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Titan Pharmaceuticals Inc. (TTNP)

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Last Post: 11/25/2015 6:45:23 PM - Followers: 159 - Board type: Free - Posts Today: 0





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Agency action expected by Feb. 27, 2016 on Probuphine for 
maintenance treatment of opioid dependence



SOUTH SAN FRANCISCO, CA – Sept. 28, 2015 – Titan Pharmaceuticals, Inc. (OTCQB: TTNP) announced today that the U.S. Food and Drug Administration has accepted for review the New Drug Application (NDA) for Probuphine®, a six-month subdermal implant containing buprenorphine hydrochloride for the long-term maintenance treatment of opioid addiction. Probuphine was developed utilizing Titan's long-term, continuous drug delivery technology, ProNeura™. The FDA has set Feb. 27, 2016 as a target date for action on the application, which was submitted by Titan's development and commercialization partner Braeburn Pharmaceuticals. 


"We are pleased that the FDA has accepted for review the resubmission of the NDA for Probuphine, and will be working with the agency and Braeburn to achieve our goal of offering the first product on the market to provide maintenance treatment of opioid addiction continuously for six months following a single treatment," said Kate Beebe, PhD, Titan's executive vice president and chief development officer. 


U.S. Health and Human Services (HHS) Department Secretary Sylvia Burwell recently announced that HHS will move to expand access to medication-assisted-treatment (MAT) by revising the regulations related to the prescribing of buprenorphine to treat opioid dependence. The current cap on the number of patients that can be treated with buprenorphine products by a physician limits the availability of this important medication-assisted-therapy. The HHS revision to the regulation will be developed to provide a balance between expanding the supply of buprenorphine based treatment, encouraging use of evidence-based MAT, and minimizing the risk of drug diversion.


"Opioid addiction has become a significant health epidemic, and greater access to safe and effective treatments is essential," Titan President Sunil Bhonsle said. "As federal officials seek to find a balance between increasing access and minimizing the risk of abuse and diversion, treatment options with an implant such as Probuphine could play an expanding and crucial role in the maintenance treatment of patients."


The Probuphine NDA resubmission includes results from a Phase 3 double-blind, double-dummy clinical study. The study met the pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints.


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.



Company Overview


Titan Pharmaceuticals, Inc. is a biopharmaceutical Company developing proprietary therapeutics primarily for the treatment of serious medical disorders.

Titan’s principal asset is Probuphine®, the first slow-release implant formulation of buprenorphine hydrochloride (“buprenorphine”), designed to maintain a stable, round-the-clock blood level of the medicine in patients for up to six months following a single treatment. The outpatient treatment of opioid dependence with daily dosed sublingual buprenorphine formulations represents a $1.5 billion market in the U.S., and a seven day transdermal patch formulation of buprenorphine for the treatment of chronic pain was launched in the U.S. in 2011. This novel implant formulation is inserted subdermally in a patient’s upper arm providing continuous medication, and has the potential to enhance patient compliance to treatment, and limit diversion for illicit use and accidental exposure to the sublingual formulations. An FDA-requested Phase 3 study is currently in progress with completion expected in mid-2015 and resubmission of the New Drug Application later in 2015. 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 $15 million milestone payment upon the approval of the NDA by the FDA. Additionally, Titan will be eligible to receive up to $165 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.

Probuphine is the first product to utilize ProNeura™, a novel, proprietary, long-term drug delivery technology. The ProNeura technology has the potential to be used in developing products for the treatment of other chronic conditions, such as Parkinson’s disease, where maintaining stable, round-the-clock blood levels of a drug can benefit the patient and improve medical outcomes.

Finally, Titan has monetized substantially all of the future royalty revenue of 8-10% of net sales of Fanapt® (iloperidone), an atypical antipsychotic compound being marketed in the U.S. for the treatment of schizophrenia by Novartis Pharma AG (“Novartis”). The future royalty revenue has been sold to Deerfield Management (“Deerfield”), a healthcare investment fund, in exchange for cash and debt considerations which have been used to advance the development of Probuphine and for general corporate purposes.



