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Titan Pharmaceuticals Fourth Quarter and Full Year 2013 Financial Results

Tuesday, April 1, 2014 - 10:00am PT | 1:00pm ET

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Titan Pharmaceuticals Latest Press Releases

South San Francisco, CA – March 31, 2014Titan Pharmaceuticals, Inc. (TTNP.OB) today reported financial results for the fourth quarter and year ended December 31, 2013.

Total revenues for 2013 were approximately $10.5 million, compared with approximately $7.1 million in 2012. Revenues in 2013 consisted of approximately $9.1 million in licensing revenues related to the amortization of the upfront license fee received from Titan’s commercialization partner Braeburn Pharmaceuticals in December 2012 and approximately $1.4 million in royalty revenues on net sales of Fanapt®, which were paid by Titan to Deerfield Management in accordance with the terms of the agreements entered into in 2011. Titan no longer recognizes Fanapt royalty revenues since all of such royalties are paid to third parties. The revenues in 2012 consisted of approximately $4.8 million in royalties on Fanapt that were passed on to Deerfield, and approximately $2.3 million associated with the licensing and stock purchase agreements with Braeburn.

 

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SOUTH SAN FRANCISCO, CA – March 26, 2014 – Titan Pharmaceuticals, Inc. (TTNP.OB) today announced that it will host a live conference call at 10 a.m. PT / 1 p.m. ET on Tuesday, April 1, 2014 to discuss the company’s financial results as of December 31, 2013. The call will be hosted by Sunil Bhonsle, president; Katherine Glassman-Beebe, Ph.D., executive vice president and chief development officer; Brian Crowley, vice president of finance, and Marc Rubin, M.D., executive chairman.

 

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South San Francisco, CA - March 3, 2014 - Titan Pharmaceuticals, Inc. (TTNP.OB) today announced that the company and its partner, Braeburn Pharmaceuticals, have agreed in principle with the U.S Food and Drug Administration (FDA) on the design of a clinical study in support of the New Drug Application (NDA) for Probuphine®, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence. The proposed clinical study will be a randomized, double blind and double dummy design that will provide information for a non-inferiority comparison of a six-month treatment with a dose of four Probuphine implants to treatment with 8mg or less of an approved daily dosed sublingual formulation of buprenorphine. Details of the study, including size and the data analysis plan, will be established following the FDA’s review of a complete study protocol, which Braeburn expects to submit within the next two weeks.

 

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South San Francisco, CA – December 23, 2013 Titan Pharmaceuticals, Inc. (TTNP.OB) today announced the receipt of the official minutes (the “Minutes”) from a Type C meeting with the U.S. Food and Drug Administration (FDA) on November 19, 2013 to discuss the Complete Response Letter (CRL) to its New Drug Application (NDA) for Probuphine®, an investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients.  Per the Minutes, the FDA emphasized its commitment to working with Titan and its partner, Braeburn Pharmaceuticals, to pursue a reasonable path to approval, and all parties agreed that seeking an indication in individuals stabilized on 8 mg/day or less of sublingual buprenorphine (SL BPN) may be a suitable approval pathway for Probuphine.  Titan and Braeburn proposed the revised indication following a review of the FDA’s comments on the briefing material and to address one of the primary concerns in the CRL regarding dose adequacy among the original study population (newly inducted patients maintained at 12-16 mg SL BPN/day).  The FDA maintained the need for clinical data in this patient population as a requirement for approval, stipulating that the study “need not be large”, “be adequate and well-controlled”, and “must support labeling for the duration of treatment (6 months)”.  Titan and Braeburn are working with experts in the field to develop a clinical study design for submission to the FDA within the next few weeks.

 

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Probuphine®

Probuphine is Titan’s novel subdermal implant formulation designed using its ProNeura technology to deliver six months of buprenorphine hydrochloride (“buprenorphine”) following a single treatment. Probuphine is being developed for the treatment of opioid dependence...

 

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Probuphine® Program Update

 

February 9, 2014
Titan Awaits FDA Response on Protocol Synopsis for New Probuphine® Study

On November 19, 2013 representatives of Titan Pharmaceuticals (Titan) and Braeburn Pharmaceuticals (Braeburn) met with the U.S. Food and Drug Administration (FDA) to discuss the contents of the Complete Response Letter (CRL) issued to the Probuphine® New Drug Application (NDA).

 

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Titan Pharmaceuticals, Inc. is a biopharmaceutical Company developing proprietary therapeutics primarily for the treatment of central nervous system (“CNS”) 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 $1.3 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...

 

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