| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| Active Biotech AB (Sweden; SSE:ACTI) | Laquinimod | Oral product | Relapsing-remitting multiple sclerosis | Data showed a significant reduction in the mean number of gadokinium-enhancing lesions in both patients who switched from placebo to laquinimod and those who continued with the dose; Teva is enrolling patients in two pivotal Phase III trials (9/18) |
| Centocor Inc. (unit of Johnson & Johnson) | Ustekinumab | Monoclonal antibody | Psoriasis | The product showed superior efficacy to Amgen Inc.'s Enbrel in a Phase III head-to-head study (9/18) |
| Emisphere Technologies Inc. (EMIS), Novartis Pharma AG (Switzerland) and Nordic Bioscience A/S (Denmark) | Salmon calcitonin | Uses Emisphere's Eligen technology | Osteoarthritis of the knee | Completed recruitment for a Phase III study (9/22) |
| NicOx SA (France; Paris:COX) | Naproxcinod | A first in the cyclooxy-genase-inhibiting nitric oxide donator | Osteoarthritis of the knee | Phase III data showed it met the three co-primary efficacy end-points at week 13, as well as the main secondary endpoint (9/15) |
| CANCER | ||||
| A.P. Pharma Inc. (APPA) | APF530 | Sustained-release formulation of granisetron | Chemotherapy-induced nausea and vomiting | Failed to show superiority over Eisai Inc.'s Aloxi in a Phase III trial (9/30) |
| Cell Genesys Inc. (CEGE) | GVAX | Immunotherapy | Prostate cancer | FDA placed a partial clinical hold on the Phase III program as a result of the company's announcement to terminate the VITAL-2 trial for the product after an analysis showed an imbalance of deaths between the treatment and control arms (9/11) |
| Cyclacel Pharmaceuticals Inc. (CYCC) | Sapacitabine | An oral nucleoside analogue | Myelodysplastic syndromes | Advanced the drug into Phase II as a second-line treatment (9/12) |
| GTx Inc. (GTXI) | Acapodene | Toremifene 80 mg | Prostate cancer | Phase III data showed that fewer men treated had prostate-specific antigen progression over time compared to placebo (9/16) |
| Hana Biosciences Inc. (HNAB) | Marqibo | Vincristine sulfate injection, Optisome) | Adult acute lymphoblastic leukemia | Achieved the prespecified response criteria needed in the pivotal trial to proceed to full enrollment (9/9) |
| ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co. | Erbitux (FDA-approved) | Cetuximab | Recurrent or metastatic squamous cell carcinoma of the head and neck | Phase III data of Erbitux plus platinum-based chemotherapy showed a statistically significant improvement in the primary endpoint of overall survival, as well as secondary endpoints of progression-free survival and overall response rate (9/11) |
| ImClone Systems Inc. (IMCL) | Erbitux (FDA-approved) | Cetuximab | Metastatic colorectal cancer | Phase III data of Erbitux plus Folfiri showed it failed to meet a secondary endpoint of increasing overall survival (9/16) |
| Novacea Inc. (NOVC) | Asentar | DN-101; a high-dse oral formulation of calcitriol | Androgen-independent prostate cancer | FDA released the clinical hold on the Phase III program that was imposed in November 2007, but the company has no plans for further development (9/11) |
| TopoTarget A/S (Denmark; CSE:TOPO) | Belinostat | A small-molecule histone deacetylase inhibitor | Peripheral T-cell lymphoma | FDA approved an SPA for a Phase III trial with 120 patients expected to begin later this year (9/5) |
| CARDIOVASCULAR | ||||
| Anthera Pharmaceuticals Inc.* | Varespladib | Cholesterol-lowering and anti-inflammatory drug | Acute coronary syndrome | Reached an agreement with the FDA on an SPA for a Phase III trial (9/24) |
| ARCA Biopharma Inc.* | Bucindolol | Beta-blocker and mild vasodilator | Heart failure | Significantly reduced hospitalization and death among patients with very favorable genotypes (9/22) |
| Chelsea Therapeutics International Ltd. (CHTP) | Droxidopa | An orally active synthetic precursor of norepinephrine | Neurogenic orthostatic hypotension | Started patient dosing in two pivotal Phase III studies (9/2) |
| Medicure Inc. (AMEX:MCU) | Aggrastat | Tirofiban HCL | Coronary artery disease | Data from a 263-patient trial showed that the drug significantly lowered the incidence of heart attack after elective coronary angioplasty (9/3) |
| Pronova BioPharma ASA (Norway; OSLO:PRON) | Omacor | Omega-3 prescription drug | Heart failure | Phase III trial reduced mortality and morbidity in patients, meeting both primary endpoints (9/2) |
| CENTRAL NERVOUS SYSTEM | ||||
| Allergan Inc. (NYSE:AGN) | Botox | Made from the toxin that causes botulism | Chronic migraine | Phase III data showed a decrease in number of headache days that was significantly greater than placebo (9/11) |
| Alexza Pharmaceuticals Inc. (ALXA) | AZ-004 | Staccato loxapine | Schizophrenia | Met the primary endpoint of reducing agitation in a Phase III trial with 5-mg and 10-mg doses (9/3) |
| Javelin Pharmaceuticals Inc. (AMEX:JAV) | Dyloject | Diclofenac sodium | Postoperative pain | Completed patient enrollment in the second of two Phase III studies (9/16) |
| Sciele Pharma Inc. (SCRX) and Addrenex Pharmaceuticals Inc.* | Clonicel | Oral, extended-release formulation | Attention deficit hyper-activity disorder | Phase III data showed statistically significant improvement over placebo (9/10) |
