Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
Acorda |
Fampridine-SR |
Selective neuronal potassium channel blocker |
Multiple sclerosis |
Began pivotal Phase III trial under FDA SPA to evaluate safety and improved walking in 240 MS patients (6/30) |
Biogen Idec |
Tysabri |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Crohn's disease |
Phase III ENCORE trial met its primary endpoint of clinical response and all secondary endpoints; the 510 patients had been dosed prior to trials and sales being voluntarily suspended (6/30) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriatic arthritis |
New Phase III data showed significantly greater inhibition of structural damage than placebo (6/9); long-term data showed sustained efficacy (6/10) |
Genentech |
Rituxan (FDA-approved) |
Rituximab; antibody that that targets and selectively depletes CD20-positive B cells |
Rheumatoid arthritis |
Phase IIb trial in 465 patients who weren't responding to methotrexate showed improved response rates vs. placebo (6/9) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Sjogren's syndrome |
Phase I/II trial in 15 patients produced improvements in disease signs and symptoms (6/10) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Lupus |
Began pivotal Phase III ALLEVIATE A and B trials that will assess disease activity (6/1) |
Millennium |
Velcade (FDA-approved) |
Monoclonal antibody that binds to alpha 4 beta 7, a T-cell integrin |
Ulcerative colitis |
Phase II trial demonstrated statistically significant improvements in remission rates vs. placebo (6/16) |
Pharma- |
Tovaxin |
Trivalent formulation of |
Multiple |
Interim data from six patients in Phase I/II trial showed reduced peripheral blood MRTC levels and improved disability scores (6/3) |
QuatRx |
Becocalcidiol |
Topical vitamin D analogue |
Psoriasis |
Phase IIb trial in 185 patients demonstrated a statistically significant improvement vs. vehicle in physicians' assessment (6/14) |
Regeneron |
IL-1 Trap |
Agent designed to attach to and neutralize interleukin-1 |
CIAS1-associated periodic syndrome |
All four patients in a pilot study experienced positive responses to loading and subsequent doses (6/10) |
Renovis Inc. |
REN-850 |
Inhibitor of leukocyte trafficking |
Multiple sclerosis |
Stopped Phase Ia trial and further development after seeing unexpected pharmacokinetics (6/13) |
The Immune |
NeuroVax |
T-cell receptor peptide vaccine |
Multiple sclerosis |
Data from ongoing trial demonstrated a significant increase in FOXP3, a gene marker that tracks regulatory T cells (6/21) |
Vertex |
VX-702 |
Oral p38 MAP kinase inhibitor |
Rheumatoid arthritis |
Began Phase II trial to evaluate safety, tolerability and activity in 300 patients with moderate to severe RA (6/10) |
CANCER | ||||
Adventrx |
CoFactor |
Form of folic acid designed to enhance the antitumor effects of 5-FU |
Metastatic colorectal cancer |
31 of 48 patients in Phase II trial with 5-FU achieved clinical benefit; 18 patients responded to treatment (6/20) |
Ariad |
AP23573 |
Oral form of agent designed to inhibit cell-signaling protein mTOR |
Endometrial cancer |
Began Phase II single-agent trial to evaluate clinical benefit in up to 45 patients (6/30) |
Astex Ltd.* |
AT7519 |
Cell-cycle inhibitor that targets cyclin-dependent kinases |
Refractory solid tumors |
Starting a Phase I trial in the U.S. and UK in patients (6/27) |
Biogen Idec |
Galiximab |
Primatized monoclonal antibody that targets CD80 on the surface of B cells |
Relapsed/ refractory follicular non-Hodgkin's lymphoma |
Phase II trial in 73 patients showed combination with Rituxan may extend event-free survival vs. Rituxan alone; an overall response rate of 64% was achieved (6/14) |
Biogen Idec |
Zevalin (FDA-approved) |
Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope |
Diffuse large B-cell lymphoma |
Data were presented showing drug is as effective as a second- line treatment in patients not eligible for stem cell transplantation (6/13) |
BioVex Ltd.* |
OncoVEX |
Oncolytic virus that delivers the gene for GM-CSF |
Malignant melanoma |
Got OK from the FDA to begin Phase II trials (6/6) |
Celgene Corp. |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Myelodysplastic syndromes |
Data from ongoing Phase II (MDS-002) trial showed 51% of patients responded to treatment; 33% became transfusion independent (6/6) |
Cell |
GVAX |
Vaccine comprises non-patient-specific tumor cells modifiedto secrete GM-CSF |
Cancers |
Company is ending development in lung cancer and myeloma as part of move to save money by focusing on the most promising indications (6/7) |
Chiron Corp. |
CHIR-258 |
Orally available tyrosine kinase inhibitor |
Multiple myeloma |
Chiron and the Multiple Myeloma Research Consortium began a Phase I trial to assess safety, tolerability and pharmacokinetics in patients (6/2) |
Cytogen |
Quadramet (FDA-approved) |
Samarium-153 bound to a small-molecule, bone-seeking phosphonate |
Cancers |
Positive data were reported from studies in prostate cancer and bone metastases (6/21) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Non-Hodgkin's lymphoma |
Trial with rituximab in 35 relapsed/ refractory patients showed an overall response rate of 42% (6/13) |
Genentech |
-- |
Topical antagonist of the Hedgehog signaling pathway |
Basal-cell carcinoma |
Began Phase I trial to evaluate safety and tolerability of a multi-dose regimen in patients (6/8) |
Genmab A/S |
HuMax-CD20 |
Human antibody that binds to the CD20 antigen |
Follicular non- Hodgkin's lymphoma |
Objective response rates of up to 63% were seen in relapsed/refractory patients still in follow-up from Phase I/II safety trial (6/10) |
Human Genome |
HGS-ETR1 |
Mapatumumab; agonistic human monoclonal antibody to TRAIL receptor 1 |
Advanced non- Hodgkin's lymphoma |
Interim data from Phase II trial in 40 patients demonstrated tolerability and signs of clinical activity (6/13) |
ImClone |
Erbitux |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Head and neck cancer |
Analysis of Phase III IMCL-9815 trial with radiation in first-line treatment confirmed it met its primary endpoint of locoregional control vs. radiation alone (6/8) |
ImmunoGen |
huC242-DM4 |
Tumor-activated prodrug targeting the CanAg antigen |
Cancers |
Began Phase I trial in patients to evaluate safety, pharmacokinetics and dosing(6/24) |
Introgen |
Advexin |
Adenoviral vector containing the p53 tumor-suppressor gene |
Various cancers |
Presented data showing potential applications of the drug alone and in combination therapies in several cancers (6/2) |
Kosan |
KOS-1022 (DMAG) |
Second-generation heat- shock protein 90 inhibitor |
Hematologic malignancies |
Began a Phase I trial to assess safety and pharmacokinetics of escalating doses in patients with leukemias (6/6) |
Kosan |
KOS-953 |
17-AAG; designed to inhibit heat-shock protein 90 |
Multiple myeloma |
Preliminary Phase I single-agent data and data from a Phase Ib combination trial both showed signs of anticancer activity(6/3) |
MediciNova |
MN-029 |
Vascular-targeting agent |
Solid tumors |
The company began a second Phase I trial of the drug (6/17) |
MediGene AG |
G207 |
Herpes simplex virus engineered to replicate in and kill cancer cells |
Malignant melanoma |
Began Phase I trial to evaluate safety, tolerability, efficacy trends and synergies with radiation therapy in about 20 patients (6/9) |
MediGene AG |
Polyphenon E Ointment |
Product from green tea leaves designed to block virus binding to cells |
Actinic keratosis |
