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September 2009

September 1

Novavax Announces Positive Results for the Second Phase II Clinical Trial of its Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine Candidate ACADIA Pharmaceuticals Announces Results from Phase III Trial of Pimavanserin in Parkinson's Disease Psychosis TransPharma Announces Successful Completion of Phase 2 Trial of ViaDerm-hPTH (1-34) in Postmenopausal Women with Osteoporosis New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of Plavix in Acute Coronary Syndrome Patients Undergoing Angioplasty Video: RE-LY Trial Met Primary Outcome for Reducing Incidence of Stroke or Systemic Embolism in Non-valvular Atrial Fibrillation Patients Study Shows Otamixaban Substantially Reduced Complications of Invasive Management of Acute Coronary Syndromes

September 4

Novel Evidence-Based Systemic Lupus Erythematosus (SLE) Responder Index Described in Peer Reviewed Publication as Potentially Significant Advance in Lupus Drug Development Array BioPharma Announces Top-Line Results from Rheumatoid Arthritis Phase 2 Trial NovaDel Article Published in Headache: The Journal of Head and Face Pain PharmAthene Presents Data for Valortim Anthrax Anti-Toxin and Third Generation rPA Anthrax Vaccine Programs at the Bacillus - ACT 2009 Conference Large Thighs Protect Against Heart Disease and Early Death Gene Signal and Collaborators Publish GS-101 Clinical Data Suggesting Safe and Effective Inhibition of Abnormal Ophthalmic Blood Vessel Growth Promising Results of Drug Trial Could Herald a Replacement for Popular Blood Thinner LIVALO Demonstrates Sustained, Long-Term Efficacy and Tolerability in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

September 8

September 10

Acorda Therapeutics Announces Interim Analysis of Two-Year Efficacy and Safety Data from Phase 3 Fampridine-SR Extension Study Reliability and Validity of Dyax's Novel Patient Reported Outcome Measures (PROs) Affirmed in Published Study Dexamethasone-Based Therapy Shows Improvement In Survival For Children With Acute Lymphoblastic Leukaemia New research indicates 95% of patients are in moderate to severe chronic pain despite one year of treatment QuatRx Announces Positive Results of Second Pivotal Phase 3 Clinical Study for Ophena (Ospemifene Tablets) in Treatment of Postmenopausal Vaginal Atrophy Protox announces positive 12 month Phase 2 BPH results MAP Pharmaceuticals' Analysis of Positive Phase 3 Levadex Data To Be Presented in Late-Breaking Session at 14th Congress of the International Headache Society Mpex Pharmaceuticals Announces Positive Phase 2b Clinical Trial Results with Aeroquin(R) (MP-376) Treatment in Cystic Fibrosis Patients Virus Responsible For Deadly Brain Disease Found In MS Patients Treated With Natalizumab Zelrix, a Novel Transdermal Patch for Migraine, Found to Provide Rapid, Consistent, and Sustained Relief for Migraine Sufferers in Phase III Trial Tetraphase Presents Study Results for Novel Classes of Antibiotics from its Breakthrough Synthetic Chemistry Platform at ICAAC 2009 Acceleron Pharma's ACE-031 Increases Lean Body Mass in Phase 1 Single Dose Clinical Trial Key Data Related to Plexxikon's Lead Oncology Program PLX4032 to Be Presented at ECCO15 / ESMO34 2009 Conference

