Pharmaceutical Company Tracking Project
TITAN PHARMACEUTICALS
Samah Al-Shatnawi
PCA-PhD student
Mark 8660
Overview
Titan Pharmaceuticals, Inc.
PUBLIC - (TICKER: TTNP)
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Biopharmaceutical company
Established in 1992
In South San Francisco, CA
2012 employees: 15
2012 sales: $ 7.117 (Mil)
Assets: $ 24.827 (Mil)
http://www.hoovers.com/company-information/cs/sales-preparation.Titan_Pharmaceuticals_Inc.59cb99e8cc2a24c2.html
http://www.manta.com/c/mm0h9p3/titan-pharmaceuticals-inc
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
http://en.wikipedia.org/wiki/Titan_Pharmaceuticals
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 ®
http://seekingalpha.com/article/1298621-titan-pharmaceutical-an-enticing-investment-opportunity
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
http://seekingalpha.com/article/1298621-titan-pharmaceutical-an-enticing-investment-opportunity
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
http://seekingalpha.com/article/1298621-titan-pharmaceutical-an-enticing-investment-opportunity
Products
 Probuphine® (buprenorphine)
Titan’s novel sub-dermal implant formulation
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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
http://www.titanpharm.com/products.htm
http://palliumindia.org/2010/07/titan-pharma-obtains-probuphine-patent/
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)
https://www.google.com/finance?q=TTNP&ei=1spuUYDTDov-lgP_ngE
News
January 2, 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)
http://finance.yahoo.com/q/p?s=TTNP+Press+Releases
http://www.biospace.com/News/titan-pharmaceuticals-announces-fda-advisory/291338
News
March 11, 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)
http://finance.yahoo.com/q/p?s=TTNP+Press+Releases
http://www.biospace.com/News/titan-pharmaceuticals-announces-fda-advisory/291338
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
http://finance.yahoo.com/q/p?s=TTNP+Press+Releases
http://www.biospace.com/News/titan-pharmaceuticals-announces-fda-advisory/291338
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
http://finance.yahoo.com/q/p?s=TTNP+Press+Releases
http://www.biospace.com/News/titan-pharmaceuticals-announces-fda-advisory/291338
News
April 18, 2013
Awaiting the FDA verdict (April 30th)
company's stock between $1.6 and $1.8
https://www.google.com/finance?q=TTNP&ei=1spuUYDTDov-lgP_ngE
TITAN PHARMACEUTICALS Stock Chart
http://investing.businessweek.com/research/stocks/charts/charts.asp?ticker=TTNP
Titan’s Financial Statements
Annual Revenues - TITAN PHARMACEUTICALS INC (TTNP)
http://investing.businessweek.com/research/stocks/earnings/earnings.asp?ticker=TTNP
Titan’s Financial Statements
http://investing.businessweek.com/research/stocks/financials/financials.asp?ticker=TTNP
Conclusion
Buy or Sell ?
Thanks!