| Sepracor Inc. (SEPR) | Eslicarbazepine acetate | A once-daily anti-epliptic agent | Epilepsy | Phase III data demonstrated that the drug, in combination with other anti-epileptic agents, significantly reduced the frequency of partial seizures in patients with refractory partial epilepsy (9/25) |
| Talecris Bio-therapeutics Inc.* | Gamunex (FDA-approved) | Immune globulin intravenous | Chronic inflammatory demyelinating poly-neuropathy | Phase III data suggested the therapy with Gamunex may improve their physical and social functioning compared to placebo (9/23) |
| Transdel Pharmaceuticals Inc. (OTC BB: TDLP) | Ketotransdel | An analgesic and anti-inflammatory topical cream containing 10% ketoprofen | Acute pain from musculo-skeletal conditions | Enrolled the first patient in the Phase III registration trial (9/22) |
| DIABETES | ||||
| Alimera Sciences Inc.* | Iluvien | An intravitreal insert of fluocinolone acetonide | Diabetic macular edema | Data safety monitoring board gave the go-ahead for two on-going pivotal Phase III trials (9/24) |
| Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. | Byetta (FDA-approved) | Exenatide; GLP-1 agonist | Diabetes | A head-to-head trial showed Byetta caused significantly lower post-meal glucose levels than DPP-4 inhibitor Januvia (9/9) |
| Biodel Inc. (BIOD) | VIAject | Ultra rapid-acting injectable human insulin intended for meal-time use | Type I and Type II diabetes | Two Phase III trials met objectives of noninferiority to Eli Lilly and Co.'s Humulin insulin injection, but data from India were excluded (9/8) |
| Generex Biotechnology Corp. (Canada; GNBT) | Generex Oral-lyn | Oral insulin spray | Type I diabetes | Enrollment for the pivotal Phase III trial reached the milestone of more than 200 subjects (9/16) |
| MannKind Corp. (MNKD) | Afresa | Technosphere inhaled insulin | Type I diabetes | Phase III data showed it was comparable with Novolog in regulating A1c levels (9/16) |
| Novo Nordisk A/S (Denmark) | Liraglutide | A glucagon-like peptide-1 analogue | Type II diabetes | Phase III data showed that adding the drug to metformin and rosiglitazone led to improved blood glucose lowering, weight loss, blood pressure reduction and improvements in beta-cell functioning (9/8); Phase III data showed that the drug, when taken alone, produced statistically significant and sustained improvements in blood sugar control, as compared with glimepiride (9/25) |
| INFECTION | ||||
| CSL Biotherapies* | Afluria | Influenza virus vaccine | Influenza | Phase III data showed that two formulations elicited immune response (9/3) |
| Optimer Pharmaceuticals Inc. (OPTR) | Prulifloxacin | An antibiotic | Infectious diarrhea in travelers | Completed enrollment in the second of two Phase III trials (9/2) |
| Theratechnologies Inc. (Canada; TSX:TH) | TH9507 | Tesamorelin | HIV with lipodystrophy | Long-term Phase III data showed no new or unexpected side effects (9/2) |
| MISCELLANEOUS | ||||
| Amgen Inc. (AMGN) | Denosumab | A fully human monoclonal antibody designed to target RANK ligand | Osteoporosis | Phase III trial met its primary endpoint, showing a significant reduction in vertebral fracture rate and a relatively clean safety profile (9/16) |
| Depomed Inc. (DEPO) | Gabapentin GR | Extended-release version of the active ingredient in Pfizer Inc.'s Neurontin | Menopausal hot flashes | Started the first of two pivotal trials (9/17) |
| DOR BioPharma Inc. (OTC BB: DORB) | orBec | Oral beclomethasone dipropionate | Gastrointestinal graft-vs- host disease | A second clinical summary of trials concluded that the product is an effective therapy, with observed response rates of 65% to 77%, which are comparable to historic controls (9/15) |
| Indevus Pharmaceuticals Inc. (IDEV) | Octreotide | Implant | Acromegaly | Began a Phase III trial (9/30) |
| Jazz Pharmaceuticals Inc. (JAZZ) | JZP-6 | Sodium oxybate | Fibromyalgia | Completed its first pivotal Phase III trial (9/11) |
| MAP Pharmaceuticals Inc. (MAPP) | Budesonide | Nebulized version | Pediatric asthma | Completed patient enrollment in its Phase III trial (9/22) |
| Pharmaxis Ltd. (Australia; PXSL) | Bronchitol | An inhalable dry powder formulation of a naturally occurring sugar-alcohol mannitol | Cystic fibrosis | Enrolled the first subject in its second Phase III trial (9/4) |
| QuatRx Pharmaceuticals* | Ophena | Ospemifene tablets; an estrogen-free oral therapy | Postmenopausal vaginal syndrome | Started a second Phase III trial (9/4); Phase III data showed it improved clinical signs including petechiae, pallor, friability, vaginal dryness and redness in mucosa, the secondary end-points, in addition to meeting its primary endpoints regarding vaginal health and symptoms (9/24) |
| Watson Pharmaceuticals Inc. (NYSE:WPI) | Rapaflo (FDA-approved) | Silodosin; a highly selective alpha-1 adrenergic receptor antagonist | Prostatic hyperplasia | Phase III data showed that treatment for up to one year effectively reduced symptoms (9/29) |
|
Notes: * Privately held. 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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange. | ||||
