Posts Tagged ‘Medivation’

Drug Helps Brain Grow New Cells

Tuesday, August 24th, 2010

Researchers have found a drug that can help the brain grow new cells, and they said their study may lead to ways to improve experimental Alzheimer’s drugs.

The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Center in Dallas who worked on the study, said in a telephone interview. “What our compound does is allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation and Pfizer experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them, and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

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Medivation terminates S.F. lease

Sunday, May 30th, 2010

San Francisco biotech Medivation has terminated its 63,817-square-foot lease at 345 Spear St., a move that comes just days after the company announced negative results of a Phase III trial for Dimebon, the Alzheimer’s drug the company is developing with Pfizer.

The termination requires Medivation to pay a $1.5 million termination fee to the landlord, Morgan Stanley Real Estate, according to a Securities and Exchange Commission filing. Medivation signed a seven-year lease on Nov. 2 last year, but under the terms of the deal the tenant doesn’t start paying rent until April 1 of this year. The lease required Medivation to pay an annual rate of $42.50 a square foot, or $226,000 a month, according to SEC documents.

The building at 345 Spear St., along with 2 Harrison St., makes up Hills Plaza, one of the most coveted buildings South of Market. The complex houses Google and the architecture giant Gensler. The Medivation space had been Sharper Image’s corporate headquarters. Jones Lang LaSalle has the listing.

Shares of Medivation plunged March 3 after the company said that data from a late-stage trial showed Dimebon was no better than a placebo at improving symptoms of Alzheimer’s, including mental abilities and overall function. The company’s stock sank $26.94, or 66.9 percent, to $13.31 on the news. The stock was trading just below $13 on Friday.

Medivation has drugs in clinical development to treat diseases including Alzheimer’s disease, Huntington’s disease and castration-resistant prostate cancer. The company was founded in 2003.

http://sanfrancisco.bizjournals.com/sanfrancisco/stories/2010/03/08/daily76.html

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Pfizer’s Lemons

Thursday, May 27th, 2010

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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This Week in Biotech: More Treats than Tricks

Thursday, November 5th, 2009

The last week of October was appropriately marked by treats and tricks. The stock market gyrated from investor ebullience over numbers showing a 3.5 percent growth of the U.S. GDP in the third quarter of 2009, to investor dismay over worries that a drop in consumer spending signals an unsustainable recovery. Meanwhile, life science companies were busy raising money and striking deals. Durham, North Carolina-based Aldagen (ALDH) took its place in a growing queue of companies hoping to go public in the coming months as the IPO window begins to open. The company, which develops regenerative cell therapies, had initially filed to go public in May of 2008 but withdrew those plans last October when the stock market crashed.
Now that the markets have strengthened, the company hopes to raise an estimated $80.5 million in an initial public offering to fund a phase 3 trial of its most advanced therapy for the treatment of critical limb ischemia, which can happen when a limb becomes damaged due to lack of blood flow. Aldagen also has a drug in a pivotal phase 3 trial for improving umbilical cord blood transplants used to treat inherited metabolic diseases in pediatric patients. Aldagen plans to list the shares on the NASDAQ Global Market under the symbol ALDH.
The world market for IPOs got a boost with the inauguration of the ChiNext exchange, a new Chinese stock exchange for small, high-tech enterprises, which started trading on Friday. All of the 28 listed companies, which included six involved in biotech and pharmaceuticals, soared in price on the first day of trading.
In the biggest deal of the week, Medivation (MDVN) will collaborate with Astellas Pharma (ALPMF.PK) to develop and commercialize MDV3100, a new generation of oral anti-androgen that is currently being evaluated in a phase 3 trial for the treatment of prostate cancer. In a deal similar to last year’s partnership between Medivation and Pfizer (PFE) for Dimebon in Alzheimer’s disease, the deal involves a significant amount of cash upfront and the option to co-promote the drug in the United States. Astellas will pay Medivation $110 million upfront and milestone payments up to $335 million as the candidate reaches certain development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. If and when the drug is approved, the companies will jointly commercialize MDV3100 in the United States, sharing equally in all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the United States and will pay Medivation tiered double-digit royalties on ex-U.S. sales.
Bay Area biotech SuperGen (SUPG) entered into a multi-year collaboration with GlaxoSmithKline (GSK) to discover and develop cancer therapeutics based on epigenetic targets in a deal that could be worth as much as $375 million for the epigenetics company. The deal is seen as validation for Supergen’s in-silico drug discovery platform. Under the terms of the deal, SuperGen will progress candidate compounds through to early clinical proof of concept. GlaxoSmithKline will then have the right to exercise an option to develop further and commercialize resulting products on a global basis. GSK will pay SuperGen $5 million upfront, which includes a $3 million common stock investment, priced at a premium to market. The deal includes the potential for development and commercial milestones, and double-tiered royalties.
Micromet (MITI) scored another hit on its BiTE antibody technology platform in a deal with Sanofi-Aventis (SNY). The companies entered a global collaboration and license agreement to develop a BiTE antibody against an antigen present at the surface of carcinoma cells. BiTE antibodies are novel therapeutic antibodies that activate a patient’s T cells to seek out and destroy cancer cells. Under this agreement, Bethesda, Maryland-based Micromet will be mainly responsible for the discovery, research and development of the BiTE antibody through the completion of phase 1 clinical trials after which Sanofi-Aventis will have full responsibility for the further development, as well as for the worldwide commercialization. Micromet gets $12 million cash upfront and is eligible for development and regulatory milestone payments of up to $241 million, plus performance-based sales milestones of up to $224 million and royalties on worldwide product sales.
Global contract research organization PPD (PPDI) is investing $100 million in Celtic Therapeutics Holdings, an investment partnership organized to acquire and develop novel mid-stage therapeutic candidates that address unmet medical needs, and advance development of these candidates to the next key product milestone, usually the beginning or end of phase 3. PPD’s investment is intended to set the stage for a strategic alliance between the companies with the goal of bringing the best products to market more quickly to meet unmet needs of patients.

