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Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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Presentation on theme: "Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660."— Presentation transcript:

1 Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660

2 Titan Pharmaceuticals, Inc.
Overview Titan Pharmaceuticals, Inc. PUBLIC - (TICKER: TTNP) Biopharmaceutical company Established in 1992 In South San Francisco, CA 2012 employees: 15 2012 sales: $ (Mil) Assets: $ (Mil)

3 Background Titan only operate in the development of pharmaceutical products Developing proprietary therapeutics primarily for the treatment of serious medical problems (CNS disorders) Product development programs focus on pharmaceutical markets with: * Significant unmet medical needs * Commercial potential

4 History Titan experienced several setbacks that put the company on the verge of financial collapse In 2008 Spheramine , failed to show statistical efficacy in the treatment of Parkinson's disease  FDA's decision to issue non-approvable letter for Fanapt ® U.S. Patent Office's decision to deny a method of use patent for Probuphine ®

5 History Resurgence of Titan In 2009
FDA surprisingly approval of Fanapt ® for the treatment of Schizophrenia U.S. patent office's approval of the Probuphine ® patent NIH grant to study Probuphine ® as a treatment for opiate dependence

6 History Resurgence of Titan In 2010 & 2011
Titan completed a pivotal  Phase III trial for Probuphine ®, demonstrated that: Probuphine ® was effective compared to placebo It was also non-inferior to Suboxone ® Positive Phase III continuation study Probuphine ®, safety and effectiveness for long term use

7 Products Probuphine® (buprenorphine) Fanapt® (iloperidone)
Titan’s novel sub-dermal implant formulation The first long acting product Treating opioid dependence Using ProNeura technology Releasing the drug for up to 6 months Fanapt® (iloperidone) Continuous Drug Delivery Technology

8 News October 29, 2012 Titan announced the submission of Probuphine® NDA company's stock ($0.85) December 17, 2012 Signed a contract with Braeburn Pharmaceuticals, a commercialization partner , for up to $305 Million company's stock up ($1.26) December 20, 2012 Titan Pharmaceuticals poster abstract, “Buprenorphine Implants for the Treatment of Opioid Dependence: Six and 12 Month Outcomes” company's stock up ($1.12)

9 News January 2, 2013 February 4, 2013 February 27, 2013
NDA for Probuphine® has been accepted for review and granted Priority Review designation by the (FDA)  FDA has set a target date of April 30, 2013 for FDA action on the NDA company's stock up ($1.27) February 4, 2013 company's stock up—the highest in 52 weeks— ($2.28) February 27, 2013 announced that the PDAC of the FDA is scheduled to review the Company's NDA for Probuphine® on March 21, 2013 company's stock ($2.05)

10 News March 11, 2013 company's stock ($1.78) March 15, 2013
Titan announced about their live conference call on Monday, March 18, 2013 as they will provide the company’s financial results as of Dec 31, 2012 company's stock ($1.78) March 15, 2013 Titan reported their financial results for the fourth quarter and year ended December 31, 2012 company's stock up ($2.07)

11 News March 20, 2013  FDA reviewer provided negative comments about the company's drug Probuphine ®: Insufficient dose Surgery-related complications Comparable to  Norplant, an implantable, progestin-releasing contraceptive which is no longer marketed in the United States. company's stock down by 42% to $1.19

12 News March 22, 2013 Titan announced that the majority of the FDA review Committee members recognized the favorable benefit-risk profile of Probuphine® Approval: (10 positive votes, 4 negative votes and 1 abstention) Effectiveness: (10 positive votes to 5 negative votes) Safety: (12 positive votes to 2 negative votes, with 1 abstention) REMS: (6 abstentions, 5 positive votes and 4 negative votes) company's stock up $1.9

13 News April 18, 2013 Awaiting the FDA verdict (April 30th) company's stock between $1.6 and $1.8


15 Titan’s Financial Statements

16 Titan’s Financial Statements

17 Conclusion Buy or Sell ? Thanks!

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