III

Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer

NEW YORK, July 12, 2007 /PRNewswire-FirstCall/ -- ImCloneSystems Incorporated and Bristol-Myers Squibb Company todayannounced results from an open-label Phase III study of ERBITUX(R)(Cetuximab) plus a taxane and carboplatin in the first-linetreatment for metastatic non-small cell lung cancer (NSCLC). Thestudy did not meet its primary endpoint of progression-freesurvival (PFS) as assessed...

Clinical Data Suggest Decreased Bleeding Risk in People With Severe Hemophilia A While Maintaining Factor VIII Levels Above One Percent

Results Highlighted in Oral Presentation at International Symposiumof Thrombosis and Haemostasis GENEVA, July 10, 2007 /PRNewswire-FirstCall/ -- BaxterHealthcare Corporation today announced the presentation of findingsfrom the ADAPT (Analysis of Data from ADVATE(R) Prospective Trials)study program database showing a statistically significantrelationship between the duration of time spent...

Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis

- Multinational Phase III Study Meets Primary Endpoint inRheumatoid Arthritis Patients Who Failed to Respond to Anti-tumorNecrosis Factor Treatments - NUTLEY, N.J., July 10, 2007 /PRNewswire/ -- Roche todayannounced that results from the Actemra Radiate (RheumAtoiDArthritIs Study in Anti-TNF FailurEs) trial successfully met itsprimary endpoint in patients with moderate to severe rheumatoi...

Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery

Rivaroxaban, a New Oral, Once-Daily Direct Factor Xa Inhibitor,Shows a Significant Reduction in Deep Vein Thrombosis and PulmonaryEmbolism Compared with Enoxaparin with Similarly Low BleedingRates GENEVA, July 8, 2007 - Late-breaking Phase III clinical trialdata presented today at the XXI International Society on Thrombosisand Haemostasis (ISTH) Congress demonstrate that once-daily...

Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery

GENEVA--(BUSINESS WIRE)--Jul 8, 2007 - Late-breaking Phase IIIclinical trial data presented today at the XXI InternationalSociety on Thrombosis and Haemostasis (ISTH) Congress demonstratethat once-daily rivaroxaban achieved superior efficacy in theprevention of venous thromboembolism (VTE) in patients undergoingknee replacement surgery in a head-to-head comparison withenoxaparin, the curren...

Response Genetics Announces Publication of a Phase III Clinical Trial Demonstrating That Low Levels of ERCC-1 Help to Predict Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer

- First prospective biomarker trial in non-small cell lung cancer - LOS ANGELES, July 09, 2007 /PRNewswire-FirstCall/ -- ResponseGenetics, Inc. today announced that positive Phase III clinicaldata published in the July 1 issue of the Journal of ClinicalOncology suggests that low expression of the biomarkerExcision-Repair Cross-Complementing 1 (ERCC-1) in patient biopsieswith advanced non-...

Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis

IRVINE, Calif.--(BUSINESS WIRE)--Jul 6, 2007 - Cobalis Corp.(OTCBB:CLSC), a pharmaceutical development company specializing inanti-allergy medications, today reported preliminary top-lineresults from two Phase III clinical trials for its drugPreHistin(TM) in patients with moderate to moderately severeseasonal allergic rhinitis, commonly known as hay fever. The trialsshowed very low symptom...

Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea

LAINATE, Italy - July 4, 2007 - Cosmo Pharmaceuticals SpA(SWX:COPN) announced today positive preliminary results from itsphase II/III study with CB-01-11 (Rifamycin SV MMX(tm)) ininfectious diarrhoea. CB-01-11 is a broad spectrum, semi-syntheticantibiotic that is not absorbed when taken in tablet form. Throughthe use of Cosmo's MMX(tm) technology, wh...

