Company* (Country; Symbol) | Product |
Description | Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland) |
Antegren (natalizumab) |
Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
The FDA designated the BLA for priority review; the BLA was submitted in May (6/28) |
CANCER | ||||
Allos Therapeutics Inc. (ALTH) |
RSR13 (efaproxiral) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
FDA issued approvable letter for treating metastases from breast cancer; Allos must show efficacy in Phase III ENRICH trial (6/2) |
Amgen Inc. (AMGN) |
Palifermin |
Recombinant human keratinocyte growth factor |
Oral mucositis |
Submitted BLA seeking approval for treating the condition in patients undergoing chemotherapy followed by a bone marrow trans- plant (6/24) |
Genetronics Biomedical Corp. (AMEX:GEB) |
MedPulser Electroporation System |
System that applies a defined electric field to target cells |
Head and neck cancer |
The FDA granted fast-track designation to the product, which is in Phase III trials in that indication (6/7) |
ILEX Oncology Inc. (ILXO) |
Clofarabine |
Second-generation purine nucleoside analogue |
Refractory/relapsed acute leukemia in children |
The FDA accepted for review the NDA; ILEX filed the final section in March (6/3) |
Medarex Inc. (MEDX) |
MDX-010 |
Fully human anti-CTLA-4 antibody |
Melanoma |
The FDA granted orphan desig- nation to the product in Stages II-IV melanoma, in which a pivotal trial is being planned (6/9) |
OSI Pharmaceuticals Inc. (OSIP) and Genentech Inc. (NYSE:DNA) |
Tarceva |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Non-small-cell lung cancer |
The NDA was accepted for the FDA's Pilot 1 Program for Continuous Marketing Applications, designed to expedite the rolling application (6/29) |
PharmaMar SA* (Spain) |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Acute lymphoblastic leukemia |
The FDA granted orphan designation to the product in that indication (6/24) |
Praecis Pharmaceuticals Inc. (PRCS) |
PPI-2458 |
Methionine aminopeptidase Type 2 inhibitor |
Non-Hodgkin's lymphoma |
FDA lifted a clinical hold it put on Phase I trial in March; Praecis satisfied the agency's concerns (6/22) |
SuperGen Inc. (SUPG) |
Dacogen |
Decitabine for injection |
Myelodysplastic syndromes |
SuperGen submitted the first section of its NDA, and plans to complete the filing in the third quarter (6/1) |
TopoTarget A/S* (Denmark) |
Topotect (ICRF-187) |
Catalytic inhibitor of topoisomerase II |
Preventing tissue damage in cancer patients |
The FDA granted orphan designation for preventing tissue dam- age following extravasation of chemotherapeutics (6/28) |
CARDIOVASCULAR | ||||
Alexion Pharmaceuticals Inc. (ALXN) and Procter & Gamble Pharmaceuticals Inc. |
Pexelizumab |
Monoclonal antibody; terminal complement inhibitor |
Coronary artery bypass graft surgery and acute myocardial infarction |
Reached agreement with FDA under special protocol assessment process on separate pivotal trials in each indication; the AMI trial involves patients treated with primary percutaneous intervention (6/4) |
CV Therapeutics Inc. (CVTX) |
Ranexa (ranolazine) |
Partial inhibitor of fatty-acid oxidation |
Chronic angina |
Reached agremeent under FDA special protocol assessment on 500-patient trial that would sup- port approval if successful (6/2) |
Discovery Laboratories Inc. (DSCO) |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature infants |
The FDA acecpted the NDA filing and designated it for standard review (6/15) |
Dyax Corp. (DYAX) |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
The FDA lifted a hold it had put on a Phase II trial a week earlier; the trial is resuming (6/4) |
Inotek Pharmaceuticals Corp.* |
INO-1001 |
Inhibitor of the nuclear cell death enzyme poly (ADP-ribose) polymerase |
ST-elevated myocardial infarction |
The FDA granted fast-track designation in STEMI patients undergoing percutaneous coronary intervention (6/23) |
