Dimebon Dimebolin Information Availability » Clinical Trials

Potential Alzheimer’s Drug Dimebon Fails in Clinical Trials

admin — Sat, 14 Apr 2012 08:06:40 +0000

Dimebon, a drug that has been in phase three of clinical trials for treatment of Alzheimer’s disease, has recently been discontinued after studies concluded it was ineffective. Dimebon is a drug that was first used in Russia decades ago as an antihistamine, and in the last few years has undergone testing to treat the symptoms of Alzheimer’s in the United States. Dimebon was never sold or marketed in the United States.

Initially, the drug showed some positive results in patients with Alzheimer’s, so clinical trials were expanded to study its effects when given with the drug denepazil (Aricept), a medication currently used to treat early Alzheimer’s. This past week, Pfizer and Medivation, the two drug companies that were conducting the trials, announced the discontinuation of Dimebon after it failed to show benefits for the recipients. In fact, some of the people receiving it declined more than those who received the placebo.

This is disappointing news, especially in light of ournation’s recent draft document on Alzheimer’s disease and other related dementias. One goal outlined in this draft is to effectively treat and prevent Alzheimer’s by 2025. Evidently, the manner in which we do this won’t include Dimebon.

http://alzheimers.about.com/b/2012/01/22/potential-alzheimers-drug-dimebon-fails-in-clinical-trials.htm

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Obama Accelerates Race for Alzheimer’s Cure

admin — Fri, 09 Mar 2012 03:52:04 +0000

President Obama introduced his initiative to speed up the pace of research into viable treatments for Alzheimer’s disease by pledging a total of $156 million in funding over the next two years. The bulk of the money, $130 million, will go to research for drugs to prevent and treat the disease, while another $26 million will be earmarked for caregiver support and public education about the disorder.

Part of the National Alzheimer’s Project Act passed in January of last year, the initiative notes the heavy toll that the disease is taking on an aging U.S. population — over 5 million Americans are estimated to have the disease, and experts fear that number could triple by 2050. Medical costs associated with Alzheimer’s patients’ care looms large, with experts calculating these at about $183 billion last year; totals could reach $1 trillion by 2050.

Since Obama envisions this project as a public-private partnership, some lucky pharmaceutical companies stand to benefit from this new initiative. Reasonably, companies with Alzheimer’s drugs already in the pipeline or ready for testing stand to reap the greatest rewards. The only problem is that it’s a been-there, done-that scenario with Alzheimer’s drug research, with much effort and money producing only a handful of mediocre treatments. Unfortunately, spectacular fails seem to be the norm in this arena.

Many misses, no real hits
Time and again, promising research turned into a collection of almost-useless data as drugs that incited hope in the battle against Alzheimer’s stumbled in clinical trials. Two of the most disappointing were Eli Lilly‘s (NYSE: LLY ) drug semagacestat, which made it through Phase III clinical trials only to find that it actually worsened the condition; and Dimebon, a Pfizer (NYSE: PFE ) and Medivation (Nasdaq: MDVN ) joint venture that eventually was proved ineffective during Phase III. Many lesser drugs have seen their research quietly discontinued, as a list on the Alzheimer’s Research Forum clearly shows.

Alas, the four therapies currently on the market do little to control or postpone the disease for long. Three of the drugs, galantamine, rivastigmine, and donepezil are cholinesterase inhibitors, which help accentuate the effectiveness of waning amounts of acetylcholine in Alzheimer’s patients’ brains. Memantine is a glutamate regulator, since excessive amounts of this chemical can cause brain-cell death.

Meantime, two drugs currently under construction could be on the market by next year, if clinical trials currently finishing up produce the desired results. The drugs, solanezumab, a product of Eli Lilly, and bapineuzumab, made by Pfizer in partnership with Johnson & Johnson and Elan (NYSE: ELN ) , show much promise and could conceivably be in use by early 2013 by making use of the accelerated approval process promised by Obama’s Alzheimer’s initiative. Experts feel that the latter drug has the most promise, but either or both could garner their manufacturers a very lucrative payout once they clear all regulatory hurdles. Another drug, Gammagard, is currently in Phase III trials set to end next year. If all goes well, Baxter International (NYSE: BAX ) , the drug’s maker, could see market share by 2015.