Aspreva and Roche Announce Preliminary Results for Phase III Study Evaluating CellCept in Lupus Nephritis

VICTORIA, BC, Canada and BASEL, Switzerland, June 27 /CNW/ -Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV) andRoche today released preliminary results for a clinical trialcomparing CellCept (oral mycophenolate mofetil, MMF) to intravenouscyclophosphamide (IVC), which is the current standard of care, forinducing treatment response in the induction phase of patientssuffering fro...

Two Phase III clinical trials on corifollitropin alfa (Org 36286) reach randomization target

OSS, the Netherlands, June 27, 2007-Organon, the humanhealthcare business unit of Akzo Nobel, announced today that twoout of three Phase III clinical trials with corifollitropin alfa(Org 36286), a new long-acting fertility hormone, have reachedtheir randomization target. Corifollitropin alfa is a new recombinant fertility hormone. It isthe first of a new class of gonadotropi...

MediQuest Concludes Confirmatory Phase III Study of Raynaud’s Therapy

BOTHELL, WA – June 25 – MediQuest Therapeutics,Inc., a specialty pharmaceutical company focused on developingtherapies for inflammatory and infectious diseases, today announcedthe completion of its confirmatory phase III study of Vascana– a topical formulation designed to treat Raynaud’sDisease. The study met its primary end point and demonstrated statistica...

Novagali Pharma Presents at AACO the Results of its Pivotal Phase III Clinical Trial of Vekacia in Children Suffering From Vernal Keratoconjunctivitis

EVRY, France, June 25, 2007 /PRNewswire/ -- Novagali Pharma, anemerging pharmaceutical company specialized in ophthalmologypresents positive results of its pivotal phase III clinical trialpositive results from the Phase III clinical study of Vekacia(R) inchildren suffering from Vernal Keratoconjunctivitis (VKC) at theXIV Afro-Asian Congress of ophthalmology (AACO) held from June 20to 25...

Second Phase III Study Evaluating Gilead's Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint

FOSTER CITY, Calif.--(BUSINESS WIRE)--June 25, 2007--GileadSciences, Inc. (Nasdaq:GILD) today announced that Study 103, aPhase III clinical trial evaluating the company's once-dailyanti-HIV drug Viread(R) (tenofovir disoproxil fumarate or tenofovirDF) 300 mg as a potential treatment for chronic hepatitis B virus(HBV) infection, met its primary efficacy endpoint. The data showthat Viread...

Phase IIIb Clinical Data Validate the Overall and Cardiovascular Safety Profile of Cycloset (A Quick Release Formulation of Bromocriptine Mesylate) in Patients with Type 2 Diabetes

Data Also Support Drug's Efficacy at Improving Glycemic Control andReducing Diabetic Cardiovascular Complications CHICAGO, Ill., June 23, 2007 /PRNewswire/ -- VeroScience, LLC,in conjunction with its commercialization partner S2 Therapeutics,Inc., reported today the results of its Phase IIIb clinical trialsupporting the overall and cardiovascular safety of Cycloset(TM) (Aquick release for...

Second Phase III Study Evaluating Gilead's Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 25, 2007 - GileadSciences, Inc. (Nasdaq:GILD) today announced that Study 103, aPhase III clinical trial evaluating the company's once-dailyanti-HIV drug Viread(R) (tenofovir disoproxil fumarate or tenofovirDF) 300 mg as a potential treatment for chronic hepatitis B virus(HBV) infection, met its primary efficacy endpoint. The data showthat Viread is...

Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial as Compared to Neostigmine

OSS, The Netherlands, June 11, 2007 /PRNewswire/ -- Sugammadex -the novel selective relaxant binding agent (SRBA) being developedby Organon, the human healthcare business unit of Akzo Nobel -demonstrated in a Phase III pivotal trial a 9-12 times fasterreversal of neuromuscular blockade as compared to neostigmine,without evidence of post operative residual curarization (PORC) orre-occurre...

Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial Compared to Neostigmine

OSS, the Netherlands, June 11, 2007-Sugammadex - the novelselective relaxant binding agent (SRBA) being developed by Organon,the human healthcare business unit of Akzo Nobel - demonstrated ina Phase III pivotal trial a 9-12 times faster reversal ofneuromuscular blockade as compared to neostigmine, without evidenceof post operative residual curarization (PORC) or re-occurrence ofmuscle relax...

