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PostPosted: Tue Nov 13, 2012 2:50 am 
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Can you imagine not needing to take Suboxone every day? No longer playing charades with a mouth full of subliva trying to warn your partner the toilet's blocked.

Not just that... how fucking awesome it would be to not have to take a pill every day, to not have to see a doctor every month. How far removed it would be from our addiction to not have that daily reminder? Especially for pill addicts, how far removed you can feel from your addiction without putting something in your mouth every day??

Anyway enough of my shit. Probuphine put their NDA in a couple weeks ago. They also applied to have it accelerated, which may see it come in 6 months instead of 10.

Quote:
Titan Files NDA on Probuphine; Partner Waits
Jason Napodano, CFAOctober 29, 2012
Monday morning, Titan Pharmaceuticals (OTC:TTNP) announced it had filed a New Drug Application (NDA) to the U.S. FDA on Probuphine for the maintenance treatment of opioid dependence in adults patients (Press Release). The NDA has been submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act and references the approved sublingual tablet formulations of buprenorphine. Titan has requested a Priority Review for the application. If granted, the Priority Review would accelerate the FDA’s decision on Probuphine from the standard ten month review for a 505(b)(2) application, to six months. Investors should hear back from the FDA on the status of the application in 60 days, or by December 28, 2012.

Background Information

Buprenorphine is a synthetic derivative of opium, chemically similar to both morphine and codeine, but has stimulatory rather than depressant effects. Buprenorphine is 25-50X more potent than morphine and is sometimes used recreationally by insufflations (crushing and inhaling the powder). Buprenorphine is a Schedule III controlled substance under the United Nations’ Convention on Psychotropic Substances.

Buprenorphine is commonly used to treat addiction to heroin, and has proven superior in its efficacy and convenience to methadone. Withdrawal from buprenorphine after short-term use is generally far milder than other potent opioids, but can have a longer duration of abuse. The drug has a pharmacologic ceiling effect, which provides an increased safety margin when compared to methadone. As a result, the drug is now generally recognized as the gold standard for the treatment of opioid addiction. There are an estimated 3.7 million people addicted to opioids in the U.S., over 80% of which are prescription drugs.

The product was first marketed in 1980 by British firm Reckitt & Colman as an analgesic. In October 2002, the U.S. FDA approved Subutex as high-dose (2 mg & 8 mg) sublingual pill preparations and Suboxone, a novel formulation of buprenorphine and naloxone, to increase the deterrence of abuse through intravenous injection. Naloxone is an opioid antagonist that blocks the high or euphoric effects for opioids such as heroine that leads to withdrawal symptoms. As a result, Suboxone is now predominantly used for this purpose.

Suboxone (buprenorphine) Use Has Soared, In A Large Market

In October 2009, the FDA approved a generic preparation of sublingual buprenorphine. Demand was so high that pharmacies began to run out of supply and Roxane Labs, the first generic filer, was unable to meet demand. Additional supply is now online. To counter the generic pressure, Reckitt Benckiser began marketing a Suboxone Film, first approved in August 2010. In September 18, 2012, Reckitt notified the FDA that it was voluntarily discontinuing supply of Suboxone tablets due to increasing concern with pediatric exposure; but we all know that Reckitt clearly had ulterior motives for its decision.

Between Suboxone tablets and Suboxone sublingual film, Reckitt took in over $1.2 billion in sales from the franchise in 2011.


Titan Pharmaceuticals developed Probuphine, a novel, subcutaneous implantable formulation of buprenorphine designed using its ProNeura technology. Probuphine delivers six months of buprenorphine without risk of accidental pediatric exposure. Patients undergo a simple 10 minute procedure to receive the Probuphine implant and the buprenorphine is slowly released in continuous fashion over the next six months. Besides the obvious zero risk of accidental exposure or potential for abuse, we see Probuphine as a meaningful improvement in compliance. Heroin addicts and their treating physicians know Probuphine is always working to curb the addictive craze.

Titan completed two phase III trials and two long-term safety analyses with Probuphine. Data from the first phase III trial was published in JAMA (2010; 304(14):1576-1583) in October 2010. Various posters of the data have been presented at the American College of Neuropsychopharmacology in December 2009 (ACNP Poster-1), the International Society of Addiction Medicine in September 2011 (ISAM Poster-2), and the American Society of Addiction Medicine in April 2012 (ASAM Poster-3).

