At the request of the U.S. Food and Drug Administration, Pfizer Inc. has halted mid-stage clinical studies of what would have been the world’s first biologic pain reliever for back and diabetes-related discomfort.
The news about the once-heralded drug tanezumab, released Monday shortly after the stock market closed, is yet another blow for Pfizer’s new-drug pipeline as the company faces the November 2011 expiration of the patent on Lipitor, the world’s leading medicine, with sales of more than $11 billion last year. It also is disappointing news to Pfizer’s drug-development team in New London, which has been involved in setting up and analyzing tanezumab’s clinical studies.
Just last month, Pfizer had presented positive data on tanezumab, demonstrating the injectable antibody’s effect on reducing knee pain in osteoarthritis patients. A week later, New York-based Pfizer, which has its biggest worldwide research site in Groton, announced that the FDA had asked it to stop a late-stage study of tanezumab in osteoarthritis patients because some people using the experimental drug wound up needing joint replacements.
The FDA’s latest request “follows further consideration of reports of adverse events in osteoarthritis patients,” Pfizer said in a statement, citing “the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied.”
Pfizer said it continues to study tanezumab as a pain reliever for cancer patients and in other groups with unmet medical needs.
Pfizer’s stock price was down 18 cents, or about 1.2 percent, at the end of trading Monday, finishing at $14.55 a share.
The latest drug-testing closure for Pfizer follows several years of bad luck and bad decisions regarding some of the company’s most-promising medicines.
Among the most spectacular failures have been heart medication torcetrapib, once heralded as a potential successor to Lipitor but, after an $800 million investment in research during clinical trials, found to result in excessive deaths; the inhaled insulin Exubera, which never caught on with patients and cost the company nearly $3 billion, and the Russian-born antihistamine Dimebon, which had shown excellent results in midstage trials on Alzheimer’s disease but utterly failed in clinical tests that ended earlier this year and cost Pfizer at least $300 million.
Tanezumab was one of the most promising drugs being developed by San Francisco-based Rinat Neuroscience Corp. when Pfizer bought the company four years ago for a reported $500 million. A pipeline review announced by Pfizer just last year put tanezumab as among its top drug prospects.
Earlier studies of the drug showed significant pain relief and no major health risks.
“Repeated dosing with this compound gives sustained pain relief,” Northwestern University researcher Thomas Schnitzer told the website MedPage Today last fall.
But naysayers have questioned the potential market for tanezumab, wondering if an injectable biologic pain reliever would be embraced. Biologic medicines are made with live organisms.
Pfizer indicated it has not given up on tanezumab. It said the shutdown of its latest clinical trials would have no effect on the employment of local scientists.
“Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab,” the company said.
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Drug makers’ attempts to find treatments for Alzheimer’s disease have produced scant results and a long string of busts. Now a broad effort is under way to learn something from those failures.
A group of major pharmaceutical companies will share pooled data from failed clinical trials in an attempt to figure out what is going wrong in the studies and what can be done to improve drug development.
In the first wave, data from 4,000 patients across 11 failed Alzheimer’s-drug clinical trials from Johnson & Johnson, GlaxoSmithKline PLC, AstraZeneca PLC, Sanofi-Aventis and Abbott Laboratories will be publicly available as of Friday.
Data from additional drug makers and the National Institutes of Health will be added in the future. The coalition aims to create similar pooled databases for Parkinson’s disease and tuberculosis, said Marc Cantillon, executive director of the Coalition against Major Diseases, which spearheaded the project, funded by the Food and Drug Administration and Science Foundation Arizona.
The data will be available to all the participating drug makers, as well as outside researchers with a valid scientific question, Dr. Cantillon said.
“Companies said they’re running into a stone wall with Alzheimer’s and Parkinson’s,” said Ray Woosley, chief executive of the Critical Path Institute, which oversees the coalition. “We really believe drugs are failing because we honestly don’t understand the disease.”
The hope is that this large database will help answer some questions that individual trials with just a couple of hundred patients can’t answer, such as how the disease progresses and whether there are differences in subgroups in the population.
