Then, a series of personality changes suddenly surfaced. DeLorenzo started doing things that were out of character, such as having more than one glass of wine after dinner and driving to Connecticut’s casinos during the day. He began repeating certain behaviors over and over, such as insisting on dining out at the same restaurant. He would get angry while driving. He became defensive, frustrated and volatile.

His wife could not understand what was happening. “I was upset and angry,” she said. “At one point, I pulled out our wedding picture and asked him, ‘What happened to this person?’”

At his 2007 annual physical exam, Doreen DeLorenzo asked the doctor about attention deficit and obsessive compulsive disorders.

The memory problems worsened.

“I couldn’t remember things in my profession, and I became concerned about the projects I was involved in,” Dennis DeLorenzo said. “It was taking longer to get work done, and I could no longer meet my deadlines. I couldn’t understand questions that clients would ask me. I would say the wrong words.”

A lifelong fan of the “Star Wars” movies, he no longer understood what “Darth Vader” meant. He lost interest in his hobby, watercolor painting, and could no longer follow the plots of TV shows.

After undergoing a battery of memory tests, a neuropsychologist diagnosed Dennis DeLorenzo with dementia in April 2008, and a few months later a psychiatrist at Yale-New Haven Hospital’s Dorothy Adler Geriatric Assessment Center pronounced the unthinkable: Alzheimer’s disease. DeLorenzo was 53 years old.

“This occurred at the height of my career, and that’s the most depressing thing,” he said. He closed his company, Design Dynamics, in January 2009. “My whole life — doing the work that I loved, getting to the high point of my architecture career, 30 years of experience — it all ended.”

The diagnosis was devastating.

“I had lost my husband,” Doreen DeLorenzo said. “We had a really good life. We used to travel, Dennis had a thriving business. The hardest part has been losing my spouse. He’s physically there, but mentally, he’s not. Birthdays and anniversaries don’t mean anything to him. Now, I’m a caregiver.”

Still, it was a relief to finally understand why her husband had changed drastically and suddenly, she added. “A calm came over me. Now I could have the compassion I needed to help Dennis.”

The diagnosis allowed him to obtain medications that have helped lift depression and curtail personality changes. Today, he occupies himself primarily with projects around his house, such as adding insulation in the attic and renovating the back porch. It’s slow going, as he tires very easily.

A former quarterback at Notre Dame High School in Fairfield, DeLorenzo continues to watch football on television and follow the New York Giants. He also retains a knack for numbers, so his wife, in an effort to keep his mind as sharp as possible, has encouraged him to do easy Sudoku puzzles, and they have taken up bingo.

“We’re in a better place now,” said Doreen DeLorenzo, who is 53. “I know it will be hard. But I just tell him we’ll take it one day at a time.”

Helping Others See

Sitting at his kitchen table on a recent morning, DeLorenzo pointed to an empty space in his yard where he had torn down an old wooden deck. He wanted to replace it with a stone patio. Before giving up his architecture practice, he said, long hours had prevented him from completing projects around the house. Now, the disease is slowing him down.

He is determined to maintain a positive attitude and do what he can to remain involved in life.

“I know this disease is not going to get any better,” said Dennis DeLorenzo, whose speech remains articulate much of the time at this stage of the disease. “If anything, it’s going to get worse. But, you shouldn’t give up.”

He has volunteered to help the Connecticut chapter of the Alzheimer’s Association increase awareness of the disease in people younger than 65 by telling his story to the public. The DeLorenzos hope that telling their story will help others realize what is going on earlier than they did.

“Until this happened, I always thought of Alzheimer’s as an older person’s disease,” Doreen DeLorenzo said.

Previously called early onset Alzheimer’s, the national Alzheimer’s Association is encouraging a change to the term “younger-onset Alzheimer’s,” because “early onset” is often confused with the early stages of the disease or with early detection.

Younger-onset Alzheimer’s is a growing problem, with an estimated 200,000 people having it in the United States. That compares with more than 5 million age 65 and older.

“We are seeing a greater incidence of younger-onset Alzheimer’s, and we don’t know why,” said Trish Clark, executive director of the state chapter of the Alzheimer’s Association. “It may be that more people are getting to their physician and getting diagnosed earlier.”

There are no studies showing the number of cases in Connecticut, she said.

Raising awareness of younger-onset Alzheimer’s will help more people get treatment and other aid earlier, Clark said, adding that it can be especially difficult for family members to deal with when it strikes at a young age.

“It’s not easy at any stage in life, but it’s extremely difficult with younger-onset because the whole family is completely derailed,” she said. “Children are trying to launch their careers, and they may have to drop out of college to be there for their parents. Spouses are still quite young, and they are looking at the prospect of caring for someone for many years. Their plans are changed forever.”