This Fool’s Take
Although any successful Alzheimer’s treatment will raise its parent company’s fortunes, the biggest winners here would be Eli Lilly, who owns solanezumab in its entirely, then Pfizer, who owns half of bapineuzumab. Coming in third would be Johnson & Johnson and Elan, each of whom have a one-quarter stake in bapineuzumab, but Elan is a much smaller company so that 25% stake could actually move the biotech’s shares the most. None of these drugs promise to cure Alzheimer’s, but the hope is that they will be capable of postponing symptoms of moderately-affected individuals for longer than current treatments. But that’s a whole lot of patients that could conceivably be helped by these treatments. If all goes well, these companies may well have the next group of blockbuster drugs on their hands.

http://www.fool.com/investing/high-growth/2012/02/29/obama-accelerates-race-for-alzheimers-cure.aspx

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3 More Stock-Moving Binary Events to Watch in 2012

admin — Thu, 05 Jan 2012 00:59:58 +0000

Binary events, FDA decisions, and clinical trial results, are the lifeblood — and death wish — of the biotech industry. They’re a necessary part of the drug development process. They don’t always fall your way, but they’re always fun to watch, even if you’re sitting on the sidelines, which is often the most appropriate place to be for many binary events.

Since drugs have FDA review times of six or 10 months and the approximate end of clinical trials is known after the last patient is enrolled, investors get forewarning that the binary events are going to happen. There are a lot of drugs that will face binary events in 2012, and I’ve already reviewed three — but here are three more I think you should watch.

Party like its 2010
On April 17 and sometime in the middle of the year, VIVUS (Nasdaq: VVUS ) and Arena Pharmaceuticals (Nasdaq: ARNA ) , respectively, should both get decisions about their obesity drugs that were turned down in 2010. The companies have been working diligently throughout 2011, attempting to satisfy the FDA’s requests for additional information about the safety of their drugs.

VIVUS has already resubmitted its application, avoiding women who could become pregnant to eliminate the risk of a potential birth-defect issue, and should hear back from the FDA on April 17. Arena has guided for a resubmission around the end of the year, which would put a decision in the middle of next year.

The FDA has treated obesity treatments as lifestyle drugs that require a clean bill of health before approval. Thus far, meeting that high standard has proved difficult. From the agency’s perspective, there’s little motivation to approve the drugs and risk another fen-phen issue.

My prediction: Same result as 2010, with the caveat that the FDA can be schizophrenic and could shift gears and become more lenient — or bow to some outside pressure. Either way, stay away until it’s clear the agency has turned over a new leaf.

Don’t forget the binary event
Near the middle of next year, Elan (NYSE: ELN ) , Johnson & Johnson (NYSE: JNJ ) , and Pfizer (NYSE: PFE ) will finally get results from the phase 3 trials testing their Alzheimer’s treatment bapineuzumab. Elan has only a 25% stake in the drug, but being considerably smaller than either of the pharmas, Elan has the most to gain from a positive result.

Predicting the results of the upcoming trial based on the phase 2 results is difficult, because, as you may recall, the earlier trial was marred with controversy. With little to go on, we’ll have to turn to history of previous Alzheimer’s treatment, which doesn’t bode well for bapineuzumab. There was Myriad Genetics‘ Flurizan, and Medivation (Nasdaq: MDVN ) and Pfizer‘s (NYSE: PFE ) Dimebon, and the list of failures in the Alzheimer’s disease space goes on. It’s a tough space to work in; even the drugs that have been approved don’t work all that well.

Fortunately for Elan, I think expectations for bapineuzumab are fairly low; I doubt a negative trial will crush the stock, but a positive one will surely cause Elan to skyrocket.

My prediction: I’m going with history on this one and predicting that one or more of the phase 3 trials fails.

Succeed indeed
In early June, the FDA should make a decision about Ariad Pharmaceuticals (Nasdaq ARIA) and Merck‘s (NYSE: MRK ) sarcoma drug ridaforolimus. Nothing is a guarantee when the FDA is involved, but the drug looks like it has a very good chance at getting on the market next year. The companies’ phase 3 trial, SUCCEED, lived up to its name, improving the progression-free survival by 21% compared with placebo.

