Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Psoriatic arthritis |
Phase III trial showed statistically significant improvements in both arthritis and psoriasis signs and symptoms (10/18) |
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Rheumatoid arthritis |
Phase III PREMIER trial showed significant benefit from Humira and methotrexate in recent-onset RA vs. either agent alone, at both two weeks and one year (10/18) |
Amgen Inc. |
Enbrel (FDA-approved) |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Rheumatoid arthritis |
Data from TEMPO trial showed 74% of patients treated with drug and methotrexate experienced no progression of joint damage over a two-year span; other data showed higher physical-function scores for the combination vs. either therapy alone (10/18) |
Amgen Inc. |
AMG 714 (HuMax-IL15) |
Human antibody against interleukin-15 |
Rheumatoid arthritis |
Data from first 100 patients in a Phase II trial showed 43% to 59% of patients, depending on dose, achieved an ACR 20 score at 14 weeks vs. 35% for placebo (10/18) |
AtheroGenics |
AGIX-4207 |
Modulator of TNF-alpha-induced inflammatory genes |
Rheumatoid arthritis |
None of three doses in Phase II OSCAR trial beat placebo in improving ACR 20 scores; development of drug in RA is ending (10/13) |
Berlex Inc. |
Betaseron (FDA-approved) |
Interferon beta-1b |
Multiple sclerosis |
Data from eight-year study showed benefits seen in the original trial continue many years later (10/11) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Rheumatoid arthritis |
New data from the ASPIRE trial showed no joint erosion at one year in 79% of patients who began the study with no joint erosion vs. 58% of methotrexate-alone patients (10/18) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Ankylosing spondylitis |
ASSERT trial in 266 patients showed a median decrease of 73% in spinal inflammation activity scores at 24 weeks vs. no effect in the placebo group (10/18) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriatic arthritis |
Phase III IMPACT I2 trial showed a 70% or more improvement in symptoms of arthritis in 27% of patients, vs. 2% for placebo, at 24 weeks, and a 90% or more improvement in PASI scores for nearly 40% of patients (10/18) |
Genelabs |
Prestara |
Prasterone; synthetic equivalent of dehydro-epiandrosterone |
Lupus |
Phase III Study GL02-01 failed to meet its primary endpoint of increasing bone mineral density; the FDA asked for the confirmatory trial in an approval letter two years earlier (10/5) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Lupus |
Phase II trial showed nine of 14 patients lowered their global BILAG scores (disease activity) by 50% or more 24 hours after therapy (10/19) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Waldenstrom's macro-globulinemia |
The company is enrolling patients in a Phase I/II trial in the U.S. and Europe (10/19) |
Marnac Inc.* |
Pirfenidone |
Agent that down-regulates cytokine expression and inhibits production of tumor necrosis factor-alpha |
Multiple sclerosis |
One-year data from Phase II trial demonstrated improvements in physical functioning and halting of disease progression in adults with secondary progressive MS (10/4) |
Repligen |
CTLA4-Ig |
Soluble form of T-cell regulatory protein |
Rheumatoid arthritis |
Company noted that Bristol-Myers Squibb Co. presented data from two Phase III trials showing drug may be effective in those not responding to TNF-a inhibitors (10/21) |
Serono SA |
Rebif (FDA-approved) |
Interferon beta-1a |
Multiple sclerosis |
PRISMS study involving two years on placebo and then two on drug showed a 54% relative reduction in relapse rates, and statistical significance on other endpoints (10/8) |
CANCER | ||||
Allos |
Efaproxyn (efaproxiral; RSR13) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
Restropective analysis of Phase III REACH trial demonstrated a statistically significant improvement in response rates at three months vs. control (10/5); updated data from REACH trial with whole-brain radiation therapy showed a significant reduction in the risk of death vs. WBRT alone (10/31) |