“Innovation no longer happens solely in one company’s lab,” said Frank Casty, AstraZeneca’s vice president of technical evaluations. “It is happening through constant interaction between scientists in the biopharma industry, patient advocates, academia and government.”
For the FDA, the project is something of a counter to criticism that it has been slowing down drug development because it is too focused on patient safety as opposed to on how well a drug works. Rather than debate whether the benefit-risk calculation for new drugs should be changed, the FDA wanted to help the industry develop better methods for determining if drugs are safe and effective, according to Mark McClellan, a former FDA commissioner who helped develop and support the coalition.
“The whole point of this type of effort is to get out of that debate,” Dr. McClellan said.
FDA Deputy Commissioner Joshua Sharfstein said, “I think the FDA recognizes that one thing that can accelerate drug development is sharing information that is relevant to a disease.”
If the database works as hoped, it may enable drug makers to build more sophisticated computer models to help design more efficient clinical trials that require fewer patients and less money, Dr. Cantillon said.
With current studies, if the results show no difference between patients getting an experimental treatment and those getting a placebo, it often isn’t clear if the drug failed or if there was something wrong in the study design that prevented the effect from being picked up in the statistical analyses.
The most recent example is Pfizer Inc.’s Dimebon, originally a Russian cold medicine that had shown promise in treating Alzheimer’s patients in a small, Russian-based trial several years ago. But, a larger, multinational late-stage study recently showed that the drug had no effect on this new sample of patients.
“People are left wondering why it didn’t work,” said Dr. Cantillon.
If a better model could be developed to predict which patients would respond, “it’s possible” that Pfizer could go back and look at Dimebon’s response in those subgroups, he said.
A Pfizer spokesman said the company “is participating in a number of public-private partnerships with governments, independent medical and scientific groups, companies and advocacy groups. Collaborations such as these can lead to more treatment options and better care for patients and the people who care for them.”
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Drug Trials Test Bold Plan to Slow Alzheimer’s
By GINA KOLATA
Marilyn Maldonado is not quite sure why she is at the Memory Enhancement Center in the seaside town of Oakhurst, N.J.
“What are we waiting for?” she asks. About 10 minutes later, she asks again. Then she asks again.
She is waiting to enter a new type of Alzheimer’s drug study that will, in the boldest effort yet, test the leading hypothesis about how to slow or stop this terrifying brain disease.
The disease is defined by freckles of barnacle-like piles of a protein fragment, amyloid beta, in the brain. So, the current thinking goes, if you block amyloid formation or get rid of amyloid accumulations — plaque — and if you start treatment before the disease is well under way, you might have a chance to alter its course.
On Tuesday, that plan got a new push. The National Institute on Aging and the Alzheimer’s Association proposed new guidelines for diagnosis to find signs of Alzheimer’s in people who do not yet have severe symptoms, or even any symptoms at all.
The guidelines are needed for the new approach to Alzheimer’s drug development. Just about every pharmaceutical company and many biotechnology companies have experimental drugs to block amyloid — there are more than 100 in the pipeline. And the companies would like to show that if they give their drugs early, they can slow or stop the disease.
That is the ultimate goal for the drug in the study Mrs. Maldonado wants to enter, sponsored by Bristol-Myers Squibb. The company is, for the first time, testing such a drug in patients who, on evaluation with memory tests and new brain scans and tests for amyloid in cerebrospinal fluid, seem to be in a very early stage of Alzheimer’s. The idea is to attack the disease when there may still be time to stop the worst brain cell death.
But there is a problem. The Food and Drug Administration says it needs to know not just that plaque was reduced or even that it disappeared, but that those who took a drug ended up with better memory and better ability to think and reason as compared with those who did not take the drug.
Alzheimer’s, though, progresses so slowly that showing that a drug, started early, affects symptoms can take far longer than companies can afford to wait.