My prediction: I’ll go out on a limb of steel and predict an FDA approval.

http://www.fool.com/investing/general/2011/12/31/3-more-stock-moving-binary-events-to-watch-in-2012.aspx

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Why Can’t I Buy Dimebon for Alzheimer’s?

admin — Thu, 17 Nov 2011 06:11:56 +0000

Why can’t, I, WE, buy Dimebon for Alzheimer’s disease?

TERMINATED. That is the word they used when the Dimebon clinical trial that my mother was enrolled in was abruptly canceled on May 7, 2010.

The termination was caused by the failure of the Dimebon Connection Study. My mother was not enrolled in the that study. But, because the study failed to produce the necessary results for potential FDA approval the rug was pulled from under our feet.

We weren’t the only ones. There were more than 2,000 patients enrolled in Dimebon clinical trials. This means at least 1,000 participants received Dimebon. The other participants received a placebo.

The study was not terminated due to any safety findings. Dimebon was well-tolerated in clinical trials.

Safety was not an issue. The problem was efficacy. In other words, the drug did not provide enough benefit to participants. From a statistical standpoint it did not stop memory loss. There was some benefits registered on the behavior scale.

Now to my point.

Dotty did benefit. While on Dimebon, she was more alert and her behavior was dramatically improved over what I had come to expect.

Keep in mind here, Dotty was diagnosed before entering the clinical trial as being in the moderate to severe stage of Alzheimer’s. She scored 14 on the MMSE. She also scored 16 during the trial.

I did ask the personnel at the clinical trial site if they thought that Dotty was showing any improvement. They told me yes. I asked how?

Here is an example. At the outset of the clinical trial they showed Dotty a picture of a fork. Then asked, what do you with this? She could not say or demonstrate how you use a fork. When they put a fork in her hand she could demonstrate what you do with a fork.

Later in the study, they did the same test over. Sure enough, Dotty looked at the picture of the fork and then demonstrated what you do with a fork.

By the way, by the point in the clinical trial I didn’t have to ask anyone anything. I saw with my own eyes, ears, and brains that Dotty was a different person.

How much better?

Hold on tight. Better than she had been in many years. Let me set this straight. I couldn’t tell if there was any improvement in Dotty’s memory, and if you would like to know the truth, I didn’t care.

What I did care about was that Dotty seemed to be more interested in living her life. She was a fuller, better person.

My point. I can accept memory loss. I don’t spend much time thinking about Dotty’s memory, or what she can or can’t remember. What I do care about is the look on Dotty’s face, and how she responds to activity.

Dotty clearly looked more there, and was clearly experiencing “more enjoyment”.

As my close friends know, I was “dancing on the ceiling”.

We are not the only one’s that saw benefits from Dimebon. There are several articles and stories on this website from other caregivers that were enrolled in the Dimebon clinical trials.

I know they want an answer to this question.

Why Can’t We Buy Dimebon in the United States?

The drug is safe. The drug has been used in Russia since 1983.

And, Dimebon was proven to be safe in the clinical trials.

http://www.alzheimersreadingroom.com/2011/11/why-cant-i-buy-dimebon-for-alzheimers.html

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Dimebon fails in late-stage human HD clinical trial

admin — Fri, 19 Aug 2011 13:34:45 +0000

Dimebon fails to improve symptoms in HD patients in the HORIZON trial

Dimebon, an experimental drug marketed by Medivation, fails to improve the symptoms of Huntington’s disease patients in the HORIZON trial. This is the end of the road for developing this drug for HD.

What is Dimebon?

Dimebon is an old drug, actually developed as an allergy medicine in Russia. Based on improvements in the mental or ‘cognitive’ symptoms in some Alzheimer’s disease patients taking the drug, it was developed by Medivation and Pfizer as a potential treatment for both Alzheimer’s and Huntington’s disease.

What’s been done before?

In the early phases of drug development, clinical trials are aimed at showing that the drug is not harmful, in small numbers of healthy volunteers or patients. The earlier DIMOND trial looked at the effect of Dimebon on 90 HD patients taking either Dimebon or a placebo. That trial showed that Dimebon was safe, and suggested there might be some benefit in the mental problems associated with HD.

A larger “phase III” trial was therefore conceived. Called HORIZON, this trial involved several hundred HD patients in Europe and the USA, with the goal of definitively proving that Dimebon helped with the cognitive symptoms of HD.

Phase III trials are the final stage before a drug company applies to the regulatory agencies for approval for a drug. Success or failure at the phase III level is what ultimately controls what drugs are available to patients.

