Company* (Country; Symbol) | Product |
Description | Indication |
Status (Date) |
AUTOIMMUNE | ||||
Human Genome Sciences Inc. (HGSI) |
LymphoStat-B |
Human monoclonal antibody that inhibits activity of B-lymphocyte stimulator |
Lupus |
The FDA selected the product for inclusion in the Continuous Marketing Application Pilot 2 program (3/4) |
CANCER | ||||
Adherex Technologies Inc. (Canada; TSE:AHX) |
Sodium thiosulfate |
Compound approved as part of treatment in cyanide poisoning |
Platinum- induced ototoxicity |
The FDA granted orphan designation to the drug in treating children with hearing loss due to chemotherapy (3/24) |
American BioSciences Inc.* |
Abraxane |
Nanoparticle albumin-bound taxane |
Metastatic breast cancer |
Company completed NDA filing with the FDA (3/8) |
Exelixis Inc. (EXEL) |
XL119 |
Small-molecule cancer compound |
Bile duct tumors |
The FDA granted orphan designation to the product in that indication, for which a Phase III trial is expected to start in 2Q:04 (3/15) |
Genmab A/S (Denmark; CSE:GEN) |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Cutaneous T- ell lymphoma |
The FDA granted fast-track status to the product for patients with CTCL who have failed available treatments (3/23) |
ILEX Oncology Inc. (ILXO) |
Clofarabine |
Second-generation purine nucleoside analogue |
Refractory/ relapsed acute leukemia in children |
ILEX submitted the final section of the NDA to the FDA; the drug has fast-track status (3/31) |
Inex Pharmaceuticals Corp. (Canada; TSE:IEX) and Enzon Pharmaceuticals Inc. (ENZN) |
Onco TCS |
Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology |
Relapsed, aggressive non- Hodgkin's lymphoma |
Companies completed rolling BLA submission seeking approval as a single agent in patients already treated with two combination regimens (3/15) |
Millennium Pharmaceuticals Inc. (MLNM) |
MLN2704 |
Chemotherapeutic agent DM1 linked to the antibody MLN591, targeted at PSMA |
Prostate cancer |
The Phase I/II product was selected for inclusion in the FDA's Continuous Marketing Application Pilot 2 Program (3/17) |
Praecis Pharmaceuticals Inc. (PRCS) |
PPI-2458 |
Methionine aminopeptidase Type 2 inhibitor |
Non-Hodgkin's lymphoma |
The FDA put a clinical hold on a Phase I trial due to animal data showing a neuropathological abnormality; Praecis has to address the finding (3/11) |
SuperGen Inc. (SUPG) |
Orathecin |
Rubitecan; oral topois- omerase-I inhibitor in capsule formulation |
Refractory pancreatic cancer |
The FDA accepted the company's NDA for filing; action is expected by Nov. 26 (2/26) |
Vion Pharmaceuticals Inc. (VION) |
Cloretazine (VNP40101M) |
Sulfonyl hydrazine DNA alkylating agent |
Acute myeloid leukemia |
The FDA granted fast-track designation for treating relapsed or refractory AML (3/8) |
CARDIOVASCULAR | ||||
H3 Pharma Inc.* (Canada) |
Sanvar |
Somatostatin analogue in an immediate-release formulation |
Esophageal variceal bleeding |
H3 filed a new drug application seeking approval for EVB to stop hemorrhage prior to endoscopic intervention and to prevent recurring bleeding (3/2) |
United Therapeutics Corp. (UTHR) |
Remodulin (FDA-approved) |
Treprostinil sodium |
Pulmonary arterial hypertension |
The FDA accepted for review the supplemental NDA seeking approval of intravenous delivery of the product (3/31) |
INFECTION | ||||
Gilead Sciences Inc. (GILD) |
Viread and Emtriva (both FDA-approved) |
Nucleotide and nucleoside reverse transcriptase inhibitor, respectively |
HIV |
Gilead submitted a new drug application seeking approval of a formulation combining the drugs in a single pill dosed once daily in combination therapies (3/15) |
Nabi |
Altastaph |
Staphylococcus aureus immune globulin (human) |
S. aureus infections in neonates |
The FDA granted fast-track designation to the product (3/3) |
MISCELLANEOUS | ||||
Amgen Inc. (AMGN) and NPS Pharmaceuticals Inc. (NPSP) |
Sensipar (cinacalcet HCl) |
Oral calcium calcimimetic |
Secondary hyper- parathyroidism and hypercalcemia |
The FDA approved the drug to treat secondary HPT in chronic kidney disease patients on dialysis and to treat elevated calcium levels in patients with parathyroid carcinoma (3/8) |
Amicus Therapeutics Inc.* |
AT1001 |
Small molecule designed to enhance alpha-galactosidase A activity |
Fabry's disease |
The FDA granted orphan designation to the preclinical drug in that indication (3/8) |
Cardiome Pharma Corp. (Canada; TSE:COM) |
Oxyprim (oxypurinol) |
Xanthine oxidase inhibitor that is the active metabolite of allopurinol |
Gout |
The FDA accepted for review the NDA for oxypurinol for treating allopurinol-intolerant hyperuricemia (gout) (3/9) |
InterMune Inc. (ITMN) |
Pirfenidone |
Small molecule believed to inhibit collagen synthesis, downregulate profibrotic cytokines and decrease fibroblast proliferation |
Idiopathic pulmonary fibrosis |
The FDA granted orphan desigation to the product, which has produced positive Phase II results (3/24) |
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 |
Miravant submitted an NDA for the fast-track product; an application also was submitted for the activating light device (3/31) |
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE =New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
