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Titan Pharmaceuticals (TTNP)

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Products


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

Click For Link To ClinicalTrials.gov


*As of August 14, 2014 - Approximately 20% enrolled.


Sponsor:

Braeburn Pharmaceuticals


ClinicalTrials.gov Identifier:
Information provided by (Responsible Party):
NCT02180659
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

President
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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Wiki
TTNP News: Securities Registration Statement (s-1) 08/29/2014 11:46:02 AM
TTNP News: Quarterly Report (10-q) 08/13/2014 02:35:21 PM
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
PostSubject
#3434  Sticky Note Titan Pharmaceuticals Announces Second Quarter 2014 Financial Results Truth4Once 08/14/14 03:41:33 AM
#3536   Unintended consequences: Why painkiller addicts turn to heroin Truth4Once 08/31/14 10:13:36 AM
#3535   Unintended consequences: Why painkiller addicts turn to heroin. dbg1969 08/31/14 09:28:26 AM
#3534   My thought is exactly opposite. Think TTNP is bluejacket6 08/31/14 01:17:47 AM
#3533   Can you be certain that isn't the case? Truth4Once 08/30/14 08:25:16 PM
#3532   OK here is the deal.......Why radio silent on dbg1969 08/30/14 06:58:16 PM
#3530   Can you be certain that isn't the case? dbg1969 08/30/14 06:44:52 PM
#3529   The Consequences Of America’s Invasion Of Afghanistan: NYC Truth4Once 08/30/14 12:45:24 PM
#3528   Article on Heroin overdoses and highest it's been Rentier 08/30/14 12:26:11 PM
#3527   What is this money for, exactly? Truth4Once 08/29/14 11:43:11 PM
#3526   Maybe it's a ploy to get Braeburn to dbg1969 08/29/14 11:43:02 PM
#3525   Aa you've said before, braeburn is covering everything matthewverymuch 08/29/14 11:34:05 PM
#3524   the shares could possibly be used for Truth4Once 08/29/14 11:26:09 PM
#3523   It is possible that the shelf registration is dbg1969 08/29/14 11:22:22 PM
#3522   Are they doing a presentation, or sitting at Truth4Once 08/29/14 11:08:17 PM
#3521   Presentation.....I have seen some stocks make significant moves dbg1969 08/29/14 11:06:34 PM
#3520   There must be hundreds of companies participating...are they matthewverymuch 08/29/14 10:56:57 PM
#3519   I guess there is still time for them Truth4Once 08/29/14 10:46:37 PM
#3518   Could be there is a 73 million share float... Rentier 08/29/14 10:44:16 PM
#3517   I agree....This is definitely PR worthy and should dbg1969 08/29/14 10:41:57 PM
#3516   Yeah you can be sure Market Makers knew Rentier 08/29/14 10:39:38 PM
#3515   Wednesday,September 10th at 9:35am at the Kennedy Truth4Once 08/29/14 10:36:21 PM
#3514   Only 11 more days until TTNP presents at dbg1969 08/29/14 10:12:01 PM
#3513   So, you think this is already priced in? matthewverymuch 08/29/14 07:14:31 PM
#3512   only 143 people own shares in this company? Truth4Once 08/29/14 06:07:22 PM
#3511   Reading the statements in boldin the s-1 matthewverymuch 08/29/14 05:52:08 PM
#3510   I'm all for it holding above .60! The hyrpowr 08/29/14 05:34:39 PM
#3509   Another company i am in has been sitting matthewverymuch 08/29/14 05:34:30 PM
#3508   It has been my experience that a registration hyrpowr 08/29/14 05:29:38 PM
#3507   Gee everyone how those $1 or $1+ stock Rentier 08/29/14 05:10:52 PM
#3506   It's a shelf registration. It's there if and matthewverymuch 08/29/14 05:08:35 PM
#3505   That's a strange bid/ask combo thru CSTI. Holding hyrpowr 08/29/14 02:20:31 PM
#3504   Thanks for the clarification. Truth4Once 08/29/14 01:01:59 PM
#3503   We intend to use the proceeds of this Truth4Once 08/29/14 12:55:35 PM
#3502   One of the most commonly used tactics in hyrpowr 08/29/14 12:54:11 PM
#3501   cut myself off there. Maybe have opportunity in bluejacket6 08/29/14 12:44:12 PM
#3500   Yup. Guess I'll just enjoy the holiday and hyrpowr 08/29/14 12:41:52 PM
#3498   After my initial rant might be something huge bluejacket6 08/29/14 12:41:25 PM
#3497   That's a stinky pink move if ever there Truth4Once 08/29/14 12:40:53 PM
#3496   WTF!!! What kind of move is that? Leave bluejacket6 08/29/14 12:35:12 PM
#3495   Securities registration. Drop the hammer before a holiday hyrpowr 08/29/14 12:22:18 PM
#3494   I see TTNP is presenting at the Rodman bluejacket6 08/29/14 11:43:21 AM
#3493   FNMA traded 11 million yesterday and it is Rentier 08/28/14 08:17:55 PM
#3492   Yeah not many trades but I saw 3 hyrpowr 08/28/14 07:15:13 PM
#3491   ? only traded 82k+ shares today...or less than Rentier 08/28/14 06:55:48 PM
#3490   It isn't about a one off post, all Rentier 08/28/14 06:52:51 PM
#3489   Some larger blocks being moved today. Would like hyrpowr 08/28/14 03:47:48 PM
#3488   Fail to see how this is a positive Truth4Once 08/28/14 12:57:20 PM
#3487   Fail to see how this is a positive matthewverymuch 08/28/14 12:43:17 PM
#3486   I especially like this: Truth4Once 08/28/14 11:37:22 AM
#3485   Good article. bluejacket6 08/28/14 09:39:13 AM
PostSubject