Allos |
Efaproxyn (efaproxiral; RSR13) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
Restropective analysis of Phase III trial identified key prognostic factors, and confirmed safety and effectiveness (10/4) |
BioCryst |
Forodesine |
Oral purine nucleoside phosphorylase inhibitor; blocks T-cell synthesis |
Cutaneous T-cell lymphoma |
Began Phase I trial to test pharmacokinetic effects of three doses in at least nine patients (10/19) |
Cell |
CT-2106 |
A polyglutamate camptothecin |
Solid tumors |
Phase I trial showed drug was well tolerated with manageable toxicities and demonstrated evidence of anticancer activity (10/4) |
CuraGen |
CG53135 |
Growth factor that promotes both epithelial and mesenchymal-cell proliferation |
Oral mucositis in cancer patients |
Began a Phase II trial in 200 patients undergoing bone marrow transplantation to assess safety and efficacy vs. placebo (10/26) |
Cytogen Corp. |
Quadramet (FDA-approved) |
Samarium-153 bound to a small-molecule, bone-seeking phosphonate |
Bone diseases related to cancer |
Two prospective trials showed the agent can be safely administered as long as patients have normal white blood cell and platelet counts (10/25) |
Dendreon |
Provenge |
Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen |
Prostate cancer |
Final three-year data from Phase III D9901 trial in 127 patients showed a statistically significant survival benefit in patients with advanced disease (10/28) |
Exelixis |
XL999 |
Spectrum-selective kinase inhibitor; targets multiple receptor tyrosine kinases |
Solid tumors |
Began a Phase I trial to evaluate tolerability and pharmacokinetics in refractory patients (10/25) |
Genmab A/S |
HuMax-EGFr |
Human antibody that targets the epidermal growth factor receptor |
Head and neck cancer |
Interim Phase I/II data demonstrated safety and that treatment was well tolerated at all doses tested (10/4) |
GenVec Inc. |
TNFerade |
Adenovector with TNF-alpha gene and a radiation- responsive promoter |
Esophageal cancer |
Interim data from 24-patient Phase II trial showed combination with chemoradiation was feasible and well tolerated (10/1) |
Human Genome |
HGS-ETR1 |
Agonistic human monoclonal antibody to TRAIL Receptor 1 |
Non-Hodgkin's lymphoma |
Began Phase II trial in up to 30 patients with refractory or relapsed disease to evaluate disease activity tumor response, as well as safety and tolerability (10/13) |
Hybridon Inc. |
IMOxine (HYB2055) |
Immunomodulatory oligonucleotide; TLR9 agonist |
Renal-cell carcinoma |
Began a Phase II trial in at least 46 patients to evaluate tumor response and other endpoints (10/26) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Non-small-cell lung cancer |
Will begin a Phase III trial (IMCL- 0452) evaluating Erbitux and chemotherapy against chemotherapy alone in 800 patients with second-line disease (10/7) |
Insmed Inc. |
INSM-18 |
Small-molecule tyrosine kinase inhibitor with activity against IGF-I and HER2/neu |
Prostate |
Began a study to define the maximum tolerated dose in patients with relapsed disease (10/19) |
Isis |
Affinitak |
Inhibitor of protein kinase C-alpha expression |
Non-small-cell lung cancer |
Phase III trial with Gemzar and cisplatin demonstrated equivalent median survival of 10 months vs. chemotherapy alone (10/27) |
MethylGene |
MG98 |
Second-generation anti-sense compound designed to inhibit the expression of DNA methyltransferase |
Metastatic renal-cell cancer |
Began Phase II trial with interferon alpha that will start with 30 to 50 patients, then be expanded to up to 200 patients (10/6) |
NeoPharm |
LE-SN38 |
Liposomal formulation of the active metabolite of irinotecan |
Advanced cancers |
Phase I trial demonstrated safety and tolerability and established a maximum tolerated dose (10/4) |
NeoRx Corp. |
NX 473 |
Next-generation platinum product |
Small-cell lung cancer |
Filed IND for Phase II trial to evaluate clinical response in 120 patients refractory or resistant to previous platinum therapy (10/26) |
Onxy |
BAY 43-9006 |
RAF kinase and VEGF inhibitor |
Advanced kidney cancer |