Worryingly, in the meantime, Dimebon had failed to improve symptoms in a large phase III study of hundreds of Alzheimer’s disease patients. The failure of that larger trial raised concerns about the drug. Nevertheless, because of the positive results from the DIMOND trial, the HORIZON trial in HD patients continued.

What are the results?

The HORIZON trial focused on two measures — a short mental quiz called the ‘mini-mental state examination’ and another score (called the ‘CIBIC-plus’), which is based on a physician’s impression of a patient’s symptoms.

Both of these measures failed to improve in the patients taking Dimebon, compared to those taking placebo. The numbers were not close — it was a clear failure on both measures.

Now what?

According to a press release issued by Medivation, David Hung (president and CEO) has said “we will discontinue development of Dimebon in Huntington disease, including the ongoing open-label extension study” — the end of the road for Dimebon in Huntington’s Disease.

Silver linings?

There’s usually an up-side to bad news in science. One way to look at this disappointing announcement is that the results were very clearly negative, with no room for doubt. That means it’s now clear that studying Dimebon further in Huntington’s disease isn’t worthwhile — so patients and researchers can spend precious time and resources developing other treatments — and, as our other HDBuzz articles will hopefully demonstrate, there are plenty of those in the pipeline.

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Why Phase 3 Trials Fail: What Investors Need to Know

admin — Fri, 11 Mar 2011 04:50:20 +0000

As readers of Seeking Alpha and investors in biotech know, investing in development stage biotechnology / biopharmaceutical companies is fraught with risk. Early-stage companies burn cash funding R&D and clinical trials, with no guarantee of approval (or even revenues in the future given successful approval!). As clinical trials progress, they become more expensive due to increases in both duration and patient size.

Sometimes this development risk is mitigated by licensing deals with big pharma in which clinical trial costs are shared and upfront / milestone payments are made in exchange for future revenues. However, when these products do not live up to expectations it negatively impacts share prices, sometimes dramatically (19/20 small molecule candidates that commence clinical trials will fail; 4/5 biologics will fail as well). Let us look at some studies of clinical trials and delve into the numbers more globally.

According to a McKinsey study analyzing phase 3 trial failures reported from 1990-2002, the results had numerous implications for pharma. Focusing on small-molecules (656 Phase 3 compounds), 58% were successful. This of course implies a 42% failure rate; a staggering sum given that both safety and efficacy should have already been demonstrated. The analysts were able to evaluate in depth 73 of the 212 failures. Shockingly, the results indicated that a full 50% of these compounds failed for a lack of efficacy compared to placebo! Another 30% were for safety concerns and the final 20% could not be proven safer or more effective than the drugs already on the market. Phase 2 is designed to establish efficacy in patients, and clearly there are shortcomings at this stage. The efficacy failures could be attributed to two main causes: mechanistic novelty and endpoint definition. Qualitative endpoints failed more often than defined endpoints. Interestingly, according to the study:

“An even more significant predictor of failure was novel mechanism. Even after the patient evaluation process in Phase 2, drugs that used novel mechanisms of action failure more than twice as often in Phase 3 as those that used known mechanisms. And if drugs had both novel mechanisms and less objective endpoints, they failed 70% of the time.”

According to another recent article, oncology candidates are particularly risky, with only 8% of candidates achieving approval that completed phase 1. Along the same lines as the McKinsey study, the author cites the Investigational Drug Steering Committee (IDSC). In general, the IDSC:

“encourage[s] the use of progression-free survival as the primary endpoint, randomization, inclusion of biomarkers, and incorporation of newer designs,” while acknowledging that “objective response as an endpoint and single-arm designs remain relevant in certain situations.” “There is a lack of predictability in the way Phase II trials are conducted in cancer because few are done in a comparative fashion.”

Similarly, the experts interviewed for the article point out that the key rests in powerful, well-designed phase 2 studies. A great piece (from the author’s Alma Mater) addresses the lack of efficacy in Phase 2, and suggests a remedy.

While companies will never be able to eliminate all of the risk in large-scale clinical trials (e.g. some long-term side effects are not foreseeable), hopefully the field as a whole can become more efficient, helping patients and investors alike. While the above data is not perfect or exhaustive and definitely not indicative of future success / failure, it is a good place to begin for any investor interested in development stage firms. In particular, all sources consulted agreed on one thing: phase 2 results are paramount. The implication appears to be that management cannot always be trusted to make the correct decision (possibly because of loss of objectivity about compounds, pressure to deliver on announcements, pipeline incentives, etc.).

