Drug Discovery Article Extract
Neurological disorders significantly outnumber diseases in other therapeutic areas, inflict higher treatment and loss of productivity costs than cancer, cardiovascular disease and diabetes put together and are growing in incidence faster than any other disease class in the EU and the US. More than 600 known neurological disorders now top the leading disease list in the developed world . In Europe, 38% of the population is said to be affected by brain disorders annually2, whose burden in 2010 was estimated to be #$%$798 billion. Over the coming years, the European Brain Council has forecasted a further 20% increase in neurologic illness in the EU3.
Despite the high risks, the rewards of developing the next AD medication appear to be much higher. Indeed, even a relatively mediocre Alzheimer’s treatment approved by the FDA could break a new blockbuster sales record. And this is why, despite varying strategies, almost all Big Pharma players are keeping one foot sturdily in the door when it comes to neuropharmaceutical development.
Hello Sarge Thank you as always for this weeks overview.
Further to your numbers, during the week we touched on AVNR pps balancing its self out some what over the last few days.
Now if we are to apply the same theory to the years from 2006 up to the April 2014 patent victory, where as we one could say it was a tad hard going at times and not without a number of sad faces. It will be all smiles and laughter for a good number of years.
To keep on your Saturday musical theme, I thought I would give this one another airing.
Enjoy the rest of your weekend my friend.
Thank you for that, I never know if I should move closer to the bunker entrance or jump for joy upon reading any thing from The Street. I would like to think on this occasion it would be the latter of the two.
I hope you are keeping well.
Hi Sarge – it appears good to have a team talk we gained a bit back on the drop.
Like your good self I also have had trouble with a few posts, nothing derogatory mind you just info on the EU. If we were discussing this from the bunker we may be accused of being a part of some resistance, militant or informer group. I will try and sneak up on them when they are not looking ;-)
Enjoy your day my friend.
I noted Saturday that you were having a little problem posting is that right?
One minute I was reading your round up and before the kettle had boiled there it was gone. However I did note that you managed to get a copy to stick a bit later. My appologise for not replying then.
Toddle Pip ;-)
Hi Hondobud – thank you for your thoughts, you covered many a good reason.
One aspect that I do not have much of a handle on is the options, I come to rely on you guys over there when it comes to that topic. As for Cramer my old friend Sarge and I have the tin hats not to far away on the very mention. You may think much in the same way as I in so much that as the pps gets higher the less inviting it is for any petty meddling.
You mention a Europe deal as a possible surprise and rightly so. A host of things come to mind regarding the EU, believe me I’m bursting full of excitement (but not as much as KK, put that bit in for my dear friend OBHF) on the topic. Funny what comes to mind, the one that just whizzed through the grey matter was about some of the predictions on the pps on news of an EU deal, they were around $5 just a year or two back. Are we not glad that we were not partnered out at that level.
I state with out fear of contradiction, given that it is confirmed we do have a multi CNS indication drug on our hands, (FWIW IMO we do have one ) We will get that elusive share holder value (and some) that we have heard so much about.
Hey you nearly set me off into full EU Mode.
Have a pleasant afternoon.
Good day to you Nomargin and good to hear from you.
If nothing else it makes a talking point from time to time.
Talk about time and Big Ben ringing out, I have been having a chuckle to my self.
Yahoo of late have been persistant in reminding me that I’m above an old Sell order limit I set many moons back, example of today’s alert below. Not sure if they still provide the service so that I can update the same, do not think I will bother to, l know where I’m at.
Stock Watch Alert: AVNR (at 5.3500) is above your limit price of 3.0
Enjoy your day.
Hello Hondobud – trust all goes well for you.
An interesting one again. FWIW It would not be for the first time that our stock price percentage drop has been disproportionate to that of the Nasdaq, I can recall on a number of occasions in the past that it has happened. From that I’m giving consideration to AVNR is still a traders paradise, the difference being it is at a higher PPS level now.
Take a look at the 5 day AVNR NASDAQ comparison chart where you will note that around the 3rd July AVNR percentage gains are above the NASDAQ. Perhaps the AVNR percentage gains and losses against the NASDAQ balance out, if one was to look into it in depth, I shall not be.
I ask my self, what if any significant changes have come about to effect the pps over the period mentioned above. I fail to find one, on that basses all things being more or less equal matters would more or less stay the same. However not our AVNR we get a little movement, which I can only relate to trading. Not that I take much notice! but it appears that the noise on the down days is more apparent than on the up days, something else that has not changed over the years.
It will be interesting to see what’s next
All the best.
BBC Health News
8 July 2014 Last updated at 00:03
British scientists have made a "major step forward" in developing a blood test to predict the onset of Alzheimer's disease.
Research in more than 1,000 people has identified a set of proteins in the blood which can predict the start of the dementia with 87% accuracy.
The findings, published in the journal Alzheimer's & Dementia, will be used to improve trials for new dementia drugs.