Phase II trial in 502 patients met its primary endpoint vs. placebo of showing the disease did not progress; however, they will wait until the end of ongoing Phase III trial to seek approval rather than on Phase II data (10/25) |
OxiGene Inc. |
Combrestatin |
Vascular-targeting agent designed to block flow of blood to a tumor |
Non-small-cell lung cancer |
Data from Phase Ib trial with radiotherapy showed promising biological response and anti- tumor effects (10/25) |
Peplin Ltd. |
PEP005 |
Topical formulation |
Actinic keratosis |
No adverse events were reported in a Phase I trial (10/25) |
Peregrine |
Cotara |
Monoclonal antibody attached to iodine-131; product from Tumor Necrosis Therapy platform |
Advanced colorectal cancer |
Initial clinical data showed the agent generally was well tolerated and that it targeted cancers (10/22) |
Sunesis |
SNS-595 |
Small-molecule cell- cycle modulator designed to induce apoptosis |
Solid tumors |
Began second of two Phase I trials that will test weekly dosing for safety, tolerability and pharmaco- kinetics in patients with advanced solid tumors (10/18) |
Telik Inc. |
Telcyta |
Small-molecule tumor- activated drug designed to induce apoptosis |
Refractory ovarian cancer |
Phase II trial of drug and carboplatin showed four complete and 10 partial responses among 26 evaluable patients, with 25.6 weeks of median progression-free survival (10/4) |
Telik Inc. (TELK) |
Telcyta |
Small-molecule tumor-activated drug designed to induce apoptosis |
Refractory ovarian cancer |
Phase II trial of drug and Doxil showed eight partial responses in 19 evaluable patients, with 34.1 weeks of median progression- free survival (10/4) |
Transave Inc.* |
SLIT Cisplatin |
Cisplatin delivered with Sustained-Release Lipid Inhaled Targeting technology |
Cancers of the lung |
The FDA approved IND for Phase I/II trials (10/26) |
Viragen Inc. |
Multiferon |
Multisubtype, natural human alpha interferon |
Malignant melanoma |
Seven-year follow-up data from a Phase II/III trial confirmed a statiscally significant increase in over- all survival for drug and surgery vs. surgery alone (10/5) |
Viventia |
Proxinium |
Product that uses tumor-seeking antibody fragments to deliver agents to cancer cells |
Head and neck cancer |
A Phase I trial in 24 patients with advanced disease demonstrated safety and some tumor responses (10/27) |
Xanthus |
Symadex |
Next-generation product based on the existing cancer drug mitoxantrone |
Advanced solid tumors |
Began a second Phase I trial, in 15 to 20 patients, to further examine dosing regimens (11/14) |
ZymoGenetics |
TACI-Ig |
Antagonist protein that binds to the cytokines |
B-cell malignancies |
Got clearance for Phase Ib trial to test the safety and pharmaco-kinetics of multiple doses in patients (10/4) |
CARDIOVASCULAR | ||||
Affymax Inc.* |
Hematide |
Peptide-based erythro-poiesis-stimulating agent |
Anemia |
Began Phase I trial to evaluate safety and pharmacokinetics and determine the effect on reticulocytes and hemoglobin (10/4) |
CV |
Ranexa |
Partial inhibitor of fatty-acid oxidation |
Acute coronary syndromes |
Began MERLIN TIMI-36 trial to test efficacy and safety during acute and long-term treatment in 5,500 patients with non-ST elevation syndromes treated with standard therapy (10/11) |
Encysive |
Thelin (sitaxsentan) |
Small molecule designed to block endothelin |
Pulmonary arterial hypertension |
STRIDE-6 study in 48 patients who had discontinued bosentan therapy showed the drug might provide benefit in that group (10/5) |
Northfield |
PolyHeme |
Oxygen-carrying blood substitute derived from human blood |
Blood loss |
Monitors recommended Phase III trial in treating hemorrhagic shock following traumatic injury continue, after second interim analysis involving 120 patients (10/13) |
Pharmacyclics |
Antrin |
Motexafin lutetium; a phototherapy |
Coronary atherosclerosis |
Phase I trial in 79 patients provided initial evidence of safety and feasibility of treatment in patients undergoing balloon angioplasty with stent deployment (10/4) |
Renovis Inc. |
Cerovive (NXY-059) |