Phase II trial in 62 patients showed a reduction in visible skin lesions vs. placebo (6/30) |
Millennium |
Velcade |
Bortezomib; proteasome inhibitor |
Various lymphomas |
Positive data were reported from a Phase II trial with rituximab in indolent lymphoma (6/13) |
Millennium |
Velcade |
Bortezomib; proteasome inhibitor |
Multiple myeloma |
Published data from single-agent and combination Phase II trials showed overall response rates ranging from 88% to 95% (6/8); Phase III APEX trial showed superiorty to dexamethasone in patients with relapsed MM (6/16) |
NeoPharm |
IL13-PE38QQR |
Tumor-targeting agent designed to deliver bacterial cytotoxic PE38 |
Glioblastoma multiforme |
Monitors recommended Phase III PRECISE trial continue as planned, following an interim analysis (6/27) |
Northwest |
DCVax-Brain |
Dendritic cell-based immunotherapy made from patients' cells |
Brain cancer |
Starting a Phase II trial in 150 newly diagnosed glioblastoma multiforme patients (6/1) |
Peregrine |
Cotara |
Chimeric tumor-necrosis therapy antibody attached to iodine-131 |
Brain cancer |
51-patient study validated the use of convection-enhanced delivery for administering Cotara (6/1) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Metastatic pancreatic cancer |
Began Phase II trial in up to 60 patients to evaluate six-month survival and other endpoints in combination with gemcitabine (6/23) |
TransMolecular |
131I-TM-601 |
Radiopharmaceutical containing a synthetic version of chlorotoxin (TM-601), which is derived from scorpion venom |
Recurrent high-grade glioma |
Began Phase II trial; initially, dosing will be tested in 12 patients; then safety and efficacy will be evaluated in 54 patients (6/1) |
Vertex |
VX-680 |
Small-molecule inhibitor of Aurora kinases |
Hematologic cancers |
They began an additional Phase I trial to evaluate safety and tolerability in patients with hematologic malignancies (6/17) |
CARDIOVASCULAR | ||||
Affymax Inc.* |
Hematide |
Peptide-based erythropoiesis- stimulating agent |
Anemia |
Phase I trial in healthy volunteers demonstrated safety and a sustained effect on red blood cell production (6/7) |
Alexion |
Eculizumab |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Follow-up data from a pilot trial showed drug maintained statistically significant reductions in red blood cell destruction and blood transfusions (6/28) |
Alteon Inc. |
Alagebrium |
A.G.E. crosslink breaker |
Systolic hypertension |
Discontinued Phase IIb SPECTRA trial after interim evaluation indicated the drug had not demonstrated efficacy (6/9) |
Arginox |
Tilarginine |
Agent designed to inhibit the production of nitric oxide |
Cardiogenic shock |
Began pivotal Phase III TRIUMPH trial that will evaluate reduced mortality vs. placebo in 650 patients (6/28) |
CardioVascular |
Cardio Vascu-Grow |
Agent designed to facilitate the growth of new blood vessels |
Coronary heart disease |
Monitors who reviewed data from four patients in a Phase I trial concluded it was safe to continue (6/15) |
CoTherix Inc. |
Ventavis (FDA-approved) |
Inhaled formulation of iloprost, a prostacyclin analogue |
Pulmonary hypertension |
Began Phase II ACTIVE trial to assess safety and efficacy in 50 patients with PH associated with idiopathic pulmonary fibrosis (6/1) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
Phase I data will allow for subcutaneous rather than intravenous delivery; also, reported positive interim data from the first 120 HAE attacks in a Phase II trial (6/30) |
Isis |
ISIS 301012 |
Capsule formulation of second- generation anti- sense inhibitor of ApoB-100 |
Cholesterol management |
Phase I trial in 36 volunteers showed rapid and prolonged reductions in ApoB- 00, along with reductions in lipoprotein and total cholesterol levels (6/9) |
Millennium |