Below, I’ve compiled a list of companies that are currently in phase 3 trials, with a brief description. While by no means passing judgment or assigning odds of success, I am simply trying to give investors a more complete picture. For the rewards of successfully owning stocks in the right companies, look no further than Amgen (AMGN), Genentech, Genzyme (GENZ), etc.

5 Companies Currently in Phase III Trials

Medivation (MDVN): enrollment was completed in a CONCERT study, a 12-month, Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) evaluating the potential efficacy of dimebon (latrepirdine*) when added to ongoing treatment with donepezil. Medivation is conducting this study under its collaboration agreement with Pfizer Inc. (PFE). Data expected in the first half of 2012.

Raptor Pharmaceutical Corp. (RPTP): announced it has reopened enrollment in its Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate (DR Cysteamine) in patients with nephropathic cystinosis. The pivotal Phase 3 clinical trial is designed as a study of the safety, tolerability, pharmacokinetics and pharmacodynamics of DR Cysteamine compared with immediate-release cysteamine bitartrate. Data expected sometime in Q2 2011.

Amarin Corp. (AMRN): reported the completion of patient randomization for its ANCHOR trial, a pivotal Phase 3 trial of AMR101. The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 (ethyl-EPA) in patients with high triglyceride levels from 200 mg/dL to less than 500 mg/dL who are also on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders) and are at significant risk of cardiovascular disease. No omega-3 based therapy is approved by the FDA for treating this patient population. This is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Data expected sometime in Q2 2011.

Omeros Corp. (OMER): expected to announce data from our Phase 3 program evaluating OMS103HP in ACL reconstruction in the first quarter of 2011. OMS103HP is added to standard arthroscopic irrigation solutions and perfused through the joint during surgery. Each active ingredient in OMS103HP was selected for its anti-inflammatory action, and each agent interacts with discrete molecular targets involved in the acute inflammatory response.

Oncolytics Biotech, Inch (ONCY): announced in October 2009 that it had reached an agreement with the FDA under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial (randomized, two-arm, double-blind, multicentre, two-stage, adaptive Phase 3 trial) examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The primary endpoint for the trial is overall survival (OS); secondary endpoints include progression free survival (PFS), objective response rate (complete response (CR) + partial response (PR)) and duration of response, and safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin.

http://seekingalpha.com/article/256697-why-phase-3-trials-fail-what-investors-need-to-know

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Medivation reports smaller 3rd-quarter loss as its drug development costs decrease

admin — Thu, 11 Nov 2010 06:18:42 +0000

SAN FRANCISCO (AP) – Drug developer Medivation Inc. reported a smaller third-quarter loss Friday as its research and development expenses declined.

The company said it lost $5.4 million, or 16 cents per share. A year ago it took a larger loss of $14 million, or 42 cents per share. Its revenue slipped 12 percent, to $14.4 million from $16.3 million. That revenue comes from payments from Medivation’s partners Astellas Pharma Inc. and Pfizer Inc.

Analysts expected a loss of 20 cents per share and revenue of $16.1 million, according to estimates compiled by Thomson Reuters.

The company’s research and development costs decreased to $15.6 million from $21.5 million. A year ago, Medivation and Pfizer were preparing to start two late-stage clinical trials of Dimebon, a drug intended to treat moderate-to-severe Alzheimer’s disease. However, in March, they said one of those studies showed Dimebon was no better than a placebo at treating symptoms of the disease. However research continued: The companies expect to finish enrolling patients in another late-stage trial on Nov. 30, and plan to report preliminary results from a third study in early 2011.

Those studies are intended to evaluate Dimebon as a treatment for mild-to-moderate Alzheimer’s disease, and Huntington’s disease, respectively.

Medivation and Astellas are collaborating on MDVN3100, an experimental prostate cancer drug.

http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D9JA7AL00

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Eli Lilly Halts Alzheimer's Drug Trial

admin — Thu, 16 Sep 2010 03:53:59 +0000

NDIANAPOLIS (TheStreet) — Eli Lilly(LLY) was forced to halt development of an experimental Alzheimer’s disease drug after an early look at results from two late-stage clinical trials determined the drug to be ineffective.

