TF Market Research

Title:ENCYSIVE PHARMACEUTICALS INC.-DRUG PIPELINE ANALYSIS
Price:$1,840.00 
Publication Date:Jan 09, 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:47 Pages (46 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 Drug Class Current Trial Trial Details61
Last Updated Partnering Details71
2. Novastan (argatroban) Blood and Description Novastan71
Therapeutic Mechanism of Action Current Trial Trial Details77
Last Updated71
Partnering Details81
3. Thelin / TBC11251 (sitaxsentan) Respiratory and Description Thelin (sitaxsentan) is81
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 Autoimmune And Description TBC4746 is a VLA-161
Last Updated Partnering Details163
8. TBC4746 / VLA-4 Antagonists Central Nervous Description TBC4746 is a VLA-161
9. TBC4746 / VLA-4 Antagonists Respiratory and Description TBC4746 is a VLA-171
Therapeutic Mechanism of Action Current Trial Trial Details173
10. CCR9 receptor antagonist Digestive System Description CCR9 receptor171
Therapeutic Current Trial Trial Details171
Last Updated 7/26/2007 11. Novastan (argatroban) Cardiovascular Description Novastan181
12. TBC3804 Description181
Last Updated 13. TBC3214 Description181
Last Updated 3/22/2007 14. Novastan (argatroban) and glycoprotein IIb/IIIa inhibitor Cardiovascular and Circulatory System D191
Therapeutic Mechanism of Action Drug Class Current Trial Trial Details191
Last Updated 15. Bimosiamose Description191
Therapeutic Mechanism of Action191
Drug Class Current Trial Trial Details201
Last Updated Partnering Details204
16. Bimosiamose Description211
Therapeutic Mechanism of Action Current Trial Trial Details211
17. Bimosiamose Description211
Therapeutic Mechanism of Action Drug Class Current Trial Trial Details212
18. Novastan (argatroban) Cardiovascular Description Novastan221
19. Thelin (sitaxsentan) / TBC11251 Cardiovascular and Description Thelin (sitaxsentan) /231
Therapeutic Mechanism of Action Current Trial Trial Details231
Last Updated241
Product Revenue241
THELIN241
Qtr 1 Qtr 2 Qtr 3 Qtr 4 Annual241
Recent Financings241
Trademarks251
Corporate Partners251
Deal Category: Miscellaneous Date251
DealValue (in $ MM)253
Date262
Partner262
Deal Category: Product Date261
John M. Pietruski -- Chairman271
George W. Cole -- Chief Executive Officer and President271
Richard Dixon -- Chief Scientific Officer and Senior Vice President, Research271
Derek Maetzold -- Vice President, Marketing and Sales281
Tommy A. Brock -- Vice President, Pharmacology and Preclinical Development281
Heather Giles -- Vice President, Strategic Planning281
D. Jeffrey Keyser -- Vice President, Regulatory Affairs281
Ann Tanabe -- Vice President, Corporate Communications and Investor Relations281
Paul S. Manierre -- Vice President, General Counsel and Secretary281
Thierry A. Plouvier -- Vice President, European Operations291
Pamela Mabry -- Director, Human Res291
Patrick Ward -- Director, Business Development291
J. Kevin Buchi -- Director291
Robert J. Cruikshank -- Director291
John H. Dillon -- Director291
Suzanne Oparil -- Director291
James A. Thomson -- Director301
James T. Willerson -- Director and Scientific Advisory Board Chairman301
Ron J. Anderson -- Director301
Ferid Murad -- Scientific Advisory Board Member301
Denton Cooley -- Scientific Advisory Board Member301
Recent Updates311
Company Announcements311
7/9/2007 -- Encysive Pharmaceuticals Announces Management Change311
6/25/2007 -- Encysive Pharmaceuticals Appoints New Chief Executive and Announces Restructuring of Company Operations311
5/1/2007 -- Encysive Pharmaceuticals Previews European Union Activities for 2007311
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 Trial321
6/3/2004 -- Encysive Updates Ex-North American Licensing Strategy for Thelin321
5/24/2004 -- New Data on Thelin (TM) Presented at American Thoracic Society's International Conference321
5/16/2003 -- Texas Biotechnology announces company name change to Encysive Pharmaceuticals321
6/18/2001 -- Texas Biotechnology to Move to Nasdaq: TXBI is new symbol321
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 target331
Financials331
9/21/2007 -- Encysive Pharmaceuticals Refinances Argatroban Royalty Notes331
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
10/19/2006 -- Encysive Pharmaceuticals Secures Equity Financing Commitment331
6/15/2005 -- SEC Declares Encysive Resale Registration Statement on Form S-3 Effective341
3/11/2005 -- Encysive Announces Pricing of $115 Million of Convertible Senior Notes341
3/9/2005 -- Encysive Pharmaceuticals to Offer $100 Million of Convertible Senior Notes341
9/13/2004 -- Encysive Pharmaceuticals Announces Closing of $36.5 Million Stock Offering341
9/8/2004 -- Encysive Pharmaceuticals Announces Common Stock Offering of 4 Million Shares341
6/4/2004 -- Encysive Pharma files $150 mln mixed shelf341
12/23/2003 -- Encysive Pharmaceuticals Announces Closing of $48.6 Million Stock Offering341
12/3/2003 -- Encysive Pharmaceuticals Announces Public Offering of Common Stock351
9/28/2001 -- Update to Texas Biotechnology shareholders; confirms stock repurchase program351
5/3/2001 -- Texas Biotechnology announces stock repurchase program351
1/5/2001 -- Texas Biotechnology receives $21.7 million from warrant exercise351
Intellectual Property351
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.361
9/26/2006 -- Lerach Coughlin Stoia Geller Rudman & Robbins LLP Files Class Action Suit Against Encysive Pharmaceuticals Inc.361
4/23/2003 -- Texas Biotechnology acquires ICOS Corporation's interest in ICOS-Texas Biotechnology, L.P.361
Product Update361
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 France371
9/13/2007 -- Encysive Pharmaceuticals Announces Launch of Thelin (sitaxentan sodium) in Spain371
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
3/21/2007 -- Encysive Pharmaceuticals Announces Patient Enrollment Initiated for TBC3711 Phase II Study371
12/14/2006 -- Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application381
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 Trial391
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 Society 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
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 Hypertension431
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 Hypertension451
3/7/2007 -- Thelin (sitaxentan sodium) Receives Australian Marketing Approval451
12/28/2006 -- FDA Accepts Encysive's Complete Response To Thelin New Drug Application451
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 Remains461
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 Canada471
Tables
TitleStarting PageNumber of Pages
of Contents31

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