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Titan Pharmaceuticals First Quarter 2013 Financial Results

Thursday, May 16, 2013 - 1:00pm ET | 10:00am PT

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Titan Pharmaceuticals Latest Press Releases

Titan Management Team to Host Conference Call May 16 at

1:00 p.m. ET / 10:00 a.m. PT

South San Francisco, CA – May 15, 2013Titan Pharmaceuticals, Inc. (TTNP.OB) today reported financial results for the first quarter ended March 31, 2013.

Net income for the quarter ended March 31, 2013 was approximately $6.0 million, or approximately $0.08 per share, compared to a net loss of approximately $5.2 million, or approximately $0.09 per share, for the comparable period in 2012. Net income in the quarter consisted of licensing revenue of approximately $3.8 million, resulting from the amortization of the non-refundable up-front license fee of $15.75 million (approximately $15.0 million, net of expenses) related to Titan’s licensing agreement with Braeburn for the exclusive U.S. and Canadian commercialization rights for Probuphine®, which was announced in December 2012. Probuphine is an investigational, long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients with opioid dependence.

 

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SOUTH SAN FRANCISCO, CA – May 9, 2013 – Titan Pharmaceuticals, Inc. (OTCBB:TTNP) today announced that it will host a live conference call at 10 a.m. PT / 1 p.m. ET on Thursday, May 16, 2013. Titan will provide the Company’s financial results as of March 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.

Highlights of the first quarter financial results will be included in a press release to be issued prior to the call.

 

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SOUTH SAN FRANCISCO, CA, April 30, 2013 – Titan Pharmaceuticals, Inc. (OTCBB: TTNP) announced that the U.S. Food and Drug Administration (FDA) has issued this evening a Complete Response Letter (CRL) to its New Drug Application (NDA) for Probuphine®, the company’s investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients.

“Titan and our partner, Braeburn Pharmaceuticals, are extremely surprised and disappointed with the FDA’s response. Probuphine is a diversion-resistant formulation that is consistent with the recently-issued FDA guidance supporting diversion- and abuse-resistant products, and the NDA was designated Priority Review by the FDA. We believe Probuphine has demonstrated both safety and efficacy in accordance with primary endpoints that were pre-agreed with the FDA and, moreover, the safety, efficacy and overall approval of Probuphine was strongly supported by the Psychopharmacologic Drugs Advisory Committee,” said Marc Rubin, M.D., executive chairman of Titan Pharmaceuticals. “Given the nationally-recognized, growing and devastating opioid dependence epidemic, there is critical need for new safe and effective treatments that reduce the likelihood of abuse, diversion and accidental pediatric exposure, and Titan and Braeburn remain committed to making Probuphine available for patients that need it.”

 

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SOUTH SAN FRANCISCO, CA, April 22, 2013 – Titan Pharmaceuticals, Inc. (OTCBB:TTNP) today announced that presentations highlighting Probuphine®, a long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients with opioid dependence, will be made at two upcoming medical meetings.

American Society of Addiction Medicine (ASAM) 44th Annual Medical-Scientific Conference, April 25-28, 2013, Chicago Walter Ling, M.D., Professor of Psychiatry, Director, Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA, will present results of the Probuphine Phase 3 development program on Friday, April 26, 2013 at a symposium sponsored by the National Institute on Drug Abuse (NIDA): “Buprenorphine: New Formulations, Medication Combinations, Indications and Longitudinal Effects.” This two-part symposium will be held at 10:30 a.m. and 2:30 p.m. CT.

American Psychiatric Association (APA) 166th Annual Meeting, May 18-22, 2013, San Francisco Katherine Glassman-Beebe, Ph.D., Executive Vice President and Chief Development Officer of Titan, will present “Buprenorphine Implants for the Maintenance Treatment of Opioid Dependence,” on Monday, May 20 at 2 p.m. PT during NIDA Symposia 74: “Advances in Pharmacotherapies for Substance Use Disorders.”

 

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Read more Titan Pharmaceuticals Press Releases

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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Fanapt® (iloperidone)

Fanapt (iloperidone) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia currently being marketed by Novartis Pharma AG (“Novartis”) in the U.S. Titan is entitled to a royalty of 8-10% of net sales of Fanapt under a sublicense agreement with Novartis that is based on a U.S. patent which expires in October 2016 (does not include a possible six-month pediatric extension).

 

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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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