The Alzheimer’s Association offers support groups for patients, families and caregivers, and maintains a 24-hour telephone line. The group conducts family training sessions to give people the skills and understanding they need to care for people with dementia, and will design a plan of care for families. There are separate training programs for those coping with younger-onset Alzheimer’s.

Clark said the DeLorenzos provide an example of the heartbreaking consequences of younger-onset Alzheimer’s. “He is facing a future of not being able to take care of his family, and he is uncertain about how this is going to affect the rest of his life,” she said. “Everything was taken away from him at a time when he was looking at a very bright future. It’s devastating, and it affects the whole family.”

The Alzheimer’s Association receives most of its funds from donations, which have dropped about 15 percent during the economic downturn. The association and other groups are advocating for an increase in federal funding of Alzheimer’s research.

New Drugs Offer Hope

A pill-dispenser sits on Dennis DeLorenzo’s kitchen counter, a reminder of his dramatically altered life. He joined a clinical trial last year at Yale-New Haven Hospital. It is testing a drug developed by Bristol-Myers Squibb. His wife drives him to the Alzheimer’s Disease Research Unit in New Haven for cognitive testing regularly.

Alzheimer’s is the most common type of dementia, which is defined as a loss of memory or other mental function significant enough to affect day-to-day living. Alzheimer’s is a progressive disease that destroys brain cells and is the seventh-leading cause of death in the United States.

Scientists have developed drugs that treat some symptoms of dementia; numerous researchers worldwide are searching for a cure. The Yale Alzheimer’s Disease Research Unit has a number of clinical trials under way. The unit is a member of the Alzheimer’s Disease Cooperative Study funded by the National Institute of Aging.

“We are seeing more people who are younger” apply to be in clinical trials, said Martha G. MacAvoy, a clinical researcher with the Yale unit. “People are becoming more educated about the disease.”

Yale is conducting trials involving both pills and injections, and recruits people with mild, moderate and severe cases of Alzheimer’s, MacAvoy said.

The clinical trial DeLorenzo is part of is testing a drug designed to stop the formation of plaque in the brain, a possible cause of the disease.

Some promising results were reported in July at the Alzheimer’s Association 2009 International Conference on Alzheimer’s Disease in Vienna. A study of an omega 3 fatty acid showed a positive result on one test of memory and learning. Another showed the drug Dimebon may improve cognitive function in people with mild to moderate Alzheimer’s. Researchers also reported finding evidence that regular exercise and a healthy diet may help maintain healthy cognitive function in late life.

Moving Forward

Frustrations mount each day, but DeLorenzo is finding ways to cope with his condition. A song comes on the radio and he cannot remember it, even though he knows heard it before. He goes to Home Depot and cannot understand the materials and tools he used to take for granted. He avoids speaking with people in public, since he often cannot understand specific words, and he uses the incorrect words. He can’t understand why he no longer has any desire to sail, once a treasured activity.

“I’m always asking myself, ‘What the hell is this going to be like in a few months or a few years?’” he said.

He does remember certain things. For instance, while he can’t remember to put oil in the lawn mower, he can remember to check the maintenance chart he has hung on the garage wall as a reminder.

“There are certain things I can remember,” he said. “At least I haven’t forgotten everything.”

Losing his business put a financial strain on the family, especially since DeLorenzo was helping his son and daughter through college.

His daughter, Rachele, 25, recently graduated from Pennsylvania State University with a degree in advertising and public relations. “I want to help, and I’m here for whatever he needs,” she said. She often drives her father to doctor appointments and other places. DeLorenzo’s son, Jason, 21, is studying architecture at the University of Colorado.

After his diagnosis, DeLorenzo was approved to receive Social Security disability payments, but he had to wait six months before the money started coming in. Fortunately, his wife has a good medical benefits package from her job as an accountant at the John B. Pierce Laboratory, located on the Yale School of Medicine campus.

The DeLorenzos were married in 1995, a second marriage for both of them. They met when he was a vice president at Svigals + Partners, a New Haven architectural firm, and she was the office manager.

Dennis DeLorenzo, who grew up in Bridgeport, obtained his architectural degree from the Georgia Institute of Technology in Atlanta in 1977. He returned to Bridgeport and joined Fletcher Thompson, then worked for a variety of companies, including the famed Newman Architects LLC in New Haven.

During his time with Svigals + Partners, he designed the well-known R.J. Julia Booksellers bookstore in Madison, and enjoyed it so much that he began to specialize in designing independent bookstores. He eventually designed about 60 bookstores around the country, from 1992 to 2009. He started Design Dynamics in 2004 in his Milford home.

