Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Inc. (BGEN)

Amevive

Alefacept; novel immuno-modulatory agent that selectively targets the CD45RO+ subset of T cells

Psoriasis

The Dermatologic and Ophthalmic Ophthalmic Drugs Advisory Committee recommended approval of Amevive (5/23)

CANCER

Antigenics Inc. (AGEN)

Oncophage

Vaccine; uses heat shock proteins to activate cellular immune responses

Renal cell carcinoma

FDA granted orphan drug status for Oncophage (5/29)

CancerVax Corp.*

Canvaxin

Allogeneic; whole-cell vaccine that expresses over 20 antigens

Cancer

FDA asked the company to provice certain information related to the production, characterization and testing of Canvaxin; it has placed a hold on the Phase III trial (5/2)

Corixa Corp. (CRXA)

Bexxar

A radioimmunotherapy; tositumomab, iodine-131

Non-Hodgkin's lymphoma

Company is requesting an appeal of the FDA's complete review letter that said additional clinical studies are necessary to win marketing approval (5/15); Corixa filed a request for formal dispute of resolution and also requested the opportunity to present Bexxar safety and efficacy data to the Oncologic Drugs Advisory Committee (5/31)

Genentech Inc. (NYSE:DNA)

Tarceva

Small-molecule epidermal growth factor receptor inhibitor

Non-small-cell lung cancer

FDA designated Tarceva a fast-track product (5/14)

Ilex Oncology Inc. (ILXO)

Campath (FDA-approved)

Alemtuzumab; humanized monoclonal antibody

Cancer

Company filed a supplemental BLA based on two-year follow-up data in patients who have been treated with alkylating agents and failed fludarabine (5/21)

ImClone Systems Inc. (IMCL)

Erbitux

Cetuximab; designed to target and block the epidermal growth factor receptor

Cancer

Company plans to run several more trials in the U.S. to satisfy the FDA's questions in order to seek approval (5/22)

MediGene AG (Germany; Neuer Markt:MDG)

G207

Modified herpes simplex virus that has been genet ically engineered to selectively multiply in tumor cells and cause cancer cell death without harm to healthy tissue

Malignant glioma

FDA granted orphan drug designation to G207 (5/8)

NaPro Biotherapeutics Inc. (NPRO) and Abbott Laboratories Inc.

Paclitaxel injection

Metastatic cancer of the ovary and metastatic breast cancer

Companies received approval from the FDA to market paclitaxel injection (5/9)

NeoPharm Inc. (NEOL)

IL13-PE38

Tumor-targeting product

Malignant glioma

FDA granted fast-track designation to the product (5/6)

SuperGen Inc. (SUPG)

MitoExtra

Mitomycin; designed to produce a stable, ready-to-inject anticancer solution with commercially attractive shelf life at room temperature

Cancer

FDA accepted as complete the company's amendment to its NDA (5/23)

CARDIOVASCULAR

United Therapeutics Corp. (UTHR)

Remodulin

Treprostinil sodium; subcutaneous treatment

Pulmonary arterial hypertension

FDA approved Remodulin (5/23)

CENTRAL NERVOUS SYSTEM

Orphan Medical Inc. (ORPH)

Xyrem

Sodium oxybate oral solution

Cataplexy associated with narcolepsy

Company submitted a complete response to the FDA to address issues raised in an approvable letter received from the agency April 9 (5/17); FDA accepted the complete response (5/23)

Penwest Pharmaceuticals Co. (PPCO)

Lexapro

A prescription drug formulated with Penwest's Prosolv; a single-isomer selective serotonin reuptake inhibitor; escitalopram

Major depressive disorder

FDA issued an approvable letter (5/29)

INFECTION

Berna Biotech Ltd.* (Switzerland)

Aerugen

Vaccine

Pseudomonas aeruginosa infection

Company received orphan status in the U.S. for its Aerugen vaccine (5/22**)

ViroPharma Inc. (VPHM) and Aventis Pharmaceuticals

Picovir

Works by inhibiting the ongoing viral replication of picornavirus capsid, a protective shell of the virus that is necessary for infection and transmission

Common cold

Company said the FDA intends to issue a not-approvable letter for the NDA (5/10)

MISCELLANEOUS

Repligen Corp. (RGEN)

SecreFlo (FDA-approved)

A synthetic porcine secretin

Pancreas divisum

Company filed a supplemental NDA to support the use of SecreFlo to aid in the location and cannulation of the minor pancreatic duct in patients with pancreas divisum undergoing endoscopic retrograde chol-angiopancreatography (5/28)


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.

NYSE = New York Stock Exchange

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