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Psychopharmacologic Drugs Advisory Committee: Notice of Meeting On PROBUPHINE   

Date: January 12, 2016

Time: 8 a.m. to 5 p.m. EST

                                

Click For FDA PDF Link

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



****Braeburn Pharmaceuticals Briefing Document For The FDA Advisory Committee Meeting **** 

                                                                                                              ****Now Available****

                                                                                                                     As Of January 8, 2016



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

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

 
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PostSubject
#6912  Sticky Note Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory TRUTH 01/12/16 07:47:10 PM
#7452   Does anyone know how post-marketing study requirements are TRUTH 02/11/16 10:44:55 PM
#7451   Does anyone know how post-marketing study requirements are Doctor Detroit 02/11/16 06:53:27 PM
#7448   Looks like the local Texas paper just used Doctor Detroit 02/11/16 11:16:27 AM
#7447   Heroin, Buprenorphine Drug Busts On The Rise In Tennessee TRUTH 02/11/16 11:05:14 AM
#7446   Notice the change in tone by Matthew Perrone, Doctor Detroit 02/11/16 10:51:45 AM
#7445   what is your opinion on FDA's response to TRUTH 02/11/16 10:18:25 AM
#7444   This plan of action for addiction is a turks 02/11/16 09:05:54 AM
#7443   FDA Unveils Action Plan To Combat Opioid Abuse TRUTH 02/11/16 01:17:10 AM
#7442   I would think it's safe to assume TRUTH 02/11/16 01:06:26 AM
#7441   You make a good point. I would think bee500 02/10/16 07:22:05 PM
#7440   I'm still betting on a early approval,you see turks 02/10/16 06:27:07 PM
#7439   It will be after hours. We will interstate 02/10/16 04:54:07 PM
#7438   I was surprised to see it up for gimmeshelter 02/10/16 04:43:18 PM
#7437   roughly 3.5%... That is pretty low interstate 02/10/16 04:25:40 PM
#7436   Short Interest Doctor Detroit 02/10/16 03:22:17 PM
#7435   Your right nobody knows,if braeburn thought that this turks 02/10/16 01:03:43 PM
#7434   I think we will see some more action Virgowhiteguy 02/10/16 12:59:07 PM
#7433   11 trading days...thank goodness for that. This Doctor Detroit 02/10/16 12:51:09 PM
#7432   I think they're just acknowledging they don't have Doctor Detroit 02/10/16 12:49:53 PM
#7431   If it was not approved. We would interstate 02/10/16 12:40:32 PM
#7430   What are the chances probuphine was sub licensed matthewverymuch 02/10/16 12:35:04 PM
#7429   Another exciting day to put in the books,rock&roll turks 02/10/16 12:11:44 PM
#7428   Yes,beyond slow,but I have to admit that this turks 02/09/16 05:06:28 PM
#7427   Slow day in TTNP land today. 12 days interstate 02/09/16 04:01:40 PM
#7426   It means nothing if probuphine isn't approved, but...from Doctor Detroit 02/09/16 02:00:20 PM
#7425   that one subject was not stable and TRUTH 02/09/16 11:16:47 AM
#7424   Is this company expecting FDA Approval on February Virgowhiteguy 02/09/16 10:32:15 AM
#7423   Even the other arm took rescue meds...however, probuphine matthewverymuch 02/09/16 10:28:30 AM
#7422   Thanks. That would be about the only KMBJN 02/09/16 10:23:25 AM
#7421   I think they are talking about rescue medication. matthewverymuch 02/09/16 10:10:18 AM
#7420   This part is untrue, isn't it? KMBJN 02/09/16 10:08:05 AM
#7419   White House Pushes Back Against Super Bowl Ad TRUTH 02/09/16 09:30:54 AM
#7418   Did I miss a TTNP PR about a rocketeer357 02/09/16 03:30:24 AM
#7417   Ditto my friend.that day is coming. turks 02/08/16 11:49:29 PM
#7416   Truth,I believe you just proved your point with turks 02/08/16 11:46:09 PM
#7415   I have enough shares. If I didn't I bluejacket6 02/08/16 11:36:20 PM
#7414   I see what you're stating but the FDA TRUTH 02/08/16 11:32:44 PM
#7413   I am to,but I learn my lesson turks 02/08/16 11:18:27 PM
#7412   Could This Opioid Implant Really End The Opioid Epidemic? TRUTH 02/08/16 11:15:56 PM
#7411   So what ya think,FDA move the ball or TRUTH 02/08/16 09:52:11 PM
#7410   Nice truth,real nice.So what ya think,FDA move the turks 02/08/16 09:22:23 PM
#7409   Isn't it great,18 days left and we are TRUTH 02/08/16 08:37:37 PM
#7408   Isn't it great,18 days left and we are turks 02/08/16 07:36:29 PM
#7407   wouldn't read too much into the pps fluctuation. bluejacket6 02/08/16 12:13:11 PM
#7406   Traders are going to trade...to me, it won't Doctor Detroit 02/08/16 11:35:36 AM
#7405   Sorry,no.I'll Crack a smile when we break 20pps.for turks 02/08/16 11:30:34 AM
#7404   If it was up 9% on 80,000 shares matthewverymuch 02/08/16 11:17:14 AM
#7403   8.07% :P interstate 02/08/16 11:08:41 AM
#7402   You see the BS,down almost 9% on 80,000 turks 02/08/16 11:01:11 AM
#7401   Dude. There is plenty of volume for matthewverymuch 02/08/16 10:59:52 AM
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