A neuroprotectant with free-radical trapping properties |
Stroke |
Partner AstraZeneca plc will continue with Phase III SAINT I and II trials after interim analysis by trial monitors (10/14) |
Vertex |
VX-702 |
Oral p38 MAP kinase inhibitor |
Acute coronary syndrome |
Phase IIa trial in 45 ACS patients undergoing PCI met safety and pharmacokinetic objectives, and reduced serum levels of the bio-marker C-reactive protein (10/18) |
V.I. |
Inactine |
Pathogen-reduction system |
Blood substitute |
Monitors recommended Phase III trial continue after reviewing data from 20% of the planned 200 patients; they also asked for clarification on certain data (10/8) |
CENTRAL NERVOUS SYSTEM | ||||
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Pseudobulbar affect |
Published Phase III results from trial of 140 PBA patients with amyotrophic lateral sclerosis showed statistically significant benefits in the Neurodex arms (10/27) |
Celgene Corp. |
Focalin XR (FDA-approved) |
Dexmethylphenidate hydrochloride extended-release capsule; a form of Ritalin |
Attention deficit/ hyperactivity disorder |
Trials in adults and children each demonstrated statistical significance against placebo (10/25) |
Corcept |
Corlux (mifepristone) |
Oral GR-II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
Began second pivotal Phase III trial, Corcept 06, that will assess psychiatric ratings at days 7 and 56 in 440 patients (10/19) |
Delex |
AeroLEF |
Aerosolized liposome- encapsulated fentanyl |
Pain following knee surgery |
Phase IIa trial testing analgesia was called encouraging (10/9) |
Endo |
DepoDur (FDA-approved) |
Sustained-release, injectable liposomal formulation of morphine |
Post-surgical pain |
Data were presented showing up to 48 hours of pain relief in a trial with 487 adults, and safety and effectiveness in a trial in 164 adults undergoing knee-replacement surgery (10/26) |
NovaDel |
-- |
Lingual spray version of sumatriptan, the active ingredient in GlaxoSmith- Kline plc's drug Imitrex |
Migraine |
Pilot pharmacokinetic study demonstrated safety and tolerability, and quicker delivery than Imitrex (10/14) |
NPS |
NPS 1776 |
Isovaleramide; broad- spectrum neuromodulator |
Migraine |
Phase IIa trial in 189 patients with moderate to severe migraine failed to reduce pain at two hours vs. placebo, which produced a higher response than expected (10/11) |
Prana Biotechnology |
PBT-1 (clioquinol) |
Small molecule that binds metal ions; designed to remove zinc bound to amyloid-beta |
Alzheimer's disease |
84-week data from nine patients in Phase II extension study showed apparent reduction of disease progression (10/12) |
Yaupon |
Lobeline |
Agent derived from a natural product with a long history of human use |
Meth- amphetamine addiction |
Began a Phase I trial, which is being supported by the National Institute on Drug Abuse (10/26) |
DIABETES | ||||
ConjuChem |
DAC:GLP-1 |
Insulinotropic hormone GLP-1 created with firm's DAC technology |
Type II diabetes |
Began Phase I trial of product with modified diluents designed to improve tolerability (10/4) |
Syrrx Inc.* |
-- |
Dipeptidyl peptidase IV inhibitor |
Type II diabetes |
Companies filed an IND to begin a Phase I trial (10/13) |
Transition |
E1-I.N.T. |
Combination of epidermal growth factor analogue and gastrin analogue |
Type I diabetes |
Got FDA OK to begin a Phase I trial to test efficacy, safety and tolerability of a 28-day course of therapy in patients (10/14) |
INFECTION | ||||
Chiron Corp. |
TPI |
Tobramycin powder for inhalation |
Infections in cystic fibrosis patients |
Phase I data suggested TPI might be a well- tolerated, more convenient alternative to existing therapies (10/14) |
Corus Pharma |
Corus 1020 |
Aztreonam lysinate formulated for inhalation |
P. aeruginosa infections in cystic fibrosis |
Phase II trial in 105 CF patients showed a significant decrease in the amount of the bacterium (10/15) |
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection |
Infective endocarditis and bacteremia due to S. aureus |
Monitors recommended Phase III trial continue, following a fourth safety review involving more than 135 patients (10/26) |
