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Most clinical trials are conducted outside the United States
The Biogen July 2018 media onslaught was not the first time it has made glowing assertions about its AD drugs that have so far gone nowhere. See this 2015 article: Biogen Reports Its Alzheimer’s Drug Sharply Slowed Cognitive Decline. https://www.nytimes.com/2015/03/21/business/alzheimers-drug-trial-shows-cognitive-decline-sharply-slowed.html
The above 2015 article says this:
“... the net impression was positive. “Out-of-the-ballpark efficacy, acceptable safety,” Ravi Mehrotra, an analyst at Credit Suisse, wrote on Friday. Shares of Biogen rose $42.33, or 10 percent, to $475.98.” ............
"'A major side effect was a localized swelling in the brain, known as A.R.I.A.-E. This has been seen with other drugs in this class, though the rate for aducanumab seems higher.
Among patients with a genetic variant that raises the risk of getting Alzheimer’s, 55 percent of those who got the highest dose suffered this side effect, and about 35 percent of the high-dose patients dropped out of the trial because of this. Among those without the genetic variant, 17 percent of those who got the highest dose suffered the side effect and 8 percent discontinued treatment.
Biogen said the swelling often did not cause symptoms and probably could be managed by watching for it and reducing doses. Dr. Doody and Dr. Gandy agreed.''
Biogen made enthusiastic statements about Aducanumab in 2015, but here we are in 2018 wherein Biogen makes promising claims about BAN2401.
Interestingly, when Biogen made the March 2015 announcement that its AD drug, Aducanumab, sharply slowed cognitive decline as the above referenced article illustrates, Biogen shares surged $40 plus points, and afterwards the stock price preceded to sink back then as well — similiar to the surge and sink with the 2018 announcement. It seems that history has indeed repeated itself when you look at what occurred in 2015 and 2018.
Clinical Trials for Children - World Health Organization
http://www.who.int/ictrp/child/en/
Is a clinical trial right for your child?
https://kidshealth.org/en/parents/clinical-trials.html
CNS clinical trials for children. See:
https://www.cnshealthcare.com/learn-more/disorders/item/35-child-adhd.html
Attention Deficit Disorder
https://www.cnshealthcare.com/learn-more/disorders/item/35-child-adhd.html
Bio: Excellent. You are correct. In support, see these references:
The New European Union Regulation for Clinical Trials
Clinical ResearcherFebruary 1, 2017
https://www.acrpnet.org/2017/02/01/the-new-european-union-regulation-for-clinical-trials/
Belgium: World Leader in Clinical Trials
https://www.pharma.be/nl/component/attachments/attachments.html?task=download&id=107
https://pharmupdates.wordpress.com/2013/01/26/the-current-state-of-clinical-trials-in-portugal/
Spain passes new regulations on clinical trials to increase transparency and simplify procedures
http://www.barcelonaclinicaltrials.org/en/spain-passes-new-regulations-clinical-trials-increase-transparency-and-simplify-procedures
UK Clinical Trials Gateway
https://www.ukctg.nihr.ac.uk/home
Yes, this is a long term speculation, but I have learned the importance of maintaining a position because you never know when sudden news may develop. Expect the unexpected. Once news breaks, it is generally too late to act to catch or avoid the big move that will come. Between now and the big news, negative or positive, you may trade the swings if you are skilled at doing that; however, I think one must maintain a position, at least a core position, to speculate on a big move down the road. I do think the odds of Anavex obtaining some sort of approval for some drug for some indication are much better than a one trick pony biotech, but this investment is a high risk investment for number of reasons. I have a substantial long term position. If I lose everything I have invested, it will be a big disappointment, but it will not change my lifestyle one way or another. Actually, even if this investment is hugely successful, it will not change my lifestyle. At my point in life, any benefit I gain will help others. My satisfaction is that I enjoy being part of various things that benefit society. I have had a good long life, and I am thankful for that. Win or lose, I believe I am always better off for trying.
Reminds me of The Manchurian Candidate, the novel and the movie. Most of the entire world has been brainwashed regarding the Amyloid hypothesis, and as Bio points out no one is willing to listen -- YET!
All eyes will be on Biogen Alzheimer’s results this week — and the stock could swing wildly.
https://finance.yahoo.com/m/dc1f6317-0202-35f3-a91b-c3928e187aae/all-eyes-will-be-on-biogen.html
Boigen the trickster!
Biogen - posted by another poster on the Biogen Ihub
http://blogs.sciencemag.org/pipeline/archives/2018/07/06/biogen-and-eisai-tease-an-alzheimers-result
"He who is prudent and lies in wait for an enemy who is not, will be victorious.”
? Sun Tzu, The Art of War
Yes, Anavex realizes the problem it is up against, and the way to approval is outside the United States. That has been my belief from the time I first purchased Anavex shares four years ago. I keep my personal life private, but some of what I write here is based on my lengthy experience in . Australia, Spain, and possibly some other venues may be favorable. I know Japan has been mentioned as one, but I think Anavex has the same or similar problem with Japan. Insidious powerful interests are present in Japan as well.
Company interests do not necessarily coincide with your interests, and that is true in all aspects of business whether it be pharmaceutical, energy, agricultural, chemical, etc. Corporate interests in the United States and many other countries influence the public with their media campaigns and most importantly influence the governments. How do they influence government? They do it through campaign funding, lobbying and regulatory agencies. Just one example (there are many) the opioid crises was created with the help of Congress. One member of Congress most responsible was from Pennsylvania. He was later appointed Drug Czar to "combat" the opioid crises -- that member of Congress would still be there but for exposure on 60 Minutes. Nevertheless, the committee to combat the opioid problem is centered in New Jersey where major drug companies are located, and drug company representatives serve on the committee. Check out what 60 Minutes exposed and also see this: NYTimes: "Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused"
https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxycontin.html?smprod=nytcore-ipad&smid=nytcore-ipad-share
There are many tactics that may be employed to prevent competition from an existing product or service or new ones. Example, larger companies have sometimes bought a smaller competitor and shut it down. If you are Dish, you might buy cable franchises from towns or cities and never deploy the cable service. I think it is a good thing that Anavex has taken steps to prevent this tactic.
Along similar lines, check out the practice of "evergreening". "Evergreening"
"Most New Drug Patents Are for Old Remedies", Research Shows by Cynthia Koons
The U.S. patent system was designed to protect new innovations, but drugmakers are more often than not using it to protect old ones.
https://www.bloomberg.com/news/articles/2017-11-01/most-new-drug-patents-are-for-old-remedies-research-shows
Major drug companies are more focused on protecting their blockbuster drug lines (billions of dollars per drug) than they are in innovation. A company does this because their drug prices may then be much higher due to continuation of their monopolies. Plus, with older drugs, costs of development/acquisition, etc., have been recouped, the active ingredient may be cheaper, and you may approach something like a 90%+ profit margin.
I will end on a note of optimism. I do believe too that there are good people that work in government and major corporations. Plus, if Anavex's drugs are proven and approved in Australia, Spain or wherever, this will be the pressure that will allow the drugs to be available everywhere. And then, maybe Anavex will join the powerful corporate interest, and the cycle will repeat itself.
Yes, all attention will focus on Biogen at the AAIC. It will be business as usual. There will be some at the AAIC that benefit from the infusion market, which is a growth industry, including physician owned centers, physicians with infusion rooms, those involved in homecare,etc. Plus, let's face it, stock analysts and Wall Street in general have much to gain by covering large pharmaceutical companies than a tiny unknown company such as Anavex. The same goes for those that write articles for scientific journals. Who the heck in these professions would be interested in a pill that may conceivably prevent progression of Alzheimer's, Parkinson's, and other debilitating CNS diseases. A pill that may allow these patients to resume their activities and regain their independence. Would nursing home facilities and home care companies advocate the development and approval of such a pill that may reduce the need for their facilities and services?
What is the costs of Alzheimer's care alone?
""Alzheimer’s is the most expensive disease in America, costing more than cancer and heart disease. .....In 2018, the direct costs to American society of caring for those with Alzheimer’s and other dementias will total an estimated $277 billion."
http://act.alz.org/site/DocServer/2012_Costs_Fact_Sheet_version_2.pdf?docID=7161
And these crazy Anavex people advocate development and approval of a pill to eliminate the enormous market for "treating" and "caring for" this old and otherwise usless dependent population. What a travesty! Stop Anavex Now!
David A. Hyman sells 38,976 shares Thursday, July 19. See above insider news.
“Borrowing is about to become less salubrious ...”
Trump’s Fed Smackdown Could Backfire
https://www.barrons.com/articles/the-yield-curve-flashes-yellow-1532113487?emailToken=cbf98f4cccc6f6fe6ea4bb76b2fd9711j1AkzLAM0iHB5WR99QfVFE2Q+vQ2A99AOV20ONZfRchiPzgoKrHtI/kuLejNTgr2hPDNVw58pDXJTUcXJfEJMw==
Barron’s NFLX - Debt - Interest Rates
“The constant knock against Netflix is that its total of $18 billion in content obligations, including $10.3 billion off of its balance sheet, is money owed years into the future on which it cannot assure investors it can make a profit. Netflix lost $1.8 billion on its service last year. “
“Netflix and Tesla ..... are the most infamous tech cash-burn stories, with Netflix consuming almost $4 billion in the past 10 years, and Tesla running through over $10 billion.”
Amazon, Netflix, and Tesla Face Tighter Capital Markets
https://www.barrons.com/articles/amazon-netflix-and-tesla-face-tighter-capital-markets-1532130076?emailToken=ae4b48a9d70a21735a7fed5fe37fcc6fPCqVFNf2iK4lu9vnMUIhu0d4Mpr1t4e8FqogAnj5Dh49NKS7MGKmkHvwHt6xctSRFtUcyZR/FMfvUHwy9OHXos0Onj1Eeoz6eAILhwP3+ihDaTP80524h0H/8xs1bwpF
Bio: You are brilliant, and your thoughts are of great service. I am convinced you are correct. This is a reply to Nidan (modified to a degree), and I am forwarding this to you to request your valuable input:
sokol Post# 158713
One thing that seems evident, as Biostockclub has pointed out, it seems even more obvious now that Biogen is doing its best to upstage Anavex next week, July 25. Biogen and its partner, Eisai, will both have webcasts on July 25, the same day Biogen and Eisai present at the AAIC, concurrent with the Anavex presentations. It seems that Biogen plans to steal the show on July 25. What, if anything, be done to counter Biogen from detracting all the attention away from the Anavex presentation on July 25? Biogen is counting detracting all of the attention away from Anavex and toward Biogen on July 25, I think.
One thing that seems evident, as Biostockclub has pointed out, it seems even more obvious now that Biogen is doing its best to upstage Anavex next week, July 25. Biogen and its partner, Eisai, will both have webcasts on July 25, the same day Biogen and Eisai present at the AAIC, concurrent with the Anavex presentations. It seems that Biogen plans to steal the show on July 25. What can be done to counter Biogen from detracting from the Anavex presentation on July 25? Biogen is counting on the media attention to shift to and be focused on Biogen on July 25 and away from Anavex.
Biogen to Host Investor Webcast to Discuss Alzheimer’s Disease Portfolio on July 25, 2018
Source: GlobeNewswire Inc.
Biogen (Nasdaq:BIIB) today announced it will host a live webcast providing a Q&A session related to its Alzheimer’s disease investigational therapies on Wednesday, July 25, 2018. The live webcast will begin at 6:00 p.m. ET/5:00 p.m. CT on July 25, 2018, with Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen, and Samantha Budd Haeberlein, Ph.D., vice president, Alzheimer’s disease, dementia and movement disorders, late stage clinical development at Biogen. To access the live webcast, please go to the Investors section of Biogen’s website at www.biogen.com/investors. Following the live webcast, an archived version of the call will be available on the website.
Biogen’s webcast follows its presentations on aducanumab and BIIB092 as well as its partner Eisai’s presentations on BAN2401 and elenbecestat at the 2018 Alzheimer’s Association International Conference (AAIC). The BAN2401 Study 201 data presentation will also be webcast live. To access that live webcast, please visit the Investors section of Eisai's website on July 25th at 4:30 p.m. ET/3:30 p.m. CT at https://www.eisai.com/ir/index.html.
One thing that seems evident, as Biostockclub has pointed out, it seems even more obvious now that Biogen is doing its best to upstage Anavex next week, July 25. Biogen and its partner, Eisai, will both have webcasts on July 25, the same day Biogen and Eisai present at the AAIC, concurrent with the Anavex presentations. It seems that Biogen plans to steal the show on July 25. What can be done to counter Biogen from detracting from the Anavex presentation on July 25? Biogen is counting on the media attention to shift to and be focused on Biogen on July 25 and away from Anavex.
Yes, and the stock, Biogen, Cramer says is not the stock for him. That says something, don’t you think, and it is not positive for Biogen.
Jim Cramer Advises His Viewers On BlackRock, Target And More
Benzinga
Craig Jones
BenzingaJuly 20, 2018
On CNBC's "Mad Money Lightning Round", Jim Cramer said Biogen Inc (NASDAQ: BIIB) could double if it meets its endpoints and it could lose 40 percent if it doesn't meet them. The company failed to meet the endpoints earlier, but now it claims that it has made them. Cramer added this stock in't for him, but he suggested viewers should make their own decision based on the risk-reward.
Biogen to Host Investor Webcast to Discuss Alzheimer’s Disease Portfolio on July 25, 2018
Source: GlobeNewswire Inc.
Biogen (Nasdaq:BIIB) today announced it will host a live webcast providing a Q&A session related to its Alzheimer’s disease investigational therapies on Wednesday, July 25, 2018. The live webcast will begin at 6:00 p.m. ET/5:00 p.m. CT on July 25, 2018, with Alfred Sandrock, Jr., M.D., Ph.D., executive vice president and chief medical officer at Biogen, and Samantha Budd Haeberlein, Ph.D., vice president, Alzheimer’s disease, dementia and movement disorders, late stage clinical development at Biogen. To access the live webcast, please go to the Investors section of Biogen’s website at www.biogen.com/investors. Following the live webcast, an archived version of the call will be available on the website.
Biogen’s webcast follows its presentations on aducanumab and BIIB092 as well as its partner Eisai’s presentations on BAN2401 and elenbecestat at the 2018 Alzheimer’s Association International Conference (AAIC). The BAN2401 Study 201 data presentation will also be webcast live. To access that live webcast, please visit the Investors section of Eisai's website on July 25th at 4:30 p.m. ET/3:30 p.m. CT at https://www.eisai.com/ir/index.html.
There is a massive gap around $228, which might need to close.
Re: Pain and mitochondrial dysfunction. Mitochondrial dysfunction is associated with aging. That is one reason why it may be that AVXL 2-73 should be considered an anti-aging medication.
However, as Xena points out it, mitochondrial dysfunction may be caused by drugs. A few years ago my cardiologist prescribed a very high dosage of a statin because there is a history of heart disease on my Father’s side of my family. I developed pain in legs, and it was very unpleasant - actually it almost shut down my exercise altogether . I researched the problem with statins. Allegedly, this sort of pain caused by a statin is rare as many doctors say, but my investigation/research concluded that it is not so rare and related to damage to mitochondria in the body .
I explained my conclusion to my cardiologist, and he (although he did not agree) recommended I not take a statin for 30 days. I did that. The pain disappeared. He then put me on a different low dose statin in combination with Zetia. Actually, after doing the latter (low dose statin plus Zetia generic), my LDL level dropped much more than ever before, and the pain has not re-occurred. However, I self medicate by taking CoQ10 as my research indicated I should. Recently, I begin taking CoQ10 combined with PQQ (supposedly that combination increases mitochondria in the body), but possibly a better combination may be MitoQ for absorption, which may be a problem when merely taking CoQ10.
In any event, AVXL 2-73, according to my research, is neuroprotective and beneficial to mitochondria in cells. Mitochondria in cells is where biochemical processes of respiration and energy production occur. In other words, mitochondria are the engines that create energy to nourish and replenish the body. It may be that the body can take care of itself as long as everything functions as it should (homeostasis). Maintaining mitochondria in the body is key if you desire to continue to function and remain independent as we age. That is what I try to do, and I suppose I am older than most everyone on this board.
