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Titan Pharmaceuticals (TTNP)

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Probuphine®-This study is enrolling participants by invitation only.

Click For Link To ClinicalTrials.gov


Braeburn Pharmaceuticals

ClinicalTrials.gov Identifier:
Information provided by (Responsible Party):
First received: July 1, 2014
Last updated: July 8, 2014
Last verified: July 2014
Braeburn Pharmaceuticals

Probuphine Graphic




Continuous Drug Delivery Technology


The continuous drug delivery system consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (“EVA”) and a drug substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the inner part of the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of dissolution. This results in a stable blood level similar to intravenous administration. Such long-term, linear release characteristics are generally desirable as this avoids peak and trough level dosing that poses problems for many Central Nervous System (“CNS”) and other disease settings.

This continuous drug delivery technology was developed to address the need for a simple, practical method to potentially provide continuous drug administration on an outpatient basis over extended periods of up to 6-12 months. In addition to Probuphine, which is the first product to complete clinical testing that has utilized this proprietary continuous drug delivery technology, Titan has conducted initial non-clinical studies with long-term delivery of dopamine agonists demonstrating the potential of this product in the treatment of Parkinson’s disease in non-clinical models of the disease.


Fanapt® (iloperidone)


Fanapt (iloperidone) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia currently being marketed by Novartis Pharma AG (“Novartis”) in the U.S. Titan is entitled to a royalty of 8-10% of net sales of Fanapt under a sublicense agreement with Novartis that is based on a U.S. patent which expires in October 2016 (does not include a possible six-month pediatric extension).

Titan has entered into several agreements with Deerfield Management LP (“Deerfield”), which entitle Deerfield to most of the future royalty revenues related to Fanapt in exchange for cash and debt considerations, the proceeds of which have been used to advance the development of Probuphine and for general corporate purposes. Titan has retained a portion of the royalty revenue from net sales of Fanapt in excess of specified annual threshold levels; however, based on sales levels to date, it is unlikely that Titan will retain any revenue from Fanapt in the next several years, if ever. Titan does not incur any ongoing expenses associated with this product.

Company Overview

Titan Pharmaceuticals, Inc is a biopharmaceutical company focused in the development of products for the treatment of central nervous system (CNS) diseases. Titan's first out licensed product, Fanapt® (iloperidone) is an atypical antipsychotic approved in the U.S. in May 2009 for the treatment of schizophrenia in adult patients. It is currently marketed in the U.S. by Novartis Pharma, AG, and Titan is entitled to receive 8-10% of global annual sales as royalty revenue for the term of the licensed patents.


Titan's second product, Probuphine, is nearing completion of the Phase 3 clinical development program in the treatment of opioid addiction. Probuphine is a novel, subcutaneous implant formulation of buprenorphine designed to deliver six months of medication following single treatment. This product has already demonstrated strong positive results in the first controlled Phase 3 study for the treatment of opioid addiction. The confirmatory Phase 3 study is currently being conducted at 20 sites in the U.S., and the results of this study are expected in Q2, 2011. Additional information on the Probuphine program is available in the PRODUCTS section of this website.


The Company's common stock is traded on the OTC Bulletin Board Markets ([TTNP.OB] www.otcbb.com) quotations system. For further information please contact info@titanpharm.com


Management Team

Sunil Bhonsle, M.B.A.

Executive Vice President and Chief Development Officer

Katherine L. Beebe, Ph.D.

Executive Chairman

Marc Rubin, M.D.


Board of Directors



Strategic Alliances

In December 2012, Titan entered into a license agreement with Braeburn Pharmaceuticals Sprl (“Braeburn”) that grants Braeburn exclusive commercialization rights to Probuphine® in the United States and Canada. Titan received a non-refundable up-front license fee of $15.75 million and will receive a $50 million milestone payment upon the approval of the NDA by the FDA. Additionally, Titan will be eligible to receive up to $130 million upon achievement of specified sales milestones and up to $35 million in regulatory milestones in the event of future NDA submissions and approvals for additional indications, including chronic pain. Titan will receive tiered royalties on net sales of Probuphine ranging from the mid-teens to the low twenties.


Product Overview

The investigational products are at various stages of development as listed below.

Titan Pharmaceuticals Products

In addition to the potential royalty revenues from iloperidone, Titan is currently focused on adding value to the company from these assets, particularly Probuphine. Additional information on Probuphine and other programs are available in the next sections. If you are interested in learning more, please contact Sunil Bhonsle, President, at     sbhonsle@titanpharm.com


