Trust all goes well for you, as with your good self I’m also optimistic that the coin will fall in our favour.
Tend to agree, cutting the Prime short was not one of KK,s smarter moves but neither or less IMO the matter was not conclusive. I give consideration to the fact that matters may have been hurried along in respect partnership thoughts. Not for one minute do I want a partnering agreement formed on the one indication to find out later that a combination from the other 30 or so indications are effective, we would not want this going cheap after all this time.
Pleased that SSPI done you a good turn.
Very best for the new year.
For certain I’m no expert in such matters of patent law however as with all on the message board one is entitled to air their views. Thanks again to all those that have debated the topic to great extent and assisting me.
Extract from the NDA 021879 EXCLUSIVITY SUMMARY Form
Did it require the review of clinical data other than to support a safety claim or change in labeling related to safety? (If it required review only of bioavailability or bioequivalence data, answer "no.") Avanir Answer Yes
PART III THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
To qualify for three years of exclusivity, an application or supplement must contain "reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant."
Please tell me if I’m wrong however as I see it a 3 year exclusivity period and new patent was granted based on new data and not that of previous data ( for example high level Q), refer to the paragraph above. In that respect in simple terms the lower levels were not apparent previously. Further more IMO as the proceeding patents would have had a much higher levels which have no approval the said patents would be of little use.
In respect of the USA systems I’m not at liberty to comment having said that I believe they are righteous. My belief is that Avanir will have a favourable result.
Very best regards to all.
Hi Sarge and a very happy new year to you and yours also.
Good to have you back amongst us., You will find the flask in the right hand corner of the bunker just as and where you left it. Correction it is Empty.
Thank you for the weekly round up.
Have a most enjoyable weekend.
I have been mulling over some of our previous correspondence regarding possible ways forward that are available which incorporated a vast scope not limited to the following.
Full go it alone.
Initial short term partnering, pending further indications!
Direct to Hospital sales.
Development Sales Partnering
Standard out licensing.
Initial Individual EU Country targets (as identified)
Buy out possibility. ;-(
I know we would have considered some other aspects but of course any one of those plays second fiddle to the patent challenge.
Have a very pleasant weekend.
Thank you very much for the update, most helpful.
I know Avanir were clearly displayed on their web site showing the Avanir Logo.
I even carried out a potential sales review some time back the spread sheet still exists on the board some where (USA EU Potential Sales Comparisons) or some thing like that.
Once again thank you for the assistance.
Originally Posted by Old Timer Friend Nirv Feb 2008 who is sadly missed.
AVANIR Signs Neurodex Clinical Research And Marketing Agreement With Medison Pharma
SAN DIEGO, Aug. 8 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals
(Amex: AVN) announced that it has entered into an agreement with Medison
Pharma, Ltd. for clinical research, marketing and distribution rights for
Neurodex in Israel. The agreement provides for Medison to conduct clinical
trials in Israel for the treatment of emotional lability in patients with
multiple sclerosis (MS) and grants Medison a license to market and sell
Neurodex in Israel, if it is approved for marketing.
Under the terms of this agreement, Medison will manage a Phase III
clinical trial intended to examine the safety and efficacy of Neurodex in the
treatment of emotional lability in MS patients. Medison will also be
responsible for managing and funding all necessary regulatory registrations
for Neurodex in Israel. Upon regulatory approval of the product, Medison will
be the exclusive distributor of Neurodex in Israel for the treatment of
emotional lability. AVANIR will receive royalties on product sales if the
drug is approved for marketing in that country. Financial terms of the
agreement were not disclosed.
No sure what has gone on here as I have not seen any publications stating the partnership for what it was, has been dissolved. (We hardly knew it existed)
During November 2012 Avanir was clearly shown on the Medison web site partner section, this is no longer the case.
I note that the web site has been updated. An new link can be located on the board. (Type in Medison and set format to all)
I’m giving consideration to several matters in this respect not limited to they may have had a difference of opinion or perhaps Avanir are just tidying matters up for future fully partnering arrangements.
? Did any one get to hear of any reported sales in Israel Madisons original base.
Have a good weekend all.
Good Morning Trade.
Hope all is well with you I'm sure it is.
IMO It should not be to long now for an anticipated AVNR patent victory.
Thanks for the note. I used call my self a Man of Kent living north of the river Medway in Kent. Just recently I have moved over a few miles to Surrey perfectly placed for all one could wish for, central London is only 30 minutes away by train and yet still remaining in the country side. The views would not be as stunning as that around your neck of the woods. As I may have said I have great memories of Ireland. I know the North and central parts most particularly Enniskillen which as you know is not to far from Sligo. The Intention will be to go back in a year or so time to wonder around and take in that tranquil atmosphere you have over there. IMO the anticipated celebrations will eventually take place, perhaps we can incorporate a glass of the black stuff.
Here Courtesy of Leerink Swann
Hi Ray Thank you for your response and acknowledgement.
