(Country; Symbol)




Status (Date)


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)

La Jolla Pharmaceutical Co. (LJPC)


B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA


The FDA accepted for review the NDA for Riquent; the filing was made in December (2/17)


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)

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)

BioCryst Pharmaceuticals Inc. (BCRX)


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)

Celgene Corp. (CEGE)

Thalomid (FDA- approved)


Multiple myeloma

The FDA accepted for review the supplemental NDA for Thalomid (2/23)

CuraGen Corp. (CRGN)


Growth factor protein

Mucositis from radiation therapy

The FDA granted orphan designation to the product in that indication (2/25)

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)

Genta Inc. (GNTA) and Aventis Pharmaceuticals


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)

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)

Pharmion Corp. (PHRM)


Azacitidine for injectable suspension

Myelodysplastic syndromes

The FDA accepted the NDA for filing and granted it priority review (2/23)

Seattle Genetics Inc. (SGEN)


Monoclonal antibody that targets CD30+ hematologic malignancies

T-cell lymphomas

The FDA granted orphan designation to the product in T-cell lymphomas (2/26)


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)

ZLB Bioplasma Inc. (affiliate of ZLB Bioplasma AG; Switzerland)


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)


Sepracor Inc. (SEPR)


Eszopiclone tablets


The FDA issued an approvable letter, which did not call for any additional trials (2/28)


Acambis plc (UK; ACAM)


Live attenuated yellow fever vaccine

Yellow fever

Acambis withdrew its BLA filing because the manufacturing facility is not ready for inspection (2/19)

Access Pharmaceuticals Inc. (AMEX:AKC)


A mucoadhesive disc containing amlexanox

Canker sores

FDA completed the initial review on the NDA (2/19)

Genome Therapeutics Inc. (GENE)


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)

Nabi Biopharmaceuticals (NABI)


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)


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)

Anika Therapeutics Inc. (ANIK)


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)

Discovery Laboratories Inc. (DSCO)


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)

Indevus Pharmaceuticals Inc. (IDEV)


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)

ISTA Pharmaceuticals Inc. (ISTA)


Ovine hyaluronidase formulation

Spreading agent

The FDA delayed NDA review period by 90 days, extending the review date until May 5 (2/6)

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)


* 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.