TF Market Research

Title:ENCYSIVE PHARMACEUTICALS INC-DRUG PIPELINE ANALYSIS
Price:$1,800.00 
Publication Date:Jan 26, 2008
Source:LIFE SCIENCE ANALYTICS
Author:HARINATHA, G.
Company:ENCYSIVE PHARMACEUTICALS INC
Brief Excerpt:... company, engages in the discovery, development, and commercialization of novel synthetic small molecule co mpounds for the treatment of various cardiovascular, vascular, and related inflammatory dise ases. It offers Argatroban, a syntheti c direct thrombin inhibitor, for the treatment of heparin-induced thrombocytopenia in the United States and Canada; and Thelin (sitaxsentan sodium), an endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension in the European Union and Australia. It also has th ree additional compounds in clinical development, including TBC####, second-generation endothelin recept or antagonist; TBC####, an oral VLA-# antagonist; and bimosiamose, a selectin antagonist. In addition, the company provides other research and development programs for various cardiovascula r and inflammatory diseases. Encysive Pharmaceuticals has collaboration and licensing agreements with Mitsubishi Ph...
Length:46 Pages (45 Billable Pages)
Geographic Region:AMERICAS, NORTH AMERICA, SOUTHWEST/SOUTHWESTERN REGION, TEXAS (STATE OF), UNITED STATES
Non-Billable Page Numbers:3
Format:Adobe Acrobat Adobe Acrobat

Sections
TitleStarting PageNumber of Pages
Company Information11
Encysive Pharmaceuticals Inc. (NASDAQ) Symbol : ENCY11
Headquarters11
Fiscal Ends December11
Selected Financial Data11
Business Summary12
Product Glance41
MedTRACK Classification41
Upcoming Milestones Date Category51
Milestone51
Product Pipeline51
Condition Treated61
Product Details61
1. Novastan (argatroban) Blood and Description Novastan61
Therapeutic Mechanism of Action Current Trial Trial Details61
Last Updated 6/4/2007 2. Novastan (argatroban) Blood and Description Novastan71
Therapeutic Mechanism of Action Drug Class Current Trial Trial Details71
Last Updated Partnering Details71
3. Thelin / TBC11251 (sitaxsentan) Respiratory and Description Thelin (sitaxsentan) is71
Therapeutic Mechanism of Action Current Trial Trial Details86
Last Updated 4. TBC3711 Description141
Therapeutic Mechanism of Action Drug Class Current Trial Trial Details143
Last Updated 4/5/2007 5. Thelin / TBC11251 (sitaxsentan) Cardiovascular and Description Thelin (sitaxsentan) is151
Therapeutic Mechanism of Action Current Trial Trial Details151
Last Updated 9/5/2007 6. Thelin / TBC11251 (sitaxsentan) Cardiovascular and Description Thelin (sitaxsentan) /151
Last Updated 5/22/2007 7. TBC4746 / VLA-4 Antagonists Central Nervous Description TBC4746 is a VLA-161
Last Updated Partnering Details162
8. TBC4746 / VLA-4 Antagonists Autoimmune And Description TBC4746 is a VLA-161
Last Updated Partnering161
Details171
9. TBC4746 / VLA-4 Antagonists Respiratory and Description TBC4746 is a VLA-171
Therapeutic Mechanism of Action Current Trial Trial Details174
10. CCR9 receptor antagonist Digestive System Description CCR9 receptor171
Therapeutic Current Trial Trial Details171
Last Updated 11. TBC3214171
Description181
Last Updated 3/22/2007 12. Novastan (argatroban) and glycoprotein IIb/IIIa inhibitor Cardiovascular and Circulatory System D181
Therapeutic Mechanism of Action Drug Class Current Trial Trial Details181
Last Updated 11/15/2007 13. Novastan (argatroban) Cardiovascular Description Novastan181
Therapeutic Mechanism181
of Action Current Trial Trial Details191
Last Updated Partnering Details191
14. Bimosiamose Description191
Last Updated 15. TBC3804 Description201