“I loved my work, and it’s a very depressing thing for me to have to give it up,” DeLorenzo said. He added that he feels bad about the effect his condition is having on his wife. “She’s the caregiver, and that means more responsibility for her,” he said.

His biggest regret, though, concerns his son, who is following in DeLorenzo’s footsteps by studying architecture.

“My son is going to become an architect,” he said. “When he was in high school, he helped me out with projects, and I took him to see projects around the country. But now, I won’t be able to follow him and help him in his career. That makes me sad.”

http://www.nhregister.com/articles/2010/01/23/news/doc4b5bb7b9ac87f060602064.txt

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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Reform or no reform, pharmaceutical industry poised to win
US healthcare reform represents one of the most important issues facing pharmaceutical stocks in 2010. However, the passage of healthcare reform is far from certain, especially since the loss of the Democratic seat in Massachusetts means the Democrats no longer hold a filibuster-proof majority in the Senate. Also, the loss of Democratic power in the Senate will likely mean any potential healthcare reform will be scaled back from the current proposals in the House and the Senate.

Further, if both houses of US Congress hold up the bill beyond the second quarter of 2010, we believe the prospects for far-reaching reform will diminish greatly, as politicians won’t likely want the contentious issue of healthcare reform hanging over mid-term elections.

Regardless of whether reform passes, we believe the pharmaceutical industry will come out on top, as the direst scenarios for the sector–a single-payer system or its “cousin,” a public plan with a Medicare-linked fee schedule–have been all but ruled out as outcomes.

Beyond reform, many drivers of 2010 pharma performance
While the conclusion of reform efforts in 2010 should be a positive for the pharma industry regardless of whether a bill successfully passes (full analysis of the reform’s impact on the pharmaceutical sector is available here), performance of the biggest pharma firms in 2010 will also be driven by several factors at the individual firm level. We’ve teased apart the winners and losers regarding upcoming clinical data for pharma firms in 2010. We’ve also reviewed the upcoming patent losses and drug launches to determine which pharmaceutical firms are best-positioned in the upcoming year.

Please note that fair values are displayed above in US dollars, our pound sterling fair values for UK-listed stocks can be found in our AstraZeneca report and our GlaxoSmithKline report.

Clinical data
Game-changing clinical data are expected throughout 2010. We believe strong data could shift negative investor sentiment surrounding pharma industry pipelines, leading to better valuations for the entire group.

Winners
Pfizer (JAK inhibitor): In the arthritis market, we will likely see data from Pfizer’s JAK inhibitor, currently in a Phase III programme known as ORAL. Based on very strong Phase II data, we think the drug could significantly dent TNF-alpha dominance in the rheumatoid arthritis market. Since the drug has already established strong efficacy, safety will be key in the Phase III data.

Bristol-Myers Squibb / AstraZeneca (dapagliflozin): In diabetes, Bristol-Myers Squibb and partner AstraZeneca should report on the majority of its five remaining trials for dapagliflozin. Based on the drug’s strong data demonstrating efficacy and weight loss in the first three studies, we expect positive results in additional studies will position the companies to file for approval in late 2010.

Johnson & Johnson (telaprevir, Xarelto): In the hepatitis C market, J&J and Vertex should report strong pivotal Phase III data on protease inhibitor telaprevir. We also expect J&J’s cardiovascular drug Xarelto will post solid data in the ROCKET study, demonstrating its ability to prevent strokes in patients with atrial fibrillation.

Merck (boceprevir, Vytorin, TRA): While we believe telaprevir may have a leg up on Merck’s hepatitis C drug candidate boceprevir based on a shorter duration of treatment, we expect both drugs will become blockbusters. We also expect data from the SHARP study will show favourable results for cholesterol-lowering drug Vytorin, which has been marred by data putting the efficacy of this combination therapy into question. While flying under the radar, Merck’s cardiovascular thrombin receptor antagonist (TRA, known as SCH 530348) is positioned to potentially match Plavix sales of over $8 billion, in our opinion. We expect data from the TIMI 50 Phase III trial in September 2010 will confirm the drug candidate’s positive Phase II data.

Losers
Bristol/Pfizer (apixaban): We expect poor clinical data from Bristol and Pfizer’s apixaban. The drug failed to show noninferiority versus Lovenox in a 3,195 patient trial called ADVANCE-1. Regardless, the companies are forging ahead with Phase III trials in stroke prevention and other cardiovascular diseases, with approximately 35,000 patients across all ongoing trials. Out of several leading replacements for warfarin, we are most sceptical of apixaban given the uninspiring efficacy shown in ADVANCE.

