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 Post subject: Re: Nalmefene Update
PostPosted: Mon Dec 20, 2010 10:20 pm 
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Lundbeck and Biotie are both indicating that the nalmefene data will be available before the end of 2010 so they have 11 more days to report or delay release of the report. It seems Lundbeck doesn't think nalmefene will add anything to their bottom line for a couple of years based on this guidance they provided to the investment firms following them.
Quote:
After 2014, Lundbeck plans for growth in both revenue and profit driven by potential product launches from the existing late-stage pipeline such as Lu AA21004, clobazam, escitalopram in Japan, as well as products not included in the floor guidance, such as desmoteplase, Lu AA24530, nalmefene, zicronapine and others.
I've got a lot more invested in TSM than stock market money but so far this has been the best investment I've made in my life because the return on investment is my life.


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 Post subject: Re: Nalmefene Update
PostPosted: Tue Dec 21, 2010 1:55 pm 
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No news on research data but I saw this on http://www.businessweek.com
Quote:
Lundbeck, Facing Lexapro Generics, Turns to Anti-Alcoholism Drug

H. Lundbeck A/S, whose best-selling antidepressant Lexapro loses patent protection in the U.S. this year, is in talks with potential marketing partners for an experimental alcoholism drug that wouldn't require patients to first give up drinking, Chief Executive Officer Ulf Wiinberg said.

The loss of the patent opens up Lundbeck, the Danish developer of drugs for depression and neurological illnesses, to generics competition.

The company has received has “many inquiries” into the anti-alcoholism product, called nalmefene, Wiinberg said. The Valby-based company aims to sell the medicine in Europe to general practitioners, and its sales force now primarily deals with specialists in central nervous system diseases.

“We're not going to hire 2,000 people,” Wiinberg said yesterday by phone.

Lundbeck has research under way in the last phase of testing usually required to seek regulatory approval. The company said it expects to apply for marketing permission in the second half of next year.

Patients who want to reduce their alcohol consumption would take the pill before they expect to begin drinking. The approach contradicts decades of treatment that requires alcoholics to abstain completely. Lundbeck will have to change both health- care providers' and consumers' behavior, Wiinberg said.

“We will put significant resources into this,” he said.

What's interesting about this is that when DuPont launched Revia in the US in 1995 the sales force could only market it to specialists and only as an adjunct to comprehensive alcohol treatment. DuPont may or may not have known that naltrexone worked better in a targeted approach but it didn't matter because the FDA would not let them market it that way. This is why Revia was given with the instructions not to drink before taking it. Fast forward to present times and what Lundbeck is trying to achieve is approval of oral nalmefene specifically for targeted use. Presumably if their results pan out and they get approval their marketing efforts to the general practicioner will be essentially the Sinclair Method.


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 Post subject: Re: Nalmefene Update
PostPosted: Tue Dec 21, 2010 10:03 pm 
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Sounds like TSM every bit of it. If they win approval (a good possibility if the trial was done well and showed good results), it will be a paradigm shift. From there, TSM data will snowball. Give it a decade and coupled with cheap genomics it will mean TSM only for those needing it and benefiting from it. Also, the immediate question becomes what is more effective, naltrexone or nalmefene. I have no doubt that there will be some non-trivial differences beyond liver toxicity.

As for the commercial side of it, I don't understand where is the big $$$ in it. There still will be a generics problem to face, right? (I don't know how these things work).


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 Post subject: Re: Nalmefene Update
PostPosted: Tue Dec 21, 2010 10:47 pm 
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Nutella, I think you are correct in your assumptions in regard to the growth potential for targeted nalmefene use. The fact that nalmefene use will not require liver function tests is huge for growth in the prescribing general practitioner market. It will make the pharmaceutical sales rep's job easier. That was always an extra step with naltrexone that made GP's hesitate to prescribe it. It will be interesting to see if nalmefene has different/more/less side effects than naltrexone. It's half-life is longer which may or may not be a good thing for targeted use. As for the potential commercialization of oral nalmefene. Biotie will hold the rights which it will license to Lundbeck. So if oral nalmefene takes off, Biotie and Lundbeck could see growth in their stock price but not for a while and Biotie is barely keeping its head above water. There are a lot of "ifs" involved in oral nalmefene catching on as a mainstream alcoholism treatment, particularly in the US where AA and abstinence based approaches dominate. Time will tell.