September 11

Variation Biotechnologies to Present Positive Influenza Vaccine Data at the 49th Annual ICAAC Meeting New WHO Data Underscores Global Threat of the World's Leading Child Killer Results from IMPROVE Study Show MRI Benefits of Rebif Seen Early in Relapsing-Remitting Multiple Sclerosis Treatment and Sustained Over Time Data Supporting Unique Efficacy of Tysabri Presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Encouraging Phase II Results With Teriflunomide In Patients With Relapsing Multiple Sclerosis New Data From CLARITY Study on Disease Activity in MS Patients Who Received Cladribine Tablets Presented at 25th ECTRIMS Congress Fewer Injection Site Reactions in Patients Using Avonex Versus Sub-cutaneous Interferon and Glatiramer Acetate for the Treatment of Multiple Sclerosis Laquinimod Immunomodulatory Action Confers Both Neuroprotective and Anti-Inflammatory Properties New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction on Cymbalta Genzyme's Alemtuzumab for Multiple Sclerosis Shows Durable Treatment Benefit in Review of Four-Year Phase 2 Trial Data Statement by Dr. Anthony Fauci, Director, National Institute of Allergy and Infections Diseases, NIH, Regarding Early Results from Clinical Trials of 2009 H1N1 Influenza Vaccines in Healthy Adults Instanyl (intranasal fentanyl spray) Sets New Standard in Management of Breakthrough Cancer Pain Data to be Presented on Multiple Targacept NNR Therapeutics at Society for Neuroscience Satellite Symposium Tetraphase Presents Study Results for Novel Classes of Antibiotics from its Breakthrough Synthetic Chemistry Platform at ICAAC 2009

September 14

Variation Biotechnologies Flu Vaccine Provides Robust Immune Response, Broad Protection against H1N1 Influenza Strain Aradigm Presents Data Demonstrating Significant Antibacterial Concentrations and Effects in Non-Cystic Fibrosis Bronchiectasis Patients Following Administration of its Once-Daily Inhaled Liposomal Ciprofloxacin Concert Pharmaceuticals Presents Clinical Results Demonstrating Reduced Drug-Drug Interactions with a Deuterium-Modified Compound Pandemic (H1N1) 2009 Influenza Update: Initial Results from First Clinical Trial of GSK?s H1N1 Adjuvanted Vaccine Altair Therapeutics Reports Successful Phase I Study of Inhaled AIR645 Kenta Biotech Reports Phase IIa Data with Lead Candidate Panobacumab in Hospital-Acquired Pneumonia ExonHit Presents Promising First Patient Results for EHT 0202, Its Alzheimer's Candidate Drug Salix Pharmaceuticals Announces Statistically Significant Results for Both the Primary and Key Secondary Analyses Of Rifaximin in the Treatment of Non-Constipation Irritable Bowel Syndrome in Two Phase 3 Trials (Target 1 and Target 2) New, Long-Term Data for Odanacatib, Merck's Investigational Cat K Inhibitor, Showed Positive Results in Treating Osteoporosis

September 15

Acorda Therapeutics Announces Data on Retention Rates and Safety from Two Phase 3 Fampridine-SR Extension Studies Schering-Plough Reports Long-Term Vicriviroc Data From Phase II Open-Label Extension Study in Treatment-Experienced HIV-Infected Patients Argenta Discovery Publishes Positive Data From a Phase II Proof of Concept Trial with Co-Administration of Inhaled ADC4022 Plus Budesonide Study in COPD Novartis investigational bronchodilator QAB149 improves lung function and reduces breathlessness compared to tiotropium in patients with COPD New efficacy data on Basilea's novel antibiotic against multi-resistant Gram-negative bacteria presented at ICAAC Wyeth Presents Data from Five-Year Vertebral Fracture Prevention Study with Bazedoxifene Kamada Presents Data on Inhaled Alpha-1 Antitrypsin in Cystic Fibrosis Patients at the European Respiratory Society Meeting 2009, Vienna Merck's ISENTRESS (raltegravir) Tablets Studied in Comparison to Efavirenz in Combination Therapy Through 96 Weeks in HIV-1 Treatment-Naïve Patients Pivotal Data Demonstrating Efficacy of Darusentan in Treating Resistant Hypertension Published in The Lancet Ipsen: Encouraging Preliminary New Data Available for the Treatment of Short Stature Children with Low IGF-1 Levels Encouraging Preliminary New Data Available for the Treatment Of Short Stature Children With Low IGF-1 Levels QVA149 Phase II data presented at the European Respiratory Society annual meeting Results of Comprehensive Safety Analysis of pirfenidone In IPF Patients Presented At European Respiratory Meeting Bayer and Onyx Announce Nexavar Data Presentations at the Joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress BioAlliance Pharma Makes Four Presentations at the 49th ICAAC Meeting Including Three Phase III Study Results with miconazole Lauriad and One with Its Integrase Inhibitor Cytheris Announces Interim Data from INSPIRE Study Showing Interleukin-7 (CYT107) Induces Dose-Dependent and Sustained Increase of CD4 T Cells in Chronic HIV-Infected Patients Medivir Has Presented Lipsovir at the Ongoing 49th ICAAC Meeting in San Francisco, USA Achaogen Announces ACHN-490 Clinical Data at the 49th Annual ICAAC Meeting NanoBio Presents Key Data on the Use of Nanoemulsions to Treat Burn Wound Infections