Merck (anacetrapib). We hold low expectations for Merck’s anacetrapib, which appears very similar to Pfizer’s failed torcetrapib. We expect Merck will discontinue the drug following Phase III data in 2010.

Wild cards
Alzheimer’s drugs bapineuzumab and dimebon represent the real wild cards for 2010. Strong Phase III data in Alzheimer’s disease would likely translate into mega-blockbuster sales at a rapid rate, as current treatment options fail to halt progression of the disease.

Pfizer and J&J (bapineuzumab): Pfizer shares rights to bapineuzumab with J&J and Elan. We project a 50% chance of success for bapineuzumab. While Phase II data showed strong performance for bapineuzumab relative to placebo, the lower-than-normal performance of the placebo group may have accounted for the portion of bapineuzumab’s success. Also, Phase II data analysis was done retrospectively, making positive statistical results less conclusive. We expect we could see the first Phase III data for this drug candidate in late 2010.

Pfizer (dimebon): Studies in Russia showed positive results from treating Alzheimer’s patients with dimebon. Given Pfizer’s $225 million payment to Medivation and commitments of close to $1 billion related to the success of the drug, the company clearly believes in dimebon’s early-stage data. However, we remain skeptical and project only a 30% chance of approval for the drug, based on incomplete early-stage data and Pfizer’s poor track record of partnerships.

http://www.morningstar.co.uk/UK/funds/article.aspx?lang=en-GB&articleid=86331&categoryid=13

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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The company discovers, develops, manufactures and markets prescription medicines for humans and animals. The company operates in more than 150 countries. The company operates through two business  segments: pharmaceutical and animal health. It also generates revenues from several other businesses including the manufacture of gelatin capsules, contract manufacturing and bulk pharmaceutical chemicals. As these businesses are small, they are grouped under ‘corporate/other segment’. Pfizer is now a significantly more diversified company, with an expanded inline portfolio offering treatments and preventive medicines for every stage of life.

In the third quarter of 2009, Pfizer reported net income of $2.9 billion on revenue of $11.6 billion. Compared to the same quarter a year ago, revenues in Q3-2009 declined 3%. However, Q3-2009 reported net income of $2.9 billion and reported diluted EPS of $0.43, both increased 26% compared with the year-ago quarter.

Analysts estimates for the quarter ending December 2009 range from a low of $0.47 to a high of $0.546 with a consensus of $0.5. For the fiscal quarter ending December 2009, the consensus EPS forecast has remained the same over the past week at $0.500 and increased over the past month from $0.497 to $0.500 (0.60%). Of the 17 analysts making quarterly forecasts, 2 raised and none lowered their forecast.

Since 2003, Pfizer’s Q4 revenues have been greater than Q3-same year revenues. During this Oct-Dec quarter, Pfizer completed its acquisition of one of its Big Pharma rival, Wyeth for $68 billion. With the completion of the acquisition, Pfizer Animal Health is now the world’s leader in the discovery, development, manufacture and sales of veterinary vaccines and medicines for livestock and companion animals.

This quarter was also notable for several other developments. The U.S. Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Pfizer’s Selzentry® (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy. Pfizer entered into an agreement with two subsidiaries of Mylan Inc. relating to a generic version of Vfend® (voriconazole), an antifungal agent. The agreement is limited to the tablet form of Vfend and does not cover Pfizer’s Vfend products for intravenous use or oral suspension. The company initiated two Phase 3 trials of

the investigational drug dimebon (latrepirdine) in patients with moderate-to-severe Alzheimer’s disease (AD). FDA approved Pfizer’s Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. FDA also approved Pfizer’s Geodon® (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. Pfizer and Protalix (NYSE-Amex: PLX) entered into an agreement to develop and commercialize taliglucerase alfa. Pfizer Animal Health’s Swine Influenza Vaccine, pH1N1 – Killed Virus, was approved by the U.S. Department of Agriculture (USDA).

During the fourth quarter, the company’s investments in high-growth opportunities could offset a portion of the 2009 cost reductions. These include increased investments in Established Products, in emerging markets, particularly in China, and in late-stage development and product portfolios.

Currently, the stock is trading at $19.49, compared to the 52 week range of $11.62 and $19.68. In the last one year the share price has gained more than 11.3%. Still it is trading at a reasonable PE of 16.28, so, I expect the stock to register some more gains to break $20 mark in the next few weeks.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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The year 2010 could be a make or break year for Medivation as the results of a confirmatory late-stage study of its investigational drug Dimebon for Alzheimer’s disease are due in the first half.

