Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER | ||||
Aphton Corp. (APHT) | GnRH pharmaccine | Immunogen, used in combination with the chemotherapeutic taxotere |
Hormone-refractory prostate cancer | FDA allowed the initiation of a clinical trial (1/16) |
Aronex Pharmaceuticals Inc. (ARNX) | Atragen | Injectable liposomal formulation of all trans retinoic acid (tretinoin) | Acute promyelocytic leukemia | FDA denied approval of the NDA (1/8) |
Dendreon Corp. (DNDN) | APC8024 | Designed to induce an immune response against tumor cells that show increased amounts of the protein antigen Her-2/neu | Breast, ovarian and colon cancer | Company received FDA clearance to begin clinical trials (1/9) |
FeRx Inc.* | MTC-DOX | Doxorubicin released through Magnetic Target Carriers, microparticles, composed of elemental iron and activated carbon | Primary liver cancer | Company received orphan drug designation from the FDA (1/29) |
ICN Pharmaceuticals Inc. (NYSE:ICN) | Tiazole | Tiaxofurin | Chronic myelogenous leukemia | FDA granted orphan status (1/16) |
IDEC Pharmaceuticals Corp. (IDPH) | Zevalin | Radioimmunotherapy; ibritumomab tiuxetan | Low-grade, follicular, CD20-positive transformed, relapsed or refractory, B-cell non-Hodgkin's lymphoma and Rituximab-refractory follicular NHL | FDA accepted the BLA for filing and granted priority review status (1/2) |
Matrix Pharmaceuticals Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epinephrine (intratumoral injection) | Head and neck cancer | Company completed its three-part NDA (1/8) |
Maxim Pharmaceuticals Inc. (MAXM) | Ceplene (formerly Maxamine) | Histamine dihydrochloride; an adjuvant to interleukin-2 | Advanced metastatic melanoma with liver metastases | FDA issued a nonapprovable letter saying the Phase III was not enough to support approval (1/19) |
Praecis Pharmaceuticals Inc. (PRCS) and Amgen Inc. (AMGN) | Abarelix depot | Gonadotropin-releasing hormone antagonist | Prostate cancer | FDA accepted and filed the NDA, granting it priority review (1/25) |
CARDIOVASCULAR | ||||
Collateral Therapeutics Inc. (CLTX) and Schering AG (Germany) | GENERX (Ad5FGF4) | Nonsurgical angiogenic gene therapy product | Stable exertional angina due to coronary artery disease | Schering submitted an application to the FDA for a pivotal Phase IIb/III study (1/10) |
Scios Inc. (SCIO) | Natrecor | Nesiritide; a recombinant form of B-type natriuretic peptide, a naturally occurring hormone that aids healthy functioning of the heart | Congestive heart failure | Company filed an amendment to the NDA (1/10) |
CENTRAL NERVOUS SYSTEM | ||||
Centocor Inc.* | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha | Moderately to severely active rheumatoid arthritis | FDA granted marketing approval to Remicade in conjunction with methotrexate for inhibiting the progression of damage in patients (1/2) |
Pozen Inc. (POZN) | MT 100 | Combination of metoclo-pramide HC1 and naproxen sodium | Migraine headache | FDA requested additional carcinogenicity studies for MT 100, which is in Phase III testing, and despite Pozen's request for a complete waiver of any such studies (1/26) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. (AMLN) | Symlin | Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin | Type I or Type II diabetes | FDA accepted the NDA for review (1/25) |
INFECTION | ||||
Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE:SGP) | PEG-Intron | Peginterferon alfa-2b; uses pegylation technology | Chronic hepatitis C | FDA granted marketing approval (1/22) |
MISCELLANEOUS | ||||
Curis Inc. (CRIS) and Stryker Corp. (NYSE:SYK) | OP-1 implant | Device combining genetically engineered bone morphogenic protein with resorbable collagen scaffold surgically implanted in bone fractures and defects | Nonunion fractures of the tibia | FDA issued a not-approvable letter and recommended that Stryker conduct a new study (1/30) |
SkyePharma plc (UK; SKYE; LSE:SKP) and Sanofi-Synthelabo Inc. (France) | Xatral OD | Sustained-release once-daily formulation of alfuzosin 10 mg | Benign prostatic hyperplasia | Companies filed an NDA with the FDA (1/22) |
Transkaryotic Therapies Inc. (TKTX) | Replagal | Agalsidase alfa; enzyme replacement therapy | Fabry disease | FDA completed its review of the BLA and has requested additional data (1/3) |
Notes: | ||||
* Privately held **Denotes the date the item ran in BioWorld International | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application | ||||