There is reason not to accept other forms of proof, like scans or cerebrospinal fluid that show changes in amyloid in the brain, the F.D.A. says. The agency has approved drugs for diseases, including sudden death from heart arrhythmias, on the basis of tests that showed symptoms, like heart rhythms, improved. Then it turned out the drugs did not affect the course of the disease and, in the case of the heart drugs, actually hastened death.
So the Alzheimer’s field is poised at an agonizing point — ready to move forward with new methods of diagnosis and drugs that might modify the course of the disease, but without proof that blocking amyloid actually makes a difference.
In the meantime. Bristol-Myers is trying a two-pronged strategy to gain faster approval. It is starting treatment early, but not so early that patients are a decade or more away from Alzheimer’s. And as it looks for effects on symptoms like memory and reasoning, the company will be tracking what happens to amyloid in the brain, hoping to show symptoms improve or no longer worsen as plaque formation slows or stops.
It is a gamble for the company, because even people with fairly mild symptoms may have too much brain damage to be helped. But it is a strategy that makes sense, said Dr. Dennis J. Selkoe, a Harvard researcher who is not affiliated with the study.
“In my view, the sweet spot for amyloid-lowering trials is mild Alzheimer’s disease,” Dr. Selkoe said. “As soon as one of those trials shows benefit, everyone will move to prevention trials,” he said. “They will begin treating before there are symptoms.”
Mrs. Maldonado may be one of the pioneers.
The Amyloid Hypothesis
Considering how important a medical problem Alzheimer’s is — afflicting 5.3 million Americans, the seventh-leading cause of death, and devastating and bankrupting families — it took a surprisingly long time to be recognized as a disease at all. And it took longer still to reach any kind of agreement on its cause.
Dr. Paul Aisen, an Alzheimer’s expert at the University of California, San Diego, remembers well the old days, in the late 1970s. He was in medical school, studying to be a geriatrician. There was no discussion of Alzheimer’s disease.
Ever since it was described by Dr. Alois Alzheimer in 1906 as a “peculiar” disease in a 51-year-old woman, doctors had considered it an oddity, a rare illness of middle, not old, age. Old people who lost their memory and ability to reason and care for themselves were said to be “senile.” That word did not refer to any specific disease like Alzheimer’s. Senility, Dr. Aisen said, was “what might happen when you got old.” And “there was nothing you could do about it.”
Then, in 1976, doctors’ eyes were opened by an editorial in Archives of Neurology by Dr. Robert Katzman, a neurologist. Alzheimer’s, he wrote, is not rare — it is common. It can arise in old age. And it is a leading cause of death and, Dr. Katzman said, a disease whose origin could be determined and whose course might be stopped.
Neurologists took note. But it was 20 years before there were any drugs for Alzheimer’s, and the four approved so far treat only symptoms, modestly and temporarily improving memory, for example, and do not affect the relentless brain cell death.
In the meantime, researchers came upon an exciting target for a drug. They discovered two enzymes that snip pieces from a large protein protruding from brain cells. The result is toxic fragments of a substance known as amyloid beta peptides. Those shards accumulate as plaques on the brain. One way to prevent plaques might be to block one of those crucial enzymes.
Just about every drug company got to work.
They had long suspected amyloid beta was a key player in the genesis of Alzheimer’s, but until they found the enzymes researchers had no way to block it. Amyloid beta itself might be injuring nerve cells or the plaques, made of accumulations of amyloid beta, could be the culprits. But whichever was true, three lines of evidence pointed to amyloid beta: rare gene mutations that lead to its overproduction cause Alzheimer’s in middle age. Down syndrome also causes overproduction of amyloid beta, and people with Down always get Alzheimer’s. And when scientists put the rare mutated genes that cause Alzheimer’s into mice, the mice developed plaques and memory problems.
The logic was not airtight. Scientists note that older people with typical Alzheimer’s often have something else wrong in their brain — damage from mini-strokes, for example. Perhaps some of these other conditions set off waves of cell death independent of amyloid beta.
But over the years, researchers say, what has become known as the amyloid hypothesis — the notion that overproduction or reduced clearance of amyloid beta is a cause of the disease and blocking amyloid beta could stop it — dominated their thinking.
