Pharmaceutical Company Tracking ProjectTITAN PHARMACEUTICALS
Samah Al-ShatnawiPCA-PhD student
Mark 8660
Overview
Titan Pharmaceuticals, Inc. PUBLIC - (TICKER: TTNP)
• 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.htmlhttp://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• 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.htmhttp://palliumindia.org/2010/07/titan-pharma-obtains-probuphine-patent/
News
October 29, 2012Titan announced the submission of Probuphine® NDAcompany's stock ($0.85)
December 17, 2012Signed a contract with Braeburn Pharmaceuticals, a commercialization partner , for up to $305 Millioncompany's stock up ($1.26)
December 20, 2012Titan 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, 2013NDA 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 NDAcompany's stock up ($1.27)
February 4, 2013company's stock up—the highest in 52 weeks— ($2.28)
February 27, 2013announced that the PDAC of the FDA is scheduled to review the Company's NDA for Probuphine® on March 21, 2013company's stock ($2.05)
http://finance.yahoo.com/q/p?s=TTNP+Press+Releaseshttp://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+Releaseshttp://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+Releaseshttp://www.biospace.com/News/titan-pharmaceuticals-announces-fda-advisory/291338
News
March 22, 2013Titan 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 $1.9http://finance.yahoo.com/q/p?s=TTNP+Press+Releaseshttp://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