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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


*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

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: Amended Statement of Ownership (sc 13g/a) 02/06/2015 03:43:58 PM
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PostSubject
#3684  Sticky Note ****Addicts DESPERATELY Waiting For A Lifesaver**** TRUTH 09/27/14 11:41:37 AM
#4362   York County Tackles Heroin Epidemic TRUTH 02/28/15 09:53:56 AM
#4361   Davis Behavioral Health Gets $1M To Fight Opioid Abuse TRUTH 02/28/15 09:48:20 AM
#4360   Opioid Painkillers Emerging As Safety Threat For Elderly TRUTH 02/27/15 07:34:18 PM
#4359   No, I haven't added anymore. Rentier 02/27/15 07:27:06 PM
#4358   FDA To Publish Biosimilars Labeling, Generic Opioids Guidance TRUTH 02/27/15 07:15:12 PM
#4357   State Will Grant $8 Million Over Five Years TRUTH 02/27/15 06:57:47 PM
#4356   This stock traDING in the 60's is such TRUTH 02/27/15 06:46:41 PM
#4355   Could fill that gap in the .70ish level Chunky Salsa 02/27/15 01:27:02 PM
#4354   YES that was a real good fine,and a turks 02/27/15 01:06:59 PM
#4353   Good find! matthewverymuch 02/27/15 12:43:38 PM
#4352   Wyckoff Police Save Man Overdosing On Heroin TRUTH 02/27/15 11:51:09 AM
#4351   How To Beat The Herd Mentality: Highline's Michael TRUTH 02/27/15 11:09:08 AM
#4350   High Alert: War On Drugs TRUTH 02/27/15 10:35:54 AM
#4349   “Ribbon Tying” Event Joins Area Agencies In Fight TRUTH 02/27/15 08:25:23 AM
#4348   Gov. Spotlights Climbing Heroin Overdose Deaths TRUTH 02/27/15 06:49:19 AM
#4347   Mr. President, Don't Cut Law Enforcement Money On TRUTH 02/27/15 01:11:48 AM
#4346   Drug Addiction And What It Means In A TRUTH 02/27/15 12:55:58 AM
#4345   Prescribed Drugs: What Can Companies Do About This TRUTH 02/26/15 11:42:58 PM
#4344   suspicion of what stealing? kind of lost me Rentier 02/26/15 11:14:30 PM
#4343   Things like below no chance in hell as TRUTH 02/26/15 11:11:50 PM
#4342   Yes, for the most part you can't as Rentier 02/26/15 11:03:28 PM
#4341   Because they won't trip a drug test at TRUTH 02/26/15 10:59:01 PM
#4340   Why are painkilers so great?! Rentier 02/26/15 10:47:30 PM
#4339   Dukes County Ranks High in State Study On TRUTH 02/26/15 06:42:23 PM
#4338   Here's The Favored Recreational Drug Of Your Grandparents' Generation TRUTH 02/26/15 02:38:05 PM
#4337   But they already have a compound for parks, TRUTH 02/26/15 02:09:42 PM
#4336   But they already have a compound for parks, matthewverymuch 02/26/15 01:45:34 PM
#4335   The market seems to be reacting like this TRUTH 02/26/15 01:38:46 PM
#4334   Heroin Treatment Requires Legal Reform TRUTH 02/26/15 01:11:30 PM
#4333   The market seems to be reacting like this matthewverymuch 02/26/15 12:58:08 PM
#4332   Mangano Announces "A Shot At Life" Drug Treatment Trial TRUTH 02/26/15 12:42:22 PM
#4331   whats your opinion about addiction going main stream TRUTH 02/26/15 12:34:47 PM
#4330   Truth, whats uour opinion about addiction going main turks 02/26/15 12:13:58 PM
#4329   Truth great article's TRUTH 02/26/15 11:01:35 AM
#4328   Truth great article's , man, with all this turks 02/26/15 10:35:13 AM
#4327   New Parkinson's Drug Cleared In Europe TRUTH 02/26/15 10:30:18 AM
#4326   America’s Pain Killer Problem is Growing, Federal Data Shows TRUTH 02/26/15 01:06:45 AM
#4325   Record Number Of Overdoses As Heroin Epidemic Hits WA TRUTH 02/26/15 12:57:01 AM
#4324   As Vermont Tackles Heroin Addiction, Progress Is Measured TRUTH 02/25/15 05:23:12 PM
#4323   HIV Outbreak Hits Southeastern Indiana TRUTH 02/25/15 03:58:32 PM
#4322   As Overdoses Rise, Westchester Wages War On Heroin TRUTH 02/25/15 03:49:08 PM
#4321   Heroin Won't Win In Cherokee TRUTH 02/25/15 07:37:19 AM
#4320   Patients With Substance Abuse History Are More Likely TRUTH 02/25/15 07:18:38 AM
#4319   Governor Hogan Establishes Heroin And Opioid Task Force TRUTH 02/25/15 01:36:31 AM
#4318   CDC: Deaths Soared As Narcotic Painkillers Grew Popular TRUTH 02/25/15 01:27:02 AM
#4317   Very true, but can't be legally sold for TRUTH 02/24/15 04:53:09 PM
#4316   Very true, but can't be legally sold for Rentier 02/24/15 04:40:56 PM
#4315   He said alkermes is in phase 3 with TRUTH 02/24/15 02:41:01 PM
#4314   He said alkermes is in phase 3 with matthewverymuch 02/24/15 02:28:23 PM
#4313   I asked sunil about that a while back...maybe matthewverymuch 02/24/15 02:24:34 PM
PostSubject