The Medicines Co. (MDCO) |
Angiomax (FDA-approved) |
Bivalirudin; direct thrombin inhibitor |
Not disclosed |
The FDA rejected supplemental filing that sought to amend the product's labeling; the FDA said new trials would be needed (6/3) |
CENTRAL NERVOUS SYSTEM | ||||
DOV Pharmaceuticals Inc. (DOVP) |
Ocinaplon |
Agent that modulates a subset of GABA-A receptors |
Anxiety |
FDA lifted hold it placed on start of Phase III trial in October subject to review of a revised protocol, which will include more frequent liver enzyme testing (6/28) |
Pozen Inc. (POZN) |
MT 100 |
Combination of metoclopramide and naproxen |
Migraine |
The FDA issued a not-approvable letter for the drug, citing potential safety issues and saying it failed to demonstrate superiority to naproxen (6/1) |
Sepracor Inc. (SEPR) |
Estorra |
Eszopiclone tablets |
Insomnia |
Resubmitted NDA on the product; the FDA issued an approvable letter in February (6/16) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. |
Exenatide |
Incretin mimetic; synthetic exendin-4 |
Type II diabetes |
Filed NDA with FDA seeking approval in treating Type II diabetes (6/30) |
Depomed Inc. (DEPO) and Biovail Corp. (Canada) |
Glumetza 500 mg and 1,000 mg |
Once-daily, extended- release formulations of the approved drug metformin |
Type II diabetes |
The FDA accepted for review the NDA, which was filed in April (6/24) |
INFECTION | ||||
Basilea Pharmaceutica AG (Switzerland; SWX:BSLN) |
BAL5788 |
Broad-spectrum cephalosporin antibiotic |
Hospital- acquired pneumonia |
The FDA granted fast-track designation to the product in that indication, the second for which it has that designation (6/16) |
MISCELLANEOUS | ||||
Adolor Corp. (ADLR) and GlaxoSmithKline plc (UK) |
Entereg (alvimopan) |
Mu opioid antagonist |
Post-operative ileus |
Adolor submitted the second portion of its NDA for Entereg, which has fast-track status (6/1); completed NDA submission (6/28) |
Barrier Therapeutics Inc. (BTRX) |
Liarozole |
Agent designed to block retinoic acid metabolism |
Congenital ichthyosis |
The FDA granted orphan designation in that indication, which encompasses a group of skin disorders (6/22) |
Cardiome Pharma Corp. (Canada; TSE:COM) |
Oxypurinol |
Xanthine oxidase inhibitor that is the active metabolite of allopurinol |
Gout |
FDA issued approvable letter saying additional clinical and manufacturing data are needed (6/24) |
Cellegy Pharmaceuticals Inc. (CLGY) |
Cellegesic |
Nitroglycerin ointment |
Pain from anal fissures |
Cellegy submitted an NDA based on new trial data, about two years after withdrawing its initial submission (6/30) |
Eyetech Pharmaceuticals Inc. (EYET) |
Macugen |
Pegaptanib sodium; pegylated vascular endothelial growth factor inhibitor |
Wet age- related macular degeneration |
Eyetech and Pfizer Inc. completed filing of NDA; an advisory panel will review the NDA Aug. 27 (6/17) |
ISTA Pharmaceuticals Inc. (ISTA) |
Istalol |
Liquid formulation of the beta-blocker timolol |
Glaucoma |
The FDA approved the product for treating glaucoma (6/7) |
Miravant Medical Technologies Inc. (OTC BB:MRVT) |
SnET2-PDT |
Photodynamic therapy that uses a light- activated drug to destroy abnormal blood vessels |
Wet age-related macular degeneration |
The FDA accepted for review the NDA application, which was filed in March, and designated it for priority review (6/1) |
RegeneRx Bio- Pharmaceuticals Inc. (OTC BB:RGRX) |
Thymosin beta-4 |
Naturally occurring peptide with multiple mechanisms of action |
Epidermolysis bullosa |
The FDA granted the product orphan designation in that indication (6/4) |
Santarus Inc. (SNTS) |
Rapinex |
Immediate-release powder formulation of the proton pump inhibitor omeprazole |
Heartburn |
The FDA approved the product for treating heartburn and other symptoms associated with gas- troesophageal reflux disease, for healing erosive esophagitis, and for treating duodenal ulcers (6/15) |
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