Gilead Sciences |
Tamiflu (FDA-approved) |
Oseltamivir; an oral neuraminidase inhibitor |
Influenza |
Data were presented showing drug was effective against the human H5N1 and avian H5N1 flu virus (10/31) |
Gilead |
Viread and Emtriva (FDA- approved as Truvada) |
Nucleotide and nucleoside |
HIV |
24-week data from Phase III trial showed 87% of those taking Gilead combination vs. 76% on Combivir achieved a reduction of viral load to less than 400 copies/mL (10/31) |
Gilead |
GS 9005 |
Protease inhibitor |
HIV |
Discontinued development after a Phase I/II trial did not demonstrate a sufficient antiviral response (10/21) |
Gilead |
GS 7340 |
Prodrug of tenofovir, the active agent in the company's HIV drug Viread |
HIV |
Company stopped development after a Phase I/II trial, concluding it lacked enough differentiation to existing drugs (10/21) |
Incyte Corp. |
Reverset |
Nucleoside analogue reverse transcriptase inhibitor |
HIV |
Subset analysis from Phase IIa showed a clinically significant reduction in viral load in treatment-experienced patients (10/31) |
Indevus |
Aminocandin |
Fungicidal agent from the echinocandins class |
Fungal infections |
Began Phase I trial to test safety, tolerability and pharmacokinetics of multiple doses in 32 healthy volunteers (10/6) |
MedImmune |
CAIV-T |
Intranasal, cold-adapted trivalent influenza vaccine; next generation of FluMist |
Influenza |
Began a pivotal head-to-head Phase III trial comparing CAIV-T to the injectable flu shot (trivalent influenza vaccine) in 7,000 children worldwide (10/20) |
Oscient |
Factive |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Acute bacterial rhinosinusitis |
Two Phase III trials met their primary endpoints: improvement or resolution of signs and symptoms at follow-up in one trial, and bacteriologic and clinical efficacy in the second (10/1) |
Peninsula |
PPI-0903 |
Next-generation cephalosporin antibiotic |
Infections and pneumonias |
Phase I trial demonstrated safety and tolerability (10/7) |
PowderMed |
-- |
Therapeutic vaccine that uses PowderMed's technology to deliver a DNA plasmid coding for four HSV2 antigens |
Herpes simplex virus-2 |
Began Phase I trial in 36 people with genital herpes to assess safety and tolerability, as well as immune responses (10/12) |
Protein |
FluBlok |
Vaccine manufactured in cell culture |
Influenza |
Got FDA OK for a Phase II trial in subjects aged 18-49 to show safety and establish a commercial dose, and to test efficacy (10/28) |
SinusPharma Inc.* |
SPRC-AB01 |
A formulation of an antibiotic for nasal inhalation |
Rhinosinusitis |
Began Phase I trial to test the safety of various doses in healthy volunteers (10/1) |
Trimeris Inc. |
Fuzeon (FDA-approved) |
Enfuvirtide; HIV fusion inhibitor |
HIV |
Retrospective 48-week data showed twice as many patients on drug with protease inhibitor regimen experienced a significant virologic response than those on PI regimen alone (10/5); new analysis of the TORO studies showed earlier use of the drug led to better treatment outcomes (10/31) |
VaxGen Inc. (OTC BB:VXGN) |
LC16m8 |
Attenuated smallpox vaccine candidate |
Smallpox |
Began a Phase I/II trial to evaluate safety in 150 volunteers (10/20) |
Vertex |
Lexiva; (FDA-approved) |
Fosamprenavir calcium; protease inhibitor |
HIV |
48-week data from the NEAT trial showed increased HDL levels in regimens with Lexiva; also, a pharmacokinetic study showed possible advantage vs. amprenavir on adverse events (10/30) |
Vertex |
VX-385 (640385) |
Protease inhibitor |
HIV |
GlaxoSmithKline plc began a pilot Phase II trial in 30 patients who will receive the drug for up to 48 weeks (10/25) |
MISCELLANEOUS | ||||
Abgenix |
ABX10241 (ABX-PTH) |
Fully human monoclonal antibody designed to target and neutralize the action of parathyroid hormone |
Secondary hyper- parathyroidism |
Interim Phase I data showed the drug was well tolerated with dose-related suppression of PTH and serum calcium levels in hemodialysis patients (10/3) |
Acuity |
Cand5 |
Small interfering RNA therapeutic designed to shut down VEGF |