We view the data as impressive. Probuphine works, and the concept is ideally suited for curbing addictive behavior without risk of accidental exposure or misuse / abuse. We’re bullish on the prospects for the drug. We base our opinion on the strong clinical data, the thoughtful and rational design for the product, and various conversations we’ve had with management and lead investigators from the confirmatory phase III trial. In August 2011, Titan hosted a call with Dr. Walter Ling, M.D., Professor of Psychiatry and Director, Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA and Dr. Richard N. Rosenthal, M.D., Chairman of Psychiatry at St. Luke’s-Roosevelt Hospital Center, a teaching hospital of Columbia University, past president of the American Academy of Addiction Psychiatry. Both doctors expressed their enthusiasm for Probuphine and why they believe it will see meaningful commercial uptake.
As noted above, in the U.S. there are an estimated 3.7 million individuals addicted to opioids. Currently, Suboxone does around 500,000 prescriptions monthly. We model that Probuphine can capture 20% of these patients at a cost of around $2,000 per course of treatment, with an estimated 40% of patients requiring two implants. Therefore, in the U.S. alone, Probuphine is a $280 million product.

Undisclosed Partner Waits
On September 14, 2012, Titan announced it had entered into a stock purchase and option agreement with another pharmaceutical company for the potential license of Probuphine. As part of the transaction, Titan sold 3.4 million shares of common stock to the potential partner at a price of $1.25 per share, netting proceeds to Titan of $4.25 million.

Given that Titan’s stock was trading at $0.72 before the announcement, we interpret the transaction as roughly $2.5 million in a straight stock purchase transaction and $1.75 million in an exclusivity option for talks on Probuphine. At the time of the deal, the exclusivity option period for negotiating a licensing deal was set to expire on October 31, 2012. However, given that Titan just filed the NDA today, both parties have agreed to extend the period until December 31, 2012. This makes sense, considering the 60 day window to accept the NDA and grant priority review should occur on or before December 28, 2012.

With peak U.S. sales of $200 million (not including another potential $100 million in Europe), we think Titan and this yet undisclosed partner should be able to come to terms in late December 2012. In the past, we have written that we believe Titan should be able to obtain upfront cash in the area of $15 million, a similar approval milestone in mid-2013, backend milestone totaling $100 million, and a ~20% royalty on sales. Under this scenario, we believe Titan is an attractive investment at today’s price. Titan’s stock could be well above $2.00 per share with the granting of Priority Review, a licensing deal, and the market’s growing confidence in approval


http://propthink.com/titan-files-nda-on-probuphine-partner-waits/3165

I hope most of all they will stick it up RB.


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 Post subject: cool
PostPosted: Tue Nov 13, 2012 6:10 pm 
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I am going to research this new drug.

It suer would take the hassle out of dosing and keeping up with a bunch of strip packs!

Hopefully insurance companies would soon cover this if it gets the final ok.

Great info TJ !

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BUPRENORPHINE



Synonyms:

UM-952;Lepetan;rx6029m;Subutex;Temgesi;Buprenex;NIH-8805;Temgesic;CL-112302;Buprenorfin


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 Post subject:
PostPosted: Tue Nov 13, 2012 7:23 pm 
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No probs Boxer.

I heard Obama's hiding RFID chips in em...

JK :lol:

:wink:


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PostPosted: Tue Nov 13, 2012 7:31 pm 
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^^hahahaha

This is an interesting alternative to the films, but I don't like the idea of having an implant. For some it could be beneficial to but I'm not sure if I'd prefer it after weighing all the options, but I would atleast consider it after the final product was finished.


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 Post subject:
PostPosted: Wed Nov 14, 2012 7:16 am 
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[font=Comic Sans MS]This is a great change in distributing medication for me. My life has changed so much
in the last 6 months, that the ONLY reminder of being an addict, that I have, is popping
that sub. IF this were to all come to a head, and work out.....I'd do it!
No more dosing....no more doc visits....pharmacies.....blah blah blah.
My life has changed so drastically, and my relationships with my friends and family
are great! I can't think of anything else that is a daily reminder MORE for me, than having
to dose.

On the other hand, it is wise to always remember that I am an addict. Once one forgets,
it's all downhill from there.

This was a great article Tee Jay! I knew NOTHING about this. Thank you so much for
bringing it to our attention! [/font]

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 Post subject: taper element included?
PostPosted: Thu Nov 15, 2012 12:39 am 
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Now,,, if the implant had a component where the dose gradually reduced to X Mg or zero over the prescribed duration,(6months) that would be a winner for me,,, and many others.


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Dr. Jeffrey Junig, M.D., Ph.D.

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