Regarding your comment “seems like it was obvious to be shown to be efficacious by Avanir given that they did not follow the FDA's recommendation of having the 30 mg dex/30 mg quin arm for comparison”. No No No Ray that is not the case at all, please read on. (They did)
For your information please find below extract of the FDA Avanir November 18th 2009 meeting records, which I trust you find self explanatory.
Meeting Date: November 18, 2009
Question 5: Does the Agency agree that Avanir has provided an appropriate plan for
summarizing the safety of the new formulations DM 30mg/Q 10mg and DM 20/Q 10 mg and the previous dose (DM 30 mg/Q 30 mg) formulation as described in ISS SAP?
Preliminary FDA Response:
The large summary ISS table that you propose is acceptable. Tables of appropriate subsets of the data are also important to include, for example a table of the new formulations versus placebo, and a table of the old formulation versus placebo and individual constituent drugs.
I would not be expecting Ray to reply to later. Ray generally replies and posts early to late evening in the USA by which time I’m sleeping being in the UK. Having said that there has been an odd occasion where Ray makes an appearance during the working day hours.
I’m done for the day as it is getting a late.
Cheers for now.
PS Ireland is a lovely country I have visited the Emerald Isle on at least 36 occasions.
Good night all.
Hope this does not come across sounding sarcastic. IMO the FDA representative’s documented wording is self explanatory, “If such a multi-arm study showed efficacy in the 30 mg Q, 30 mg DM arm, but not in lower dose combinations, the Division would be willing to reconsider the approvability of the higher dose”. Where as Ray commented “or the FDA conveyed to Avanir that the FDA would not approve a PBA drug with more than 10 mg of quinidine.” From the FDA meeting the latter does not appear to be the case at the time of the meeting document.
I hope I have interpreted your ? correctly.
In the event you are referring to the patent challenge and any effect it may have on that you will have to excuse the pun and let the Judge, Judge on that.
When you decide to post, it is always well put and meaningful as demonstrated again here.
My very best regards.
Good afternoon Fred - if nothing else Mr Thumbs Down has given us a laugh, I was not expecting any thing other than that from who ever it was.
LOL regarding your positive thought.
Cheers for now.
Good morning Horcents.
I’m well my friend, more importantly trust you are also.
You will be pleased to hear we are getting a break from the rain in our neck of the woods.
My very best to you.
Hi Greatday good to hear from you, I’m pleased to say all is well for me, I’m sure you are also.
Good question regarding Europe as you would guess I can not answer that one in a few words. To cut short, Avanir are fortunate to have several options available all of which are not to difficult to put in place, we would have looked at them briefly in the past.
It is very apparent that there is a great need for new effective CNS drugs not just in the EU but around the world. I think the EMA has picked up on N and its possible pipeline and would be very interested in the development of the same. The EMA and most of the EU health systems would be fully aware of the cost savings in respect of a multi indication drug; there lies the key to ultimate success. I’m sure once we get the patent challenge out of the way we will get an indication how they will kick off. I have a feeling the kick off may not be the same as the permanent way it will go.
Just to say again to quote KK “Who ever wants in it will not come cheap”
All the best.
Thank you for the reply much appreciated, you are a fine gentleman.
Thankfully I’m very fortunate to be very well placed with respect to AVNR. As you can see from a recent post I have looked in to AVNR in greater depth, maybe more than the normal, in that respect I remain resolute with my conviction. Heaven forbid if I were to influence others I’m sure that is not the case.
I wish you all the very best for the future in what ever you do.
My very best regards.
Dear Mr Thumbs down.
Would you kindly consider coming out from behind the curtain and discuss the matter
in the event you have some thing you would like to debate further.
Hi Ray For one reason or another I can not reply to you on the SA Forum, in that respect I will do so here.
Your comment “Somehow, it was either obvious to Avanir in late 2006 that 10 mg of quinidine would work, or the FDA conveyed to Avanir that the FDA would not approve a PBA drug with more than 10 mg of quinidine.”
I’m not so certain that is the case. I’m fortunate to have a a great number of copy letters between the FDA and AVNR I hope it is alright for me to say that as they were obtained by means which any body can do. One of the meeting discussion records is as follows, please note the last sentence.
The sponsor proposed at the meeting, a 3-arm randomized withdrawal study using
30 mg DM with 10 mg Q, 15 mg DM with 5 mg Q, and placebo. The Division
suggested that one arm use 15 mg DM with 10 mg Q, rather than the proposed
15/5 combination, because 5 mg of Q might not provide the necessary inhibition of
CYP 2D6. The Division also raised the possibility that an arm with 30 mg Q, 30 mg
DM could be useful to establish assay sensitivity. If such a multi-arm study
showed efficacy in the 30 mg Q, 30 mg DM arm, but not in lower dose
combinations, the Division would be willing to reconsider the approvability of the