The 50 day moving average is trying to cross the 200 day moving average for a golden cross that technicians consider bullish. Plus, I liked the way the share price held up recently around $3 - $3.10. I think we have a suspected market low based on the price bars closes, opens and lows for July 16 - 18, plus the 50 day MA has been headed upwards toward the 200 day MA and likely to cross the 200 day MA. The price action is showing resilience leading up to the AAIC presentations next week. Of course, this suspected low must be confirmed next week, but I think the market is preparing for some good news for Anavex’s share price. If the expectation for good news does not develop, ...well, you know what will happen.
Classic double top. “Buying the dip” here may prove to be an unfortuante experience.
Curing Alzheimer's Unites In One Of The Most Divisive Times In American History
The Change Act introduced in June 2018, among other things, may speed up potential cures for Alzheimer's: "A highly-targeted approach to overcome barriers to a faster cure for Alzheimer’s disease, the CHANGE Act is designed to encourage early and accurate assessment, detection and diagnosis; support innovative approaches to relieve caregiver burden; and remove regulatory barriers to and provide the infrastructure for developing and implementing promising treatments."
Read more about it here:
https://www.forbes.com/sites/robinseatonjefferson/2018/06/27/curing-alzheimers-unites-in-one-of-the-most-divisive-times-in-american-history/#60ca09ae7138
Historically, new ideas and new scientific theories have been rejected for various reasons.
Galileo was tried and convicted for his new idea that the earth revolved around the sun. Darwin's theory of evolution and natural selection is not well received, many people are resistant to vaccinations, and man made climate change is presently a hotly contested issue.
This is not to say that all new theories should be embraced. The point is that human beings generally do not like change and are resistant to new ideas. This is so even though it may be in their best interest to examine and be open to new theories for such things as treating Alzheimer's -- especially in the case of treating Alzheimer's when there is no real treatment for the disease.
However, powerful companies, powerful interests, and most people continue to believe and postulate that plaque removal alone is the key and apparently the only solution for Alzheimer's. They cling to accepting plaque removal as fact even though it has consistently failed over the years.
Perhaps Galileo said it best:
"In questions of science, the authority of a thousand is not worth the humble reasoning of a single individual."
I think that people will come around to accepting completely new drugs for treating AD, but I also believe that the above helps to explain the resistance that Anavex faces. People want to believe in the established and major pharmaceutical companies -- even when these companies pursue a path that simply is not working.
Patent life is complicated, but Investor is correct. Generally, a patent is good for twenty years from the date on which the application for the patent was filed in the United States. Having said that, patents may be extended. Byway of only one example, Pediatric Exclusivity (PED) may add an additional 6 months to patent life. Additionally, there are many other ways to extend exclusivity for marketing a drug, and I am speaking about patent exclusivity as well as other forms of exclusivity. There are several forms of exclusivity besides patent exclusivity. Plus, new forms of "exclusiviyty" -- legal and illegal are being invented every day. There have been many detailed discussions on this board over the last several years about patent exclusivity. However, you probably need to read the following, which is by no means an end all discussion of exclusivity, and do in depth research on bringing the following up to date:
In any event, here is a very simple article that outlines drug exclusivity. It does not cover the subject thoroughly enough, and you may need to bring it up to date. Here is the simplistic explanation of drug exclusivity:
How Long Is A Drug Patent Good For?
by Rhona Finkel on August 26, 2012
The answer to the question is deceptively simple.
Drug patents are good for 20 years in the United States. There you have it.
But really the matter is far more complex than it would seem.
Patents are good for 20 years after the invention of a drug--not after the drug comes to market. It can easily take eight years for the pharmaceutical companies to gather enough data to get approval for their new invention from the U.S. Food and Drug Administration. Meanwhile the FDA can send the drug company back for more clinical studies (experiments using humans as subjects to test the drugs’ efficacy and side effects) and more data, and all the while the patent clock is ticking.
That's why the name of the game for pharmaceutical companies is working to extend those patents for a top-selling drug.
Why, you might ask, is extending patent such an important maneuver for pharmaceutical companies? Why don't they just 'go gently into that good night' of generics, as Dylan Thomas might have advised?
Well, money for one thing. Lots of it.
Biggest selling medicine ever, Lipitor (atorvastatin), the anti-cholesterol heart medicine, lost patent last fall. Pfizer, the drug's maker, noted a 19% decline in the first quarter after the patent ended, almost solely due to falling Lipitor sales.
After Eli Lilly's Prozac (flouoxetine) went off patent in 2002, sales fell a sharp 9% for Lilly in the second quarter, mainly due to loss of Prozac income.
When Lilly (again) lost patent on its antipsychotic Zyprexa (olanzapine) in October of 2011, it was hit hard. Sales plummeted 73%, mainly due to the loss of Zyprexa sales, and, as FiercePharma puts it, "[t]hat dramatic drop was blamed for every negative in Lilly's Q2 report, from margin shrinkage to earnings per share pain."
The Journal of Pharmacy and BioAllied Sciences notes that when Merck lost patent protection in 2000 for Pepcid (famotidine) to treat ulcers and gastric reflux, its bottom line changed radically. Pre-patent expiration Merck earned $755 million in US sales. Following patent expiration, sales plummeted to $110 million.
Is it any wonder that companies would like to do whatever is in their power to keep the patents running as long as possible?
How Drug Patents May be Extended
There are ways to extend the original 20-year patent, much of which got eaten up with clinical trials--a variety of ways.