“Ninety percent of us in the field believe it is correct,” Dr. Aisen said.
An Antibody Approach
Testing of the amyloid hypothesis began a few years ago with two experimental anti-amyloid drugs, homotaurine and tarenflurbil.
Patients who took them did not improve.
But, some researchers asked, was that a fair test? The first drug was not very potent, and little of the second reached the brain. And it was not clear whether either was really affecting amyloid because there were no direct measurements of plaques or amyloid beta protein.
The results, said Dr. Samuel E. Gandy, a professor of Alzheimer’s disease research at Mount Sinai School of Medicine, were “uninterpretable.”
Then there was the vaccine approach — immunize against amyloid beta and let the immune system clear plaque. It worked in mice and so, to great excitement, researchers tested it in patients. But a preliminary study was abruptly halted when 18 of 300 patients developed a brain inflammation. Two immunized patients who later died after reaching “severe end-stage dementia” had almost no plaque in their brains on autopsy — the vaccine had apparently cleared plaques but not noticeably affected their disease.
But that is not proof a vaccine would not work, said Dr. Selkoe, a founder of the company that did the study and a consultant to it. Two patients hardly constitutes a full analysis of the trial data, he says.
Now, the company, Elan, and its collaborators are trying a different tack. Instead of using a vaccine, they made an antibody to amyloid beta, a drug called bapineuzumab.
Some initial results were published in March. A new type of scan that can show plaques found the drug was removing them. But so far it is unclear whether patients are improving.
Johnson & Johnson, which partnered with Elan and its collaborator, Pfizer, says it will continue the study.
That makes sense, said Dr. Gandy, who is not part of the study.
“We have no idea how long we might need to treat,” he said.
Tough Road to Consensus
Dr. Russell Katz, director of the F.D.A.’s division of neurology products, is in a quandary about Alzheimer’s drugs. What, he must decide, should be the criteria for showing that a drug works?
Should the F.D.A. say it is sufficient to show that a treatment prevents or lessens the formation of plaque?
The agency is not ready to do that, Dr. Katz said.
“You only care if down the road the patient gets better,” Dr. Katz said. “What we are concerned about is approving a drug based on a lab test and being wrong about what happens to the patient clinically.”
With Alzheimer’s, Dr. Katz said, “the great fear is that maybe amyloid has nothing to do with the disease.” If that were the case, and the agency approved a drug that blocked amyloid formation, millions of healthy people could end up taking something useless or even dangerous. And because it takes so long for Alzheimer’s to develop, it could be decades, if ever, before anyone knew the drug did not work.
“It is a conundrum,” Dr. Katz said. “We all hope to get to the point in our understanding of the disease process where everyone in the field says: ‘Look. We know it now. Amyloid causes Alzheimer’s, and we have drugs that decrease amyloid.’ But we are not there yet.”
Bristol-Myers Squibb, though, is betting amyloid beta is the culprit. And it is betting it can show an effect in people who are in the early stages of Alzheimer’s.
Still, Dr. Aisen is concerned that even those patients, people like Mrs. Maldonado, might be beyond help. Treatment may have to start much earlier. So he is planning a large federal study to test amyloid-blocking drugs in people over 70 with normal memories but evidence of some amyloid accumulation. His criteria for success will not be the F.D.A.’s current one. Instead, he will ask whether the drugs slow the brain atrophy that is characteristic of Alzheimer’s and prevent amyloid from accumulating in subjects’ brains.
“If you think Bristol-Myers Squibb is going out on a limb, this is going farther,” Dr. Aisen said. If blocking amyloid beta and slowing brain atrophy are not accepted as sufficient evidence that a drug works, a study with normal 70-year-olds could end up taking 10 to 15 years to show an effect on the actual symptoms of Alzheimer’s.
After her scan that recent day, Mrs. Maldonado was entered in the Bristol-Myers study.
She is 82, a former school bus driver living in nearby Jackson with a diagnosis of mild memory impairment. She came with her son-in-law to the Memory Center that day, in black slacks and a flowered blouse, wearing a gold bracelet and gold rings. Her short white hair was fluffy, freshly washed. And she had a way about her, a joking demeanor, intended to disguise her forgetfulness.
Her brain, the scan showed, was riddled with plaque.
Dr. Joel Ross, who runs the Memory Center, told her the results.
“We found you are producing a sticky material called plaque,” he told her.
“Yeah,” she said.
“It’s coating some of your brain.”
“Yeah,” she said again.
“If you stay this way there will be a lot of it.”
“Yeah.”
“So we’re going to give you a drug that may clear it up.”
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SAN FRANCISCO, May 10 /PRNewswire-FirstCall/ –Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2010.
“After thorough review of all available dimebon data, including the disappointing CONNECTION results, Medivation remains committed to determining whether dimebon may offer clinical benefit to Alzheimer’s and Huntington disease patients,” said David Hung, MD, president and chief executive officer of Medivation. ”We will continue to enroll patients in the 12-month Phase 3 CONCERT trial in mild-to-moderate Alzheimer’s patients and the six-month Phase 3 HORIZON study in Huntington disease, and will stop our two ongoing Phase 3 trials in moderate-to-severe Alzheimer’s disease. In reaching this conclusion, we considered all dimebon data generated thus far, including the negative CONNECTION data, the clinical benefit seen in two prior dimebon trials in mild-to-moderate Alzheimer’s disease and Huntington disease, the excellent safety and tolerability profile in all dimebon trials to date covering more than 2,000 patients, the preclinical data consistently showing that dimebon is pharmacologically active, and the potential risks and returns of continuing development for Alzheimer’s and Huntington diseases. We believe both the CONCERT and HORIZON studies offer independent pathways to registration, and we will be meeting with the Food and Drug Administration this quarter to discuss the CONNECTION data and obtain guidance on our proposed regulatory path forward.”
“We also continue to make progress on our MDV3100 program,” continued Dr. Hung. “This year we and our partner Astellas expect to complete enrollment in the Phase 3 AFFIRM trial in advanced prostate cancer patients and to initiate three new trials in earlier-stage prostate cancer, including a second Phase 3 trial. Our cash position remains strong and, based on current assumptions, we expect our cash to last beyond 2012, without regard to whether Pfizer elects to remain in our dimebon collaboration. We also expect to have reported top-line data from the CONCERT, HORIZON and AFFIRM trials by the end of 2012.”
Recent Accomplishments and Anticipated Milestones
Dimebon(latrepirdine*)
Completed an analysis of data from the Phase 3 CONNECTION trial in patients with mild-to-moderate Alzheimer’s disease, and confirmed that dimebon did not show clinical benefit in this trial. The analysis did not identify any systematic issues with the conduct of the trial or with the drug product that would explain the results.
Continued to enroll patients in CONCERT, with the goal of completing patient accrual in 2010. This 12-month randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with mild-to-moderate Alzheimer’s disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil.
Continued to enroll patients in HORIZON, with the goal of completing patient accrual in 2010. This six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating dimebon’s potential benefits on cognition in patients with Huntington disease.
Agreed with our partner Pfizer to discontinue the CONSTELLATION and CONTACT Phase 3 trials in patients with moderate-to-severe Alzheimer’s disease. These trials were part of a label expansion strategy for dimebon, which can be revisited at a later time if the results of the ongoing CONCERT trial warrant.
*Latrepirdine is the proposed generic name for dimebon.
MDV3100
Announced publication in The Lancet of positive efficacy data from the Phase 1-2 trial of MDV3100 in advanced prostate cancer patients. MDV3100 demonstrated anti-tumor activity as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. MDV3100 was generally well-tolerated in this trial at doses up to and including 240 mg/day.
Continued to enroll patients in the AFFIRM trial, with the goal of completing patient accrual in 2010. This randomized, double-blind, placebo-controlled Phase 3 survival trial is evaluating 160 mg/day of MDV3100 in men with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Obtained issuance of a U.S. patent claiming MDV3100′s composition of matter. The term of this patent runs through 2027, and under current law is eligible for up to five years’ patent term extension based on time spent pursuing regulatory approval to market MDV3100.
On track to initiate three new MDV3100 trials in earlier-stage prostate cancer this year: a Phase 3 trial in men with chemotherapy-naive castration-resistant prostate cancer; a Phase 2 head-to-head trial comparing MDV3100 with bicalutamide; and a Phase 1 trial in hormone-naive patients. Initiation of the Phase 3 trial would trigger a $10 million milestone payment under our collaboration agreement with Astellas.
Corporate
Implemented a 20 percent workforce reduction to focus resources on the prioritized CONCERT and HORIZON dimebon trials and expanded development of MDV3100.
First Quarter 2010 Financial Results
Revenue for the first quarter of 2010 was $15.7 million, consisting of partial recognition of the non-refundable up-front payments of $225.0 million received from Pfizer in the fourth quarter of 2008 and $110.0 million received from Astellas in the fourth quarter of 2009. Both up-front payments were recorded as deferred revenue upon receipt and are being recognized on a straight-line basis over the estimated performance period of the Company’s obligations under the applicable collaboration agreement, which the Company presently expects to complete in the second quarter of 2013 for the Pfizer collaboration and in the fourth quarter of 2014 for the Astellas collaboration.
For the three months ended March 31, 2010, total operating expenses were $33.4 million, compared with total operating expenses of $22.1 million for the same period in 2009. These figures include non-cash stock-based compensation expense of $3.5 million in the quarter ended March 31, 2010, compared with $2.6 million for the same period in 2009.
Beginning in October 2008, Pfizer became responsible for 60 percent of all dimebon-related development and commercialization costs in the U.S., and 100 percent of such costs outside the U.S. Beginning in October 2009, Astellas became responsible for 50 percent of all MDV3100-related development and commercialization costs in the U.S. (other than costs for clinical trials supporting development in both the U.S. and either Europe or Japan, including the ongoing Phase 3 AFFIRM trial and the two additional trials in earlier-stage prostate cancer we expect to initiate in 2010, which are borne two-thirds by Astellas and one-third by Medivation) and 100 percent of such costs outside the U.S. The parties make quarterly true-up payments as necessary to ensure that each bears its applicable share of costs. For the first quarter of 2010, the net true-up payments payable to Medivation were $4.6 million and $6.1 million under the Pfizer and Astellas collaborations, respectively. Medivation presents these cost-sharing true-up payments in the applicable expense line of its consolidated statement of operations.
Medivation reported a net loss for the quarter ended March 31, 2010, of $17.5 million, or $0.51 per share, compared with a net loss of $5.6 million, or $0.19 per share, for the same period in 2009.
Cash, cash equivalents and short-term investments at March 31, 2010, totaled $255.5 million, compared with $278.2 million at December 31, 2009.
2010-12 Financial Outlook
Medivation currently expects that total operating expenses for 2010, net of cost-sharing payments from Pfizer and Astellas, will be between $105 and $115 million. This forecast includes approximately $13.5 million of non-cash stock-based compensation expense. We also expect to receive a $10 million milestone payment from Astellas in 2010 upon initiation of the second Phase 3 study of MDV3100.
Medivation believes that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012, without regard to whether Pfizer elects to remain in the dimebon collaboration. By the end of 2012, the Company expects to have reported top-line data from the CONCERT trial in mild-to-moderate Alzheimer’s disease, the HORIZON trial in Huntington disease, and the AFFIRM trial in castration-resistant prostate cancer patients who have failed chemotherapy.
Conference Call Information
To participate by telephone in today’s live call beginning at 4:30 p.m. Eastern Time, please call 877-303-2523 from the U.S. or +1-253-237-1755 internationally. In addition, the live conference call is being webcast and can be accessed on the “Events and Presentations” page of the “Investor Relations” section of the Company’s website at www.medivation.com. A replay also will be available for 30 days following the live call.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, Medivation is conducting a clinical development program that includes CONCERT, a Phase 3 trial assessing dimebon in patients with mild-to-moderate Alzheimer’s disease, and HORIZON, a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered into a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for both early- and late-stage prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. Additional trials in earlier-stage prostate cancer will begin in 2010. For more information, please visit us at www.medivation.com.