September 17

Bioheart Inc. Announces Positive Results in the MARVEL Phase II/III Clinical Trial TYSABRI Data: ECTRIMS (European Committee for the Treatment and Research in Multiple Sclerosis) 18 month Follow-up Data on Phase III Study of Pixantrone in Late Stage Relapsed or Refractory, Aggressive Non-Hodgkin's Lymphoma Continues to Demonstrate Significant Improvement in Complete Remission and Progression Free Survival Over Standard Chemotherapy Positive Phase IIb Results for GSK1838262 (XP13512) Reported for Neuropathic Pain Associated with Post-Herpetic Neuralgia Anemic Patients With MDS Gain Long-Term Benefits From Erythropoietin and Myeloid Growth Factor Hormones Phase III Study Showed Patients Lived Longer Without Low-Grade Lymphoma Progressing When Rituxan Was Used First-Line for Maintenance STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen (rBet v 1) of Birch Pollen: Positive Results for a Phase IIb/III Trial

September 22

Dynavax Announces HEPLISAV Data to Be Presented at IDSA Medical Conference Survival Benefit Maintained in Long Term Follow-up of IES with Pfizer's AROMASIN (Exemestane Tablets) Provectus Completes Treatment of All Patients in Phase 2 Trial of PV-10 for Metastatic Melanoma Phase 3 Trial Shows Denosumab Delayed Skeletal Related Events in Advanced Cancer Patients With Bone Metastases Impax Pharmaceuticals Reports Positive Results of Phase II Trial of IPX066, a Novel Formulation of Carbidopa-Levodopa for Parkinson's Disease Incyte Announces Positive Top-Line Phase IIb Results for Topical INCB18424 in Psoriasis Bayer's Novel Anti-Cancer Compound Regorafenib (BAY 73-4506) Showed Stabilization or Regression in 81 Percent of Kidney Cancer Patients Avastin could play an important role in improving the daily lives of patients with the most aggressive form of brain cancer Micromet Reports Interim Data from Phase 1 Study of BiTE Antibody MT110 for the Treatment of Solid Tumors 'Headache' Publication Describes Potential Mechanistic Rationale for Levadex Favorable Adverse Event Profile New results from ADVANCE trial at International Diabetes Federation (IDF) Congress 2009 New phase II data presented at ECCO 15 - 34th ESMO Congress reinforces exciting potential of Algeta's Alpharadin as a new treatment for bone metastases in cancer patients Important data for NicOx' naproxcinod published in the American Journal of Cardiology Abbott's XIENCE V Continues to Outperform TAXUS With Sustained Clinical Advantages and Impressive Long-Term Safety Results in SPIRIT III Trial