The Hatch-Waxman Act
Legislation was passed in 1984 to try to even the patent playing field for drugs that got unfairly held up by the FDA regulatory process. The Drug Price Competition and Patent Term Restoration Act of 1984 (a.k.a. the “Hatch-Waxman” Act), allows for patent extensions to compensate for the delays in the approval process as the FDA is working to grant permission to bring the drug to market. There are, however, some limits.
The entire patent extension is limited 5 years, no matter how long drug development was held up. And the remaining amount of protected years following FDA approval is capped at 14.
Other means of extending patents exist, and pharmaceutical companies, after investing over a billion in each drug, work to make use of them.
Additional Research
One of the simplest, most straightforward techniques for extension of patent involves research on children. Any drug company can get an extra 6 months of patent protection by testing its medication on children to determine the best doses for them. And this 'pediatric exclusivity' extension can be used not just once but twice.
Other Techniques and Strategies to Maximize Patent Life
But, as often as the pediatric exclusivity extension is taken advantage of, it only gets the company a year at most. So the pharmaceutical industry uses a variety of other techniques to keep their branded drugs exclusively on the market--and the generics away--for as long as possible.
These strategies are sometimes referred to as "evergreening." Some such strategies for extending patent include:
1. New formulations
A simple way for a drug company to extend patent production on a medication is to get new patents for new formulations of a drug. This often revolves around simplifying dosing and administering of the pill, so extended-releaseformulations, where a patient need take, say, only 1 dose a day, or a week, instead of multiple doses a day, of the medicine, usually prolongs patent protection. Both extended-release formulations SeroquelXR (quetiapine) and Glucophage XR (metformin) added on years to the life of the drug patents. Even though Seroquel went generic early this year, maker AstraZeneca is able to hold on to their expensive exclusivity for the XR formulation through 2017.
Anti-diabetes drug Glocophage, after having extended patent for 6 months due to pediatric testing, was still earning over $3 billion in sales, and Bristol Myers Squibb was loathe to say goodbye. Part of their strategy to keep the drug branded was developing the XR version, which bought them 3 years of patent extension.
2. New means of administering the drug
If the drug is delivered in an alternative fashion than when it received original patent, it might be up for extension.
Migraine treatment drug Imitrex (sumatriptan) made over $1 billion in annual sales for GlaxoSmithKline, and thus the company was mightily motivated to hold on to the patent, set to expire in 2006. To do so they developed an intranasal spray, which received FDA approval, and let them keep hold of the drug--and profits--for 5 more years.
Most recently Intermezzo, designed to treat middle-of-the-night awakening, earned a new patent, even though it's a form of the generic zolpidem, or brand Ambien. Because Intermezzo dissolves under the tongue and isn't in pill form, it was granted approval as a new chemical entity last November by the FDA.
Even though Intermezzo has the same active formula as Ambien, the fact that is has a different dosage and different means of taking it earned Transcept Pharmaceuticals 5 years of patent protection for selling the new drug.
Johnson and Johnson's antipsychotic Risperdal (risperidone) went off patent in 2008, but, repackaged as a long-acting intramuscular injection, and named Rispderdal Consta, the patent protection extended until 2013.
3. New Uses for the Drug
A drug can earn three years extension under the three year new use/new clinical exclusivity FDA rule. The name of the game here is not to re-work the medication or re-formulate it, but merely to find a new use for it.
A 2006 article in Biopharm International notes how well this worked for pharmaceutical giant Eli Lilly. Lilly patented atomexitine in the early 1980s to treat depression. But further research indicated that the compound could treat attention deficient hyperactivity disorder. So Lilly received new patent protection for atomexetine as an ADHD drug, which it marketed as Strattera. This held patent protection until the end of 2010, long after doctors had stopped using amotexitine as an antidepressant.
4. Purifying of the isomers and re-branding
Perhaps the most famous recent case of this is the re-branding of the older, off-patent anti-depressant Celexa (citalopram) as the new Lexapro (escitalopram).
Celexa--like many drugs--is made of two isomers (this harks back to college chemistry, I know, but isomers are basically chemicals that have the same number of atoms of the same elements but differ in structure) and, as is frequently the case, only one of them is actually effective. Forest Pharmaceuticals knew as long as it had its Celexa that only one isomer was active, but it won patent for the double-isomer drug.
However, Forest, like many other companies, when it came time for Celexa to lose its patent, reformulated the drug by removing the inactive isomer, yielding a medication with only the active chemical compound.
Although in essence and efficacy it's basically Celexa, officially Lexapro is a new drug, earning its own patent and exclusive marketing rights.
[Forest was not the first to think up this creative solution. Remember the allergy pill Seldane (terfenadine)? Same two-isomer issue, so when Sanofi-Aventis wanted a first-rate allergy drug without having to create a compound from scratch, they merely developed a single-isomer version of Seldane, and earned themselves a first-rate patent on Allegra (fexofenadine).]
5. New combinations of drugs
Lilly had an active patent on antipsychotic Zyprexa, a name you might remember from above, while its patent on anti-depressant Prozac had expired. In a move that would extend the patent on Zyprexa and keep Prozac profitable, despite the emergence of a generic, Lilly developed and patented a new drug that was a combination of both, called Symbyax, one of very few drugs FDA-approved for treating bipolar depression—and they've got patent protection on that specific combination of drugs locked up until 2017.
Glucovance, approved as the first "combination oral antihyperglycemic [or diabetes] agent," is also simply a combination of two previous medications. Remember that Bristol Myers Squibb's top-selling diabetes drug Glucophage was set to lose patent in 2000. So first Bristol Myers utilized their pediatric patent extension, which brought them into 2001. Then they combined Glucophage with already-generic glyburide, another diabetes medication--and earned a new patent--for another 3 years--just as they were losing one on one of their best-selling drugs.