Frova Phase III Study Data Demonstrates That Short-Term Prevention Treatment Reduces Frequency and Severity of Menstrual Migraine

CHICAGO, IL, Jun 09, 2007 (MARKET WIRE via COMTEX News Network)-- Endo Pharmaceuticals Inc., a wholly owned subsidiary of EndoPharmaceuticals Holdings Inc. (NASDAQ: ENDP), has presented resultsfrom a Phase III randomized, double-blind, placebo-controlledclinical trial evaluating Frova (frovatriptan succinate) 2.5 mgtablets as a six-day preventative treatment in women withdifficult-to-tre...

Pivotal Phase III Trial Showed Promacta (eltrombopag olamine) Raised Platelet Counts and Reduced Bleeding in Patients With Chronic ITP

VIENNA, Austria, June 11, 2007 /PRNewswire/ -- GlaxoSmithKlineplc announced results from an international, pivotal Phase IIIstudy of its investigational non-peptide oral platelet growthfactor, PROMACTA(R) (eltrombopag olamine). Data from this studyshowed that PROMACTA at 50-75mg once daily resulted in astatistically significant increase in platelet counts and alsoreduced bleeding in adul...

Phase III Clinical Trial with 4-Month Long-Acting Formulation of Triptorelin: Ipsen Decides Not to Perform Further Administration

PARIS--(BUSINESS WIRE)--Jun 11, 2007 - Regulatory News-Ipsen(Paris:IPN) announced today that the preliminary data from theongoing phase III study for its investigational 4-month formulationof triptorelin do not support the expected sustainable blood levelsof triptorelin for a duration of 4 months in all patients.Therefore, Ipsen has decided not to perform the secondadministration as planned...

Eurand to Present Zentase Phase III Data

MILAN, Italy, and DAYTON, Ohio, June 08, 2007/PRNewswire-FirstCall/ --Eurand to present data on Zentase atEuropean Cystic Fibrosis Society AnnualMeeting. . -- Exocrine pancreatic insufficiency (EPI) is adeficiency of digestive enzymes normally produced bythe pancreas that can result from a number<...

Further Statistical Analysis of the Recent Phase III trial on Lead Product M6G Shows Additional Benefits

* Statistically significant reduction in sedation during theearly post-operative period compared to morphine * Statistically significant reduction in nausea in the femalepatient population compared to morphine Cambridge, UK, 8th June 2007 - CeNeS Pharmaceuticals plc (AIM:CEN), the Cambridge based biopharmaceutical company, announcesadditional data from post-hoc analysis of th...

AVANIR Pharmaceuticals Presents Zenvia Phase III Data in Diabetic Peripheral Neuropathic Pain at International Congress on Neuropathic Pain

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Jun 8, 2007 - AVANIRPharmaceuticals (NASDAQ:AVNR) today announced the presentation ofPhase III data, including efficacy, safety and improvements inpatient-centered outcomes in patients with diabetic peripheralneuropathic (DPN) pain treated with the investigational drugZenvia(TM) (dextromethorphan/quinidine (DM/Q)), an NMDA receptorantagonist and sigma-1...

Phase III Study Evaluating Gilead's Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 6, 2007 - GileadSciences, Inc. (Nasdaq:GILD) today announced that Study 102, aPhase III clinical trial evaluating the company's once-dailyanti-HIV drug Viread (tenofovir disoproxil fumarate or tenofovirDF) 300 mg as a potential treatment for chronic hepatitis B virus(HBV) infection, met its primary efficacy endpoint. The study showsthat Viread is no...

Indevus Reports Positive Data From Phase III NEBIDO Trial

Compound Achieves All Key Endpoints for Both Efficacy and Safety LEXINGTON, Mass., June 07, 2007 /PRNewswire-FirstCall/ --Indevus Pharmaceuticals, Inc. today announced final results fromits Phase III pharmacokinetic trial for NEBIDO (testosteroneundecanoate), a long- acting injectable testosterone therapy underdevelopment for the treatment of male hypogonadism which theCompany licensed fr...

Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

CHICAGO – June 2, 2007 – Long-term treatment withpegylated interferon alfa-2b in stage III melanoma had asignificant and sustained impact on relapse-free survival (RFS),according to the results of the largest adjuvant trial everconducted in patients with stage III melanoma. Results of the PhaseIII study, led by...

Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL)

Preliminary Results of Largest Randomized, Placebo-controlled TrialEver Conducted in CTCL Presented at the American Society ofClinical Oncology CHICAGO, June 04, 2007 /PRNewswire/ -- Preliminary results ofthe largest randomized, placebo-controlled clinical trial everconducted in patients with cutaneous T-cell lymphoma (CTCL) showedthat ONTAK was more than twice as effective as placebo in...

GenVec Announces Update of Safety and Efficacy Data from Pivotal Phase II/III PACT Study of TNFerade at ASCO

GAITHERSBURG, Md.--(BUSINESS WIRE)--Jun 4, 2007 - GenVec, Inc.(Nasdaq: GNVC) announced today that updated preliminary safety andefficacy data from the clinical development program of its leadproduct TNFerade(TM) was presented in a poster session ongastrointestinal cancers at the annual meeting of American Societyfor Clinical Oncology in Chicago, IL by Dr. Mitchell Posner, of theUniversity o...

Topline Results of Phase III Study in Acute Ischemic Stroke (Dias-2) Do Not Demonstrate Difference Between Desmoteplase and Placebo

NEW YORK, May 31, 2007 /PRNewswire-FirstCall/ -- ForestLaboratories, Inc. and PAION AG today announced topline results ofthe DIAS-2 (Desmoteplase In Acute Ischemic Stroke) study with thecompound Desmoteplase. The Phase III study was designed toinvestigate the improvement of clinical outcome in patients withacute ischemic stroke treated with Desmoteplase within 3 to 9 hoursafter onset of...

Top Line Results of Phase III Study in Acute Ischemic Stroke (DIAS-2) Do Not Demonstrate Difference Between Desmoteplase and Placebo

PAION AG and US Partner Forest Laboratories, Inc. TodayAnnounced the Top Line Results of the DIAS-2 (Desmoteplase In AcuteIschemic Stroke) Study with the Compound Desmoteplase Aachen (Germany), May 31st, 2007 - PAION AG (Frankfurt StockExchange, Prime Standard: PA8) and its US partner ForestLaboratories, Inc. (NYSE: FRX) today announced topline results ofthe DIAS-2 (Desmoteplase In...

Lev Pharmaceuticals Completes Phase III Prophylaxis Trial of C1-Esterase Inhibitor for Hereditary Angioedema

NEW YORK, May 31, 2007 /PRNewswire-FirstCall/ -- LevPharmaceuticals, Inc. ("Lev" or the "Company") announced today thatit has completed patient treatment in the prophylactic portion ofits Phase III clinical trial of C1-esterase inhibitor (C1-INH) forhereditary angioedema (HAE). The clinical trial, designated CHANGE,examined and evaluated the efficacy and safety of C1-INHreplacement thera...

Gilead Announces Achievement of Primary Efficacy Endpoint in Second Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 29, 2007 - GileadSciences, Inc. (Nasdaq:GILD) today announced that its Phase IIIAIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation forthe treatment of people with cystic fibrosis (CF) who havepulmonary Pseudomonas aeruginosa (P. aeruginosa) met its primaryefficacy endpoint of change at Day 28 from baseline in respiratorysymptoms, as assess...

Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study

EVANSTON, Ill.--(BUSINESS WIRE)--May 23, 2007 - NorthfieldLaboratories, Inc. (NASDAQ: NFLD) reported today results of itspivotal Phase III trauma trial with PolyHeme(R), its humanhemoglobin-based oxygen-carrying red blood cell substitute. Thetrial was designed to seek an indication for use in the treatmentof life-threatening red blood cell loss when transfusion isrequired and red blood cell...

Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study for Milnacipran as a Treatment for Fibromyalgia Syndrome

NEW YORK, May 22, 2007 /PRNewswire-FirstCall/ -- ForestLaboratories, Inc. and Cypress Bioscience, Inc. today announcedthat preliminary top-line results from a 1,196 patient randomized,three month, double-blind, placebo-controlled pivotal Phase IIIstudy demonstrate statistically significant therapeutic effects ofmilnacipran as a treatment of fibromyalgia syndrome. At this timethe companie...

Organon's Asenapine Effective in a Phase III Study for the Treatment of Bipolar I Disorder; Results Unveiled at 2007 APA Meeting

SAN DIEGO, May 21, 2007 /PRNewswire/ -- Asenapine -- aninvestigational drug being developed by Organon, the humanhealthcare business unit of Akzo Nobel, for bipolar I disorder andschizophrenia -- was demonstrated to be more effective than placeboin treating acute manic and mixed episodes associated with bipolarI disorder, according to new Phase III results, from a studypresented at the A...

Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD

Phase III clinical trial may commence shortly CARMIEL, Israel, April 18, 2007 /PRNewswire-FirstCall/ ---Protalix BioTherapeutics, Inc. today announced that it has receivedwritten notice from the United States Food and Drug Administration(FDA) that it may initiate a Phase III clinical trial in the UnitedStates of its lead product candidate, prGCD, a proprietary plantcell expressed recombin...

AVANIR Pharmaceuticals to Present Zenvia Phase III Data in Diabetic Peripheral Neuropathic Pain at Second International Congress on Neuropathic Pain

ALISO VIEJO, Calif.--(BUSINESS WIRE)--May 8, 2007 - AVANIRPharmaceuticals (NASDAQ:AVNR) today announced Phase III data on theefficacy, safety and improvements in patient-centered outcomes inpatients with diabetic peripheral neuropathic (DPN) pain treatedwith the investigational drug Zenvia(TM) (dextromethorphan /quinidine) will be presented in two scientific posters at theSecond Internation...

King Pharmaceuticals Announces Plan to Present Results from Phase III Clinical Trial Evaluating ALTACE as Monotherapy and in Combination with Hydrochlorothiazide at the American Society of Hypertension Annual Meeting

BRISTOL, Tenn.--(BUSINESS WIRE)--May 8, 2007 - KingPharmaceuticals, Inc. (NYSE:KG) announced today that the resultsfrom a Phase III clinical trial for its ALTACE(R) (ramipril)diuretic combination product will be presented at the AmericanSociety of Hypertension's Twenty-Second Annual Scientific Meetingin a poster on Saturday, May 19, 2007 at the Hyatt Regency Hotel,Chicago, Illinois. The pos...

ISTA Pharmaceuticals Announces Statistically Significant Preliminary Results From its U.S. Phase II/III Clinical Study Of Bepotastine

IRVINE, Calif., May 08, 2007 /PRNewswire-FirstCall/ -- ISTAPharmaceuticals, Inc., today announced results from the preliminaryanalysis of its U.S. Phase II/III clinical study of bepotastine forthe treatment of allergic conjunctivitis. The study evaluated twoconcentrations of bepotastine, each dosed once daily and twicedaily. The primary endpoints of the study were the assessment ofeffica...

Phase III Data on Safinamide in Parkinson’s Disease Presented at American Academy of Neurology 59th Annual Meeting

GENEVA, Switzerland, May 2, 2007 – MerckSerono S.A. (virt-x: SEO) announced today that Phase III data onsafinamide, a new agent in Phase III development for the treatmentof Parkinson’s disease symptoms, were presented by ProfessorFabrizio Stocchi at the American Academy of Neurology 59th AnnualMeeting in Boston, Massachusetts, USA. These d...