Last Updated 16. Bimosiamose Description201
Therapeutic Mechanism of Action Drug Class Current Trial Trial Details203
Last Updated 17. Bimosiamose Description211
Last Updated 9/24/2007 18. Novastan (argatroban) Cardiovascular Description Novastan221
Last Updated 6/4/2007 19. Thelin (sitaxsentan) / TBC11251 Cardiovascular and Description Thelin (sitaxsentan) /231
Therapeutic Mechanism of Action Current Trial Trial Details231
Last Updated231
Product Revenue231
THELIN231
Qtr 1 Qtr 2 Qtr 3 Qtr 4 Annual231
Recent Financings231
Trademarks241
Corporate Partners241
Deal Category: Miscellaneous Date241
DealValue (in $ MM)243
Partner252
Date252
Deal Category: Product Date251
Management Profile261
John M. Pietruski -- Chairman261
George W. Cole -- Chief Executive Officer and President271
Richard Dixon -- Chief Scientific Officer and Senior Vice President, Research271
Richard Goeggel -- Chief Accounting Officer271
Derek Maetzold -- Vice President, Marketing and Sales271
Tommy A. Brock -- Vice President, Pharmacology and Preclinical Development271
Heather Giles -- Vice President, Strategic Planning271
D. Jeffrey Keyser -- Vice President, Regulatory Affairs271
Ann Tanabe -- Vice President, Corporate Communications and Investor Relations281
Paul S. Manierre -- Vice President, General Counsel and Secretary281
Thierry A. Plouvier -- Vice President, European Operations281
Pamela Mabry -- Director, Human Res281
Patrick Ward -- Director, Business Development281
J. Kevin Buchi -- Director281
Robert J. Cruikshank -- Director281
John H. Dillon -- Director291
Suzanne Oparil -- Director291
James A. Thomson -- Director291
James T. Willerson -- Director and Scientific Advisory Board Chairman291
Ron J. Anderson -- Director291
Denton Cooley -- Scientific Advisory Board Member301
Recent Updates301
Company Announcements301
7/17/2007 -- Encysive Pharmaceuticals Retains Morgan Stanley to Assist in Review of Strategic Alternatives301
7/9/2007 -- Encysive Pharmaceuticals Announces Management Change301
6/25/2007 -- Encysive Pharmaceuticals Appoints New Chief Executive and Announces Restructuring of Company Operations301
5/1/2007 -- Encysive Pharmaceuticals Previews European Union Activities for 2007301
9/29/2006 -- Law Offices of Howard G. Smith Announces Class Action Lawsuit Against Encysive Pharmaceuticals Inc.311
6/26/2006 -- Encysive Pharmaceuticals Announces Clinical Organizational Changes311
2/11/2005 -- Encysive Pharmaceuticals Announces Plans to Release Topline Data From STRIDE-2 Clinical Trial311
6/3/2004 -- Encysive Updates Ex-North American Licensing Strategy for Thelin311
5/24/2004 -- New Data on Thelin (TM) Presented at American Thoracic Society's International Conference311
5/16/2003 -- Texas Biotechnology announces company name change to Encysive Pharmaceuticals311
6/18/2001 -- Texas Biotechnology to Move to Nasdaq: TXBI is new symbol311
Deals & Alliances321
4/26/2005 -- Encysive Pharmaceuticals Restructures Agreement with Revotar Biopharmaceuticals321
10/8/2001 -- Revotar Biopharmaceuticals AG-majority-owned subsidiary of Texas Biotechnology - licenses new research target321
Financials321
12/19/2007 -- Encysive Pharmaceuticals Receives Delisting Warning Letter From NASDAQ321
9/21/2007 -- Encysive Pharmaceuticals Refinances Argatroban Royalty Notes321
8/20/2007 -- Encysive Pharmaceuticals Raises Approximately $15 Million in Equity Offering331
2/7/2007 -- Encysive shares buoyed by GlaxoSmithKline news331
2/6/2007 -- Encysive Pharmaceuticals Completes $60 Million Note Offering Secured by Argatroban Royalties331