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

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Current Price
Bid Ask Day's Range
TTNP News: Statement of Changes in Beneficial Ownership (4) 10/01/2015 04:57:11 PM
TTNP News: Current Report Filing (8-k) 09/28/2015 03:03:45 PM
TTNP News: Current Report Filing (8-k) 09/28/2015 08:22:27 AM
TTNP News: Statement of Changes in Beneficial Ownership (4) 09/16/2015 06:49:15 PM
TTNP News: Current Report Filing (8-k) 09/09/2015 06:03:09 AM
#5431  Sticky Note From brae's website... matthewverymuch 06/08/15 08:17:08 AM
#6430   When Titan was an OTC stock it couldn't Rentier 11/25/15 06:41:48 PM
#6429   $TTNP recent news/filings stocktrademan 11/25/15 02:13:18 PM
#6428   TTNP $4.44, indicators curling up on chart..... Wrinkles 11/25/15 01:04:46 PM
#6426   E*Trade shows: Real Time Extended Hours Quote TRUTH 11/25/15 01:16:07 AM
#6425   I am merely showing where members are probably TRUTH 11/24/15 10:53:29 PM
#6424   CNBC shows a last of $4.47 after hours Chia 11/24/15 10:26:34 PM
#6423   Again, my links are from FDA themselves those Rentier 11/24/15 09:05:10 PM
#6422   PDUFA dates are deadlines for the FDA to TRUTH 11/24/15 11:19:38 AM
#6421   Agree yes best to do research before buying mentalist 11/24/15 11:08:41 AM
#6419   Feb 2015? Sorry if that is the Rentier 11/24/15 10:59:23 AM
#6418   A PDUFA date, is the date set it Rentier 11/24/15 10:58:09 AM
#6417   I play the P3 NDA PDUFA ADCOM, that mentalist 11/24/15 10:50:26 AM
#6416   Pdufa date. Look it up. matthewverymuch 11/24/15 10:25:13 AM
#6415   PDUFA? The PDUFA (Prescription Drug User Fee Rentier 11/24/15 09:58:08 AM
#6414   Yes it will run into PDUFA like the mentalist 11/24/15 04:26:53 AM
#6413   This stock won't do anything until next year, Rentier 11/23/15 10:13:08 PM
#6412   Definitely misspoke. TRUTH 11/23/15 10:29:45 AM
#6411   No sir, my average before split is around mentalist 11/23/15 10:12:41 AM
#6409   Your buy in price is $3.80 pre split?! Rentier 11/20/15 07:55:52 PM
#6408   Here is some great info on S8 filings, mentalist 11/20/15 04:18:54 PM
#6407   Just look at the volume since the S8 mentalist 11/20/15 03:53:03 PM
#6406   Aren't they receiving shares? Why would they be selling? matthewverymuch 11/20/15 03:17:39 PM
#6405   BTW you think management are selling from the mentalist 11/20/15 02:56:49 PM
#6404   First of I would have waited as long mentalist 11/20/15 02:37:34 PM
#6403   What would you have management do? matthewverymuch 11/20/15 02:13:18 PM
#6402   Also we are trading at $0.75 pre split mentalist 11/20/15 01:58:45 PM
#6401   It will run into pdufa, fingers crossed for mentalist 11/20/15 01:34:39 PM
#6400   Watch the last sale near to 4pm as mentalist 11/20/15 01:32:09 PM
#6399   Whatever I'm starting to check this stock way too Doctor Detroit 11/20/15 11:51:03 AM
#6398   Waddya know?? Down again. matthewverymuch 11/20/15 11:10:08 AM
#6397   I believe this fact to be interesting: TRUTH 11/20/15 07:10:12 AM
#6396   What KBIO is doing isn't relevant here. Rentier 11/19/15 08:51:52 PM
#6395   Kbio,at one point was up over 800% today,titan turks 11/19/15 01:58:14 PM
#6394   DOCTOR (Old English D)........terrific find....hopefully a true first Chia 11/18/15 11:39:28 PM
#6393   Exact Phrase "Braeburn Pharmaceuticals" and last update "past week." Doctor Detroit 11/18/15 11:47:42 AM
#6392   Dr Detroit - I cannot get that to BillCat 11/18/15 10:59:57 AM
#6391   It amazes me even with all the turks 11/18/15 10:49:03 AM
#6390   Nice find :) mentalist 11/18/15 10:24:37 AM
#6389   Great sign actually,a company wouldn't lay out turks 11/18/15 10:23:15 AM
#6388   According to Google Advanced Search, it was within Doctor Detroit 11/18/15 10:11:16 AM
#6387   Need to get approved first, when was that mentalist 11/18/15 09:49:11 AM
#6386   Hopefully this is a good sign.... Doctor Detroit 11/18/15 09:37:21 AM
#6385   Would be great if we have a panel, mentalist 11/18/15 09:36:41 AM
#6384   Panel Since the whole FDA review process is a Doctor Detroit 11/18/15 09:32:15 AM
#6383   or Panel TRUTH 11/17/15 11:02:58 PM
#6382   We just need the sales, well I hope mentalist 11/17/15 08:00:30 PM
#6381   "tiered royalty based on a percentage of net Rentier 11/17/15 07:21:36 PM
#6380   He doesn't need to worry he gets paid Rentier 11/17/15 07:18:09 PM
#6379   Research Report Update mentalist 11/17/15 12:47:34 PM
#6378   Yahoo news article out by zack's.Nice READ. turks 11/17/15 12:22:28 PM