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TTNP News: Current Report Filing (8-k) 07/21/2014 05:13:36 PM
TTNP News: Current Report Filing (8-k) 06/09/2014 05:11:54 PM
TTNP News: Titan Pharmaceuticals Receives Notice of Allowance for Patent of Implantable Polymeric Device for Sustained Release of Dopami... 06/09/2014 07:00:00 AM
TTNP News: Statement of Ownership (sc 13g) 05/21/2014 03:22:30 PM
TTNP News: Quarterly Report (10-q) 05/14/2014 04:14:49 PM
#3326  Sticky Note Braeburn Pharmaceuticals Enrolls First Patients In Late-Stage Clinical Truth4Once 07/21/14 06:39:14 PM
#3387   Is one of the benefits of being in Rentier 07/31/14 04:51:36 PM
#3386   Bloodbath out there today...ttnp is holding up pretty matthewverymuch 07/31/14 12:36:23 PM
#3385   Yep! Turks, We both know there's no cure bluejacket6 07/31/14 12:06:47 PM
#3384   Blue, you are so right, many many think turks 07/31/14 11:44:47 AM
#3383   Listening to the news on my way to bluejacket6 07/31/14 10:41:18 AM
#3382   Truth, that is the truth, the trial could turks 07/30/14 11:31:38 PM
#3381   Higher than average volume with 2.5 hours to Truth4Once 07/30/14 09:03:14 AM
#3380   Approval will break us out of this range. Rentier 07/29/14 04:54:53 PM
#3378   TIME!! Higgins recommendation didn't have much effect, though it bluejacket6 07/29/14 04:28:18 PM
#3377   What, in your opinion, will break us out matthewverymuch 07/29/14 03:38:44 PM
#3376   Looks as though there is a trading range bluejacket6 07/29/14 03:27:36 PM
#3375   Ah...i thought you were talking about the biotech matthewverymuch 07/29/14 02:04:48 PM
#3374   http://pumacap.com/about.html Not as bad as some of the other hyrpowr 07/29/14 02:00:20 PM
#3373   Who is PUMA? matthewverymuch 07/29/14 01:52:44 PM
#3372   Headed for the buy zone again. I don't hyrpowr 07/29/14 01:43:11 PM
#3371   Higher than average volume with 2.5 hours to matthewverymuch 07/29/14 01:32:31 PM
#3370   FDA approves new opioid pain reliever designed to Truth4Once 07/28/14 05:27:41 PM
#3369   Purdue earns a nod--and a quick slap--for abuse-resistant painkiller Truth4Once 07/28/14 05:17:27 PM
#3368   Nice day off trading here! many shares bought bluejacket6 07/28/14 03:47:11 PM
#3367   As an aside, michael higgins has a history matthewverymuch 07/25/14 01:52:54 PM
#3366   I would like to think the doctors would Truth4Once 07/25/14 01:16:44 PM
#3365   Pressure for pill form obviously comes from the bluejacket6 07/25/14 01:09:45 PM
#3364   so why??? do they get approval.think we already Truth4Once 07/25/14 11:20:24 AM
#3363   That's the problem,they're not out there in the turks 07/25/14 10:46:45 AM
#3362   These "experts" really need to get feedback from Truth4Once 07/25/14 09:15:08 AM
#3361   My sister is a addict Truth4Once 07/25/14 08:48:38 AM
#3360   Every little bit helps. With pills always a bluejacket6 07/25/14 08:11:53 AM
#3359   A new formulation of a powerful narcotic painkiller Truth4Once 07/25/14 01:14:11 AM
#3358   EU Agency Endorses Suspension of Oral Methadone Products Truth4Once 07/25/14 12:53:35 AM
#3357   Every time I read about another pill or turks 07/25/14 12:29:08 AM
#3356   Good article Rent. More prove something needs to bluejacket6 07/24/14 10:57:01 PM
#3355   FDA approves hard-to-abuse narcotic painkiller Rentier 07/24/14 07:49:43 PM
#3354   GM ALL bluejacket6 07/24/14 08:42:59 AM
#3351   Interesting comparison, apples to oranges. Rentier 07/23/14 05:25:01 PM
#3350   Thumbs up matthewverymuch 07/23/14 03:56:01 PM
#3349   Cramer had an interesting piece on Puma this bluejacket6 07/23/14 02:28:28 PM
#3348   Wish I could buy Integrity369 07/23/14 01:28:49 PM
#3347   A prior post today stated why I didn't bluejacket6 07/22/14 10:17:32 PM
#3346   I bought more today, what did you do... Rentier 07/22/14 05:05:01 PM
#3345   Never here me whine at all about the bluejacket6 07/22/14 05:00:45 PM
#3344   Not surprised one bit by today's action. Rentier 07/22/14 04:53:22 PM
#3343   For starters it isn't an opinion. The Rentier 07/22/14 04:50:57 PM
#3342   I saw it but didn't have sideline money bluejacket6 07/22/14 04:16:00 PM
#3341   I'm officially pissed off today! I was playing hyrpowr 07/22/14 02:51:03 PM
#3339   Exactly!! bluejacket6 07/22/14 02:12:04 PM
#3338   To be expected. Truth4Once 07/22/14 02:10:30 PM
#3337   A little matthewverymuch 07/22/14 02:10:13 PM
#3336   Yep!! Does it surprise you? bluejacket6 07/22/14 01:55:42 PM
#3335   Seriously? matthewverymuch 07/22/14 01:11:05 PM
#3334   That is, would attach the file, but not matthewverymuch 07/22/14 09:01:10 AM