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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
#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
#3333   Received another follow up paper from michael higgins. matthewverymuch 07/22/14 08:53:37 AM
#3332   Rent everyone has an opinion. Email me your bluejacket6 07/21/14 11:34:26 PM
#3331   should be worth that much more. Rentier 07/21/14 11:12:12 PM
#3330   Study will begin and end when it does. bluejacket6 07/21/14 10:29:42 PM
#3329   The dialogue on here is almost comical with Rentier 07/21/14 09:20:20 PM
#3328   Hmmm..didn't know that was even an option.. matthewverymuch 07/21/14 07:01:34 PM
#3327   Good find mvm.... Truth4Once 07/21/14 06:48:55 PM
#3326   Braeburn Pharmaceuticals Enrolls First Patients In Late-Stage Clinical Truth4Once 07/21/14 06:39:14 PM
#3325   Another version of the PR found on the matthewverymuch 07/21/14 04:59:29 PM
#3324   You very well could be right I'm just bluejacket6 07/21/14 02:59:35 PM
#3323   You have a point but if we knew,then Truth4Once 07/21/14 11:22:09 AM
#3322   at least we are on our way. Truth4Once 07/21/14 11:20:26 AM
#3321   Yes, blue especially when there a private held turks 07/21/14 11:16:32 AM
#3320   You can't know when the information was past bluejacket6 07/21/14 11:11:27 AM
#3319   Actually I think they delayed it by a turks 07/21/14 11:09:27 AM
#3318   I feel that information should be released to Truth4Once 07/21/14 11:08:31 AM
#3317   TRUTH Not seeing how this would have affected PP bluejacket6 07/21/14 10:58:13 AM
#3316   I'm thinking late end of august to Sept. turks 07/21/14 10:50:06 AM
#3315   Now don't get me wrong.... Truth4Once 07/21/14 10:48:05 AM
#3314   Enrollment should be complete, realistically, by october. matthewverymuch 07/21/14 10:21:56 AM
#3313   Thats actually very good, 14 sites an another turks 07/21/14 10:01:25 AM
#3312   Possibly due to the fact that we were Truth4Once 07/21/14 09:44:54 AM
#3311   Unfortunately it looks like a ho-hum reaction. shadolane 07/21/14 09:36:35 AM
#3310   Titan Pharmaceuticals Announces First Patient Enrollment in Clinical Truth4Once 07/21/14 09:04:36 AM
#3309   Ask and you shall receive... http://finance.yahoo.com/news/titan-pharmaceuticals matthewverymuch 07/21/14 08:43:11 AM
#3308   Imo, this week we get news(pr) about trial turks 07/21/14 01:21:39 AM
#3307   Yeah if we hit a soft spot next bluejacket6 07/20/14 12:11:24 AM
#3306   Doesn't take much to move this up or hyrpowr 07/18/14 12:13:56 PM
#3305   Yeah I'm really close to turning a nice bluejacket6 07/18/14 11:24:39 AM
#3304   I'm with you on that, like I said turks 07/18/14 11:21:11 AM
#3303   I see weak hands are taking small profits bluejacket6 07/18/14 11:12:11 AM
#3302   News = excitement for those who don't normally bluejacket6 07/17/14 04:36:54 PM
#3301   Crazy stock matt, many times it don't make turks 07/17/14 02:29:43 PM