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

Dec 15, 2015

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

Pharmaceutical Company Tracking ProjectTITAN PHARMACEUTICALS

Samah Al-ShatnawiPCA-PhD student

Mark 8660

Page 2: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-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

Page 3: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 4: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 5: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 6: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 7: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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/

Page 8: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 9: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 10: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 11: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 12: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 13: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

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

Page 14: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

TITAN PHARMACEUTICALS Stock Chart

http://investing.businessweek.com/research/stocks/charts/charts.asp?ticker=TTNP

Page 15: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

Titan’s Financial Statements

Annual Revenues - TITAN PHARMACEUTICALS INC (TTNP)

http://investing.businessweek.com/research/stocks/earnings/earnings.asp?ticker=TTNP

Page 16: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

Titan’s Financial Statements

http://investing.businessweek.com/research/stocks/financials/financials.asp?ticker=TTNP

Page 17: Pharmaceutical Company Tracking Project TITAN PHARMACEUTICALS Samah Al-Shatnawi PCA-PhD student Mark 8660.

Conclusion

Buy or Sell ?

Thanks!