Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
La Jolla Pharmaceutical Co. (LJPC) |
Riquent |
B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
La Jolla submitted an NDA seeking approval in treatment of patients with lupus who are at risk of renal disease (12/16) |
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CANCER | ||||
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Allos Therapeutics Inc. (ALTH) |
RSR13 |
Efaproxiral; small-molecule radiation sensitizer |
Brain metastases from breast cancer |
Allos submitted the final component of its NDA to market the drug as an adjunct to whole-brain radiation therapy (12/4) |
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AmpliMed Corp.* |
Amplimexon |
Imexon injection |
Pancreatic cancer |
FDA granted the product orphan designation in that indication (12/4) |
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Genentech Inc. (NYSE:DNA) |
Avastin |
Antibody designed to inhibit VEGF |
First-line metastatic colorectal cancer |
The FDA accepted the Avastin BLA for filing; it is under priority review, with action expected by the end of March 2004 (12/1) |
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Genta Inc. (GNTA) |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced malignant melanoma |
Genta completed its NDA submission of drug in combination with dacarbazine (12/9) |
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Inex Pharmaceuticals Corp. (Canada; TSE:IEX) |
Onco TCS |
Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology |
Relapsed, aggresive non-Hodgkin's lymphoma |
Inex submitted the chemistry, manufacturing and control section of an NDA to the FDA; the complete filing is expected in 1Q:04 (12/2) |
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Millennium Pharmaceuticals Inc. (MLNM) |
MLN2704 |
Monoclonal antibody directed at prostate-specific antigen conjugated to chemotherapeutic agent DM1 |
Metastatic androgen- independent prostate cancer |
FDA granted fast-track status to the product (12/4) |
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Pharmacyclics Inc. (PCYC) |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class |
Brain metastases from non-small-cell lung cancer |
The FDA granted fast-track status to Xcytrin (12/2) |
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Telik Inc. (TELK) |
Telcyta |
Small-molecule pro-drug |
Third-line therapy for metastatic non-small-cell lung cancer |
FDA granted Telcyta fast-track status (12/2) |
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CARDIOVASCULAR | ||||
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Alexion Pharmaceuticals Inc. (ALXN) |
Eculizumab |
A humanized monoclonal antibody C5 complement inhibitor |
Paroxysmal nocturnal hemoglobinuria |
The FDA designated the product orphan status in that indication (12/8) |
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CV Therapeutics Inc. (CVTX) |
Ranexa |
Ranolazine; partial inhibitor of fatty-acid oxidation |
Angina |
FDA briefing document before panel meeting pointed to safety concerns; panel members suggested the drug was approvable pending another trial in a broader patient population (12/9) |
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Miravant Medical Technologies Inc. (MRVT) |
PhotoPoint MV2101 |
Photodynamic therapy |
Hemodialysis access graft disease |
The FDA granted orphan drug designation to the drug for preventing the disease in patients with new vascular grafts (12/18) |
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Pharmion Corp. (PHRM) |
Vidaza |
Azacitidine for injectable suspension; demethylating agent |
Myelodysplastic syndromes |
Pharmion submitted an NDA for the product, which has orphan and fast-track status (12/29) |
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DIABETES | ||||
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Amylin Pharmaceuticals Inc. (AMLN) |
Symlin |
Pramlintide acetate; an analogue of human amylin |
Types I and II diabetes |
Amylin received a second approvable letter from the FDA that asked for additional data on patient populations and methods of use (12/17) |
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Insmed Inc. (INSM) |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Extreme insulin resistance |
The FDA granted orphan designation to the drug in that indication (12/15) |
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INFECTION | ||||
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Acambis plc (UK; ACAM) |
Arilivax |
Live, attenuated vaccine to prevent yellow fever |
Yellow fever |
Acambis filed a BLA with the FDA seeking approval of the vaccine; the product, approved in 10 countries, is sold outside the U.S. by Chiron Corp. (12/12) |
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Stressgen Biotechnologies Corp. (Canada; TSE:SSB) |
HspE7 |
Heat-shock protein |
Recurrent respiratory pappilomatosis |
The FDA designated HspE7 a fast-track product (12/4) |
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Trimeris Inc. (TRMS) and Hoffmann-La Roche Inc. |
Fuzeon (FDA-approved) |
Enfuvirtide; HIV fusion inhibitor |
HIV |
Companies submitted 48-week data to FDA to support application for full approval; drug has accelerated approval (12/16) |
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MISCELLANEOUS | ||||
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Altus Biologics Inc.* |
TheraCLEC |
Oral enzyme-replacement therapy |
Malabsorption due to exocrine pancreatic insufficiency |
The FDA designated TheraCLEC a fast-track product (12/1) |
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Anika Therapeutics Inc. (ANIK) |
Orthovisc |
High-molecular-weight form of hyaluronic acid |
Osteoarthritis of the knee |
The FDA issued an approvable letter on the premarket approval application, pending inspection of the manufacturing facility (12/2) |
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Cardiome Pharma Corp. (Canada; TSE:COM) |
Oxyprim (oxypurinol) |
Xanthine oxidase inhibitor that is the active metabolite of allopurinol |
Gout |
Cardiome submitted an NDA seeking approval for treating allopurinol-intolerant hyperuricemia (gout); drug has orphan status (12/23) |
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Dyax Corp. (DYAX) and Debiopharm SA* (Switzerland) |
DX-890 |
Protein inhibitor of human neutrophil elastase |
Cystic fibrosis |
FDA granted orphan designation to the drug for CF (12/15) |
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Inspire Pharmaceuticals Inc. (ISPH) |
Diquafosol tetrasodium |
Ophthalmic solution |
Dry eye |
FDA sent approvable letter asking for an additional clinical study; Inspire plans to ask if study completed after NDA filing would be sufficient (12/22) |
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Nastech Pharmaceutical Co. Inc. (NSTK) and Questcor Pharmaceuticals Inc. |
Nascobal |
Nasally delivered formulation of cyanocobalamin |
Vitamin B-12 deficiency |
Companies filed NDA seeking approval of new formulation; Nastech developed the product and Questcor owns worldwide rights (12/30) |
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Ortec International Inc. (OTC BB:ORTN) |
OrCel |
Collagen sponge seeded with allogeneic epidermal and dermal cells |
Venous leg ulcers |
Ortec submitted the first of two modules of its premarket approval application; the filing was scheduled to be completed by the end of January 2004 (12/23) |
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Serono SA (Switzerland; NYSE:SRA) |
Zorbtive (FDA-approved) |
Somatropin for injection; also named Serostim |
Short bowel syndrome |
The FDA approved the recombinant human growth hormone (12/2) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
ASX = Australian Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