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Began TSM 7/19/10 Pre-TSM 50-70 US (106UK/84AU)
Ave. units/4 weeks for 1 year (#AF/4 wks) 22.8(1AF),29(0),30(1),27(2),23(2),20(6),16(8),17(9),13(12),15.5(9),15.8(11),15.1(10),14.6(11)
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 Post subject: Re: Nalmefene Update
PostPosted: Thu Dec 23, 2010 10:04 am 
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Below is a link to a story on http://www.bloomberg.com about oral nalmefene in anticipation of the study results being released. Of note, the oral nalmefene study had 1850 participants.

http://www.bloomberg.com/news/2010-12-22/alcoholics-may-stop-at-one-drink-with-help-from-lundbeck-anti-abuse-drug.html

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Began TSM 7/19/10 Pre-TSM 50-70 US (106UK/84AU)
Ave. units/4 weeks for 1 year (#AF/4 wks) 22.8(1AF),29(0),30(1),27(2),23(2),20(6),16(8),17(9),13(12),15.5(9),15.8(11),15.1(10),14.6(11)
regained control wk 33


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 Post subject: Re: Nalmefene Update
PostPosted: Thu Dec 23, 2010 11:10 am 
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Here's the guy who is tasked with figuring out a way to market targeted nalmefene to doctors assuming it gets approval in Europe. I wonder if he realizes how many drunks are counting on him. http://www.manufacturingchemist.com/events/article_page/Lundbeck_appoints_vp_of_global_product_strategy/58393


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 Post subject: Re: Nalmefene Update
PostPosted: Mon Jan 03, 2011 8:33 am 
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Here was the news this morning on the nalmefene trials http://www.4-traders.com/LUNDBECK-1412962/news/LUNDBECK-First-two-clinical-phase-III-studies-confirm-the-profile-of-nalmefene-as-efficacious-and-sa-13529246/ Unfortunately, there is no data available yet to evaluate. It was suggested in another article I read that the data would be released later. This announcement is for the financial sector only to stimulate interest in Lundbeck and Biotie stock.

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Began TSM 7/19/10 Pre-TSM 50-70 US (106UK/84AU)
Ave. units/4 weeks for 1 year (#AF/4 wks) 22.8(1AF),29(0),30(1),27(2),23(2),20(6),16(8),17(9),13(12),15.5(9),15.8(11),15.1(10),14.6(11)
regained control wk 33


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 Post subject: Re: Nalmefene Update
PostPosted: Wed Jan 05, 2011 11:38 am 
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StV, thanks for posting all of this. VERY interesting! I will pass this along to my CFP hubby, might need to make some speculative investments! :) :) :)

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 Post subject: Re: Nalmefene Update
PostPosted: Wed Jan 05, 2011 11:56 am 
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Saint Vincent wrote:
I wonder if he realizes how many drunks are counting on him.


True words! LOL :lol: :lol: :lol:

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 Post subject: Re: Nalmefene Update
PostPosted: Wed Jan 05, 2011 12:13 pm 
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Unfortunately, the success of oral nalmefene in Europe is going to do a lot more with how it's marketed to the GP's than how effective it is in clinical trials. If Lundbeck can stimulate the right kind of interest it could gain traction. The wrong marketing approach and it will die on the vine. If it ever makes it to the US it could be marketed directly to consumers ala Viagra and demand could be patient driven. Lundbeck will not enjoy a 10 year patent protection in the US so they may not even bother filing with the FDA.

_________________
Began TSM 7/19/10 Pre-TSM 50-70 US (106UK/84AU)
Ave. units/4 weeks for 1 year (#AF/4 wks) 22.8(1AF),29(0),30(1),27(2),23(2),20(6),16(8),17(9),13(12),15.5(9),15.8(11),15.1(10),14.6(11)
regained control wk 33


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