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When it comes to shopping around for new drugs from biotech partners, Pfizer is a bit like a naive used car buyer. It seems to pay a lot of attention to the gloss on the surface, and not enough to whether the engine inside will work.
How else can you explain the company shelling out $225 million on the Alzheimer’s drug Dimebon from Medivation? In its first big trial last week, the drug showed no effect whatsoever on Alzheimer’s symptoms. The result is so bad it raises serious questions about what Pfizer was thinking when it licensed the drug two years ago.
From a chemistry perspective, the old antihistamine was never anything special, University of Southern California Alzheimer’s expert Lon Schneider has pointed out. But Pfizer (apparently) got excited based on one smallish trial with promising results conducted entirely in Russia. There also was a lot of buzz about the drug doing something special to mitochrondria. In fact, the mechanism of the drug was always murky.
Over the years, Pfizer has bought enough biochemical duds to fill an entire junkyard. Here is a list of some of Pfizer’s past lemons:
Exubera
Pfizer spent billions and many years and testing this version of inhaled insulin, even as after the gadget got ever more clunky and the drug was linked to signs of decreased lung function. It finally pulled the plug in 2007.
Macugen
Pfizer licensed this drug for macular degeneration for $300 million, but it has been a commercial flop.
Esperion Therapeutics
In 2003, Pfizer paid $1.3 billion for this company testing a protein “Roto-Rooter” for clogged arteries. After the deal, hardly a peep was heard about the product again. In December, Pfizer sold the protein product for $10 million to the Medicines Company. (Pfizer will get more if the new owner revives the drug.)
Indiplon
Pfizer licensed this sleeping pill from Neurocrine Bioscience in 2002 for $200 million—then dumped it in 2006 when the Food and Drug Administration turned it down.
Vicuron Pharmaceuticals
In 2005, Pfizer snared this company for $1.9 billion to gain access to its new antibiotic and new antifungal. The antibiotic has yet to be approved, while the antifungal’s sales were just $18 million last year, according to Bernstein Research.
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In regards to Dimebon (Dimbolin) the Medivation firm has announced that it selected the patients for its clinical trial. Does this mean that no other Dimebon will be available for patients until after the trial ends , is published in peer journals and the FDA approves this medication for use in Alzheimer’s Disease ?
Medivation Completes Enrollment in Confirmatory, Pivotal Phase 3 ‘CONNECTION’ Trial of Dimebon in Patients With Alzheimer’s Disease
SAN FRANCISCO, June 11, 2009 /PRNewswire-FirstCall via COMTEX News Network/ — Medivation, Inc. (Nasdaq: MDVN) today announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer’s disease.
The international, double-blind, placebo-controlled, pivotal Phase 3 study enrolled 598 patients, exceeding the enrollment target of 525 patients. More than 40 percent of the patients enrolled were in the United States. The six-month study is evaluating the effect of dimebon on the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician’s Interview-Based Impression of Change plus caregiver interview (CIBIC-plus) — the two endpoints have historically been accepted by the U.S. Food and Drug Administration (FDA) to support registration of currently approved drugs for mild-to-moderate Alzheimer’s disease.
“Completion of patient enrollment in this second pivotal trial moves us closer to our goal of submitting a marketing application to the FDA and bringing dimebon to market for the many Alzheimer’s patients suffering from this devastating disease,” said Lynn Seely, M.D., chief medical officer of Medivation. “We are gratified by the strong interest in this trial as indicated by our exceeding the enrollment goal. Together with our partner Pfizer, we are executing a comprehensive clinical plan to support an NDA filing, currently targeted for 2011, with a broad and differentiated label for dimebon in Alzheimer’s disease. We are also conducting a Phase 3 safety study, which will provide us and Pfizer the opportunity to seek marketing approval earlier if results of the CONNECTION study confirm our previously completed first pivotal study, which was published in the Lancet last year.”
