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Buzz in Alzheimer's Discussion Community
Is Bexarotene A Magical Cure for Alzheimer's, or a Magic Eraser
This week the Alzheimer's community is buzzing about a new research study published in Science Express that indicates amyloid plaque (Abeta) was removed from Alzheimer's infected mice in a few hours by an already existing, FDA approved drug, Bexarotene.
http://www.alzheimersreadingroom.com/2012/02/is-bexarotene-magical-cure-for.html
Thanks for that detail. Do I know you? Just kidding, lol,
bad joke.
Since Alzheimer's would be a completely new indication, I believe there is a clear case for a patent extension, and, hopefully, Eisai will publicly clarify their patent related intentions in the near future. I strongly suspect public news releases will be a big part of any near term stock price movement regardless of how aggressive or successful any marketing strategies may be. In any case, hold on tight should the FDA announce "fast track" status for this already available drug.
Silly to not just try some in a few Alzheimer’s patients that are capable of signing a hold harmless.
Original PDF link from Eisai:
11 December, 2011
Eisai Co., Ltd.
U.S. FDA Accepts Resubmission of Lorcaserin New Drug Application
-- FDA Target Action Date Set for June 27, 2012 --
Eisai Co., Ltd.’s U.S. subsidiary Eisai Inc. and Arena Pharmaceuticals, Inc. (“Arena”) announced today
that the U.S. Food and Drug Administration (FDA) has accepted for filing and review Arena’s
resubmission of the New Drug Application (NDA) for lorcaserin. The FDA has categorized it as a Class 2
resubmission, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27,
2012.
Lorcaserin, discovered and developed by Arena, is intended for weight management, including weight
loss and maintenance of weight loss, in patients who are obese (Body Mass Index, BMI?30) or patients
who are overweight (BMI?27) and have at least one weight-related co-morbid condition. Lorcaserin is
the subject of an exclusive licensing agreement concluded between Eisai Inc. and Arena
Pharmaceuticals GmbH, the wholly-owned Swiss subsidiary of Arena concerning its marketing and
supply in the United States.
Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a Complete
Response Letter (CRL) in October 2010. Arena submitted a response to the lorcaserin CRL in December
2011.
For more information about the response to CRL, visit http://www.eisai.com/news/news201201.html.
*** ENDS ***
http://www.eisai.com/pdf/others/e20120111.pdf
Patents till 2016, had to look
Generic drug company Banner Pharmacaps has positioned itself to be first in line to market a generic version of Eisai skin cancer drug Targretin.
The High Point, North Carolina company has filed with the Food and Drug Administration an abbreviated new drug application for Bexarotene 75 mg gelatin capsules. Targretin was approved to treat cutaneous T-cell lymphoma, or CTCL, a rare type of skin cancer. In CTCL, T-cells that normally fight infections become cancerous, affecting the skin and blood. An estimated 2,000 CTCL cases are diagnosed in the United States annually.
Banner said that it believes it is the first applicant to file an ANDA with the FDA. If its generic version of Targretin is approved by regulators, being first to file gives Banner a head start over other generics with 180 days of marketing exclusivity.
Eisai makes Targretin in a capsule. Banner’s drug delivery platform makes drugs in gelatin-based capsule dosage forms that the company says enhances and controls the absorption of poorly soluble active pharmaceutical ingredients.
Targretin was developed by San Diego biotech company Ligand Pharmaceuticals (NASDAQ:LGND), which received FDA approval on the drug in 1999. Eisai acquired Targretin and three other cancer products from Ligand in 2006 for $205 million. Targretin’s patents expire in 2016.
http://www.medcitynews.com/2011/10/generic-cancer-drug-from-banner-aims-to-take-on-eisais-targretin/
This is awesome--An existing cancer drug seems to improve many of the effects of Alzheimer's disease in mice, a study published in the journal Science has found.