Lilly shares fell 2% to $34.75 in Tuesday’s pre-market trading on news of the setback for the Alzheimer’s drug semagacestat, one of two drugs being in the company’s pipeline that are in late-stage studies against the neuro-degenerative disease.

The failure of semagacestat will also heighten concerns about Lilly’s future growth given the looming loss of patent protection through 2014 on drugs that presently account for 60% of the company’s revenue.

Tuesday, Lilly said it would take a charge of 3-4 cents a share in the third quarter to account for the halting of the semagacestat clinical trials. The company reiterated 2010 guidance of $4.44 to $4.59 a share on a reported basis.

The two phase III clinical trials of semagacestat enrolled more than 2,600 patients with mild to moderate Alzheimer’s, randomizing them to treatment with semagacestat or a placebo. An interim analysis of the studies found that semagacestat-treated patients were performing worse on tests of cognition and ability to complete daily living tasks compared to patients treated with a placebo. In addition, semagacestat patients were at a higher risk for developing skin cancer.

Lilly said Tuesday that phase III trials involving the company’s other late-stage Alzheimer’s drug solanezumab are continuing. Both semagacestat and solanezumab are designed to reduce the levels of amyloid beta plaques, protein substances that attach to and destroy neurons in the brain. Amyloid beta is thought to one of the causes of Alzheimer’s.

Semagacestat works by inhibiting an enzyme, gamma secretase, which the body uses to form amyloid beta plaques.

Earlier this year, Pfizer(PFE) and Medivation(MDVN) said a phase III study of their Alzheimer’s drug Dimebon also failed, although additional clinical trials of that drug continue.

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Alzheimer's disease No end to dementia

admin — Sat, 31 Jul 2010 05:29:08 +0000

Ten years ago people talked confidently of stopping Alzheimer’s disease in its tracks. Now, they realise they have no idea how to do that

DRUG companies are notoriously secretive. The clock starts running on a patent when it is filed, so the longer something can be kept under wraps before that happens, the better for the bottom line. You know something is up, then, when a group of these firms announce they are banding together to share the results of abandoned drug trials. And on June 11th several big companies did just that. They publicised the profiles of 4,000 patients from 11 trials so that they could learn from each other’s failures. An act of selflessness, perhaps, but also one of desperation.

Alzheimer’s disease is one of those things that policymakers would rather hide from. It is, perhaps, the classic illness of old age. Physical frailty is expected, and can be coped with. Mental frailty is much scarier for the sufferer and more demanding for those who have to look after him. It is expensive, too. Alzheimer’s is estimated to cost America alone some $170 billion a year. And it is getting commoner as average lifespans increase. The number of people suffering from the disease is expected to triple by 2050. Effective treatments would thus be embraced with enthusiasm by sufferers and society alike. The right Alzheimer’s drug could earn a drugmaker a lot of money. The incentives are there. But the science has still failed to deliver.

At the turn of the century, Alzheimer’s research seemed promising. A flurry of drugs which treated symptoms of the disorder had just hit the market and researchers were setting out confidently on a deeper investigation of its causes. Understanding those, they felt sure, would result in a cure. It still might, but the truth is that the hoped-for understanding has not come. As a consequence, a long list of would-be cures have failed in late-stage clinical trials, at enormous cost to the companies producing them. The latest of these, Dimebon, made by Pfizer, was abandoned as recently as March, after $725m had been spent on research and development.

Beta testing

The problem of what causes Alzheimer’s is profound. The physical manifestations of the disease that Alois Alzheimer noticed in 1906 are sticky plaques of one type of protein, now known as beta-amyloid, and nerve-cell-engulfing tangles of a second type, called tau protein. Since 1991 the smart money has been on the hypothesis that the disease is caused by the plaques, and that the tangles are mere consequence. For the past two decades, therefore, most attention has been given to developing drugs that will remove amyloid plaques from an affected brain. Five drugs that do this are on the market, but they only delay the onset of dementia. Once their effectiveness has run its course, memory loss and cognitive decline progress unimpeded, and sometimes even accelerate.