Integrilin (FDA-approved) |
Eptifibide; glycoprotein IIb/IIIa inhibitor |
Acute coronary syndromes |
Began EARLY ACS trial to assess safety and efficacy vs. placebo in 10,500 patients with non-ST elevation ACS (6/28) |
Myogen Inc. |
Enoximone |
Small-molecule inhibitor of Type III phospho-diesterase |
Chronic heart failure |
Phase III ESSENTIAL I & II trials in patients with advanced CHF failed to demonstrate a statistically significant benefit in any of the three co-primary endpoints(6/26) |
Sangamo |
EW-A-401 |
Agent encoding a zinc finger DNA-binding protein transcription factor designed to activate all isoforms of the VEGF-A gene |
Critical limb ischemia |
Began a Phase I trial in up to 16 patients to assess safety, as well as to gather efficacy data (6/23) |
Surface |
SLx-2101 |
Selective, oral PDE-5 inhibitor |
Cardiovascular diseases |
Began a Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy male subjects (6/8) |
V.I. |
Inactine |
Pathogen-reduction system |
Blood substitute |
The company is ending development of the product; enrollment was suspended in a Phase III trial in November 2004 after an adverse event was seen (6/30) |
ZymoGenetics |
rhThrombin |
Recombinant human thrombin |
For use in intraoperative bleeding |
Phase II trial showed the product may be a safe and effective tool to stop bleeding in vascular surgery (6/20) |
CENTRAL NERVOUS SYSTEM | ||||
Acadia |
ACP-103 |
Small-molecule, 5-HT2A inverse agonist |
Parkinson's disease |
An interim trend analysis from the first 30 patients in a Phase II trial showed improved reductions in psychotic symptoms vs. placebo (6/22) |
Amarin Corp. |
Miraxion (LAX-101c) |
Compound that inhibits certain enzymes, including phospholipases and caspases |
Huntington's disease |
Began Phase III trial to assess the drug's impact on signs and symptoms in 300 patients with mild to moderate HD (6/14) |
Aradigm |
Intraject system |
Needle-free delivery system for a triptan |
Migraine and cluster headaches |
Self-injection study in healthy subjects achieved bioequivalent blood plasma levels to a marketed injected product (6/29) |
Arena |
APD125 |
Antagonist at the 5-HT2A serotonin receptor |
Insomnia |
Phase I trial demonstrated safety and a statistically significant increase in the amount of deep sleep, and positive signals in other sleep parameters (6/30) |
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Diabetic neuropathic pain |
Began Phase III trial that will assess efficacy, safety and tolerability vs. placebo (6/23) |
Cortex |
CX717 |
Ampakine analogue |
Sleep deprivation |
The Defense Advanced Research Projects Agency is sponsoring a trial using a simulated night shift work paradigm (6/21) |
Myriad |
Flurizan |
Selective amyloid beta 42 lowering agent |
Alzheimer's disease |
Moderate AD patients given 800 mg twice daily demonstrated a 45% slowing of decline (p=0.059) in their performance of activities of daily living (6/20) |
Neurochem |
Alzhemed |
Small molecule designed to interfere with association between glycosaminoglycans and A-beta protein |
Alzheimer's disease |
Monitors recommended continuation of Phase III trial after second interim review, including data from 742 patients (6/13) |
Neurocrine |
Indiplon |
Capsule form of a non- benzodiazepine agent that targets the GABA-A receptor |
Insomnia |
Phase III trial in 358 elderly patients showed significant improvements in latency to sleep onset; another study in elderly patients demonstrated significant improvement in sleep maintenance vs. placebo (6/14) |
NeurogesX |
NGX-4010 |
High-concentration trans- capsaicin dermal patch |
Postherpetic neuralgia |
Began 300-patient Phase III trial to study pain reduction vs. a control patch (6/15) |
Neurologix |
-- |
Gene therapy entailing injection of a virus directly into the brain |
