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Titan Pharmaceuticals (TTNP)

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Last Post: 3/29/2015 11:47:57 PM - Followers: 166 - Board type: Free - Posts Today: 0


 






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: Statement of Changes in Beneficial Ownership (4) 03/18/2015 07:48:51 PM
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PostSubject
#3684  Sticky Note ****Addicts DESPERATELY Waiting For A Lifesaver**** TRUTH 09/27/14 11:41:37 AM
#4576   Next Steps In Addressing The Opioid Crisis TRUTH 03/29/15 11:47:57 PM
#4575   When the FDA is asked if there are TRUTH 03/29/15 09:21:59 PM
#4574   Like the post, love the answer, yes if turks 03/29/15 05:31:27 PM
#4573   Missing The Mark On Addiction TRUTH 03/29/15 10:07:19 AM
#4572   Pain Medications Killing Too Many Americans TRUTH 03/29/15 09:57:16 AM
#4571   Can you please explain the Titan connection for TRUTH 03/29/15 01:13:25 AM
#4570   I might not totally grasp this post, how TRUTH 03/29/15 12:58:22 AM
#4569   Can you please explain the Titan connection for Ppower 03/29/15 12:42:06 AM
#4568   I might not totally grasp this post, how Ppower 03/29/15 12:38:25 AM
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#4565   DEALING WITH DRUGS: Addicts Travel Rough Road To Recovery TRUTH 03/27/15 07:19:06 AM
#4564   SPECIAL REPORT -- Opiate Abuse Problem Is Spreading TRUTH 03/27/15 07:04:51 AM
#4563   CDC Requests More $$ For Antibiotic Resistance, Opioid Abuse TRUTH 03/27/15 06:53:25 AM
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#4561   Didn't think we would be down here again TRUTH 03/26/15 10:01:16 AM
#4560   I would like to grab one more block bluejacket6 03/26/15 09:58:06 AM
#4559   All I will say is that there are TRUTH 03/26/15 09:14:26 AM
#4558   Truth, alot of shorting going on but when turks 03/26/15 08:54:51 AM
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#4554   Teens Need To Know Risks Of Prescription Drugs TRUTH 03/25/15 10:47:26 PM
#4553   I can't quite grasp the shorts, though, and TRUTH 03/25/15 10:25:00 PM
#4552   I agree, Kirbs. I would love for The Maven 03/25/15 09:25:14 PM
#4551   A Truly Effective Way To Deal With 'Problem TRUTH 03/25/15 06:05:00 PM
#4550   Governor's Committee Looking For Ideas To Halt State's TRUTH 03/25/15 05:50:17 PM
#4549   New Effort To Curb Opioid Abuse Clears Legislative Hurdle TRUTH 03/25/15 05:37:31 PM
#4548   Why it's still 1-2 months out? Kirbs72 03/25/15 12:21:00 PM
#4547   Good for you. I am getting tired of matthewverymuch 03/25/15 12:19:15 PM
#4546   Ok by me. Will be happy to add there Kirbs72 03/25/15 12:18:07 PM
#4545   Not the way this is trading. We are matthewverymuch 03/25/15 12:16:01 PM
#4544   Amid Crisis, States Expand Access To Opioid Rescue Drug TRUTH 03/25/15 10:11:07 AM
#4543   Titan Pharmaceuticals Schedules Conference Call to Review Fourth TRUTH 03/25/15 09:32:15 AM
#4542   4th quarter and annual results with CC April turks 03/25/15 09:10:46 AM
#4541   The Problems With Prescription Drug Addiction TRUTH 03/25/15 06:31:56 AM
#4540   ~ i strongly agree with you..i expect above kei 03/24/15 09:40:23 PM
#4539   ~ great observation as usual, truth! kei 03/24/15 09:39:21 PM
#4538   This is an OTCBB stock. Not surprising at Kirbs72 03/24/15 09:25:08 PM
#4537   Unfuckenbelievreable, is this guy for real, don't they turks 03/24/15 09:20:10 PM
#4536   I'm thinking this will likely be trading over Kirbs72 03/24/15 08:13:41 PM
#4535   ****BEWARE OF ARTICLE WITH INCORRECT DATA ON TTNP**** TRUTH 03/24/15 07:58:25 PM
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#4529   Drugs To Treat Opioid Addiction Not 'Socially Accepted' TRUTH 03/24/15 05:28:24 AM
#4528   PHARMACY FORECAST 2015–2019 PDF TRUTH 03/23/15 12:18:52 PM
#4527   Forecasting Pharmacy's Future TRUTH 03/23/15 12:04:43 PM
PostSubject