About Dimebon
Dimebon is an investigational compound currently in Phase 3 development for the treatment of Alzheimer’s disease and in clinical development for Huntington disease. In preclinical models of Alzheimer’s disease and Huntington disease explored thus far, dimebon has been shown to inhibit brain cell death, potentially by stabilizing and improving mitochondrial function in a way that prevents neuron death and dysfunction. The dimebon mechanism is thought to be distinct from that of currently available Alzheimer’s disease medications.
In addition to CONNECTION, dimebon is being studied in the 12-month Phase 3 CONCERT trial, which is evaluating the efficacy of dimebon when added to ongoing treatment with donepezil (Aricept(R)) in patients with mild-to-moderate Alzheimer’s disease, and in a Phase 3 safety study. Two Phase 3 studies in moderate-to-severe Alzheimer’s disease are also planned to start this year.
In Huntington disease, a Phase 2 study has been completed. Medivation and Pfizer expect to initiate a Phase 3 trial this year to evaluate the potential benefits of dimebon on cognition in patients with Huntington disease.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive degenerative brain disorder that gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation announced a global agreement with Pfizer Inc to develop and commercialize dimebon for the treatment of Alzheimer’s and Huntington diseases. With Pfizer, the Company is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer’s medications in patients with mild, moderate or severe Alzheimer’s disease. Further development of dimebon in patients with Huntington disease is also planned. In addition, a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer is ongoing, and a Phase 3 trial is expected to begin this year. For more information, please visit us at http://www.medivation.com.
This press release contains forward-looking statements, including statements regarding the timing and potential results of clinical trials, and the anticipated timing of regulatory filings, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation’s clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation’s clinical trials, partnering of Medivation’s product candidates, manufacturing of Medivation’s product candidates, competition with Medivation’s product candidates should they receive marketing approval, the adequacy of Medivation’s financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2009, filed on May 11, 2009, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
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The cholinteresterase inhibitors thus far available are currently only approved by the F.D.A. (The US Food and Drug Administration) , are approved by the FDA as only being effective for Alzherimer patients who have thus far mild to moderate disease. However these drugs and medications – that is the cholinesterase classification medication grouping, may well show promise for those who are in the earliest as well as later stages of the disease , as well. In addition they could well be of benefit and benefits to those with mil cognitive impairment as well.
One large study evaluated the use of Aricept (dozepezil) in the treatment of mild cognitive impairment and found that it significantly reduced conversion to active Alzheimer’s progressive disease.
Current Treatment for Alzheimer’s Disease – Prescription cholinesterase inhibitors include Exelon and Aricept. These drugs have varying side effects and can have contraindications with other medication, so it can be difficult for doctors to find the right pharmaceutical match and …
Methods and compositions using cholinesterase inhibitors – The invention provides methods for treating and/or preventing Alzheimer’s disease, psychiatric illnesses, encephalitis, meningitis, fetal alcohol syndrome, Karsakoff’s syndrome, anoxic brain injury, cardiopulmonary resuscitation …
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Galantamine: Welsh daffodils containing galantamine may help fight … – Galantamine is a competitive and reversible cholinesterase inhibitor. It is believed it works by enhancing cholinergic function by increasing the concentration of acetylcholine in the brain. The atomics resolution 3D structure of the …
While cholinesterase inhibitors are now believed to he most helpful in persons with severe Alzheimer’s disease ,sometimes patients can be maintained on these classes and classifications of drugs indefinitely due to the fact and observation that in clinical practice , that often patients who stop taking these drugs or types of medications deteriorate rapidly when the drugs are arbitrarily stopped or withdrawn. Indeed there is new and upcoming evidence from studies that suggest that stopping cholinesterase inhibitors will result in decline in functioning to a level that the patient would have been at it they – he or she – had not been taking the drug in the first place.
In addition drugs in this class appear to have an added benefit in improving behaviour as well as overall cognitive abilities.
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