Partly as a consequence of this, the plaque theory is waning. Most researchers still believe beta-amyloid is the culprit, but the idea that free-floating protein molecules, rather than the proteins in the plaques, are to blame is gaining ground. This idea is supported by a study published in April in the Annals of Neurology, which showed that mice without plaques, but with floating beta-amyloid, were just as weakened by the disease as mice with both. If that is true in people, too, many more drugs now in clinical trials may prove to be ineffective.

Another fundamental problem is that, whatever is causing the damage, treatment is starting too late. By the time someone presents behavioural symptoms, such as forgetfulness, his brain is already in a significant state of disrepair. Even a “cure” is unlikely to restore lost function. A biochemical marker that indicates the progress of the disease would thus help identify those for whom early action would be advisable, and might help to distinguish people with Alzheimer’s from those with the less hostile forms of forgetfulness that tend to come with old age. Such a marker would also benefit the organisers of clinical trials. They would be able to see more easily whether a drug was working.

To this end, the Alzheimer’s Disease Neuroimaging Initiative (ADNI), established by America’s National Institutes of Health (NIH) in 2004, is measuring the levels of certain proteins in the cerebrospinal fluid of people who may have Alzheimer’s or may go on to develop it. Though the project still has a long way to go, it has already helped develop a test to diagnose the early stages of the disease.

ADNI’s anagram DIAN, the Dominantly Inherited Alzheimer Network, based at Washington University in St Louis, is taking another approach to the biomarker question. Its researchers are studying families with a genetic mutation that triggers the early onset of Alzheimer’s. That terrible knowledge means it is possible to predict which members of a family are destined to get the disease, and compare their biochemistry with that of relatives who do not have the mutation.

It is hard pounding, however, and—as the drug companies’ confession suggests—it is the “R” rather than the “D” of research and development that needs to be emphasised at the moment. A bad time, then, to be cutting back on “R”. That tripling of future sufferers is going to be expensive. Yet Alzheimer’s research, on which the NIH spent $643m in 2006, is to receive only $480m in 2011. It has not been singled out for these cuts. They are part of a general belt-tightening at the agency. But in this as in everything, you get what you pay for. And that might, in the future, be an awful lot of witless, wandering elderly.

http://www.dimebonalzheimers.com/

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Additional Sources New Upcoming Medications Alzheimer's Arena – Financial Analysts

admin — Wed, 26 Aug 2009 11:51:26 +0000

Pfizer and the Japanese drug maker Eisai, currently co-market Aricept, the leading Alzheimer’s drug today with worldwide sales of more than $2 billion.

But Aricept loses patent protection at the end of next year, which is one reason why Pfizer has decided to invest heavily in new Alzheimer’s drug research.
Last September, Pfizer acquired worldwide commercial rights to Dimebon, an experimental Alzheimer’s drug currently in phase III studies. Pfizer paid Medivation(MDVN Quote), Dimebon’s owner, $225 million upfront for the rights, making it one of the largest drug partnership deals of 2008.

Pfizer also has four Alzheimer’s drugs in its own pipeline, most of which are in the early stages of clinical trials. This includes an experimental Alzheimer’s drug acquired in 2006 when Pfizer bought privately held Rinat Neuroscience.

Wyeth has 10 Alzheimer’s drugs in clinical trials, both internally and through partnerships, the most important of which is with Irish drug maker Elan(ELN Quote). The two companies share development efforts and marketing rights to bapineuzumab, which is being studied in four phase III clinical trials.

If the acquisition of Wyeth announced Monday closes as is, Pfizer would boost its Alzheimer’s drug pipeline from five drugs in clinical trials to 15, including two of the four drugs currently in pivotal phase III studies. (Eli Lilly(LLY Quote) and Baxter(BAX Quote) own the other two phase III Alzheimer’s drugs.)

Any new drug that could potentially stop or even reverse the loss of memory or cognitive decline that makes Alzheimer’s such a devastating disease would be a mega-blockbuster. Actual sales estimates vary and are conditional on the efficacy and safety profile of the drug, but it’s not out of bounds to forecast a groundbreaking Alzheimer’s drug achieving peak sales of well over $10 billion, perhaps even $20 billion a year.

