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Titan Pharmaceuticals, Inc.
 
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TITAN PHARMACEUTICALS ANNOUNCES NOTIFICATION OF FDA ACTION DATE EXTENSION FOR PROBUPHINE
 
                                                    The FDA has extended the date for agency action by the standard period, from Feb. 27, 2016 to May 27, 2016.



 

SOUTH SAN FRANCISCO, CA – February 19, 2016 – Titan Pharmaceuticals, Inc.(NASDAQ: TTNP) announced today that the U.S. Food and Drug Administration (FDA) has notified Titan and its development and commercialization partner Braeburn Pharmaceuticals that it will require additional time to review the New Drug Application for Probuphine® for the maintenance treatment of opioid addiction. The FDA has extended the date for agency action by the standard period, from Feb. 27, 2016 to May 27, 2016. 

 

Following the Psychopharmacologic Advisory Committee meeting in January, the FDA requested additional changes to the Risk Evaluation and Mitigation Strategy (REMS) portion of the NDA, which were promptly submitted by Braeburn. The FDA determined that the submission qualified as a major amendment to the NDA during the review process and elected to extend the action date. 

 

"We are disappointed by the delay, but recognize the FDA regulatory process. Together with Braeburn we will continue to work with the agency to finalize the REMS and the product labeling, and complete the review process," said Titan President and CEO Sunil Bhonsle. "We are confident that Probuphine will ultimately offer patients and caregivers an important new treatment option for opioid addiction."

 

 

CLINICAL SUMMARY

SIX CLINICAL STUDIES COMPLETED TO DATE WITH FINAL PHASE 2 STUDY UNDER WAY
1 Initial small dose finding study
2 & 3 Two well-controlled Phase 3 safety and efficacy studies showing clinical and statistical superiority over placebo and non-inferiority to Suboxone published in Journal of American Medical Association and Addiction
4 & 5 Two open-label long-term treatment safety studies
6 Relative bioavailability study



 
STUDY RESULTS
  • Mild-to-moderate adverse events typical of the safety profile of buprenorphine; low number of serious adverse events similar to placebo
    Well-tolerated implant procedure
    No evidence of implant diversion or misuse

KEY BENEFITS

EFFICACY

Effective in reducing illicit opioid use

COMPLIANCE

Treatment with the ProNeura™ implant is expected to enhance patient compliance

SAFETY

Non-fluctuating drug exposure over six months may provide superior safety and tolerability

EASE OF USE

Patients are dosed once every six months in an outpatient setting

 

PRONEURA™

Titan's proprietary long-term, drug delivery platform provides continuous drug release and non-fluctuating medication levels over a period of three months to a year depending on drug characteristics. ProNeura products are subdermal implants that are ideal for treating chronic diseases for which the maintenance of stable medication levels could offer advantages over other routes of administration.

   OVERVIEW

    ProNeura offers continuous drug delivery and 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.

   
    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 to 12 months.

Overview

 

 

 

 