Parkinson's disease |
Preliminary data from Phase I trial in 12 patients suggested no safety concerns (6/8) |
Sepracor |
Lunesta (FDA-approved) |
Eszopiclone tablets; a non- enzodiazepine agent |
Insomnia |
Positive data were presented from trials with Prozac in patients with major depressive disorder (6/21); statistically significant data were reported in two other patient populations (6/20) |
Solstice |
Myobloc (FDA-approved) |
Botulinum toxin type B |
Cervical dystonia |
Head-to-head trial in 111 toxin-naive subjects with CD showed drug to be clinically equivalent to Botox for efficacy (6/21) |
Somaxon |
Silenor |
Low dose of the approved depression drug doxepin |
Insomnia |
Began a Phase III trial that will measure sleep maintenance, as well as sleep onset and duration (6/9) |
TorreyPines |
NGX267 |
Selective cholinergic muscarinic receptor agonist (M1 subtype) |
Alzheimer's disease |
Filed an IND to begin clinical testing of the product (6/7) |
DIABETES | ||||
Agennix Inc.* |
Talactoferrin |
Topical talactoferrin alfa |
Diabetic ulcers |
Phase II trial in 55 patients met its primary endpoint of 75% or better healing at the end of 12-week dosing (6/13) |
Alkermes |
-- |
Inhaled insulin system based on Alkermes' AIR delivery technology |
Type I diabetes |
Phase II trial in 259 patients showed similar blood sugar levels to treatment with injected insulin (6/14) |
Amylin |
Byetta (FDA-approved) |
Exenatide; incretin mimetic |
Type II diabetes |
Long-term data from open-label extension of pivotal trial showed sustained improvements in glucose control and progressive weight reduction (6/10) |
Amylin |
Symlin (FDA-approved) |
Pramlintide acetate; an analogue of human amylin |
Type I and II diabetes |
Phase II trial in 204 obese diabetics showed a statistically significant 3.6% weight loss vs. placebo (6/3) |
Generex |
Oral-lyn |
Oral insulin spray formulation |
Diabetes |
Presented data from various studies showing glucodynamic profiles and metabolic effects (6/14) |
Isis |
ISIS 113715 |
Antisense inhibitor of protein tyrosine phosphatase (PTP-1B) |
Type II diabetes |
Interim data from Phase II trial showed drug reduced HbA1C and plasma glucose after six weeks of dosing (6/14) |
Keryx Bio- |
KRX-101 |
Sulodexidel; oral heparinoid compound |
Diabetic nephropathy |
Began Phase III trial to test the drug against placebo in about 1,000 patients; also began Phase IV study in 2,200 patients (6/29) |
MannKind |
Technosphere Insulin |
Dry-powder, inhaled insulin formulaiton |
Type II diabetes |
Data from two studies showed the benefit of use in conjunction with an oral diabetes medication (6/14); began pivotal Phase III trial to evaluate pulmonary safety (6/29) |
Nektar |
Exubera |
Dry-powder, inhaled insulin formulation |
Type I and II diabetes |
Two-year Phase III trials demonstrated effective, sustained glycemic control in Type II patients; trial in 226 Type I patients showed effectiveness in achieving tight glycemic control (6/14) |
INFECTION | ||||
Barrier |
Hyphanox |
Tablet formulation of itraconazole, an antifungal agent |
Vaginal candidiasis |
Phase III non-inferiority trial failed to meets its primary endpoint of therapeutic cure vs. fluconazole (6/29) |
Cadence |
CPI-226 (MX-226) |
Omiganan pentahydro- |
Catheter-related infections |
Starting a Phase III trial under an FDA SPA to evaluate efficacy vs. 10% povidone-iodine in about 1,250 patients (6/27) |
Chemokine |
CTCE-0214 |
Stable peptide agonist of stromal cell-derived factor-1 |
Infections |
Phase I trial in 24 subject demonstrated safety and efficacy results that warrant continued investigation (6/1) |
Chiron Corp. |
PA-824 |
Tuberculosis drug candidate |
Tuberculosis |
The Global Alliance for TB Drug Development began Phase I trials (6/14) |