6/15/2005 -- SEC Declares Encysive Resale Registration Statement on Form S-3 Effective331
3/16/2005 -- Encysive Announces Closing of $130 Million Convertible Senior Note Offering331
3/11/2005 -- Encysive Announces Pricing of $115 Million of Convertible Senior Notes331
3/9/2005 -- Encysive Pharmaceuticals to Offer $100 Million of Convertible Senior Notes331
9/8/2004 -- Encysive Pharmaceuticals Announces Common Stock Offering of 4 Million Shares341
12/23/2003 -- Encysive Pharmaceuticals Announces Closing of $48.6 Million Stock Offering341
12/3/2003 -- Encysive Pharmaceuticals Announces Public Offering of Common Stock341
8/20/2003 -- Encysive Pharmaceuticals files $50 million shelf registration statement341
9/28/2001 -- Update to Texas Biotechnology shareholders; confirms stock repurchase program341
5/3/2001 -- Texas Biotechnology announces stock repurchase program341
1/5/2001 -- Texas Biotechnology receives $21.7 million from warrant exercise341
Intellectual Property351
12/28/2007 -- Encysive Pharmaceuticals Announces Patent Infringement Lawsuit Against Barr Laboratories351
9/19/2007 -- Encysive Pharmaceuticals Announces Dismissal of Class Action Lawsuit351
10/10/2006 -- Shareholder Class Action Filed Against Encysive Pharmaceuticals Inc. by the Law Firm of Schiffrin & Barroway, L351
9/27/2006 -- Schatz & Nobel, P.C. Announces Class Action Lawsuit Against Encysive Pharmaceuticals, Inc.351
9/26/2006 -- Lerach Coughlin Stoia Geller Rudman & Robbins LLP Files Class Action Suit Against Encysive Pharmaceuticals Inc.351
Mergers & Acquisitions351
4/23/2003 -- Texas Biotechnology acquires ICOS Corporation's interest in ICOS-Texas Biotechnology, L.P.361
Product Update361
1/14/2008 -- Encysive Pharmaceuticals Launches Thelin (sitaxentan sodium) in Belgium and Luxembourg361
11/26/2007 -- Encysive Pharmaceuticals Launches Thelin (sitaxentan sodium) in Italy361
11/5/2007 -- Encysive Pharmaceuticals Announces Presentation of Sitaxsentan Data in Eisenmenger Syndrome At AHA Meeting361
10/24/2007 -- Encysive Pharmaceuticals Announces Long-Term Study of Sitaxsentan Presented At Chest Meeting361
10/11/2007 -- Encysive Pharmaceuticals Launches Thelin (Sitaxentan Sodium) in France361
9/13/2007 -- Encysive Pharmaceuticals Announces Launch of Thelin (sitaxentan sodium) in Spain371
9/4/2007 -- Encysive Pharmaceuticals Announces Completion of Patient Enrollment in Phase II Diastolic Heart Failure Trial371
8/6/2007 -- Encysive Pharmaceuticals Files Request for Formal Dispute Resolution With U.S. FDA371
7/13/2007 -- Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium)371
4/16/2007 -- Encysive Pharmaceuticals Announces Launch of Thelin (Sitaxentan Sodium) in the Netherlands371
4/2/2007 -- Encysive Pharmaceuticals Announces Launch of Thelin (Sitaxentan Sodium) in Republic of Ireland371
12/18/2006 -- Encysive Pharmaceuticals Announces Launch of Thelin in Germany371
11/6/2006 -- Encysive Pharmaceuticals Announces Launch of Thelin in United Kingdom381
11/2/2006 -- Encysive Submits Complete Response to FDA For Thelin New Drug Application381
6/22/2006 -- Encysive Pharmaceuticals Announces Presentation of New STRIDE-2X Data at EULAR Congress381
3/23/2006 -- Encysive Pharmaceuticals Delays Studies With TBC3711381
1/9/2006 -- Encysive Pharmaceuticals Initiates Dose Ranging Study of TBC3711381
10/20/2005 -- Encysive Pharmaceuticals Announces New Thelin Data to be Presented at CHEST 2005381
9/14/2005 -- Encysive Pharmaceuticals Announces Interim Topline Data From STRIDE-2 Extension Trial381
9/6/2005 -- Encysive Pharmaceuticals Presents Thelin Data at European Society of Cardiology391
