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Biogen has a history of partnering up with lesser drug companies. For ex, it comarkets Tysabri (one of its 4 MS drugs) with Elan. Tysabri was Elan's drug more than 4 years ago.
From Wiki:
Elan Corporation, plc (NYSE:ELN) is pleased to announce the closing today of the TYSABRI (natalizumab) Collaboration Transaction with Biogen Idec. The agreement was announced on February 6, 2013. Under the terms of the agreement, Elan receives $3.25 billion in cash and will receive double digit tiered royalty payments, on all indications, for the life of the complete TYSABRI asset. For the first twelve months Elan will receive 12% royalties on in-market sales of TYSABRI, and thereafter, Elan will receive 18% royalties on in-market sales up to $2 billion and 25% royalties on in-market sales exceeding $2 billion. In 2012, in-market sales of TYSABRI were $1.6 billion.
Biogen also cosponsors another MS drug, Ampyra (dalfampridine). Its partner for that drug is Acorda Therapeutics. 2013 revenue was $302M.
As an aside, the name of one of Biogen's MS drugs is Avonex. Sounds strikingly similar to Anavex. Mere coincidence?
What would you consider positive 41 weeks results: improvement from baseline, stabilization, slight decrease of scores, moderate decrease? For me, positive scores, given subtherapeutic dosings and the adverse affect of donepezil, would be: moderate drop in scores for the 273+donepezil group and slight decrease in scores for the 273 monotherapy group. Maybe a moderate decrease in scores would be OK for this group too. Very good and unexpected results, imo, would be stabilization of scores for the 273 monotherapy subjects. I'd like to see full results for the 273 monotherapy group.
“2-73 has already demonstrated early positive data in AD, and Anavex has demonstrated potential utility in multiple other preclinical models of CNS diseases, including MS. Thus, we see Biogen coming on board, even for early stage studies, as further validating. In addition, what we’ve been learning from CNS-based studies, whether AD or MS, is that the data are complex across multiple endpoints. As such, having the KEM system with Ariana in place to help analyze complex data is, in our view, a strategic positive for Anavex,” Kolbert concludes.
I'd love to know the P300 score at 31 weeks for just the 7 on 273. Would it have remained stable or not declinced as much from week 5 to week 31 as the overall group's did? I wish all 7 were on 50mg. I wonder how different their scores might be?
Anavex with its 8 employees spend all its time and $ on research? And take on massive debt in the process? They're just not set up for that at this stage.
Donepezil "might" be competing? 2-73 is a competitive agonist for the sigma receptor. It competes for that receptor site. Most these patients (mild to mod) have been on dzp a long time and we know beyond 3 months, it stops improving patients scores. So, dzp is occupying those receptors without doing anything of benefit after 3 months to a year. Those receptors could have been occupied by 273. Which has greater affinity for sigma 1, dzp or 273? DZP's affinity is 14.6. What is 273's affinity? IDK. You tell me
I don't doubt 273 and dzp had synergy in the mouse study. Why? Because in the mouse study the dzp was actually helping not just sitting there. Why? Because the mice were put on it fresh, for the first time, at the same time they were put on 273. That didn't happen in the clinical study. The design of the mice and human studies were not the same. If the subjects were put on dzp fresh when they started 273, I think we'd see improvement similar to the mouse study. But that synergy only lasts so long as dzp's beneficial affect overcomes the disease's progression.
When comparing this trial to others, make sure you're comparing apples to apples. Is the patient population the same? Other studies (cough, aducanumab) use prodromal patients that aren't that sick or progressed with Alzheimers. They do this to pad their results. They also use huge n's, which reduces risk. They put patients on the max dose tolerated that is deemed therapeutic. Did anavex do any of this for their trial? No. Does 273 cause severe brain swelling or raunch someone's gastrointestinal tract? No. The MMSE overall score was stable from baseline, that is what I referred to. In the 7 montherapy subjects is has risen at 31 weeks. That is not, as you said, BS.