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
Staphylococcus aureus |
Phase III endocarditis and bacteremia trial met its primary end-points of non-inferiority; an sNDA filing is planned (6/27) |
DOR |
RiVax |
Fragment of ricin toxin |
Ricin vaccine |
Early results from Phase I trial in volunteers showed the agent was safe and immunogenic (6/15) |
Dynavax |
-- |
Vaccine combining immunostimulatory sequence with HBV surface antigen |
Hepatitis B |
Phase II/III trial in older population showed statistically significant superiority in protective antibody response and robustness of protective effect vs. Engerix-B (6/14) began pivotal Phase III trial to compare efficacy to Engerix-B in 400 older patients (6/23) |
Gilead Sciences |
Hepsera (FDA-approved) |
Adefovir dipivoxil; a nucleotide analogue |
Hepatitis B |
Phase III Study 438 in 185 patients supported the efficacy and tolerability of the drug at 144 weeks (6/30) |
Gilead |
GS 9137 (JTK-303) |
Oral HIV integrase inhibitor |
HIV |
Began Phase I/II trial to evaluate tolerability, safety and antiviral activity in HIV-positive patients (6/21) |
Immtech |
DB289 |
Oral, dicationic antiviral agent |
African sleeping sickness |
FDA agreed to SPA on pivotal Phase III trial that will evaluate efficacy vs. pentamidine in 250 patients in Africa (6/16) |
MedImmune |
CAIV-T |
Trivalent vaccine; next generation of FluMist |
Influenza |
Phase III trial met its objective of producing similar immune responses to FluMist (6/16) |
Oscient |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Community- acquired pneumonia |
Pivotal Phase III trial in 460 patients showed non-inferiority of five-day treatment vs. the approved seven-day treatment (6/6) |
Protein |
FluBIOk |
Influenza vaccine derived from recombinant hemagglutinin |
Influenza |
Trial in 460 healthy subjects met its primary endpoints by showing safety and inducing strong titers against influenza (6/14) |
SciClone |
Zadaxin |
Synthetic preparation of thymosin alpha-1 |
Hepatitis C |
Six of 30 nonresponsive patients taking drug with pegylated interferon alpha and ribavirin achieved a sustained viral response (6/21) |
TaiGen |
TG-873870 |
Novel quinolone antibiotic |
Infections |
Began a Phase Ib trial that will examine safety and dosing (6/18) |
MISCELLANEOUS | ||||
Alteon Inc. |
Alagebrium |
A.G.E. crosslink breaker |
Erectile dysfunction in diabetics |
The FDA put a hold on Phase IIa EMERALD trial pending submission of additional data on preclinical toxicity tests (6/9) |
Altus |
TheraCLEC |
Oral enzyme-replacement therapy designed to replace digestive enzymes |
Pancreatic insufficiency |
Phase II trial in 125 patients with cystic fibrosis demonstrated a statistically significant improvement in fat absorption (6/20) |
Altus |
ALTU-238 |
Long-acting crystalline formulation of recombinant human growth hormone |
Growth hormone deficiency |
Successfully completed Phase I trial and said it plans to begin a Phase II trial in adults (6/6) |
Arena |
APD356 |
Small-molecule, selective 5HT2C serotonin receptor agonist |
Obesity |
Began Phase IIb trial to evaluate safety and weight loss over 12 weeks in 400 patients (6/23) |
CollaGenex |
Oracea |
Non-antimicrobial tetracycline derivative |
Rosacea |
Two Phase III trials totaling 537 patients demonstrated statistical significance vs. placebo (6/6) |
Genaera |
Evizon (squalamine) |
Anti-angiogenesis agent; vascular endothelial growth factor inhibitor |
Wet age-related macular degeneration |
Reached agreement with FDA on SPA for pivotal trials (6/27); began first of two trials under the SPA, a trial to demonstrate safety and benefit on visual acuity at one year (6/30) |
Halozyme |
Cumulase |
Ex vivo formulation of recombinant human PH20 hyaluronidase |
Treatment of oocytes |
