EX-99.2 3 v403916_ex99-2.htm EXHIBIT 99.2

Exhibit 99.1

COMPANY FACT SHEET Titan Pharmaceuticals Overview Titan Pharmaceuticals Inc. (TTNP.OB), based in South San Francisco, CA, is a specialty phar-maceutical company developing proprietary therapeutics utilizing its ProNeura™ implant drug delivery technology. ProNeura provides non-fluc-tuating levels of medication continuously over pe-riods of six months to a year and is ideal for use in the treatment of select chronic diseases for which subdermal delivery may offer advantages over oral administration. Titan’s lead product candidate is Probuphine®, a novel, subdermal implant formulation of bu-prenorphine designed to provide six months of medication for the maintenance treatment of opi-oid dependence following a single administration. Titan is also in the early stages of developing a ProNeura-based product for the treatment of Par-kinson’s disease, and also investigating opportuni-ties with other chronic treatments. The ProNeura Platform Titan’s ProNeura platform offers a simple, practical method to provide continuous drug administration on an outpatient basis over periods of 6-12 months. Such long-term, linear release characteristics are generally desired to avoid the peak- and trough-level dosing that poses problems for many diseases, especially diseases of the central nervous system. The ProNeura drug delivery system consists of a small, solid rod made from a mixture of ethylene-vinyl ace-tate (“EVA”) and a drug substance. The product is a solid matrix that is placed subdermally, normally in the inner part of the upper arm, during a simple office pro-cedure, and is removed in a similar manner at the end of treatment. The drug substance is released continu-ously through the process of dissolution, resulting in a stable blood level similar to intravenous administration. Titan has issued patents and patent applications cover-ing the use of this platform technology in the treatment of certain chronic diseases, such as opioid dependence and Parkinson’s disease among others. INNOVATIONS IN MEDICINE™ Probuphine for the Treatment of Opioid Dependence: The First of Its Kind Opioid Dependence & Treatment Addiction is a complex and chronic disease of brain circuitry, and involves cycles of relapse and remission, often requiring long-term care and treatment. Without treatment, opioid dependence is progressive and can lead to disability and even premature death. In the U.S., treatment with daily sublingual buprenor-phine is the gold standard for treating opioid depen-dence. Buprenorphine is a mixed partial agonist at the mu receptor and an antagonist at the kappa receptor. These characteristics enhance the safety profile of this compound as compared to methadone, making it par-ticularly suitable for opioid dependence treatment. In 2013, U.S. sales of daily dosed sublingual formulations of buprenorphine were approximately $1.5B. However, some of the key challenges with the daily dosed bu-prenorphine formulations include: Poor patient compliance Fluctuating blood levels during treatment Drug diversion and abuse Accidental ingestion and overdose in vulnerable populations, especially children Probuphine Probuphine is capable of delivering continuous, poten-tially therapeutic levels of buprenorphine for six months following a single treatment. The characteristics of the implant may address all the significant challenges of treatment with oral buprenorphine while providing around the clock medication for maintenance treat-ment of opioid dependence.

Probuphine Clinical Development & Commercialization Program A final Phase 3 trial of Probuphine is in progress, with results expected by mid-2015. Pa-tient enrollment is complete in this two-arm double blind, double dummy, non-inferiority study in stable patients receiving maintenance treatment with =8 mg/day of buprenor-phine therapy. Successful completion is expected to provide the clinical data requested by the FDA in the complete response letter, and permit resubmission of the NDA later in 2015. Probuphine has the potential to be approved in the U.S. in the first half of 2016. Management Marc Rubin, M.D. Executive Chairman Sunil Bhonsle, M.B.A. President Kate L. Glassman Beebe, Ph.D. Executive Vice President & Chief Development Officer 1 Probuphine® is a subdermal implant of buprenorphine HCL embedded within a polymer matrix. It provides discrete, long-term delivery of a potential medical treat-ment for opioid dependence. 2 Probuphine is designed to release sustained therapeutic drug levels in patients with opioid dependence for up to six months. Time ProNeura implants provide stable, non-fluc-tuating drug levels for 6-12 months v. daily oral delivery. Board of Directors Marc Rubin, M.D. Executive Chairman Sunil Bhonsle, M.B.A. President; Secretary Joseph A. Akers Audit Committee Victor J. Bauer, Ph.D. Titan’s partner, Braeburn Pharmaceuticals, has exclusive rights to market Probuphine in the U.S. and Canada. Under terms of the license agreement, Titan received $15.25 million as an upfront payment, and will receive $15 million upon U.S. approval of Probuphine, additional potential sales milestones of up to $165 million and a tiered royalty based on a percentage of net sales from the mid-teens to the low twenties. Titan is evaluating opportunities for Probuphine in other countries for the treatment of opioid dependence and potentially chronic pain, with the goal of establishing one or more partnerships. ProNeura for Parkinson’s Disease Parkinson’s Disease and Treatment About one million people in the U.S. have Parkinson’s disease and that number is expect-ed to double by 2030 due to the aging population, according to the Parkinson’s Disease Foundation. Parkinson’s disease is characterized by the loss of dopaminergic neurons in the brain, which alters activity in regions that impact movement and motor function. To counter the loss of dopamine, current drugs for Parkinson’s disease are designed to replace or mimic dopamine in the brain. While these drugs can be effective, after several years of treatment they often lose their benefit and may trigger serious side effects. Re-search indicates that the pulsatile dopaminergic stimulation from current oral treatments may be responsible for the motor side effects and that continuous dopaminergic stim-ulation (CDS) by subcutaneous infusion of dopamine agonists may palliate these motor complications. ProNeura for Parkinson’s Development Program ProNeura has the potential to deliver continuous, non-fluctuating levels of dopamine agonists and provide CDS for six months or longer with a single treatment. Titan evalu-ated Ropinirole (Requip®), a generic dopamine agonist, in a Parkinsonian primate model using its ProNeura technology. The non-clinical proof-of-concept study demonstrated sustained levels of Ropinirole in the blood for several months following implantation and controlled Parkinson’s disease symptoms without dyskinesia. Titan is consulting close-ly with expert scientific advisors and the FDA, and anticipates completing non-clinical studies and filing an Investigational New Drug application in time to commence a proof of concept clinical study in 2016, following potential approval of Probuphine. Audit Committee; Compensation Committee Eurelio M. Cavalier Compensation Committee; Corporate Governance & Nominating Committee M. David MacFarlane, Ph.D. Audit Committee; Corporate Governance & Nominating Committee James McNab Jr. Corporate Governance & Nominating Committee Ley S. Smith Audit Committee; Corporate Governance & Nominating Committee Titan Pharmaceuticals, Inc. 400 Oyster Point Blvd., Suite 505 South San Francisco, CA 94080-1921 Tel: (650) 244-4990 Fax: (650) 244-4956 www.titanpharm.com