Company* |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Genentech Inc. (NYSE:DNA) and and XOMA Ltd. (XOMA) |
Raptiva |
Efalizumab; a targeted T-cell modulator designed to selectively and reversibly block the activation, migration to the skin and trafficking of the T cells |
Plaque psoriasis |
An FDA panel recommended the approval of Raptiva (9/9) |
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CANCER | ||||
Antigenics |
Oncophage |
Personalized cancer vaccine |
Metastatic melanoma and and renal cancer |
FDA placed a partial clinical hold on two Phase III trials, citing insufficient product characterization data (9/3) |
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Dendreon Corp. (DNDN) |
Provenge |
Immunotherapy |
Prostate cancer |
FDA designated Provenge as a fast-track development program (9/4) |
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Genentech Inc. (NYSE:DNA) |
Avastin |
Bevacizumab; anti-EGFR antibody |
Metastatic colorectal cancer |
Company completed filing of BLA as part of first-line combination therapy; product has fast-track status (9/26) |
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Epeius Biotechnologies Corp.* |
REXIN-G |
Tumor-targeted gene therapy vector |
Pancreatic cancer |
FDA designated REXIN-G as an orphan drug (9/8) |
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Genta |
Ganite |
Gallium nitrate injection |
Cancer-related hypercalcemia |
FDA approved Ganite to treat hypercalcemia that is resistant to hydration (9/18) |
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Genta |
Genasense |
Antisense oncology compound |
Malignant melanoma |
Company began filing a rolling NDA based on Phase III data that demonstrated a 25% improvement in patients who finished the minimum follow-up of 12 months (9/10) |
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ILEX Oncology |
Clofarabine |
Purine nucleoside |
Acute lymphoblastic leukemia |
FDA granted fast-track status for clofarabine to treat children (9/9) |
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Inex Pharmaceuticals Corp. (Canada; TSE:IEX) |
Onco TCS |
Vincristine encapsulated in Inex's TCS liposomal delivery technology |
Relapsed, aggressive non-Hodgkin's lymphoma |
Began rolling NDA submission by submitting first of three sections dealing with safety and pharmacokinetics (9/30) |
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Introgen Therapeutics Inc. (INGN) |
Advexin |
Supplies p53 protein |
Squamous-cell carcinoma of the head and neck |
FDA designated Advexin as a fast-track product (9/17) |
PhotoCure ASA (the Netherlands; PHCUF) |
Metvix |
Methyl aminolevulinate |
Skin cancer |
An FDA panel said Mevix would not be recommended for approval (9/11) |
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Spectrum Pharmaceuticals Inc. (SPPI) and GPC Biotech AG (Germany; FSE GPC) |
Satraplatin |
Oral platinum compound |
Hormone- refractory prostate cancer |
FDA granted fast-track status (9/22) |
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Telik Inc. (TELK) |
Telcyta |
A small-molecule prodrug that is activated by GST P1-1 |
Ovarian cancer |
FDA granted fast-track designation for Telcyta for third-line therapy in patients with platinum-refractory or -resistant ovarian cancer (9/3) |
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CARDIOVASCULAR | ||||
Nuvelo Inc. |
Alfimeprase |
Thrombolytic agent |
Acute peripheral arterial occlusion |
Data safety monitoring board recommended the Phase II trial continue, following analysis from first 36 patients (9/25) |
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Xechem International Inc. (XKEM) |
Niprisan |
A phytopharmaceutical drug; a composition of four traditional plants |
Sickle-cell disease |
FDA granted orphan drug designation (9/2) |
CENTRAL NERVOUS SYSTEM | ||||
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Cephalon Inc. (CEPH) |
Provigil (FDA-approved) |
Modafinil tablets; oral formulation of compound |
Sleepiness associated with sleep apnea |
FDA advisory panel recommended approval (9/26) |
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Endo Pharmaceuticals Inc. (subsidiary of Endo Pharmaceuticals Holdings Inc.; ENDP) |
DepoMorphine |
Morphine sulfate sustained-release liposome injection; an analgesic |
Post-operative pain |
FDA accepted the NDA for DepoMorphine (9/22) |
|
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Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc. |
Namenda |
Memantine; NMDA receptor antagonist |
Alzheimer's disease |
FDA panel recommended approval of the product (9/25) |
INFECTION | ||||
Cubist Pharmaceuticals Inc. (CBST) |
Cubicin (formerly Cidecin) |
Daptomycin for injection |
Skin infections |
FDA approved Cubicin for infections caused by Gram-positive bacteria (9/15) |
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Cubist Pharmaceuticals Inc. (CBST) |
Cubicin (formerly Cidecin) |
Daptomycin for injection |
Infective endocartitis |
Data monitoring board recommended continuation of Phase III trial, after review of first patient group (9/30) |
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IntraBiotics Pharmaceuticals Inc. (IBPI) |
Iseganan |
Antimicobial peptide; a protegrin |
To reduce the risk of pneumonia |
FDA granted fast-track status for isegnanan in patients receiving mechanical ventilation to reduce the risk of pneumonia (9/5); reached agreement with FDA on special protocol assessment (9/22) |
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MISCELLANEOUS | ||||
Amgen Inc. (AMGN) |
Cinacalcet |
Cinacalcet hydrochrloride, a calcimimetic |
Secondary hyperparathyroidism associated with chronic kidney disease |
Company filed an NDA (9/9) |
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Idun Pharmaceuticals Inc.* |
IDN-6556 |
Intended to protect livercells from apoptosis |
Liver and other solid organ transplantations |
FDA granted orphan drug status (9/24) |
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Inspire Pharmaceuticals Inc. (ISPH) |
-- |
Diquafosol tetrasodium ophthalmic solution |
Dry eye |
FDA accepted the NDA filing (9/9) |
|
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QLT Inc. (QLTI) |
Visudyne |
Light-activated therapy |
Subfoveal choroidal neovascularization |
FDA granted fast-track status to Visudyne therapy (9/18) |
|
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. |