More on PFE ‘Fast Money’ Portfolios of the WeekStock Wrap: The Real Story, August 5Mad About Options: Keeping Healthy With BaxterPfizer Prescribes SustainabilityDollar Drops as Risk Appetite GrowsToday’s Outrage: Bemoaning the ‘Strong’ DollarWyeth Lifts ’09 Forecast as Earnings GainPfizer’s Blah Quarter Points to Wyeth DealDividend.com: Midday PlaybookCramer’s Take on Headline Stocks Market Activity Elan Corporation PLC| ELN UPEli Lilly & Company| LLY UPPfizer’s cholesterol drug Lipitor, with $13 billion a year in sales, loses patent protection in 2011. If Pfizer were to hit it big with a groundbreaking Alzheimer’s drug, the company and its investors would find it a lot easier to forget about lost Lipitor sales.
Before Pfizer can start counting new Alzheimer’s revenue, the company faces a host of challenges, not the least of which is waiting to see how many, if any, of these experimental Alzheimer’s drugs will actually wind up working.

Even before that, Pfizer could face scrutiny from the Federal Trade Commission, owing to potential antitrust issues arising from amassing such a large portfolio of Alzheimer’s drugs. This could lead to Pfizer having to divest some of its Alzheimer’s assets, says Jack Walsh, a commercial litigator with the law firm Lathrop & Gage in St. Louis, Mo.

Pfizer spokesman Jack Cox said, “We can’t speculate on the actions of regulators, but we recognize that this is a large, complex transaction. We will work closely with the regulatory bodies to obtain the necessary clearances.”

And Pfizer may have a tricky time managing relationships with its two main Alzheimer’s partners – Medivation and Elan — both of which will want to be seen as a priority over the other when it comes to Pfizer’s time and financial commitment.

More on PFE ‘Fast Money’ Portfolios of the WeekStock Wrap: The Real Story, August 5Mad About Options: Keeping Healthy With BaxterPfizer Prescribes SustainabilityDollar Drops as Risk Appetite GrowsToday’s Outrage: Bemoaning the ‘Strong’ DollarWyeth Lifts ’09 Forecast as Earnings GainPfizer’s Blah Quarter Points to Wyeth DealDividend.com: Midday PlaybookCramer’s Take on Headline Stocks Market Activity Elan Corporation PLC| ELN UPEli Lilly & Company| LLY UPPfizer singled out bapineuzumab in its press release discussing the Wyeth acquisition and also talked about the importance of the drug and Alzheimer’s, in general, on its Monday conference calls.
Corey Davis, drug analyst at Natixis Bleichroeder, says this was likely Pfizer trying to ease any misgivings Elan may have, especially given Pfizer’s existing commitment to Medivation.

“The fact that Pfizer specifically talked about bapineuzumab was probably a signal to Elan that Pfizer intends to maintain Wyeth’s investment in the drug,” said Davis, who covers Elan with a buy rating.

But if Pfizer was sending the love to Elan on Monday, it wasn’t necessarily reciprocated.

Elan spokeswoman Mary Stutts said the company expects a federal antitrust review of the Pfizer-Wyeth deal, particularly in terms of the Alzheimer’s assets, and that until that review is completed, Elan is taking a wait and see attitude.

“We cannot assume at this point that Pfizer will be Elan’s partner for bapineuzumab,” said Stutts.

She added that the current contract between Elan and Wyeth for bapineuzumab and a second Alzheimer’s drug, ACC-001, does include change of control provisions. Stutts would not elaborate on the details of those provisions.

Doug Petkus, a spokesman for Wyeth, said the focus of both Wyeth and Pfizer continues to be on Alzheimer’s research, including bapineuzumab, but he would not say what ultimately happens to the relationship with Elan if and when Pfizer acquires Wyeth.

Data from a phase II study of bapineuzumab, presented last year, raised doubts about the drug’s efficacy and safety. While Elan has moved aggressively to enroll patients in two U.S.-based phase III clinical trials, Wyeth has had problems enrolling patients in two international studies due to safety concerns raised primarily by regulators in Europe.

Natixis analyst Davis believes there is little chance that Pfizer will decide to drop bapineuzumab altogether. “The phase III studies are pretty much on auto-pilot now, so I don’t think Pfizer has much incentive to make major changes.”

Medivation CEO David Hung says his company’s partnership with Pfizer remains unchanged.

“We have not been told of any changes, so I assume that we’re on track. The partnership [for Dimebon] has gone very well and Pfizer speaks enthusiastically about the drug. Alzheimer’s is definitely an area where Pfizer is committed to investing a lot of resources.”

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Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com