Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Centocor Inc. (unit of Johnson & Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Chronic severe plaque psoriasis

The FDA expanded label, approving drug to treat chronic severe plaque psoriasis in adults when other systemic therapies are medically less appropriate (9/27)

CANCER

Abraxis BioScience Inc. (ABBI)

Abraxane

Paclitaxel protein-bound particles for injection; albumin-bound

Breast cancer

FDA advisory panel recommended against approval for use in the adjuvant treatment of node-positive breast cancer (9/7)

Amgen Inc. (AMGN)

Vectibix (panitumumab)

Fully human monoclonal antibody directed against the epidermal growth factor receptor

Metastatic colorectal cancer

The FDA approved the drug for treating EGFr-expressing metastatic colorectal cancer that progresses despite other treatments (9/27)

Callisto Pharmaceuticals Inc. (AMEX:KAL)

Atiprimod

Small-molecule agent designed to inhibit VEGF and interleukin-6

Carcinoid tumors

The FDA granted orphan designation to the product in that indication (9/26)

Genentech Inc. (NYSE:DNA) and Biogen Idec Inc. (BIIB)

Rituxan (FDA-approved)

Rituximab; antibody that targets and depletes CD20-positive B cells

Non-Hodgkin's lymphoma

The FDA approved two additional uses in patients with CD20-positive, B-cell NHL: for first-line treatment of previously untreated patients with follicular NHL in combination with CVP regimen, and for low-grade NHL in patients with stable disease or who have responded to CVP (9/29)

Genentech Inc. (NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Advanced breast cancer

The FDA requested additional data from Phase III trial with paclitaxel; company plans to resubmit BLA in mid-2007 (9/11)

Genta Inc. (GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced chronic lymphocytic leukemia

FDA advisory panel voted against recommending approval of the product in that indication (9/5)

Protherics plc (UK; LSE:PTI)

Voraxaze

Product containing the recombinant enzyme glucarpidase

Toxicity from methotrexate

Submitted BLA with FDA, seeking approval as an adjunctive therapy in those experiencing or at risk of toxicity from the cancer agent methotrexate (9/18)

Threshold Pharmaceuticals Inc. (THLD)

Glufosfamide

Small molecule containing a glucose molecule and an alkylator

Pancreatic cancer

The FAD granted orphan designation to the drug in that indication, for which Phase II and III trials are ongoing (9/28)

CARDIOVASCULAR

Alexion Pharmaceuticals Inc. (ALXN)

Soliris (eculizumab)

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Submitted a BLA with the FDA, seeking approval for treating the rare genetic blood disorder (9/20)

CENTRAL NERVOUS SYSTEM

Cephalon Inc. (CEPH)

Fentora

Fentanyl buccal tablet

Pain

The FDA approved the drug for managing breakthrough pain in cancer patients already receiving opioid therapy (9/25)

Labopharm Inc. (Canada; TSX:DDS)

--

Once-daily formulation of the analgesic tramadol

Pain

FDA issued approvable letter on NDA filed in November 2005; it was not clear if new trials would be needed (9/29)

Vernalis plc (UK; VNLS) and Endo Pharmaceuticals Inc. (ENDP)

Frova (FDA-approved)

Frovatriptan; 5HT 1B/1D agonist

Menstrually related migraine

The FDA accepted for filing the supplemental NDA that was submitted in July (9/20)

INFECTION

Oscient Pharmaceuticals Corp. (OSCI)

Factive (FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone antibiotic

Community-acquired pneumonia

The FDA issued an approvable letter on supplemental NDA, asking for data clarification; company believes no new trials will be needed (9/22)

Oscient Pharmaceuticals Corp. (OSCI)

Factive (FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone antibiotic

Acute bacterial sinusitis

FDA panel recommended against approving supplemental NDA in that indication and said a study showing superiority was called for (9/12)

MISCELLANEOUS

DOR BioPharma Inc. (AMEX:DOR)

orBec

Oral formulation of beclomethasone dipropionate; a corticosteroid

Gastrointestinal graft-vs.-host disease

Filed NDA with the FDA, seeking approval in that indication (9/22)

Ortec International Inc. (OTC BB:ORTN)

OrCel

Collagen sponge seeded with allogeneic epidermal and dermal cells

Epidermolysis bullosa

FDA said humanitarian device exemption for use in hand reconstruction and donor sites in EB patients was approvable pending inspection of manufacturing facility (9/29)


Notes:

* Privately held.

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration;

IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act;

SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange.

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