Age-related macular degeneration |
Began a Phase I safety trial that also will evaluate factors associated with efficacy (10/7) |
AEterna |
-- |
Depot formulation of cetrorelix, a luteinizing hormone-releasing hormone antagonist |
Benign prostatic hyperplasia |
Phase II trial in 250 patients demonstrated durable and statistically significant improvement of clinical signs and symptoms at all doses except the lowest (10/7) |
Amgen Inc. |
Sensipar (FDA-approved) |
Cinacalcet HCl; oral calcium calcimimetic |
Hypercalcemia |
Results from 122-patient study showed drug controlled calcium levels in patients with para-thyroid carcinoma and reduced levels in those with primary hyperparathyroidism (10/3) |
Amgen Inc. |
AMG 162 |
Fully human monoclonal antibody that binds to and inhibits RANK ligand |
Bone loss |
Phase II trial showed twice-yearly injections significantly increased bone mineral density at the total hip compared with placebo at 12 months (10/3) |
BioSante |
Bio-E-Gel |
Estradiol transdermal gel |
Hot flashes and vaginal atrophy |
All doses studied in a Phase II trial in menopausal women showed significant decreases in the frequency and severity of hot flashes vs. baseline (10/7); data showed decreases of at least 90% in 55% of subjects and at least 95% in 50%, both significant vs. placebo (10/19) |
Bone Care |
Hectorol (FDA-approved) |
Doxercalciferol; pro-hormone vitamin D2 analogue |
Secondary hyper- parathyroidism |
Retrospective data showed better compliance than paricalcitol for recommended guidelines (10/31) |
Bone Care |
Hectorol (FDA-approved) |
Doxercalciferol; pro-hormone vitamin D2 analogue |
Secondary hyper- parathyroidism |
Positive efficacy data were presented from a Phase III trial in pre-dialysis chronic kidney disease patients (10/28) |
Cellegy |
Tostrelle |
Testosterone gel |
Female sexual dysfunction |
Interim Phase II data showed that drug patients experienced a 95% increase in frequency of satisfactory sexual activity over baseline and 45% over placebo (10/27) |
Critical |
CTI-01 |
Ethyl pyruvate; small molecule believed to inhibit release of cytokines |
Inflammatory conditions |
Phase I trial in 60 healthy adults demonstrated safety and tolerability in all doses tested (10/13) |
CuraGen |
CR002 |
Fully human monoclonal antibody that targets platelet-derived growth factor-D |
IgA nephropathy |
Is beginning a Phase I trial to study safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers (10/26) |
DUSA |
Levulan (FDA-approved) |
Photodynamic therapy |
Facial photoaging/ acne |
Investigator study in 20 patients demonstrated statistically significant improvement when used before intense pulsed light (10/4); began a Phase II trial in acne (10/22) |
Eyetech |
Macugen |
Pegaptanib sodium injection; pegylated anti-VEGF aptamer |
Wet age-related macular degeneration |
Data showed the treatment effect of the drug extends for two years; a benefit also was seen for those who received drug for two years vs. only one year (10/21) |
FibroGen Inc.* |
FG-3019 |
Fully human antibody directed against connective tissue growth factor |
Idiopathic pulmonary fibrosis |
Phase I trial in 21 patients showed the agent was safe and well tolerated (10/27) |
GenVec Inc. |
AdPEDF |
Product that uses an adenovector to produce pigment-epithelium- |
Wet age-related macular degeneration |
Phase I trial in 28 patients demonstrated safety and delivery feasibility (10/22) |
Genzyme |
Renagel (FDA-approved) |
Sevelamer hydrochloride; phosphate binder |
Renal disease |
Data from RIND study showed a significant difference in the change in coronary artery calcification over 18 months in favor of Renagel vs. calcium-based phosphate binders (10/29) |
Hemispherx |
Ampligen |
RNA drug with potential action as an immuno-modulator and antiviral |
Chronic fatigue syndrome |
Presented data from Phase II trial in 234 patients showing drug improved treadmill performance (19.3%) vs. placebo (4.1%) (10/11); pivotal Phase III trial demonstrated statistically significant increases in the primary endpoint, exercise treadmill duration, at 40 weeks compared to placebo (10/18) |