… Read on to find out more about Medivation and the upcoming near term catalyst.

Incorporated in Delaware in October 1995, the company began operations on December 17, 2004 after acquiring Medivation Neurology Inc. Prior to June 8, 2005, Medivation’s corporate name was Orion Acquisition Corp II. The company’s investigational drugs include Dimebon, which is under late-stage studies for the treatment of Alzheimer’s disease and Huntington’s disease; and MDV3100, which is also under phase III development for the treatment of castration-resistant prostate cancer.

Dimebon – A potential game changer?

Dimebon was approved as an antihistamine to treat hay fever in Russia in 1983. The drug was sold over the counter there for many years before it was withdrawn from the market following the introduction of more selective treatments.

In October 2003, Medivation Neurology acquired the patent rights for the use of Dimebon and related compounds to treat neurodegenerative diseases from Selena Pharmaceuticals Inc. As mentioned earlier, Medivation is evaluating Dimebon as a potential treatment for Alzheimer’s disease and Huntington’s disease and the development programs for the two indications are partnered with Pfizer Inc. ( PFE | Quote | Chart | News | PowerRating).

Dimebon has a unique mechanism of action, distinct from currently available treatments. Unlike other drugs used to treat Alzheimer’s disease that focus on targets implicated in cognition and memory loss, such as cholinesterase inhibition or NMDA receptor antagonism, Dimebon potentially operates via a novel mitochondrial mechanism of action. It is still not clear how Dimebon works because in preclinical studies, treatment with Dimebon has shown an increase in a brain protein, known as beta amyloid, in animal models of Alzheimer’s. Beta amyloid is the main constituent of plaques found in the brains of people with Alzheimer’s and is thought to be a key player in the development and progression of the disease.

According to Alzheimer’s Association, about 5.3 million Americans suffer from Alzheimer’s disease and the number is expected to triple by 2050.

Till date, there has been no cure for Alzheimer’s, which is often referred to as ‘the long good bye’. Forest Laboratories Inc.s’ (FRX) Namenda, Sciele Pharma Inc.’s (SCRX) Cognex, Pfizer/Eisai’s Aricept, Novartis AG’s (NVS) Exelon, and Janssen-Ortho Inc.’s Razadyne are some of the drugs to treat Alzheimer’s.

The FDA-approved drugs, which are currently in the market, can slow the progression of symptoms of the disease like, memory loss, difficulty in communicating, impaired judgment and a loss of initiative. In clinical studies, researchers who evaluated Dimebon’s potential to improve patients’ thinking and memory ability, overall function, psychiatric and behavioral symptoms, and ability to perform daily activities, have found improvement in all the five outcome measures.

The development programs for Dimebon include the following pivotal trials in various stages of completion:

- A completed pivotal trial in mild-to-moderate Alzheimer’s disease, conducted in Russia, the results of which were published in The Lancet in 2008. According to the journal, in the double-blind, placebo-controlled trial, after both six months and a full year of treatment, the 183 patients with mild-to-moderate Alzheimer’s disease treated with Dimebon experienced statistically significant improvements compared to placebo in all the key aspects of the disease: memory and thinking, activities of daily living, behavior and overall function.

- A confirmatory six-month phase III trial dubbed CONNECTION in patients with mild-to-moderate Alzheimer’s disease. The 6-month study enrolled 598 patients, exceeding the enrollment target of 525 patients in the United States, Europe, and South America. The top-line results from the trial are expected in the first half of 2010.

- A phase III safety study in 750 Alzheimer’s disease patients on a variety of background anti-dementia drugs, which has been fully enrolled.

- An ongoing twelve-month phase III trial dubbed CONCERT in 1050 mild-to-moderate Alzheimer’s disease patients who are taking Aricept, the leading approved Alzheimer’s disease medication.

- A phase III trial dubbed CONSTELLATION in patients with moderate-to-severe Alzheimer’s disease was initiated last November. The six-month double-blind, placebo-controlled study , which will assess the effects of adding Dimebon to Namenda, will enroll approximately 570 patients at about 80 sites in the United States, Canada and Europe.

- A phase III study dubbed CONTACT in patients with moderate-to-severe Alzheimer’s disease was also initiated last November. The six-month study, which will assess the potential benefits of adding Dimebon to ongoing treatment with Aricept, will enroll approximately 600 patients with moderate-to-severe Alzheimer’s disease and neuropsychiatric symptoms at 75 sites in Europe and South America.

According to the company, the first three studies – the Russian trial, CONNECTION trial and the safety trial should allow the potential early new drug application filing option for Alzheimer’s indication in 2010.

