some authorities and practitioners in the field have believed that the drug will only work for a six month time period whereas others have continued treatment with the drug and made substantiated claims that a beneficial effect can be demonstrated in Alzheimer’s patients for several years. Indeed the medication may have a disease modifying and limited beneficial effect all on its own.

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http://www.dimebonalzheimers.com