"disappointing mmse Ph 2 scores"? Umm, hardly. Stabilised MMSE out 31 weeks is not too shabby. And, improving MMSE for the 7 on 273 alone at 31 weeks. For some reason, gee I wonder (sarcasm), Anavex is being held to a different standard by the digital rags. Simply slowing the progression, the goal of every Alzheimers drug in development, isn't enough. No, only cure or indefinite stabilzation is acceptable. Keep in mind Anavex's patient pool is sicker and further progressed than the other studies and the Anavex study doesn't have patients taking the max tolerated dose of the drug. Donepezil is suppressing 273 by taking up space on receptors too. And of course the author complains about lack of control group, not understanding this is an adaptive study design encouraged by fda and efficacy of this trial is only a secondary end point. Oracle, Motley Fool, and The Street employ hacks that don't do their DD and listen too much to the FUD put out by hedge funds and the likes of Adam Feuerstein. In fact, it would not surprise me if they are working for the hedge funds themselves
Is "serious brain swelling" an issue though? Can you have it, but it's fine, doesn't cause symptoms, and isn't a reason to stop a med that is producing that side affect. Can you just live with it for 5 years and it remains in a steady state (not worsening) but not causing any problems?
Biogen was smart to collaborate with Anavex on MS. It is a legit company with great management, scientific advisory board, and a pipeline of drugs that is impressive. It has the potential, more than any other biotech imho, to change the world in the next few years. I suspect this cooperative agreement will lead to an even closer relationship btw Biogen and Anavex in the months to come. If that's the plan, Biogen won't regret it. Checkout the publications for 2-73 and 3-71 on Anavex's website under the news tab and read up on the early successes the company has been having. They are very impressive for many different diseases. Alzheimers is just the beginning for Anavex. The rocketship Anavex is about to launch, take a seat on it for the ride of your life.
Aducanumab's MMSE and CDR-SB scores at 6 months in the link below . The 10mg/kg dose has increased incidence of causing serious brain swelling so don't know if that could be the Max Tolerable Dose.
According to cliinicaltrials.gov Anavex's current trial has only 25% of patients on the max tolerated dose (50mg). 75% of Ph 2 2-73 patients are on 30mg. I will be glad to see data in Ph 3 for lots of patients placed on just 273 w/out donepezil and a majority of patients placed on 50mg. That should give us a boost. Keep in mind the Aducanumab trial enrolled prodromal patients, which the Anavex trial did not, and no patients with moderate Alzheimers, which the Anavex study did enroll. The MMSE scores for 2-73 listed on the AAIC poster were taken at 7, not 6, months and remember that during the first 5 weeks of Ph 2 there was that 12 day washout period and during that same period patients were on reduced dosing. After the first 5 weeks of Ph 2 they were placed on daily 30 or 50mg. The next PK/PD data I think should show if there is a dose response difference between the 30mg and 50mg groups. I don't know if Aducanumab showed any favorable affect on mood and insomnia, which 273 did.
http://www.nature.com/nature/journal/v537/n7618/fig_tab/nature19323_ST1.html
Biogen's Phase 2 trial results for Aducanumab published Sept 1st. Like most drugs that have been in development to target Alzheimers, it is an antibody targeting amyloid plague. All of the antibody drugs have proven to be lackluster and the FDA discourages their development (however, it did grant fast track for aducanumab, go figure)
Preclinically aducanumab showed removal of amyloid in mice. Ph 2 results published Sept 1st showed it slowed cognitive decline based on MMSE and CDR-SB scores. Note - slowing decline is not as good as halting or reversing decline. 273's pooled scores showed halting of MMSE decline over 31 weeks and the 7 patients solely on 273 without donepezil showed improvement of MMSE at 31 weeks.
165 patients were enrolled in the aducanumab trial vs only something like 32 for the Anavex 273 Ph 2 trial. It must be generally thought that the more patients enrolled increases a trial's chances for success b/c big pharma enrolls 1-2+ thousand patients in their Ph 3 Alzheimers trials and likes to cherry pick patients w/mild Alzheimers for better results
Brain scans at 12 months for patients on the highest dose (10mg/kg of body weight) of aducanumab showed amyloid plague essentially gone. However, that high dose had elevated incidence of causing serious brain swelling. The Ph 2 aducanumab trial only enrolled prodromal and mild Alzheimers patients. Prodromal means patients that have exhibited cognition problems but have yet to develop Alzheimers. It is A LOT easier obtaining good results in an Alzheimers trial if the patients have only mild symptoms and/or just developed symptoms. Keep in mind that Anavex's Ph 2 trial enrolled patients with mild or moderate Azheimers disease, and no prodromal patients that I know of (can anybody confirm that b/c the AAIC poster did mention patients in the Ph 2 trial with mild cognitive impairment/MCI which confused me). I don't know if the Biogen trial's patients were concurrently on donepezil, like the 273 trial. If they were, they probably had more recently just gone on donepezil so maybe it was exerting much more of a positive effect for them (donepezil only helps for first 6 months or so of going on it). Also, donepezil shouldn't compete with aducanumab for receptor sites or hinder its efficacy, which seems to be the case for 273 since donepezil, like 273, is a ligand for sigma 1 and muscarinic recptors.
My library is sending me a pdf copy of the article on aducanumab's phase 2 results appearing in "Nature" August 31. Should get that in 2 weeks to check out just how much it slowed cognitive decline.
http://www.fiercebiotech.com/biotech/biogen-s-aducanumab-data-impresses-media-but-not-market
I've finally gotten around to checking out Biogen's drug Aducanumab. Like most drugs that have been in development to target Alzheimers , it is an antibody targeting amyloid plague. Preclinically it showed removal of amyloid in mice. Ph 2 results published Sept 1st showed it slowed cognitive decline based on MMSE and CDR-SB scores. Note - slowing decline is not as good as halting or reversing decline. 273's pooled scores showed halting of MMSE decline over 31 weeks and the 7 patients solely on 273 without donepezil showed improvement of MMSE at 31 weeks. Brain scans at 12 months for patients on the highest dose (10mg/kg of body weight) of aducanumab showed amyloid plague essentially gone. However, that high dose had elevated incidence of causing serious brain swelling. The Ph 2 aducanumab trial only enrolled prodromal and mild Alzheimers patients. Prodromal means patients that have exhibited cognition problems but have yet to develop Alzheimers. It is A LOT easier obtaining good results in an Alzheimers trial if the patients have only mild symptoms and/or just developed symptoms. Keep in mind that Anavex's Ph 2 trial enrolled patients with mild or moderate Azheimers disease, and no prodromal patients. I don't know if the Biogen trial's patients were concurrently on donepezil, like the 273 trial. If they were, they probably had more recently just gone on donepezil so maybe it was exerting much more of a positive effect for them (donepezil only helps for first 6 months or so of going on it). Also, donepezil shouldn't compete with aducanumab for receptor sites or hinder its efficacy, which seems to be the case for 273 since donepezil, like 273, is a ligand for sigma 1 and muscarinic recptors. http://www.fiercebiotech.com/biotech/biogen-s-aducanumab-data-impresses-media-but-not-market
Who said "the 9 months is going to be tough"?
Isn't the PK/PD data long overdue? Maybe they're waiting to present it at CTAD? IDK, it just seems delayed.
I personally feel Anavex's most likely route for FDA approval and success is treating depression, anxiety, and insomnia. We'd be a nice alternative to Prozac and Valium with fewer side effects and not turn people into zombies. More people have those conditions than Alzheimers and Parkinson's, that's for sure.
Do the patients with MCI also have mild Alzheimers? Orrrr, extra mild Alzheimers? What differentiates them with the patients in the mild-moderate group that have mild symptoms?
Any small cap or micro cap biotech company that has a lick of promise and intriguing compounds in clinical trials is going to attract the attention of AF, JF, and their hedge fund collaborators. They play the odds that most these drugs fail and simply work off that premise. They start with a narrative (the company is a scam and the drugs or worthless) before even investigating the company in depth. Whatever information they find that can be spun to fit their narrative they exploit. Never anything positive is written until writing is on the wall that it is a success. Then they make excuses or just refuse to comment.
What makes you think Ph 3 would use 30mg of 2-73 and not the MTD of 50mg? Wednesday's dose response results may very well show greater improvement with the 50mg arm
Where the poster says "16 therapeutic responses reported", does that correlate with ADCS-ADL? 12 week interim results revealed months ago that 11 or 14 subjects reported improved ADCS-ADL scores. Can we surmise that another 5 out of the 32 reported "therapeutic responses" and will also have improved ADCS-ADL scores?
I am glad the trial has established that 50mg is the MTD. Perhaps that dose will yield better improvement than 30mg
Fidelity told me even if you have a margin account, they will not lend out your shares without your permission. Fidelity doesn't allow you lend out your shares unless you have like $250K minimum in your account
cramer also said if you're not willing to engage in these manipulations and lies, you shouldn't be "in the game" (ie on wall st)
Adam @#$%ing Feuerstein "brutally honest"? He is amoral, the only time he is honest is when it suits his employers' (hedge funds) interests whom feed him FUD to disseminate to the masses. His attacks on AVXL have all been lies. Just look at his street.com hit piece from Nov 9 that critiqued Anavex and its 5 week results. Full of fiction. When it comes to AVXL he is either brutally dishonest or woefully ignorant. I'll go with him being a lying sack of @#$%. He cheerleads for his buddy Martin Shkreli and works for the craven Jim Cramer. That right there should tell you something about his character and ethics. He is machiavellian. He has no use for truth and facts. If truth makes his bosses $, fine he'll submit that. If lies get the job (sinking a biotech stock) done, he'll go with that. More often than not he goes with the latter option.