Drug-treated oocytes demonstrated significantly increased fertilization rates in a trial vs. the standard bovine-derived hyaluronidase extract (6/22) |
Halozyme |
rHuPH20 |
Recombinant human hyaluronidase |
For use in breaking down hyaluronan |
Phase I trial in 100 volunteers showed no allergic reactions to the product (6/21) |
Indevus |
Sanctura |
Once-daily version of FDA-approved trospium chloride agent |
Overactive bladder |
Pilot Phase II trial demonstrated similar efficacy to the approved twice-daily drug (6/15) |
Isolagen Inc. |
Isolagen Process |
Autologous cellular therapy |
Interdental papillary insufficiency |
Phase II trial demonstrated statistical superiority to placebo at four months after treatment (6/30) |
Neurochem |
Fibrillex |
Glycosaminoglycan mimetic with anti- myloid properties |
Amyloid A amyloidosis |
Further analyses from Phase II/III trial showed reductions in the risk of renal decline or all-cause mortality (6/5); another analysis showed early clinical effect (6/9) |
Nymox |
NX-1207 |
Investigational drug for BPH |
Benign prostatic hyperplasia |
Follow-up data from 18-23 months in Phase I and II trials showed statistically significant symptomatic improvements (6/8) |
Sucampo |
Tacrolimus |
Eye-drop formulation of tacrolimus |
Dry-eye syndrome |
Company voluntarily suspended development program after safety concerns were seen in another product containing tacrolimus (6/24) |
Symbollon |
IoGen |
Iodine-based oral drug |
Breast pain associated with fibrocystic breast disease |
Began first Phase III pivotal trial of drug to evaluate clinical effects in about 175 women (6/14) |
Santarus Inc. |
Zegerid |
Immediate-release capsule formulation of the proton pump inhibitor omeprazole |
Gastrointestinal conditions |
Trial in 36 patients showed significantly reduced gastric acidity throughout the night vs. Protonix (6/14) |
Tercica Inc. |
Increlex |
Mecasermin injection; recombinant human insulin-like growth factor-1 |
Short stature caused by IGF deficiency |
Presented pharmacokinetic and safety data from various studies (6/6 and 6/7) |
Theravance |
GSK159797 |
Inhaled, longer-acting Beta2 agonist |
For use as a bronchodilator |
Phase II trial showed clinically significant increases in bronchodilation over 24 hours with little impact on heart rate (6/27) |
Theravance |
GSK656398 (formerly TD-5742) |
Inhaled, long-acting muscarinic antagonist; bronchodilator |
Chronic obstructive pulmonary disease |
Partner GlaxoSmithKline plc began Phase I trial to assess safety, tolerability and pharmaco-kinetics (6/13) |
Threshold |
TH-070 |
lonidamine; an indazole- 3-carboxylic acid |
Benign prostatic hyperplasia |
Began Phase II trial to evaluate dosing, safety and activity in about 200 patients (6/27) |
Transkaryotic |
Iduronate-2- sulfatase |
Enzyme-replacement therapy |
Hunter syndrome (MPS II) |
Pivotal Phase III AIM trial showed a statistically significant improvement in forced vital capacity and six-minute walk test, the primary endpoints (6/20) |
Vernalis plc |
Frova (FDA-approved) |
Frovatriptan; 5HT 1B/1D agonist |
Menstrually related migraine |
Six-month data from Phase III trial indicate the drug is well tolerated; no serious adverse events were reported (6/27) |
Vivus Inc. |
Avanafil |
Oral phosphodiesterase type-5 inhibitor |
Erectile dysfunction |
Phase II trial in 284 patients demonstrated statistical significance vs. placebo (6/23) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; EMEA = European Medicines Agency; FDA = Food and Drug Administration; IND = Investigational new drug application; MAA = Marketing authorization application; NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OSE = Osaka Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
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