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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#8417  Sticky Note CNBC:FDA May Approve Implantable Drug To Ease Opioid Withdrawal TRUTH 05/02/16 12:32:58 PM
#8434   Interesting,Articles coming out daily,funny that there is still turks 05/03/16 05:44:36 PM
#8433   Synergies Braeburn is owned by Apple Tree Partners, who Doctor Detroit 05/03/16 04:39:03 PM
#8432   New form of Buprenorphine — implant Doctor Detroit 05/03/16 04:05:24 PM
#8431   Treatment Without Medication Won’t Help Maine Overcome Its TRUTH 05/03/16 01:53:52 PM
#8430   Survey: Painkillers Bigger Problem Than Alcohol TRUTH 05/03/16 01:32:43 PM
#8429   New Salvo Against Opioid Abuse TRUTH 05/03/16 12:24:56 PM
#8428   CNBC:Painkiller Epidemic: Nearly Half Of Americans Know An Addict TRUTH 05/03/16 11:55:03 AM
#8427   Another great article,shows the need for undivertable treatments turks 05/03/16 10:25:03 AM
#8425   Expand Prescribing Of Buprenorphine For Opioid Abuse? Experts TRUTH 05/03/16 09:07:16 AM
#8424   The Cost Of Painkiller Addiction:Opioid-Related Hospitalizations Up 72%, TRUTH 05/03/16 05:24:06 AM
#8423   Squawk Box? Yeah, and Mad Money, too! ekmey 05/02/16 06:46:05 PM
#8422   wow. great article. needs a mention noretreat 05/02/16 04:49:50 PM
#8421   Interesting article about expanding prescribing of buprenorphine: KMBJN 05/02/16 02:38:01 PM
#8420   This speaks for itself: Doctor Detroit 05/02/16 02:30:29 PM
#8419   Best article so far,truth. turks 05/02/16 01:10:52 PM
#8418   WOW!!! Fantastic article. tipdigger86 05/02/16 12:41:19 PM
#8417   CNBC:FDA May Approve Implantable Drug To Ease Opioid Withdrawal TRUTH 05/02/16 12:32:58 PM
#8416   America’s Drug Crisis:When Will We Wake Up To TRUTH 05/02/16 08:04:09 AM
#8415   An Opioid Treatment Model Spawns Imitators TRUTH 05/02/16 07:56:12 AM
#8414   DEA, Law Enforcement Offer Bleak Outlook On Opioid TRUTH 05/01/16 01:32:37 PM
#8413   Ok,we are on the same boat,good.Quick question,my previous turks 04/30/16 05:02:04 PM
#8412   I like to use conservative numbers so any tipdigger86 04/30/16 04:29:06 PM
#8411   Tip,17%is the low end,I believe they said the turks 04/30/16 03:45:07 PM
#8410   Hey Doc, I think your off by 406 turks 04/30/16 12:58:08 PM
#8409   25% of market = $400M in sales x tipdigger86 04/30/16 12:23:02 PM
#8408   ...uh, math was never my strong suit. Doctor Detroit 04/30/16 11:28:27 AM
#8407   Truth,by reading this article I have a very turks 04/30/16 10:47:51 AM
#8406   Opioid Epidemic Requires National Response TRUTH 04/30/16 07:05:18 AM
#8405   FDA Reconsiders Training Requirements For Painkillers TRUTH 04/29/16 10:05:17 PM
#8404   Nice breakdown. Haven't gone through the numbers but Jabroni123 04/29/16 07:37:32 PM
#8403   Numbers... Only if you're bored of watching the paint Doctor Detroit 04/29/16 06:11:53 PM
#8402   The story is gaining traction....good news! tipdigger86 04/29/16 05:13:14 PM
#8400   Just published. buckiii2 04/29/16 03:16:21 PM
#8398   Yeah..20 more days to become the turd in matthewverymuch 04/29/16 02:53:00 PM
#8397   http://www.ptcommunity.com/news/2016-04-29-000000/subdermal-buprenorphine-implan tipdigger86 04/29/16 02:24:54 PM
#8396   Guys this is a huge powerful article and turks 04/29/16 11:09:21 AM
#8395   New implant set to join fight against U.S. Doctor Detroit 04/29/16 10:09:30 AM
#8394   Leading Addiction Treatment Site Hopes To Triple In Size TRUTH 04/29/16 09:00:24 AM
#8393   If there are going to be less outpatient TRUTH 04/29/16 06:49:19 AM
#8392   Wow. Great article. I'm in Bergen, Co This state ddbl_our_buck 04/29/16 06:40:14 AM
#8391   Guthrie Votes For Bipartisan Solutions To Opioid Epidemic TRUTH 04/29/16 05:18:08 AM
#8390   MEDICAID RATE CHANGES COULD LEAVE ADDICTS, MENTALLY ILL TRUTH 04/29/16 05:07:36 AM
#8389   The Substance Abuse and Mental Health Services Administration TRUTH 04/29/16 04:58:14 AM
#8387   Dr. Detroit - You mean "And probuphine is BillCat 04/28/16 01:10:05 PM
#8386   Can you believe it,Monday is the May 2nd turks 04/28/16 12:43:39 PM
#8385   I have no more words. Just disgusting. TRUTH 04/28/16 11:01:43 AM
#8384   So the immediate fall out from the FDA's TRUTH 04/28/16 10:31:25 AM
#8383   Tennessee Pain Clinics to Stop Using Opioids Doctor Detroit 04/28/16 09:34:20 AM
#8382   Prince Had Opioid Medication On Him At Time TRUTH 04/28/16 08:56:41 AM
#8381   Long-Acting Buprenorphine Implant Effective For Opioid Dependence TRUTH 04/27/16 04:25:34 PM
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