Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-
approved)

Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood

Crohn's disease

FDA granted approval for Remicade to provide long-term remission level control of the debilitating symptoms of Crohn's disease (7/1)

CANCER

Aastrom
BioSciences Inc. (ASTM)

SC-1

Autologous bone marrow stem cells produced using the AastromReplicell system

Cancer

FDA granted orphan drug status for SC-1 (7/18)

Amgen Inc.
(AMGN)

Aranesp (FDA-
approved)

Darbepoetin alpha; a recombinant erythro-
poietic protein

Chemotherapy- induced anemia in patients with non-myeloid malignancies

FDA granted approval (7/22)

Antigenics Inc.
(AGEN)

Oncophage

Cancer vaccine; uses heat shock proteins to activate cellular immune responses

Metastatic
melanoma

FDA granted orphan drug status for Oncophage (7/23)

Aphton Corp.
(APHT)

G17DT

Antigastrin immunogen

Adenocarcinoma
of the pancreas and gastric cancer

FDA granted orphan drug status for G17DT (7/17)

Atrix Laboratories
Inc. (ATRX)

Eligard (FDA-
approved)

Leuprolide acetate for injectable suspension

Advanced prostate cancer

FDA approved Eligard (7/25)

CARDIOVASCULAR

Biopure Corp.
(BPUR)

Hemopure

Oxygen-carrying blood treatment

Acute anemia

Company filed a BLA with the FDA (7/31)

CENTRAL NERVOUS SYSTEM

Alkermes Inc.
(ALKS) and
Janssen Pharmaceutica Products LP

Risperdal Consta

A twice-monthly
injectable form of the anti-psychotic drug Risperdal

Psychosis

Companies received a not-approvable letter from the FDA (7/1)

Orphan Medical
Inc. (ORPH)

Xyrem

Sodium oxybate oral
solution

Cataplexy associated with narcolepsy

FDA approved Xyrem (7/18)

DIABETES

BioStratum
Inc.*

Pyridorin

Non-enzymatic glycoxidation inhibitor

Diabetic kidney disease

FDA granted fast-track status for Pyridorin (7/22)

INFECTION

BioMarin
Pharmaceutical Inc. (BMRN) and Genzyme General (GENZ)

Aldurazyme

Enzyme replacement therapy; laronidase

Mucopolysac- charidosis I

Companies completed the rolling BLA submission (7/29)

MedImmune
Inc. (MEDI)

FluMist

Intranasal influenza
vaccine

Influenza

FDA issued a complete response letter concerning the BLA and asked for more information, but did not stipulate that new trials must be conducted (7/11)

SuperGen Inc.
(SUPG)

Orathecin

Oral anticancer
compound

HIV

Company received orphan drug status from the FDA for pediatric patients infected with HIV (7/25)

MISCELLANEOUS

Exhale Therapeutics Inc.*

ETX-100

A pulmonary therapeutic

Alpha-1 antitrypsin deficiency

FDA granted orphan drug status to ETX-100 (7/16)

Insmed Inc.
(INSM)

Somato-
Kine

Recombinant protein
being developed as
an insulin sensitizer

Growth hormone insensitivity syndrome

FDA granted orphan drug designation to SomatoKine (7/18)

Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

BLA = Biologics License Application