EISAI (ESALY) DRUG, TARGRETIN - EXTRAPOLATION UP TO YOU
<Researchers identified a drug which, in animals, rapidly decreases both plaque area and soluble amyloid beta levels in mouse models of Alzheimer's disease. And it's FDA-approved.>
<The drug in question is Targretin (bexarotene, Eisai Inc.) which was approved for the treatment of cutaneous T-cell lymphoma in 2000.>
<When Landreth and his team treated several different mouse models of Alzheimer's disease with Targretin, levels of soluble amyloid beta decreased within six hours. The team tested their mice on several learning tasks; in some of those tasks, they saw improvements with as little as one week of treatment, though in others, longer treatment was necessary. The drug also improved the animals' olfactory abilities, which are normally impaired by plaque deposition. Finally, animals that had lost the ability to build nests – a social behavior for mice – were once again able to do so after Targretin treatment.>
<Although he has no solid proof, Landreth's hunch is that the drug's effectiveness at improving behavioral symptoms is in large part due to its effects on soluble amyloid beta, not plaques. "I think that as we pull down Abeta levels, synaptic function improves, and that subserves the improvement in behavior," he said.>
http://www.bioworld.com/content/eisai-lymphoma-drug-reverses-alzheimers-disease-symptoms-0
ESALY - Eisai
INVESTMENT IDEAS > BIOTECH
Biotech Ideas: Cancer Drug Reverses Alzheimer’s Symptoms in Mice
Targretin was found to significantly reduce beta amyloid plaque in the brains of mice with Alzheimer’s disease. Amyloid plaque buildup is the hallmark of Alzheimer’s disease in humans.
The drug is currently marketed by Eisai Co. as a skin cancer treatment, however the drug was shown to reduce amyloid buildup in the brains of mice by half in three days, according to Bloomberg.
http://wire.kapitall.com/investment-idea/biotech-ideas-cancer-drug-reverses-alzheimers-symptoms-in-mice/
FDA Accepts Resubmitted Application For Weight-Loss Drug Lorcaserin
Arena Pharmaceuticals Inc. (ARNA) and its partner, Eisai Co.'s (ESALY, 4523.TO) U.S. unit, said the U.S. Food and Drug Administration accepted their resubmitted new drug application for antiobesity drug lorcaserin.
Shares of Arena jumped 11% premarket to $1.78 as the biotechnology company said the FDA assigned a new Prescription Drug User Fee Act target date of June 27. The stock has gained 15% over the past three months through Monday's close.
The FDA requested in 2010 multiple sets of new data from Arena about lorcaserin, and the company said last week it submitted a response to the agency's two remaining concerns: the link between mammary tumors and a particular hormone in rats and deeper understanding about the drug's activity at three serotonin receptor subtypes.
Arena is one of three small drug developers that had its respective weight-loss pill candidates rejected by the FDA recently. Vivus Inc. (VVUS) and Orexigen Therapuetics Inc. (OREX) were also turned down by the agency, which raised major safety concerns about all three treatments. Vivus resubmitted its application in October, while Orexigen suspended development of its weight-loss drug Contrave.
Eisai's American depositary shares closed Monday at $40.76 and were inactive premarket.
-By Melodie Warner, Dow Jones Newswires; 212-416-2283; melodie.warner@dowjones.com
this study is promising – so promising that the Alzheimer’s Association will be funding the next step in understanding the mechanisms behind the study.
Research on skin cancer drug shows possible benefit in Alzheimer’s
http://www.alznorcalblog.org/2012/02/09/research-skin-cancer-drug-shows-benefit-alzheimers/
Since Targretin (bexarotene) is already on the market, aren't physicians going to try it out of compassion in certain Alzheimer's patients? What about the high cost? The buzz should start picking up very soon IMHO.
http://dementianews.wordpress.com/2012/02/15/alzheimers-brain-plaques-rapidly-cleared-by-cancer-drug-in-mice-bbc-news-nhs-choices/
http://abcnews.go.com/Health/AlzheimersCommunity/alzheimers-disease-skin-cancer-drug-sparks-hope-desperation/story?id=15573971#.TzvGY83y-pY
From Wikipedia
Japanese pharmaceutical Eisai bought the rights to Targretin and three other anti-cancer products from Ligand in 2006.[4]
In 2012 it was announced in a preprint that researchers had discovered that bexarotene reduced amyloid plaque and improved mental functioning in a small sample of mice engineered to exhibit Alzheimer's symptoms. Three different mouse models (APP/PS1, APPPS1-21, Tg2576) were used. It is thought that bexarotene stimulates expression of apolipoprotein E (ApoE), which leads to intracellular clearance of ß-Amyloid. The Alzheimer's Foundation of America expressed concern that people desperate to find a treatment for Alzheimer's not take matters into "their own hands."
In the United States, patents on the drug expire in 2016.[4
http://en.wikipedia.org/wiki/Bexarotene
Avg daily volume - 3434
2/10/2012 volume - 52,455
Cancer drug improves symptoms of Alzheimer's in mice, study says
Published 10 February 2012
An existing cancer drug seems to improve many of the effects of Alzheimer's disease in mice, a study published in the journal Science has found.
