Company* |
Product | Description | Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Acorda |
Fampridine-SR |
Selective neuronal potassium channel blocker |
Multiple sclerosis |
Reached agreement with FDA on SPA for Phase III trial that will measure improvement in walking (5/4) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Ulcerative colitis |
Supplemental BLA filed with the FDA has been designated for priority review (5/31) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriatic arthritis |
The FDA approved the drug to reduce the signs and symptoms of active arthritis in patients with PA; it is the ninth FDA approval of the product (5/17) |
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
The FDA designated fast-track status to Riquent for treating lupus renal disease (5/31) |
CANCER | ||||
Amgen |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia |
Submitted supplemental NDA seeking approval of extended dosing to treat chemotherapy-induced anemia in patients with non-myeloid malignancies (5/6) |
Cell |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Prostate cancer |
Agreed to SPA with FDA for its second Phase III trial (VITAL-2) in prostate cancer; it will compare GVAX and Taxotere to Taxotere and prednisone (5/18) |
Lorus |
GTI-2040 |
Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase |
Acute myeloid leukemia |
The FDA awarded orphan status to the drug in that indication, for which Phase II trials are ongoing (5/4) |
Onyx |
Sorafenib (BAY 43-9006) |
RAF kinase and VEGF inhibitor |
Metastatic kidney cancer |
The product was accepted into the FDA's Pilot 1 Program for continuous marketing applications (5/4) |
OSI |
Tarceva (FDA-approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Advanced pancreatic cancer |
Submitted supplemental NDA for use of drug with gemcitabine for treating advanced, previously untreated patients (5/2) |
Structural |
Troxatyl |
Troxacitabine; nucleoside analogue |
Acute myelogenous leukemia |
The FDA granted orphan designation to the drug, which is in Phase I/II trials in that indication (5/12) |
CARDIOVASCULAR | ||||
Arginox |
Tilarginine Acetate Injection |
Agent designed to inhibit the production of nitric oxide |
Cardiogenic shock |
The FDA granted orphan designation to the product in that indication, for which Phase III trials were starting (5/23) |
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
Filed NDA with FDA seeking approval as a once-daily treatment for patients with PAH (5/25) |
PR |
PulmoLAR |
2-methoxyestradiol (2ME), an endogenous non- estrogenic metabolite of estradiol |
Pulmonary arterial hypertension |
The FDA granted orphan designation to the drug; Phase I trials are expected to begin in 2005 (5/12) |
CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. |
Vivitrex |
Long-acting, injectable form of naltrexone |
Alcohol dependence |
The FDA granted priority review to the NDA, which was filed in May, putting the review deadline at Sept. 30, 2005 (5/27) |
Alkermes Inc. |
Risperdal Consta (FDA-approved) |
Risperidone formulated in Alkermes' long-acting Medisorb technology |
Psychosis of Alzheimer's disease |
The FDA issued J&J a not-approvable letter on the supplemental NDA filing (5/26) |
CytRx Corp. |
Arimoclomol |
Small molecule designed to provide cellular protection by activating molecular chaperone proteins |
Amyotrophic lateral sclerosis |
The FDA granted orphan drug designation to the product in ALS (5/5) |
Neurocrine |
Indiplon |
Tablet form of a non-benzodiazepine agent that targets the GABA-A receptor |
Insomnia |
The company has completed submission of an NDA with the FDA for treating insomnia in both adult and elderly patients (5/26) |
INFECTION | ||||
Depomed Inc. |
Proquin XR |
Once-daily, extended- release formulation of ciprofloxacin hydrochloride |
Uncomplicated urinary tract infections |
The FDA approved the product; Depomed was in late- stage negotiations with potential marketing partners (5/20) |
Vicuron |
Anidulafungin |
Broad-spectrum agent from the echinocandin class |
Esophageal candidiasis |
Filed amendment to existing NDA; amendment in invasive candidiasis/candidemia is expected in the third quarter (5/31) |
Vicuron |
Dalbavancin |
Glycopeptide agent from the same class as vancomycin |
Complicated skin and soft-tissue infections |
The FDA said it would extend its review date on the NDA for three months; action now is expected by Sept. 21, 2005 (5/11) |
MISCELLANEOUS | ||||
Copernicus |
-- |
Drug based on DNA nanoparticle technology |
Cystic fibrosis |
The FDA granted orphan desig-nation to the drug in that indication (5/2) |
Halozyme |
Hylenex (formerly Enhanze SC) |
Formulation of recombinant human hyaluronidase |
For use as a spreading agent |
The FDA accepted the NDA for filing and review; it was filed in March (5/26) |
InKine |
INKP-102 |
New-generation sodium phosphate purgative tablet |
Bowel cleansing prior to colonoscopy |
The company filed an NDA seeking approval of the product (5/3) |
Tercica Inc. |
Increlex |
Mecasermin injection; recombinant human insulin-like growth factor-1 |
Short stature caused by IGF deficiency |
The FDA accepted for filing and granted priority review to the NDA, which was filed in February (5/2) |
| | ||||
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; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||