7/28/2005 -- Encysive Files for European Marketing Approval of Thelin391
6/16/2005 -- Encysive to Retain European Rights to Thelin391
5/25/2005 -- Encysive Pharmaceuticals Submits New Drug Application for Thelin391
5/22/2005 -- Encysive Announces Six Thelin Abstracts Presented at American Thoracic Society391
International Conference401
2/14/2005 -- Encysive Pharmaceuticals Announces Topline Data From Stride-2 Pivotal Trial in PAH401
10/18/2004 -- New Thelin Data Presented at American College of Rheumatology Meeting401
10/5/2004 -- Thelin Shows Promise in Patients Failing Bosentan Therapy401
9/8/2004 -- Encysive Reaches Enrollment Target for STRIDE-2, the Company's Pivotal Phase III Trial for Thelin401
8/31/2004 -- Data on Thelin Presented at the European Society of Cardiology Annual Congress411
8/26/2004 -- Encysive Pharmaceuticals Announces Results From Thelin and Viagra Drug Interaction Study411
7/6/2004 -- Encysive Pharmaceuticals Reiterates Guidance for STRIDE-2 Trial Enrollment411
9/16/2003 -- Results of Argatroban Plus Glycoprotein IIb/IIIa Inhibitors for interventional heart procedures announced411
8/5/2003 -- Encysive announces its majority-owned subsidiary, Revotar Biopharmaceuticals AG,411
reported positive data in Asthma with small molecule selectin antagonist421
7/15/2003 -- Physician presents results and describes mechanism of action of direct thrombin inhibitor421
5/19/2003 -- Encysive Pharmaceuticals announces full results for Sitaxsentan in Pulmonary Arterial Hypertension421
4/23/2003 -- Results of pilot study of Argatroban with Glycoprotein IIb/IIIa Inhibitors announced431
10/21/2002 -- ICOS-Texas Biotechnology L.P. announces phase IIb/III trial results for Sitaxsentan431
10/2/2002 -- Texas Biotechnology announces preliminary results for the use of Argatroban as A treatment for Acute Ischemic St431
7/22/2002 -- ICOS-Texas Biotechnology L.P. provides update on the Sitaxsentan phase IIb/III Pulmonary Arterial Hypertension T441
Regulatory441
6/15/2007 -- FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)441
5/30/2007 -- Canadian Health Authority Approves Thelin (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension441
3/7/2007 -- Thelin (sitaxentan sodium) Receives Australian Marketing Approval441
12/28/2006 -- FDA Accepts Encysive's Complete Response To Thelin New Drug Application441
12/15/2006 -- Encysive Pharmaceuticals' Thelin (sitaxentan sodium) Receives Positive Opinion From Australian Health Authority451
12/14/2006 -- Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days451
12/7/2006 -- Encysive Pharmaceuticals Receives FDA Clearance to Resume Clinical Studies With TBC3711451
7/24/2006 -- FDA Issues Approvable Letter for Thelin (Sitaxsentan Sodium); One Outstanding Item Remains451
6/2/2006 -- Encysive Pharmaceuticals' Thelin (sitaxentan sodium) Receives Positive Opinion From European Authorities451
5/25/2006 -- Encysive Pharmaceuticals Submits Complete Response to FDA for Thelin New Drug Application461
3/24/2006 -- Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin461
8/17/2005 -- Encysive Pharmaceuticals' Application for Thelin Accepted for Review By EMEA461
7/14/2005 -- Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension461
11/11/2004 -- Thelin Gets Orphan-Drug461
4/9/2002 -- Glaxosmithkline and Texas Biotechnology receive FDA approval for new of Argatroban461
8/1/2001 -- Texas Biotechnology announces approval of Argatroban in Canada461
Tables
TitleStarting PageNumber of Pages
of Contents31

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