Company* (Country; Symbol)




Status (Date)


Human Genome Sciences Inc. (HGSI)


Human monoclonal antibody that inhibits activity of B-lymphocyte stimulator


The FDA selected the product for inclusion in the Continuous Marketing Application Pilot 2 program (3/4)


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.*


Nanoparticle albumin-bound taxane

Metastatic breast cancer

Company completed NDA filing with the FDA (3/8)

Exelixis Inc. (EXEL)


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)


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)


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)


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)


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)


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)


H3 Pharma Inc.* (Canada)


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)


Gilead Sciences Inc. (GILD)

Viread and Emtriva (both FDA-approved)

Nucleotide and nucleoside reverse transcriptase inhibitor, respectively


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)



Staphylococcus aureus immune globulin (human)

S. aureus infections in neonates

The FDA granted fast-track designation to the product (3/3)


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.*


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


The FDA accepted for review the NDA for oxypurinol for treating allopurinol-intolerant hyperuricemia (gout) (3/9)

InterMune Inc. (ITMN)


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)


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)


* Privately held

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