Market research firm Decision Resources expects Dimebon to be launched in 2012 and has pegged potential peak sales of the drug across the *seven markets at $1.5 billion. (*United States, France, Germany, Italy, Spain, the United Kingdom and Japan).

In addition to Alzheimer’s, Dimebon is tested as a potential treatment for Huntington disease. Huntington disease is a fatal genetic disease for which no medications are currently approved by the FDA to treat the cognitive impairment associated with the condition.

A six-month, double-blind, placebo-controlled phase III trial dubbed HORIZON was initiated last July and has a target to enroll approximately 350 patients with Huntington disease at approximately 50 sites in North America, Europe and Australia.

MDV3100 – For a niche market

MDV3100 is yet another investigational drug of Medivation, which is under phase III development in patients with castration-resistant prostate cancer, also known as hormone refractory prostate cancer, who have failed Taxotere-based chemotherapy.

Prostate cancer treatment remains an unmet medical need. According to the American Cancer Society, more than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer.

Usually hormone therapies like Bicalutamide or other standard anti-androgen treatments are used to treat prostate cancer. When the prostate cancer becomes metastasized or has spread to the bone or other organs, it will not respond to hormonal treatment and is called castration-resistant or hormone-refractory prostate cancer. The main alternatives available to men with castration-resistant prostate cancer include radiation, and chemotherapy drugs like Sanofi-Aventis’ (SNY) Taxotere in combination with steroid drug Prednisone. But these treatments are considered to have severe side effects.

In clinical studies, MDV3100 has not only demonstrated anti-tumor activity in patients who had become resistant to Bicalutamide or other standard anti-androgen treatments, but has also been generally well tolerated with fatigue being the most frequently reported adverse event. Dendreon Inc. (DNDN) has developed a treatment for advanced prostate cancer, which is pending regulatory decision. The FDA is expected to announce its decision on Dendreon’s Provenge on May 1.

The MDV3100 program is partnered with Tokyo-based Astellas Pharma Inc. The phase III trial of MDV3100 dubbed AFFIRM was initiated last September and is currently enrolling men with castration-resistant prostate cancer who were previously treated with Taxotere-based chemotherapy. The study is expected to enroll approximately 1,200 patients at sites in Europe, the United States, Canada, South America, Australia and South Africa. Last week, the company announced treatment of the first European patient in the AFFIRM trial.

Strategic partnerships

In September 2008, Medivation entered into an agreement with Pfizer to develop and commercialize Dimebon. Under the Pfizer Collaboration Agreement, which became effective in October 2008, Medivation received an up-front cash payment of $225 million in the fourth quarter of 2008. Medivation is also eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments.

The cost of developing and commercializing Dimebon for the United States market is shared by Pfizer and Medivation on a 60%/40% basis, with Pfizer assuming the larger share. The profits or losses resulting from the commercialization of Dimebon in the United States will also be shared by the two companies in the same proportion. Outside the United States, Pfizer bears all development and commercialization costs and will pay Medivation tiered royalties on the aggregate net sales of Dimebon.

In October 2009, Medivation inked an agreement with Astellas to develop and commercialize MDV3100. Under the Astellas Collaboration Agreement, Medivation received an up-front cash payment of $110.0 million last November. Medivation is required to share 10% of the up-front payment and any development milestone payments received under the Astellas Collaboration Agreement with the academic institution from which the company licensed its rights to MDV3100. Medivation is also entitled to receive up to $335.0 million in development milestone payments, plus up to an additional $320.0 million in commercial milestone payments.

The costs of developing and commercializing MDV3100 for the United States market are shared by Medivation and Astellas on a 50%/50% basis. The profits or losses resulting from the commercialization of MDV3100 in the United States will also be shared by the two companies in the same proportion. Astellas has the responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.

Financials – Knowing the numbers

Medivation has no marketed drugs and has incurred losses since inception. As of September 30, 2009, Medivation had an accumulated deficit of $151.2 million. Last week, speaking at the J.P. Morgan Annual Healthcare Conference, Medivation CEO David Hung said that his company has a strong financial foundation with more than $275 million in cash.

According to Medivation, in less than 6 years, it has advanced 2 molecules – Dimebon and MDV3100 from preclinical stage to phase III programs for a total cost of a mere $175 million, thanks to the company’s cost-effective approach to drug development. That compares favorably with the average time of 10-15 years taken by Big Pharma to advance a single compound from preclinical testing to registration and total cost of around $800 million.

