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Last Post: 7/5/2015 1:54:20 PM - Followers: 166 - Board type: Free - Posts Today: 2


 






Products


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

Click For Link To ClinicalTrials.gov


*November 20, 2014 -  the study is 100% enrolled. 
   * First patients enrolled on Jul 21, 2014 *                                  * DrKate Glassman-Beebe- Executive Vice President and Chief Development Officer-Titan Pharmaceuticals

Click For cnn.com Link 


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

 


 

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TTNP News: Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) 06/26/2015 03:40:43 PM
TTNP News: Current Report Filing (8-k) 06/15/2015 08:25:22 AM
TTNP News: Current Report Filing (8-k) 06/09/2015 06:05:25 AM
TTNP News: Quarterly Report (10-q) 05/13/2015 02:47:57 PM
TTNP News: Current Report Filing (8-k) 04/28/2015 04:27:49 PM
PostSubject
#5474  Sticky Note TITAN PHARMACEUTICALS REPORTS POSITIVE RESULTS FROM PHASE 3 TRUTH 06/08/15 02:27:45 PM
#5431  Sticky Note From brae's website... https://braeburnpharmaceuticals.com/braeburn-pharmaceuti matthewverymuch 06/08/15 08:17:08 AM
#5700   State Efforts Lag In Reversing Overprescribing Of Opioids TRUTH 07/05/15 01:54:19 PM
#5699   So you think them doing the RS before TRUTH 07/05/15 12:36:23 AM
#5698   So you think them doing the RS before Rentier 07/04/15 09:00:47 PM
#5697   The RS will not hurt the stock. TRUTH 07/04/15 04:07:46 PM
#5696   That is ones opinion. That is not mine. interstate 07/04/15 09:15:28 AM
#5695   I understand and know this, but mark my Rentier 07/03/15 11:10:22 AM
#5694   Very true, if the reverse split is going Rentier 07/03/15 10:59:45 AM
#5693   sunil and rubin strike again. TRUTH 07/02/15 02:41:06 PM
#5692   Keep going down until things are finalized....by then matthewverymuch 07/02/15 10:54:21 AM
#5691   That would be great. shadolane 07/02/15 10:42:23 AM
#5690   I am not going to say what ticker interstate 07/02/15 10:34:19 AM
#5689   Yes anything is possible I guess based on shadolane 07/02/15 10:16:09 AM
#5688   Reverse splits are looked at badly because pinks interstate 07/02/15 09:47:28 AM
#5687   My observations have been that companies doing well shadolane 07/02/15 09:31:28 AM
#5686   Why do you think the price will go interstate 07/02/15 09:16:48 AM
#5685   The only way I can see them coming Rentier 07/02/15 07:51:27 AM
#5684   yeah, 36 million is all fine and good Rentier 07/02/15 07:48:35 AM
#5683   Actually it is about both to them, they Rentier 07/02/15 07:46:41 AM
#5682   One in four people prescribed opioids progressed to TRUTH 07/02/15 07:01:46 AM
#5681   There is a temptation to sell and buy TRUTH 07/01/15 06:27:48 PM
#5680   PPS will probably keep going down until there Doctor Detroit 07/01/15 04:10:05 PM
#5679   The market isn't banking on approval. Down every matthewverymuch 07/01/15 04:00:18 PM
#5678   OK why us everybody assuming that a RS TRUTH 07/01/15 03:50:21 PM
#5677   It certainty wasn't my idea,lol. OK why turks 07/01/15 03:43:11 PM
#5676   U.N. Drug Body Warns Of More Heroin Deaths TRUTH 07/01/15 03:22:53 PM
#5675   Understood. That is what I am trying to interstate 07/01/15 03:16:05 PM
#5674   I;d like to know whose idea it was TRUTH 07/01/15 02:49:57 PM
#5673   Good to hear it is at least possible matthewverymuch 07/01/15 02:44:50 PM
#5672   Look at dvax this year - went up BillCat 07/01/15 02:36:27 PM
#5671   EMail Response From The CDER TRUTH 07/01/15 02:10:20 PM
#5670   Remember it is about the Market Cap and TRUTH 07/01/15 01:50:26 PM
#5669   Aren't companies who do rs just asking for matthewverymuch 07/01/15 12:59:37 PM
#5668   Believe me. I would rather have a share interstate 07/01/15 08:48:11 AM
#5667   It is never about the PPS. It is interstate 07/01/15 08:45:46 AM
#5666   If the do end up doing one (which Rentier 06/30/15 10:34:28 PM
#5665   Lets for the sake of crazy they did Rentier 06/30/15 10:01:13 PM
#5664   Female drug users shun treatment for fear of TRUTH 06/30/15 05:09:47 PM
#5663   The prospect of a rs plus those stupid matthewverymuch 06/30/15 11:04:12 AM
#5662   Proxy Statement.... Doctor Detroit 06/30/15 09:47:10 AM
#5661   Braeburn wants probuphine for chronic pain. It's official TRUTH 06/29/15 03:49:52 PM
#5660   Implant Could Be ‘Game Changer’ in Pain Treatment TRUTH 06/29/15 03:36:53 PM
#5659   Braeburn wants probuphine for chronic pain. It's official. matthewverymuch 06/29/15 01:54:41 PM
#5658   http://www.painnewsnetwork.org/stories/2015/6/28/implant-could-be-game-changer-f matthewverymuch 06/29/15 12:16:16 PM
#5657   Hi truth, think your right about timing been turks 06/29/15 10:41:14 AM
#5656   Every time I have had shares that have Chia 06/28/15 11:56:41 PM
#5655   They won't put it to a vote. Rentier 06/28/15 09:24:16 PM
#5654   How do we shareholders vote on this? matthewverymuch 06/28/15 07:30:27 PM
#5653   There won't be a reverse split...For one there Rentier 06/28/15 05:44:45 PM
#5652   We will know soon enough: the stockholders meeting Doctor Detroit 06/28/15 02:51:18 PM
#5651   Timing is everything here.... TRUTH 06/27/15 12:15:06 PM
PostSubject