Experts warned that the test was not yet ready for doctors' surgeries.
Research into treatments for Alzheimer's disease has been plagued by failure. Between 2002 and 2012, 99.6% of trials aimed at preventing or reversing the disease flopped.
Doctors believe the failure is down to treating patients when it is already too late, since symptoms appear around a decade after the start of the disease.
Identifying patients earlier is one of the priorities for dementia research.
Thank you for bringing this to our attention.
Regarding the Licence IMO we are being kept a little in the dark in this respect.
Migraine would not have been a part of the original 5 indications CNS Licence agreement. However AVNR have the patent rights and then we had the statement from KK saying as far as I recall, that further trials were to be conducted using DD/Q where as different licence agreements may be apparent.
IMO it is high time that we have some clarity in respect of the licence agreements from AVNR.
When Dr R Smith got in with Neal’s regarding speech and swallowing, I have often considered if Dr R S was trying to bring this forward to get some thing from it before the DD/Q change over, cynical view perhaps but I strongly believe Dr RS was keen on N for S&S. Interestingly as far as I recall on the Dr RS videos he states loud and clear about two aspects other than pba that appear to show good efficacy which happen to be Speech and Swallowing as well as agitation.
I’m sure AVNR will see Dr R. Smith is taken care of. I have in the back of my mind perhaps this may be a part of an acquisition of AVNR. As stated before some clarity in this respect would be appreciated from AVNR.
Very best regards
Hello Sarge Thank you for the weekly round up.
Certainly is good to see the $5+ being sustained.
A post or two I made during the week were a bit militant for me; today I’m going to carry on in the same vain. I put it down to the thought of Ralph’s concoction you two were discussing. By the way own up about the flask.
SA Headlines Feb 26 2014
Limited upside for Avanir even with patent trial victory says Jefferies
Believing a Nuedexta patent trial victory is mostly priced in, analyst Thomas Wei maintains his hold rating on the stock with $4 price target.
April 29 2014 closing pps price $3.42 Thomas backed in price must be below $4 if that was his price target. Hey Thomas I’m not out to make you look bad you done a fine job by your self on this occasion.
Enjoy the rest of your weekend my friend.
PS In the event you are going to own up regarding the flask. Please give it a good rinse out considering the effect of Ralph’s special.
For what ever reason my reply to you will not post as one post. I’m going to break it down a bit to see if that works. Here we go
Thank you for your post, you touched on many a valid point.
Regarding not to expect much from Nuedexta in Europe. IMO it all depends how they go about it (distribution) so I do not necessary agree with what some are saying.
Cheers Razor – I would like you to see my reply to rside that I just mention. I shall give it a go in a new thread to see if it will stick there. We have been over some of the contents before.
Thank you for your note.
Hello Razor – good to hear from you my friend.
I no we, IMO no longer have to worry about that bunch, their scampering about has less and less effect and more so in the long term, I have come to reconise that. Nothing will change here IMO they will more than likely carry on grabbing a little bit here and there, and we can be entertained by their followers during such times. However as mentioned we have been joined by some heavy hitters who’s feathers are best not ruffled.
Yes I’m chirpy, perhaps it is best Sarge has the Flask (We know you have it Sarge)
I have had a devil of a job posting again. I have been trying to reply to rside I will get there in the end. Perhaps I have been a little militant in my postings of late ;-)
My very best regards
Hello Onlyfacts - good to see you are showing grit here and thanks for helping out.
Note for Robert - if I was to listen to anyone on the subject matter Onlyfacts would be my man.
Hi Robert- trust you are well.
Sorry no introduction on the previous trial posts, I copied and pasted direct.
Hope it helps.
First received: April 23, 2012
Last updated: April 15, 2014
Last verified: April 2014
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agitation in Patients With Alzheimer's Disease.
Further study details as provided by Avanir Pharmaceuticals:
Primary Outcome Measures:
• Neuropsychiatric Inventory (NPI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
• Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Standard Measurements (e.g. AEs, ECG, Labs, PE and Neuro Exam)
• ADCS-CGIC (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Rating) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
• QoL-AD (Quality of Life - Alzheimer's Disease measure) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
• ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
• CSI (Caregiver Strain Index) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Alzheimer's Patients
Eligible patients for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.
This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.
Up to 200 patients will be enrolled at approximately 40 centers in the US.
Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within 2 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible patients will be randomized into the study.
Ages Eligible for Study: 50 Years to 90 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Key Inclusion Criteria:
Diagnosis of probable Alzheimer's disease (AD).
The patient has clinically significant symptoms of agitation secondary to AD, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
Either out-patients or residents of an assisted-living facility or a skilled nursing home.
CGI-S score is ≥ 4 (moderately ill) at screening and baseline.
Mini Mental State Examination (MMSE) score at screening between 8 and 26(inclusive).
Caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. Caregiver must spend time with the patient a minimum of 4 times per week on 4 separate days.
Key Exclusion Criteria:
Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
Patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic