Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Cambridge Antibody Technology Group plc (UK; CATG; LSE:CAT) and Abbott Laboratories Inc.

D2E7

Monoclonal antibody; adalimumab

Rheumatoid arthritis

CAT and Abbott submitted D2E7 for approval in the U.S. and and Europe (4/17**)

XOMA Ltd. (XOMA) and Genentech Inc. (NYSE:DNA)

Xanelim

Efalizumab; humanized antibody

Psoriasis

Companies said an FDA-requested pharmacokinetic study comparing XOMA-produced material and Genentech-produced material did not achieve the predefined statistical definition for comparability (4/5)

CANCER

Atrix Laboratories
Inc. (ATRX)

Eligard (FDA-
approved)

30-mg four-month leuprolide acetate depot product

Advanced prostate cancer

Company submitted an NDA (4/16)

Dendreon Corp.
(DNDN)

Mylovenge

Cancer vaccine designed to trigger the immune system

Multiple myeloma

FDA granted orphan drug status (4/24)

Dendreon Corp.
(DNDN)

Provenge

Therapeutic vaccine

Hormone-
resistant prostate cancer

FDA told Dendreon to stop enrolling patients in a second Phase III trial due to questions relating to specific composition of cellular components of Provenge (4/30)

CARDIOVASCULAR

AnorMED Inc. (Canada; TSE:AOM) and Shire Pharmaceuticals Group plc (UK)

Foznol

Lanthanum carbonate

Elevated blood phosphate levels, in patients with end-stage kidney disease

Shire submitted an NDA to the FDA (4/30)

ISTA Pharmaceu-
ticals Inc. (ISTA)

Vitrase

Injectable enzyme; hyaluronidase

Vitreous hemorrhage

FDA said the company can proceed with an NDA, considering visual acuity as the primary endpoint (4/10)

Texas Biotech-
nology Corp. (TXBI)

Argatroban
(FDA-
approved)

A direct thrombin inhibitor anticoagulant

Heparin-induced thrombocytopenia

FDA approved the supplemental NDA for the new use of Argatroban as an anticoagulant in patients with, or at risk for, heparin-induced thrombocytopenia (4/9)

CENTRAL NERVOUS SYSTEM

Orphan Medical
Inc. (ORPH)

Xyrem

Sodium oxybate oral solution

Cataplexy associated with narcolepsy

FDA issued an approvable letter (4/10)

INFECTION

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

Aldurazyme

Laronidase; an enzyme replacement therapy

Mucopoly-
saccharidosis I

Companies filed the first portion of a rolling BLA (4/15)

MISCELLANEOUS

Cellegy Pharma-
ceuticals Inc. (CLGY)

Cellegesic

Nitroglycerin ointment

Anal fissures

Company decided to withdraw its NDA after the FDA refused to approve the drug without more information (4/26)

ICOS Corp. (ICOS)
and Eli Lilly and Co.

Cialis

Tadalafil; an oral PDE5 inhibitor

Erectile dysfunction

FDA issued an approvable letter, which required additional pharmacology studies (4/30)

Repligen Corp.
(RGEN)

SecreFlo

Synthetic porcine secretin

To diagnose pancreatic exocrine dysfunction, or chronic pancreatitis

FDA granted approval to market SecreFlo (4/5)

Notes:

* Privately held

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

LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application