Between the two pills that make up its composition, Glucovance lowers blood glucose by helping the body make better use of insulin and by increasing the amount of insulin the pancreas produces. It was the first pill to combine the mechanisms of the two other pills into one--and it thus earned itself new years of patent protection.
6. Seven-year orphan drug exclusivity extension.
Under the U.S. Orphan Drug Act, in order to promote drug development for rare, or 'orphan,' diseases, this protection is given to medications used to treat diseases affecting 200,000 or fewer people in the U.S.
Research and development for drugs for rare disorders was lagging in the U.S. when Congress passed the 1983 act, which provided a number of incentives for companies to develop drugs that would never have a wide market. One of those was a 7-year monopoly on drug sales. And that only applied to the first approved use. The company was able to apply for a different use for the drug, and it could obtain exclusive rights for that, as well.
This exclusivity blocks the FDA from approving any competing generics for the orphan use during this time. The drugs get special consideration under the rule, since it is assumed that drug-makers could not recoup the cost of developing and marketing the drug through sales under normal patenting restrictions.
As an example Avonex (Interferon beta-1a), for treating relapse in patients with multiple sclerosis, won market exclusivity for 7 years, ending in 2003, under the Orphan Drug Act.
7. 30-Month Stays of FDA Approval
This has less to do with any reformulation of a medication, and more about just holding on tight to a patent, fighting off threats to a drug's exclusivity status.
Sometimes a generic company, instead of waiting for the patent to expire and being in direct competition with multiple other drug makers, will apply for approval anyway, claiming either that the original patent is invalid, or that the new generic product doesn't infringe upon that patent.
This almost without fail leads to the developing company suing the generic for patent infringement. The lawsuit triggers an automatic 30-month stay. During that time the FDA may not respond to the generic company's drug application--and the holders of the patent have earned themselves nearly 3 years of extension.
Take GlaxoSmithKline's efforts to keep antidepressant Paxil (paroxetine) safe from generic competition. Canadian drug-maker Apotex filed to patent a generic version of Paxil in March 1998. GSK duly sued, which yielded that 30-month stay, expiring in November 2000.
But GSK, knowing they had a good thing going, didn't stop there. As the Paxil patent expired, GSK took option #2, developing a new formulation that patients could take just once a day, as opposed to twice. They went for option #1, as well, gaining new FDA approval and extending the patent by finding use for Paxil in eating disorders and premenstrual syndrome.
Those new patents entitled GSK to bring more infringement lawsuits against Apotex, and, by the end, they had forced an automatic stay of FDA approval on APotex's version for over 5 years.
[Apotex was less than amused. Bernard Sherman, chief executive of Apotex, claimed that GSK had "repatented every conceivable form" of Paxil to block the competition. "It's an absurdity," he said.]
Another big pharmaceutical company to utilize more than one technique to keep the life of the patent long is Eli Lilly. Lilly doubled its efforts to keep its earnings from Prozac strong by both developing a pill to be taken only once a week and getting new FDA approval for its use in treating premenstrual dysphoric disorder.
GSK reformulated antidepressant Wellbutrin (buproprion) into a sustained-release form and got an additional patent when studies showed the drug helped smokers quit. The company marketed the smoking cessation drug under the name Zyban.
But sometimes even the most ingenious efforts don't always pay off.
With the patenting of Prozac Weekly, Eli Lilly thought they could staunch what was bound to be a flood of losses due to generic flouxetine entering the market. But the drug never sold all that well and certainly didn't come close to bringing in the profits that the original Prozac did. A $2 billion a year money-maker for Lilly before it lost patent in 2001, Prozac was the drug of a lifetime. Prozac Weekly never came close, as in 2004 all the Prozac products made $184 million, less even than the much-cheaper generic.
And despite all of a company's best efforts to keep the patent game alive, the day will come when even a drug-maker's best-selling product will go off patent. They'd best have a number of other drug options in the pipeline by then, to stay financially sound.
Source: How Long Is A Drug Patent Good For? - Drugsdb.com http://www.drugsdb.com/blog/how-long-is-a-drug-patent-good-for.html#ixzz4TsEmHrHy
In conclusion, this thing about market exclusivity of Anavex's drugs has been debated-vetted on this board over several years, and it is the least of my concerns. Actually, it is not a concern at all. If anyone desires to go through that discussion all over again, please proceed, but without me.
Next stage of national drug trial underway
By Sandy Cheu on July 13, 2018 in Industry, Research & Clinical
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Dementia specialist aged care provider HammondCare is leading the Australian component of an international trial testing a drug that aims to slow down cognitive decline in people with Alzheimer’s disease.
The trial is recruiting 450 people aged 60-85 living with mild cognitive impairment or mild Alzheimer’s disease across 12 sites nationally and will run for a minimum of 12 months.
It aims to demonstrate that the drug Anavex 2-73 shows benefits and improvements to those living with Alzheimer’s disease and to bring the drug to the market in the future.
The drug is a disease-modifying therapy and this trial follows promising results in an earlier Australian study, which achieved significant cognitive improvement in some participants.
This trial will test whether the drug can stabilise the progression of the disease, said Associate Professor Stephen Macfarlane, head of clinical services at HammondCare and principal investigator of the trial.
Professor Stephen Macfarlane
“It’s also important if we can slow the rate of cognitive decline to a meaningful degree,” Associate Professor Macfarlane told Australian Ageing Agenda.
“Improvement is asking a lot from a brain that is significantly damaged by the time people first develop symptoms,” Professor Macfarlane said.
While the causes of Alzheimer’s disease are unknown, damage to the brain from a build-up of toxin proteins is a theory, Professor Macfarlane said.
“We really need a drug that can impact on the course of the disease, not only to save lives but also save on future aged care costs,” Professor Macfarlane said.
“If the trial itself is successful and we come across a drug that modifies the course of the disease, it would be a complete game changer as far as aged care requirements go,” he said.
Previous findings
The trials are being run by American biopharmaceutical company Anavex Life Services and involved laboratory and animal testing in the first phase.
In Australia, the second phase of the trial, which commenced in 2015, involved 32 people with mild Alzheimer’s disease over a 12-month period across five sites in Melbourne.
A company sponsoring the new trial is working to determine the characteristics that differentiated participants who responded well to the drug compared to those who responded less well through genetic analysis and dosage amounts, Professor Macfarlane said.
“The new trial is designed to leverage those learnings from the earlier study and try to maximise the chances for success,” he said.
For many participants of the previous trial, their results at 12 months showed their cognitive status remained largely unchanged, he said.
Professor Macfarlane said some participants also regained functions previously lost, such as the ability to paint and play the piano while a person who re-sat the driving exam successfully regained their licence.
At the end of the study, participants requested an extension to continue to have access to the drug, which was granted.
In addition to this trial, Anavex received approval to earlier this week to also commence trialling the drug with people living with Parkinson’s disease and dementia.
https://www.australianageingagenda.com.au/2018/07/13/next-stage-of-national-drug-trial-underway/
Comment below to have your say on this story
Send us your news and tip-offs to editorial@australianageingagenda.com.au
Subscribe to Australian Ageing Agenda magazine and sign up to the AAA newsletter
Next stage of national drug trial underway
By Sandy Cheu on July 13, 2018 in Industry, Research & Clinical
FacebookTwitterGoogle+LinkedInEmailMore
Dementia specialist aged care provider HammondCare is leading the Australian component of an international trial testing a drug that aims to slow down cognitive decline in people with Alzheimer’s disease.
The trial is recruiting 450 people aged 60-85 living with mild cognitive impairment or mild Alzheimer’s disease across 12 sites nationally and will run for a minimum of 12 months.
It aims to demonstrate that the drug Anavex 2-73 shows benefits and improvements to those living with Alzheimer’s disease and to bring the drug to the market in the future.
The drug is a disease-modifying therapy and this trial follows promising results in an earlier Australian study, which achieved significant cognitive improvement in some participants.
This trial will test whether the drug can stabilise the progression of the disease, said Associate Professor Stephen Macfarlane, head of clinical services at HammondCare and principal investigator of the trial.
Professor Stephen Macfarlane
“It’s also important if we can slow the rate of cognitive decline to a meaningful degree,” Associate Professor Macfarlane told Australian Ageing Agenda.
“Improvement is asking a lot from a brain that is significantly damaged by the time people first develop symptoms,” Professor Macfarlane said.
While the causes of Alzheimer’s disease are unknown, damage to the brain from a build-up of toxin proteins is a theory, Professor Macfarlane said.
“We really need a drug that can impact on the course of the disease, not only to save lives but also save on future aged care costs,” Professor Macfarlane said.
“If the trial itself is successful and we come across a drug that modifies the course of the disease, it would be a complete game changer as far as aged care requirements go,” he said.
Previous findings
The trials are being run by American biopharmaceutical company Anavex Life Services and involved laboratory and animal testing in the first phase.
In Australia, the second phase of the trial, which commenced in 2015, involved 32 people with mild Alzheimer’s disease over a 12-month period across five sites in Melbourne.
A company sponsoring the new trial is working to determine the characteristics that differentiated participants who responded well to the drug compared to those who responded less well through genetic analysis and dosage amounts, Professor Macfarlane said.
“The new trial is designed to leverage those learnings from the earlier study and try to maximise the chances for success,” he said.
For many participants of the previous trial, their results at 12 months showed their cognitive status remained largely unchanged, he said.
Professor Macfarlane said some participants also regained functions previously lost, such as the ability to paint and play the piano while a person who re-sat the driving exam successfully regained their licence.
At the end of the study, participants requested an extension to continue to have access to the drug, which was granted.
In addition to this trial, Anavex received approval to earlier this week to also commence trialling the drug with people living with Parkinson’s disease and dementia.
https://www.australianageingagenda.com.au/2018/07/13/next-stage-of-national-drug-trial-underway/
Comment below to have your say on this story
Send us your news and tip-offs to editorial@australianageingagenda.com.au
Subscribe to Australian Ageing Agenda magazine and sign up to the AAA newsletter
Nidan:
This is what I sent a few days ago to:
Alzheimer's Association Public Relations Department
Phone: +1.312.335.4078
Email: aaicmedia@alz.org
Apparently, Biogen and Eisai plan to provide late breaking news at your conference about BAN240. So far, their disclosures have been sketchy.
The Biogen and Eisai drug, BAN240, failed before. So what's new about their latest announcement?
WSJ article: ”Analysts said questions remain about the results of the BAN2401 study. For one thing, researchers used a novel measure of efficacy that was developed by Eisai’s in-house researchers, rather than standard measures in the field.”
They, Biogen and Eisai, obtained a different outcome with a new measure of efficacy. Biogen’s partner Eisai, a Japanese pharmaceutical company, came up with a new standard to measure ”success”. This ”success” measured by a new internally conflicted standard should by itself raise a red flag.