Closing Thoughts

There is more room on the upside for Medivation if the late-stage trial results of Dimebon due in the first half of this year pan out the way as expected. But that said, since the results of the clinical trial can be a make-or-break event, investing in the stock requires a high tolerance for risk and volatility.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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Decision Resources of Waltham, Mass., said in the summary of a research paper released this week that its projection is based on the assumption that Dimebon’s “impressive clinical trial data” in a study of patients with mild to moderate Alzheimer’s continues to show the drug’s efficacy. Pfizer scientists in Groton are among those developing Dimebon.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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The research has been published in the Archives of Neurology.

“This is the first clinical trial that has focused on what is perhaps the most disabling aspect of the disease,” said University of Rochester Medical Center neurologist Karl Kieburtz, M.D., the lead author of the study. “While more investigation needs to be done, these results are encouraging and show, for the first time, a statistically significant benefit in terms of improved cognitive function in patients with Huntington’s disease.”

Huntington’s disease is a progressive neurodegenerative disorder that impacts movement, behaviour, cognition, and generally results in death within 20 years of the disease’s onset. The disease steadily erodes a person’s memory and their ability to think and learn. Over time, this cognitive impairment contributes to the loss of the ability to work and perform the activities of daily life. There are no treatments current available that effectively alter the course of the disease or improve cognition.

It is believed that mitochondria – the part of the cell that helps convert food to energy – plays a role in the development of Huntington’s disease. Lampridine stabilizes and enhances mitochondrial function, a result that has been shown to improve behavioral, cognitive, and functional outcomes in Alzheimer’s disease. Scientists speculate that this may have the same effect in patients with Huntington’s disease.

The investigators studied the impact of the drug on 91 patients over a 90 day period

http://timesofindia.indiatimes.com/life/health-fitness/health/Alzheimers-drug-shows-promise-for-Huntingtons/articleshow/5551362.cms

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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“This is probably not the last time that Pfizer cuts positions,” said Les Funtleyder, strategist for Miller Tabak & Co. in New York.

Pfizer announced this week that the company would exit its former worldwide research-and-development headquarters in New London within the next two years. But Pfizer said a local work force numbering about 5,000 would be left virtually unchanged as 1,400 New London workers are expected to move to new or revamped quarters at a sister campus in Groton.

“We expect the vast majority of colleagues in New London will move their offices to the Groton Research Campus,” Pfizer spokeswoman Liz Power said in an e-mail response to questions Tuesday. “There will be some positions (throughout the company) that will be eliminated due to the overall consolidation of the research network and integration of Pfizer and Wyeth.

“That said, we expect to maintain a significant presence in southeastern Connecticut.”

Funtleyder said Pfizer, which acquired New Jersey-based Wyeth Pharmaceuticals last month for $67 billion, is likely to take a wait-and-see attitude toward further R&D job cuts as it continues a consolidation related to the the consolidation itself is likely to create a lot of job churn locally as Pfizer hand-picks scientists from sites it is planning to close or downsize and then moves them to Groton, Funtleyder said. These “favorite sons,” as he calls them, would likely replace scientists working locally, creating angst among R&D staff over job security.

“You’re probably going to see some new faces around Groton,” he said. “I have a question for management: How do you keep your R&D staff productive when they are concerned about their employment?

“I don’t think there’s a good answer to that,” he added. “Productivity will probably decline.”

Pfizer had few additional details about the consolidation process when presented with specific questions Tuesday. It is unclear whether New London workers will be shifted to the Groton campus as space becomes available, or whether the switch would be accomplished in one sudden move.

Pfizer did say, however, that the New London staff will be moved into office space rather than be integrated into current Groton laboratories.

“The Groton Research Campus will be the center of our PharmaTherapeutics R&D operation,” Power said. “In addition, we are upgrading the Groton Research Campus to ensure that it continues to be conducive to discovery and development of new medicines.”

Funtleyder said drug discovery is exactly what’s required to stop job losses at Pfizer, the New York-based pharmaceutical giant where cuts are expected to reach about 30,000 over a four-year period.

“The name of the game is getting good products to market,” he said. “They really do have to get the R&D process running, and that’s easier to say than to do.”

Pfizer has an Alzheimer’s drug called Dimebon that looks promising, as well as a JAK-3 inhibitor for rheumatoid arthritis, but each is a year or two away from reaching the market.

“All it takes is one of the drugs to do well,” Funtleyder said, though he admitted there is no product on the table that is likely to overtake the selling power of Lipitor, the world’s leading medicine, which goes off patent at the end of 2011.

As for Pfizer’s decision to drop its nearly $300 million former R&D headquarters as part of the company’s network of research sites, Funtleyder saw it as a strictly business decision.

