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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."
|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
Effective in reducing illicit opioid use
Treatment with the ProNeura™ implant is expected to enhance patient compliance
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
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.
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.
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.
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.
Sunil Bhonsle, M.B.A.
Executive Vice President and Chief Development Officer
Katherine L. Beebe, Ph.D.
Marc Rubin, M.D.
Board of Directors