Even then this ”success” may not be so great considering their drug is an infusion and the same WSJ article points out: ”The study involved 856 subjects in the early stage of the disease. Among the side effects that the companies reported were reactions at the sites of the infusion and swelling around blood vessels observed with brain imaging.”
Making multiple trips to a clinic or medical office for infusions as opposed to taking a pill poses difficulties in addition to the risks of adverse events, and for what: BAN240 does not stop or reverse Alzheimer’s. To sum up : The drug is IV injected, only works at the highest dosage if at all, takes months to kick in, and the new cognitive tests were created in house. It would be of interest to know what percentage of those receiving ONLY the highest dosage, the one that reportedly works, developed adverse events.
This very recent announcement is lacking many significant details even though Biogen/Eisai have been conducting research and clinical trials on the drug for a very long time.
Alzheimer’s is a cruel disease. Let's not promote false hopes - especially one based on the amyloid hypothesis that has been virtually a 100% failure. What does the AAIC know about this late breaking news about BAN24 that was a once-failed treatment for Alzheimer’s disease?
I and many others that have friends and families affected by Alzheimer’s deserve to know the plain and simple truth as opposed to the promotion of more of the same that may not work!
Perfect. I may send Nicole an email later, but not to be repetitive.
Nidan:
If you desire to contact an AAIC staff person with your questions or concerns, here is one contact:
Invited and oral presentations
Nicole Sanders
Alzheimer's Association
Phone: +1.312.335.5897
Email: NSanders@alz.org
Bio:
Thank you. Thanks to Dia as well. I hear you. In re-thinking my post, it was too cynical. Reviewing what many good posters have researched and pointed out about the AAIC presentations, it does appear that on this upcoming AAIC occasion that Anavex is taking all of their weapons to war. Several posters have pointed out that the number of presentations by Anavex on July 25, three presentations I believe, and the crendentialed people Anavex will have on stage or in attendance to mingle and get the AVXL 2-73 message across. I apologize for my jaded message. Anavex deserves to win, and it looks like it is getting fully prepared for any eventuality. As Dia pointed out, It is an easy choice for me too. I would chose AVXL 2-73. May logic prevail! If so, society will benefit, and we should all work for the benefit of society. I will try to do better next time.
I have learned that many times logic has nothing to do with decisions made by governments and major corporations or large organizations. Here I will use a state government as an example. I live in a State that has a budget problem such that it may mean cuts in education, health and other areas that are beneficial to society. An issue has come up about releasing prisioners from serving their terms because the State does not have funds to house or maintain the number of prisioners it has jailed.
One question I asked is why we in this State insist on mandatory 2 year sentences for a person that merely uses or possesses marijuana when these people do not otherwise have criminal records, are artists, students, or the like that do nothing more than occasionally use marijuana. Could the State cut the budget by changing the law that results in the mandatory prision sententeces of these people? The State jails thousands of these people when many states have decriminalized the use of this substance and when we may face the possibility that real criminals in the larger State prisons may be released because of budget problems.
The answer I received is are you crazy. The Sheriffs do not want that to happen because the Sheriffs house many of these marijuana users in local prisons and receive per diem from the State for doing so. The Sheriffs do not want to give up receipt and control of these funds. Besides, it is easier to maintain these prisioners that probably do not belong in prison in the first place.
Put simply, because of the way money flows, it gets complicated. The Sheriffs, whose job it is to apprehend criminals, simply does not want to give up its local revenue source, and these "law enforcement" officers may prefer that hardened prisioners from the larger State prisons be released instead.
Now using this example, does anyone know where the AAIC receives its major contributions? My word, could it be that major contributions come from big pharma? Could it be that the AAIC and its staff whose salaries depend on funding from major corporations might be of the same mind as the Sheriffs I use in the example above? Could it be that the AAIC people and the doctors that attend the convention may hear the Anavex presentation as outlined in your good post, but chose to side with this other drug presentation instead even though:
The other drug had
1. inconvenience and cost of IV delivery
2. some brain swelling concerns at the higher most effective doses
3. took some months to show benefit, and
4. the benefit was generally to slow decline
Yes, congratulations. It is hard work starting out on your own. However, when I did the same year's ago, I developed the attitude that anything that is easy may not be worth doing. From reading your post you are extremely capable and will be a success. I went my own way because I did not like being forced to do work that I did not feel good about doing even if it was easy. After making that decision, I immediately felt relieved, and I had this good feeling each morning as I started my day. It was the right thing for me to do.
Impressive. Thank you.
Biogen and Eisai stacked the deck:
The drug, BAN240, failed before. So what's new. Biogen and Eisai stacked the deck, that's what's new.
WSJ article: ”Analysts said questions remain about the results of the BAN2401 study. For one thing, researchers used a novel measure of efficacy that was developed by Eisai’s in-house researchers, rather than standard measures in the field.”
They, the foxes in the henhouse, arranged things for a desired outcome by internally coming up with a new measure of efficacy. Biogen’s partner Eisai, a Japanese pharmaceutical company, came up with a new standard to measure ”success”. Even then this ”success” is not so great considering their drug is an infusion and the same WSJ article points out: ”The study involved 856 subjects in the early stage of the disease. Among the side effects that the companies reported were reactions at the sites of the infusion and swelling around blood vessels observed with brain imaging.” Making multiple trips to a clinic or medical office for infusions as opposed to taking a pill poses difficulties in addition to the risks of adverse events, and for what: BAN240 does not stop or reverse Alzheimer’s.