Company* |
Product | Description |
Indication | Status (Date) |
AUTOIMMUNE | ||||
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Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland) |
Antegren (natalizumab) |
Humanized monoclonal anti- body; alpha-4 antagonist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
Companies said, after talk with FDA, they plan to file for approval on one-year instead of two-year data; BLA is expected in mid-2004 (2/18) |
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La Jolla Pharmaceutical Co. (LJPC) |
Riquent |
B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
The FDA accepted for review the NDA for Riquent; the filing was made in December (2/17) |
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CANCER | ||||
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Allos Therapeutics Inc. (ALTH) |
RSR13 (efaproxiral) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
The FDA accepted for review the NDA for RSR13 as an adjunct to whole-brain radiation therapy, and designated it for priority review (2/3) |
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Atrix Laboratories Inc. (ATRX) |
Eligard (FDA- approved) |
Leuprolide acetate for injectable suspension |
Prostate cancer |
Atrix submitted an NDA, seeking approval of the 45-mg dosage in patients with advanced, homone- sensitive disease (2/23) |
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BioCryst Pharmaceuticals Inc. (BCRX) |
BCX-1777 |
Purine nucleoside phosphorylase inhibitor; blocks T-cell synthesis |
T-cell non- hodgkin's lymphoma |
The FDA granted orphan desig- nation in that indication, in which a Phase II trial is planned (2/5) |
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Celgene Corp. (CEGE) |
Thalomid (FDA- approved) |
Thalidomide |
Multiple myeloma |
The FDA accepted for review the supplemental NDA for Thalomid (2/23) |
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CuraGen Corp. (CRGN) |
CG53135 |
Growth factor protein |
Mucositis from radiation therapy |
The FDA granted orphan designation to the product in that indication (2/25) |
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Genentech Inc. (NYSE:DNA) |
Avastin (bevacizumab) |
Antibody designed to inhibit vascular endothelial growth factor |
Metastatic colorectal cancer |
The FDA approved Avastin in combination with 5-FU for treating first-line metstatic colorectal cancer (2/26) |
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Genta Inc. (GNTA) and Aventis Pharmaceuticals |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced melanoma |
The FDA accepted the NDA on the drug and granted it priority review status (2/6) |
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ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co. |
Erbitux (cetuximab) |
Antibody designed to block the epidermal growth factor receptor |
Colorectal cancer |
The FDA granted approval of the drug in patients with metastatic disease who are refractory to or intolerant of irinotecan (2/12) |
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Pharmion Corp. (PHRM) |
Vidaza |
Azacitidine for injectable suspension |
Myelodysplastic syndromes |
The FDA accepted the NDA for filing and granted it priority review (2/23) |
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Seattle Genetics Inc. (SGEN) |
SGN-30 |
Monoclonal antibody that targets CD30+ hematologic malignancies |
T-cell lymphomas |
The FDA granted orphan designation to the product in T-cell lymphomas (2/26) |
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CARDIOVASCULAR | ||||
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United Therapeutics Corp. (UTHR) |
Remodulin (FDA- approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
Company filed a supplemental application seeking to add intra- venous route of delivery to label (2/2) |
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ZLB Bioplasma Inc. (affiliate of ZLB Bioplasma AG; Switzerland) |
Rhophylac |
Plasma-derived Rh0 immune globulin, intravenous |
Hemolytic disease of the fetus and newborn |
The FDA approved the product, which was approved in Switzerland in 1996 and introduced across Europe in 2002 (2/17) |
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CENTRAL NERVOUS SYSTEM | ||||
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Sepracor Inc. (SEPR) |
Estorra |
Eszopiclone tablets |
Insomnia |
The FDA issued an approvable letter, which did not call for any additional trials (2/28) |
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INFECTION | ||||
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Acambis plc (UK; ACAM) |
Arilvax |
Live attenuated yellow fever vaccine |
Yellow fever |
Acambis withdrew its BLA filing because the manufacturing facility is not ready for inspection (2/19) |
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Access Pharmaceuticals Inc. (AMEX:AKC) |
OraSure |
A mucoadhesive disc containing amlexanox |
Canker sores |
FDA completed the initial review on the NDA (2/19) |
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Genome Therapeutics Inc. (GENE) |
Ramoplanin |
Naturally occurring antibiotic |
Clostridium difficile-associated diarrhea |
FDA granted fast-track status to the product in that indication, for which Ramoplanin is in Phase II testing (2/18) |
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Nabi Biopharmaceuticals (NABI) |
Altastaph |
Product containing anti- bodies to protective outer sugar coatings on Staphylococcus aureus bacteria |
S. aureus infections in low-birth-weight infants |
The FDA granted orphan designation to the product in that indication; the drug is in Phase II trials (2/11) |
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MISCELLANEOUS | ||||
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Adolor Corp. (ADLR) |
Entereg (alvimopan) |
Mu opioid antagonist |
Postoperative ileus |
The FDA designated Entereg a fast-track product; it is being developed with GlaxoSmithKline plc (2/24) |
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Anika Therapeutics Inc. (ANIK) |
Orthovisc |
High-molecular-weight form of hyaluronic acid |
Pain from osteoarthritis of the knee |
The FDA granted marketing approval to the product, which will be sold in the U.S. by Ortho Biotech Products LP (2/5) |
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Discovery Laboratories Inc. (DSCO) |
Surfaxin |
Engineered version of natural human lung surfactant |
Acute respiratoy distress syndrome |
FDA selected drug for Continuous Marketing Application Pilot 2 Program, expected to expedite development (2/19) |
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Indevus Pharmaceuticals Inc. (IDEV) |
Trospium |
Muscarinic receptor antagonist |
Overactive bladder |
The FDA extended by 90 days the NDA review period on the drug; action is expected by May 28 (2/13) |
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ISTA Pharmaceuticals Inc. (ISTA) |
Vitrase |
Ovine hyaluronidase formulation |
Spreading agent |
The FDA delayed NDA review period by 90 days, extending the review date until May 5 (2/6) |
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Neurochem Inc. (Canada; NRMX) |
Fibrillex glycan mimetic |
Oral agent designed to prevent amyloid fibrilformation; glycosamino- |
Amyloid A amyloidosis |
The FDA designated the drug fast-track status; the drug is in a pivotal Phase II/III trial (2/11) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange. | ||||