September 23

Idera Pharmaceuticals Presents Interim Data from Phase 1b Clinical Trial of IMO-2055 in Combination with Tarceva and Avastin in Non-Small Cell Lung Cancer Plexxikon Announces Encouraging Data from Phase 1 Extension Study of PLX4032 Showing Objective Responses in Metastatic Melanoma Patients Nexavar in Combination With Chemotherapy Demonstrates 74 Percent Improvement in Progression-Free Survival in Patients With Advanced Breast Cancer in Phase 2 Study Data Presented from Two Phase 3 Erbitux Studies in First-Line Metastatic Colorectal Cancer Patients at Joint 15th European Cancer Organisation and 34th European Society for Medical Oncology Multidisciplinary Congress From inoperable disease to potentially life saving surgery - new Avastin data gives hope to colorectal cancer patients with liver metastases Initial COIN Study Results Presented at European Oncology Congress AEterna Zentaris Announces Completion of Phase 1 Study with Oral AEZS-112 in Cancer Lux Biosciences Reports Phase 1 Safety Results and Open Label Efficacy Results for LX214, a Potential Best-in-Class Treatment for Dry Eye Elixir Medical Corporation Announces Positive First-In-Man Results for Three Drug Eluting Coronary Stent Systems with Durable and Bioabsorbable Polymers SPIRIT IV Results Reaffirm Strong Performance of Boston Scientific PROMUS and TAXUS Express Stents Abbott's XIENCE V Demonstrates Significantly Lower Rates of MACE and Stent Thrombosis Compared to TAXUS(R) Liberte in Investigator-Initiated COMPARE Trial Keryx Reports Results of Open Label Extension Study Examining Long-Term Use of Zerenex, an Iron-Based Phosphate Binder, for the Treatment of Hyperphosphatemia PAREXEL Consulting Releases New Study Data on Drug Development Timelines in Safety First Era TAXUS Liberte Stent Continues to Demonstrate Significant Improvements Over TAXUS Express Stent in Small Vessels and Long Lesions NKTR-102 Shows Encouraging Anti-Tumor Activity in Ovarian Cancer in Phase 1 and Preclinical Data Presented at the ECCO 15 and 34th ESMO Multidisciplinary Congress Vectibix in Combination With Chemotherapy Significantly Improves Progression-Free Survival in Second-Line Metastatic Colorectal Cancer Denosumab Demonstrates Superiority Over Zometa in Delay of Complications Due to Bone Metastases in Advanced Breast Cancer Patients Results of ADAGIO Study with AZILECT in Parkinson's Disease Published in New England Journal of Medicine

September 24

Two Phase Iii Studies Confirm Efficacy Of Iressa In EGFR MUTATION+ NSCLC Results of ADAGIO study with Azilect in Parkinson's disease published in The New England Journal of Medicine IAVI Statement on Results of Phase III ALVAC-AIDSVAX Trial in Thailand Alkermes Announces Amylin and Lilly Will Present More than 20 Studies for Exenatide at EASD 2009 Genzyme's Campath Meets Primary Endpoint in Phase 3 Combination Therapy Trial for Chronic Lymphocytic Leukemia Interim Results From Phase Iii Trist Study Of Trovax In Renal Cancer Ticagrelor Reduced Cardiovascular Deaths and Heart Attacks in ACS Patients Undergoing Heart Procedures: New Data from PLATO Trial Vertex Pharmaceuticals Announces Publication of Telaprevir Abstracts for Presentation at the 60th AASLD Meeting NEVO? Sirolimus-Eluting Coronary Stent Associated with Significantly Less Chest Pain at Six Months Than Taxus Liberte Stent

September 29

Alimera Reports Safety and Efficacy Results From the 18-Month Interim Readout of the Human PK Iluvien(R) Study Hythiam Announces First Peer-Reviewed Publication of Statistically Significant Results from Randomized, Double-Blind, Placebo-Controlled Study Updated Single Agent Phase 2 Data of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Renal Cell Carcinoma Reported at the Eighth International Kidney Cancer Symposium New Data Suggest that Gelnique (oxybutynin chloride) gel 10% Does Not Impact Cognition among Healthy Older Adults pSivida Reports Safety and Efficacy Results from 18-Month Interim Readout of Human PK Iluvien Study Acrux Announces Successful AXIRON Phase III Trial Results Sanofi-aventis launches major insulin research program in partnership with the international scientific community

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