ICOS Corp. |
Cialis (FDA-approved) |
Tadalafil; oral PDE5 inhibitor |
Erectile dysfunction |
An analysis of 11 trials showed 82% of 349 men with ED and benign prostatic hyperplasia experienced improved erectile function with Cialis (10/20) |
InterMune Inc. |
Actimmune (FDA-approved) |
Interferon gamma-1b |
Idiopathic pulmonary fibrosis |
48-week GIPF-004 trial in 210 patients showed no increase vs. placebo in serious adverse events (10/28) |
ISTA |
Xibrom |
Bromfenac sodium solution; topical non-steroidal anti-inflammatory agent |
Ocular inflammation following cataract surgery |
Integrated data from two Phase III trials showed a statistically significant proportion of patients achieved treatment success vs. placebo (10/25) |
Miravant |
Photrex (SnET2) |
Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels |
Wet age-related macular degeneration |
Presented favorable, additional data from Phase III trial; the FDA has asked for a confirmatory trial (10/25) |
Nabi Bio- |
PhosLo |
Calcium acetate |
Control of blood phosphorus in endstage renal disease |
Company is replacing Phase IV PRECISE study with the CARE-2 study, which will compare drug with Renagel; Lipitor will be added to both arms (10/5) |
NPS |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
Additional data from pivotal Phase III trial showed a reduced risk of a first vertebral fracture in postmenopausal osteoporotic women; elevated calcium levels also were noted (10/21) |
NPS |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
NIH-sponsored study showed one year of Preos followed by one year of alendronate was more effective at building bone than two years of alendronate alone (10/4) |
ProMetic Life |
-- |
Topical gel formulation of recombinant alpha-1- antitrypsin |
Atopic dermatitis |
Phase II trial in Canada failed to meet its primary or secondary endpoints; separately, encouraging data were seen in a UK pediatric study in five patients with severe dermatological disorder (10/7) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations (single-point alterations in DNA that stop translation) |
Cystic fibrosis and Duchenne muscular dystrophy |
Preliminary results from a Phase I trial demonstrated the drug was orally bioavailable and generally well tolerated (10/19) |
QLT Inc. |
Visudyne (FDA-approved) |
Verteporfin for injection; a photodynamic therapy |
Wet age- related macular degeneration |
Phase III Visudyne in Occult trial will continue until its 24-month endpoint, following an analysis by monitors at 12 months (10/14) |
Savient |
Puricase |
Polyethylene glycol conjugate of uricase |
Gout |
Data were presented that showed positive results from Phase I trials (10/18) |
Serono SA |
Cetrotide |
Cetrorelix acetate for injection |
To prevent premature ovulation during infertility treatment |
In a trial comparing GnRh antagonists, 66.7% of Cetrotide patients required one injection while 62.5% using ganirelix acetate needed four or more injections to achieve the same endpoint (10/19) |
Tercica Inc. (TRCA) |
-- |
Recombinant human insulin-like growth factor-1 |
Short stature caused by IGF deficiency |
Began Phase IIIb trial in 160 pre-pubertal children to evaluate the safety and efficacy in promoting statural growth (10/28) |
Theratechnol- |
ThPTH |
Transdermal formulation of synthetic parathyroid hormone |
Osteoporosis |
Phase I trial showed rapid delivery of PTH, good bioavailability and biologic activity, and a good safety profile (10/4) |
Unigene |
-- |
Oral formulation of parathyroid hormone |
Osteoporosis |
Phase I trial showed delivery of PTH into the bloodstream and that the PTH molecule was intact and biologically active (10/12) |
Vivus |
Alista |
Topical formulation of alprostadil |
Female sexual arousal disorder |
Phase II trial showed a statistically significant increase in successful and satisfactory sexual events in the 25 women who completed at least six doses of drug or placebo (10/28) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug 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; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