Some have speculated AVXL may rise to $10 or $12 before AAIC. I think it could go to $14+. Why? More anticipation for this trial update which has been delayed for months. Anectdotal stories, 12 week interim results look good, good 5 week PK/PD, moa looks good for lots of cns diseases, more tutes and funds buying in, avxl better known now, etc.
So it could fall to $6.20 or it could fall to $6.60-7 or it could jump up to $9? Is that the best that TA can do for us? Doesn't seem very specific
Well there were a few pull backs of $1-2 leading up to CTAD. I could see this kiss $8 again then fall to Tom's $6.20 price in a day.
So, in a nutshell, for those waiting for good pull back to buy shares, wait for $6.20?
I posted this months ago. Maybe if enough investors petition Anavex, they'll consider doing this. How can you assess synergy if donepezil has already "shot its wad" so to speak
I think what was granted on Nov 10, 2015 was just a transfer of the patent, but that didn't the change the timeline for when the patent was set to expire (2016)
Why would approval of Anavex Plus prevent a company from selling a generic of 2-73 6 yrs from now? I don't get that
One of the patent expert dudes on ymb said even with no patent for the drug we still get 5 years of exclusivity protection for the drug for some reason. I believe there is 7 yrs of market exclusivity for the use of drug for a specific orphan disease, but that wouldn't provide exclusivity for other diseases.
eggahmuffin on ymb posted the followiwng last week: "As I understand it, based on the following fda info, Anavex would get 5 years exclusivity for 2-73 even if it's patents had expired. Am I misunderstanding this? Comments?
wwwDOTfdaDOTgov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm
"A 5-year period of exclusivity is granted to new drug applications for products containing chemical entities never previously approved by FDA either alone or in combination. No 505(b)(2) application or ANDA may be submitted during the 5-year exclusivity period except that such applications may be submitted after 4 years if they contain a certification of patent invalidity or noninfringement. A 3-year period of exclusivity is granted for a drug product that contains an active moiety that has been previously approved, when the application contains reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval of the application. For example, the changes in an approved drug product that affect its active ingredient(s), strength, dosage form, route of administration or conditions of use may be granted exclusivity if clinical investigations were essential to approval of the application containing those changes."
2-73 is an "innovative dementia care practice". It also has implications on psychosocial factors of dementia since it has affected the mood of the patients in the trial according to McFarlane.
When the sell off occur and how severe will it be? A repeat of CTAD taking it down to $3's or $4's?
And you think the shorts, hedge funds, profit takers, and traders are gonna let it go up untouched? Doubt it. This ain't my first time to the rodeo
Could someone cogently list all the patents that exist involving the furan compound known as 2-73?
I thought we just need a patent for the furan compound, but apparently that isn't good enough for whatever reason. I "think" the greek inventor of 2-73 got a Greek patent for the compound back in '97 but it has run out and we can't renew a patent for it. Is that correct? God, could this @#$% be any more convoluted?
If Anavex can't renew the patent for the compound, what's the point of getting it fda approved b/c as soon they do, a dozen generic companies will manufacture it b/c it will be w/out patent protection?
You get out after the stock has been in a topping phase, just before or at the beginning of its bear run down
Why can't Anavex get a patent for 2-73 to treat Alzheimers? It is their drug, they own it. I don't get it. If they get that patent, no generics of it can come out for something like 18 yrs!
no, part a was 5 weeks, part b was another 12
attilathehunt1 posted this on ymb yesterday: "Over 2M naked short sales sold by MM to index funds. This most likely puts a cap on us for some time. The same thing happen to NVIV last year. The only thing to break this trend is for fantastic news."
Any truth to this statement?
Is this the bottom for avxl til aaic or do you see more dips down to $4 in the next month?
Why is Anavex even bothering with 1-41, isn't that just a metabolite of 2-73? Why should we expect that could offer anything that 2-73 does not? Fewer side effects? I just don't get it. Anyone have insights as to why Anavex is even bothering with it?