Researchers in Ohio found the drug bexarotene was effective in increasing levels of the protein ApoE, which in turn sped up the clearance of amyloid-beta, a hallmark of Alzheimer's disease. They also discovered that the drug quickly improved memory deficits and behaviour. This supports previous research which has shown that ApoE helps clear amyloid plaques in the brain.
Alzheimer's Society comment:
'This exciting study could be the beginning of a journey towards a potential new way to treat Alzheimer's disease. However, this is very early days. People with Alzheimer's should not rush to get this drug, as we need much more research to establish if it has benefits for humans.
'Investigating the added benefits of existing licensed drugs is an innovative approach in our fight against the condition, and one which Alzheimer's Society is championing through its Drug Discovery programme. This could see new treatments for dementia being developed much sooner.'
Dr Anne Corbett
Research Manager
Alzheimer's Society
http://alzheimers.org.uk/site/scripts/news_article.php?newsID=1158
Targretin® (bexarotene) capsules
Targretin® (bexarotene) capsules 75 mg are used to treat the skin problems arising from a disease called cutaneous T-cell lymphoma (CTCL) when at least one systemic therapy has not worked. A doctor must advise on the proper use of Targretin capsules.
CTCL is a rare disease. In CTCL, T-cells become cancerous and affect the skin and the blood. Normally T-cells are used by the body to fight infections. CTCL symptoms are often mistaken for a rash, eczema or psoriasis.
In the United States, there are nearly 2,000 new cases annually and the annual incidence continues to rise and its cause is unknown.
Do not take Targretin capsules if you are pregnant or plan to become pregnant.
Targretin capsules may harm your fetus (unborn baby). You should contact your doctor immediately if you believe or suspect you are pregnant while you are taking Targretin capsules and until one month after you stop taking Targretin capsules.
If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start Targretin capsule therapy and monthly while you are on therapy, confirming you are not pregnant.
You must use effective contraception (birth control) continuously starting one month before beginning treatment with Targretin capsules until one month after you stop taking Targretin capsules. It is strongly recommended that two reliable forms of contraception be used together. At least one of these two forms of contraception should include condoms, diaphragms, cervical caps, IUDs, or spermicides.
If you are male and your partner is pregnant or capable of becoming pregnant, you should discuss with your doctor the precautions you should take.
Do not take Targretin capsules if you are allergic to this medicine.
Targretin capsules can greatly increase blood levels of lipids (triglycerides and cholesterol) and these levels must be monitored and, if elevated, treated.
Targretin capsules can cause an underactive thyroid and periodic blood tests will be needed to detect this. Medication to control the condition may be necessary.
Before you start to take Targretin capsules, tell your doctor if you are pregnant, have or previously had an inflamed pancreas (pancreatitis), are breastfeeding, are taking gemfibrozil (Lopid®) a medicine to reduce high triglyceride cholesterol (fats) levels in the blood, or are taking tamoxifen (Nolvadex®).
You should tell your doctor if you are allergic to retinoid medications (for example: Accutane® [isotretinoin], Soriatane® [acitretin], Tegison [etretinate], Vesinoid® [tretinoin]), have or ever had high triglyceride (a fatty substance) levels in your blood, diabetes mellitus (sugar diabetes), gall bladder disease, any liver disease, if you regularly drink more than a small amount of alcohol, are taking any prescription medication for fungal infections, bacterial infections, or seizures, or eat a lot of grapefruit or drink a lot of grapefruit juice.
Because vitamin A in large doses may cause some side effects which are similar to those seen in patients applying Targretin gel, do not take more than the recommended daily dietary allowance of vitamin A (4000 to 5000 International Units). If you are not sure, ask your doctor or pharmacist.
Your skin may become more sensitive to sunlight while taking this medicine. Minimize exposure to sunlight and do not use a sunlamp.
The most common side effects with Targretin capsules are an increase in blood lipids (fats in the blood), headache, weakness, underactive thyroid, decreased white blood cells and diarrhea.
Please also see the Targretin capsules Full Prescribing Information and patient's instructions for use including Boxed WARNING and additional important safety information.
For more information about Targretin Capsules, visit www.Targretin.com or call Eisai Medical Services Oncology at (877) 873-4724. To report suspected adverse reactions, call (877) 873-4724.
For more information about reimbursement services and patient assistance, call the Eisai Assistance hotline at (866) 613-4724.
Targretin® is a registered trademark of Eisai Inc.
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