“They don’t think they can get a return on their investment,” he said. “They figured the best thing to do is cut their losses.”

Peter Levine, whose Amber Properties owns an office complex on Howard Street that Pfizer vacated earlier this year, called the pharmaceutical giant’s decision to abandon New London disappointing — but certainly understandable in the current economic environment.

He called the Pfizer site a “unique asset,” though he said it’s probably “worth a lot less than anyone thinks.”

Still, he said, “I’m cautiously optimistic that over time there will be a use for that property. … The parcel is much better than it was 15 years ago (before Pfizer bought it), and it will have another life.”

http://www.tradingmarkets.com/.site/news/Stock%20News/2644714/

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optionMONSTER’s Heat Seeker tracking system detected the purchase of 11,111 November 22.50 calls for about $5.40 against open interest of only 123 contracts. The trade came just seconds after the same number of October 20 calls were sold for $7.60 against open interest of 11,141.

MDVN rose 2.45 percent to $27.43 on Friday and is up 88 percent this year. The biotech drug developer leapt to an all-time high over $30 in September 2008 after announcing a partnership with Pfizer to develop and market its Dimebon neurological drug. The shares collapsed along with the rest of the market the following month, but have been fighting their way back since.

In Friday’s options trade, an investor apparently replaced an existing position in the October calls with new ownership in the November strikes. The call-rolling strategy allowed a bullish position in the stock to be extended by one month while recovering $2.20 in premium.

MDVN last reported earnings on Aug. 5 and hasn’t yet indicated its next release date.
Overall options action in the name was 16 times greater than average in the session. Calls outnumbered puts by 72 to 1.

(Chart courtesy of tradeMONSTER)

http://www.nasdaq.com/newscontent/20091019/bullish_trader_sticks_with_medivation_38948.aspx?storyid=38948

Dimebon Alzheimers Disease

http://www.dimebonalzheimers.com

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Pfizer is awaiting U.S. approval of the improved version of its blockbuster Prevnar vaccine for infants and young children. The product, acquired through Pfizer’s recent purchase of rival U.S. drugmaker Wyeth, prevents a range of infections caused by pneumococcal bacteria.

Martin Mackay, president of PharmaTherapeutics at Pfizer, told investors at the annual J.P. Morgan Healthcare Conference in San Francisco that Prevnar 13 is among the most promising of the company’s products in late-stages of testing.

The current Prevnar vaccine, which protects against seven strains of streptococcus pneumoniae, is approved for infants and young children. The newer product, which protects against 13 strains of the bacterium, would be marketed to young children as well as adults over 50 years of age, if approved by regulators.

Pfizer said its other promising late-stage products include: Tanezumab, an antibody used to treat osteoarthritis; CP-690,550, a so-called JAK3 Inhibitor to treat rheumatoid arthritis; Dimebon and Bapineuzumab to treat Alzheimer’s disease and PF-2341066 to treat non-small cell lung cancer.

Pfizer shares were up 4 cents to $18.87 on the New York Stock Exchange during mid-day trade.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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“Late stage prostate cancer remains an obvious and large unmet clinical need,” said Professor Johann de Bono, Medical Oncologist, Royal Marsden Hospital, UK, and Principal European investigator for the AFFIRM trial. “This study will provide an opportunity to test MDV3100, a promising developmental drug candidate for those men with the most advanced prostate cancer and in great need of a new therapeutic option.”

Prostate cancer is the third leading cause of cancer deaths in men across Europe, with more than 300,000 cases being diagnosed each year and accounting for almost 25% of all cases of cancer in men living in Europe.1,2

The randomized, placebo-controlled, double-blind, multi-national AFFIRM trial is expected to enroll approximately 1,200 patients at sites in Europe, the United States, Canada, South America, Australia and South Africa. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo.

For more information about the AFFIRM trial please go to http://www.medivation.com . Medivation, Inc. recently announced a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100.The companies will collaborate on a comprehensive development programme that will include additional studies to develop MDV3100 for both early- and late-stage prostate cancer.

Notes to Editor

About MDV3100

MDV3100 is an investigational therapy in clinical development for the treatment of advanced prostate cancer. The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more compIete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer. MDV3100 was generally well tolerated in this trial at doses up to and including 240 mg/day, with fatigue being the most frequently reported adverse event.

About Prostate Cancer

Prostate tumors that have stopped responding to, or are growing despite the use of, active hormone treatment strategies are characterized as castration-resistant. Patients with castration-resistant prostate cancer have a poor prognosis and few treatment options.

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 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 and severe Alzheimer’s disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for 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. For more information, please visit us at http://www.medivation.com.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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