Finally, Ligand Pharmaceuticals (LGND) is buying struggling Metabasis Therapeutics (MBRX) for the fire sale price of $3.2 million and contingent value rights. The La Jolla, California biotech, which has a pipeline of drugs to treat metabolic diseases, went public in June 2004 at $7 a share. Today its stock trades below 50 cents. The company burned through more than $200 million without getting any drugs to market and cut its staff down to seven people earlier this year as it ran low on cash. Under the agreement, Ligand will pay Metabasis’ shareholders $1.8 million and take over more than $1.3 million in liabilities. Metabasis shareholders will receive contingent value rights that entitle them to cash payments as frequently as every six months as cash is received by Ligand from proceeds from the sale or partnering of any of the Metabasis drug development programs, among other triggering events. Ligand has committed to spend at least $8 million in new research and development funding on the Metabasis programs within 42 months following the closing of the transaction.

Dimebon Alzheimer’s Disease

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Bullish trader sticks with Medivation-10/19/2009

Friday, October 30th, 2009

Medivation has spent the last 10 months rallying back from the 2008 market crash, and one trader expects it to keep moving higher.

MDVN ChartoptionMONSTER’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 Alzheimer’s Disease

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Medivation Gets Partner for Prostate Drug

Thursday, October 29th, 2009

SAN FRANCISCO, Calif. (TheStreet) — Medivation(MDVN Quote) CEO David Hung has delivered another drug partnership, this time for the company’s prostate cancer drug MDV-3100.

Japanese drug maker Astellas said Tuesday that it will pay an upfront fee of $110 million in cash to Medivation in exchange for worldwide marketing rights to MDV-3100, which recently began a pivotal phase III study.

Medivation is also eligible to receive from Astellas another $335 million in cash milestone payments tied to MDV-3100 meeting future development and regulatory goals, plus an added $320 million in commercial milestone payments.

Astellas and Medivation will jointly market MDV-3100 in the U.S. and share costs and profits equally. Astellas will sell the drug outside the U.S. and pay Medivation a double-digit royalty based on sales. A phase III study of MDV-3100 enrolled its first prostate cancer patient on Sept. 23. The study compares MDV-3100 againt a placebo in 1,200 patients with advanced prostate cancer who have already received first-line treatment with the chemotherapy drug Taxotere. The primary goal of the study is to demonstrate that MDV-3100 can prolong survival in these patients.

In September 2008, Medivation’s Hung negotiated one of the biggest partnership deals of that year when Pfizer(PFE Quote) bought worldwide commercial rights to Dimebon, Medivation’s Alzheimer’s drug.

More recently, Johnson & Johnson(JNJ Quote) paid roughly $900 million in May to acquire Cougar Biotechnology, which is developing a prostate cancer drug very similar to Medivation’s MDV-3100.
Medivation shares closed Monday at $26.10.

– Reported by Adam Feuerstein in Boston

http://www.thestreet.com/story/10617222/1/medivation-lands-partner-for-prostate-cancer-drug.html?cm_ven=GOOGLEFI

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Dimebon Dimebolin Information Availability

Sunday, March 15th, 2009

Dimebom is a new pharmaceutical treatment alternative for patients suffering from Alzheimer’s Disease.   Dimebon is an older medication that has recently been discovered to be most helpful in treating patients with Alzheimer’s disease.   Dimebom (the actual drug is known chemically as Dimebolin) is an older  Russian antihistamine drug.  It was popularly used in Russia as an antihistamine for hayfever, allergies and the like.  In fact the drug was sold as an easy to obtain antihistamine – sold over the counter without a prescription.

Dimebom is currently in clinical trials in the United States by a company named Medivation .    The website for Medivation, the pharmaceutical company involved with the clinical development and testing of Dimebom in the United States? Can be found at link   www.medivation.com .   To learn more about Medivation’s clinical trials of Dimebom the link is

http://www.medivation.com/pipeline_dimebontrials.html#p3

For more information on CONNECTION study locations, eligibility and enrollment, please visit www.connectionstudy.com or call toll-free 1-877-888-6386

At this point in time Dimebom is not available in any manner to Alzheimer Patients or their families, outside of the study material afforded by the Medivation Company and the Medivation clinical trials themselves.

Dimebon Alzheimer?s Disease

http://www.dimebonalzheimers.com

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