Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Abbott
Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Early rheumatoid arthritis

Filed supplemental BLA with the FDA seeking approval in early RA (12/22)

Abbott
Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Psoriatic arthritis

Filed supplemental BLA with the FDA seeking approval in PA (12/16)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor- alpha

Ankylosing spondylitis

The FDA approved the drug in that additional indication (12/21)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Psoriatic arthritis

The FDA accepted for filing the supplemental BLA for treating PA patients with active disease (12/1)

CANCER

Active Biotech
(Sweden; SSE:ACTI)

TTS CD3

Tumor-targeted superantigen

Non-small-cell lung cancer

The FDA granted fast-track status to the product, which is in Phase I trials in NSCLC (12/1)

Amgen Inc.
(AMGN)

Kepivance

Palifermin; recombinant human keratinocyte growth factor

Oral mucositis in cancer patients

The FDA approved the drug for severe oral mucositis in patients with blood cancers undergoing high-dose chemotherapy followed by a bone marrow transplant (12/15)

Amgen Inc.
(AMGN)

AMG 706

Oral multi-kinase inhibitor that selectively targets vascular endothelial growth factors

Gastrointestinal stromal tumors

The FDA granted fast-track designation to the product, which is in Phase II trials (12/6)

CuraGen Corp.
(CRGN)

CG53135

Growth factor that promotes both epithelial and mesenchymal cell proliferation

Oral mucositis in cancer patients

The FDA granted fast-track designation to the product for treating OM from hematopoietic stem cell transplantation following myeloablative chemotherapy (12/2)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD20

Human antibody that binds to the CD20 antigen

Chronic lymphocytic leukemia

The FDA granted fast-track status to the drug for patients with CLL who have failed fludarabine therapy (12/16)

Genzyme
Corp.
(GENZ)

Clolar (clofarabine)

Second-generation purine nucleoside analogue

Pediatric leukemia

The FDA approved the drug for treating children with refractory or relapsed acute lymphoblastic leukemia (12/29)

ILEX
Oncology
Inc.
(merged
with Genzyme
Corp., GENZ)

Clofarabine

Second-generation purine nucleoside analogue

Pediatric leukemias

FDA advisory panel recommended approval of the drug in pediatric refractory or relapsed acute lymphoblastic leukemia but not in acute myeloid leukemia (12/1)

Inex
Oncology Corp.
(Canada; TSE:IEO)
and Enzon
Pharmaceuticals
Inc.
(ENZN)

Marqibo (Onco TCS)

Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology

Non-Hodgkin's lymphoma

An FDA advisory panel voted unanimously against recommending accelerated approval of the drug for treating relapsed, aggressive NHL (12/1)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

The FDA accepted for review the supplemental NDA and granted priority review for treating MM patients who have received at least one prior therapy (12/1)

PhotoCure ASA
(Norway; OSE:PHO)

Metvix (FDA-approved)

Methyl aminolevulinate

Basal-cell carcinoma

The FDA said the NDA was not approvable (12/3)

QLT Inc.
(Canada; QLTI)

Eligard (FDA-approved)

Leuprolide acetate for injectable suspension; LHRH agonist

Prostate cancer

The FDA approved the six-month formulation for the palliative treatment of advanced prostate cancer (12/15)

CARDIOVASCULAR

Amgen Inc.
(AMGN)

AMG 531

Peptibody; a platelet growth factor

Immune thrombocytopenic purpura

The FDA granted fast-track designation to the product (12/6)

CoTherix Inc.
(CTRX)

Ventavis

Inhaled formulation of iloprost, a prostacyclin analogue

Pulmonary arterial hypertension

The FDA approved the product for treating PAH in patients with NYHA Class III or IV symptoms (12/29)

NitroMed
Inc.
(NTMD)

BiDil

Nitric oxide-enhancing oral agent

Heart failure in African-Americans

Completed filing of an amendment to its NDA (12/23)

CENTRAL NERVOUS SYSTEM

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Pseudobulbar affect

Began submission of rolling NDA; the filing is expected to be completed in 1H:05 (12/16)

Cephalon
Inc.
(CEPH)

Actiq (FDA-approved)

Oral transmucosal fentanyl citrate

Pain in cancer patients

Filed supplemental NDA with the FDA seeking approval of a sugar-free formulation of the drug (12/1)

Labopharm
Inc.
(Canada;
TSE:DDS)

--

Once-daily formulation of the analgesic tramadol

Pain

Finalized SPA with the FDA for the ongoing Phase III trial (MDT3-005) (12/16)

Savient
Pharmaceuticals
Inc.
(SVNT)

Nuflexxa

1% sodium hyaluronate

Pain in osteoarthritis of the knee

The FDA approved the company's premarket approval application (12/7)

Sepracor
Inc.
(SEPR)

Lunesta (formerly Estorra)

Eszopiclone tablets

Insomnia

The FDA approved the drug for treating those who have difficulty falling asleep, as well as for those unable to sleep through the night (12/16)

INFECTION

Vicuron
Pharmaceuticals
Inc.
(MICU)

Dalbavancin

Glycopeptide agent from the same class as vancomycin

Complicated skin and soft-tissue infections

Filed NDA with the FDA seeking approval for treating cSSTIs caused by Gram-positive bacteria (12/21)

MISCELLANEOUS

Cellegy
Pharmaceuticals
Inc.
(CLGY)

Cellegesic

Nitroglycerin ointment

Pain from anal fissures

The FDA issued a not-approvable letter; Cellegy is considering its options (12/23)

Chiron Corp.
(CHIR)

Pulminiq

Cyclosporine inhalation solution

For use in patients getting lung transplants

The FDA accepted the NDA filing and designated it for priority review; the NDA was filed in October (12/15)

Eyetech
Pharmaceuticals
Inc.
(EYET)

Macugen

Pegaptanib sodium injection; pegylated anti-VEGF aptamer

Wet age-related macular degeneration

The FDA approved Macugen, which will be marketed by Eyetech and Pfizer Inc. (12/17)

Inamed Corp.
(IMDC) and
Genzyme
Corp.
(GENZ)

Captique

Dermal filler product based on Genzyme's non-animal stabilized hyaluronic acid technology

Correction of moderate to severe facial wrinkles

The FDA approved the product, which Inamed will market (12/2)

ISTA
Pharmceuticals
Inc.
(ISTA)

Vitrase (FDA-approved)

Ovine hyaluronidase formulation

For use as a spreading agent

The FDA approved a single-use vial of the already- approved product (12/3)

PTC
Therapeutics
Inc.*

PTC124

Oral agent that targets nonsense mutations

Cystic fibrosis

The FDA granted orphan designation to the drug for treating CF due to a nonsense mutation in the CFTR gene (12/8)

Santarus Inc.
(SNTS)

Zegerid

Immediate-release capsule formulation of the proton pump inhibitor omeprazole

Gastrointestinal conditions

The FDA approved the drug for reducing the risk of upper GI bleeding in critically ill patients and for short- term treatment of active benign gastric ulcers (12/22)


Notes:

* Privately held.

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application;

NDA = New drug application; SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; OSE = Oslo Stock Exchange; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange.

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