Company*

(Country; Symbol)

Product

Description

Indication

Status

(Date)

Elan Corp. plc (Ireland; NYSE:ELN) and Biogen Idec Inc. (BIIB)

Tysabri (FDA-approved)

Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells

Crohn's disease

Elan and Biogen Idec submitted a supplemental BLA (12/15)

NicOx SA (France; Eurolist:NICOX)

HCT 3012

Naproxcinod; nitric oxide-donating derivative of naproxen

Osteoarthritis

FDA said a large cardiovascular outcomes study would not be required for NDA submission (12/11)

Nuvo Research Inc. (Canada; TSX:NRI)

Pennsaid

1.5% w/w diclofenac sodium solution; topical nonsteroidal antiinflammatory drug

Osteoarthritis of the knee

FDA issued an approvable letter (12/29)

Access Pharmaceuticals Inc. (AMEX:AKC)

MuGard

Oral rinse

Oral mucositis in cancer patients

FDA approved MuGard (12/13)

Adventrx Pharmaceuticals Inc. (AMEX:ANX)

ANX-530

Vinorelbine emulsion

Cancer

FDA accepted an IND and the company plans to start recruitment of 28 patients for a Phase I trial (12/26)

Biomira Inc. (Canada; BIOM; TSX:BRA)

Stimuvax

Liposomal vaccine encapsulating a sequence of the MUC1 cancer mucin

Non-small-cell lung cancer

Reached an agreement with the FDA on an SPA for a Phase III trial with about 1,300 patients (12/12)

Cyclacel Pharmaceuticals Inc. (CYCC)

CYC116

Orally available inhibitor of aurora kinases A and B and VEGFR2

Cancer

Submitted an IND to begin clinical trials (12/13)

Exelixis Inc. (EXEL)

XL518

A specific inhibitor of MEK

Cancer

Company submitted an IND to the FDA (12/21)

Genta Inc. (GNTA)

Genasense

Chemotherapy booster

Chronic lymphocytic leukemia

FDA declared the product non-approvable (12/15)

Hana Biosciences Inc. (HNAB)

Marqibo

Vincristine sulfate liposomes injection

Acute lympho-blastic leukemia

Hana filed a request for an SPA with the FDA for the design of a proposed registration trial (12/21)

IDM Pharma Inc. (IDMI)

Junovan

Mifamurtide for injection

Resectable high-grade osteosarcoma

FDA accepted for review the NDA (12/26)

Medarex Inc. (MEDX)

MDX-010

Ipilimumab; a fully human antibody against CTLA-4, a molecule on T cells

Metastatic melanoma

FDA granted fast-track designation for MDX-010 used in combination with chemotherapy in untreated patients and as a monotherapy in second-line patients (12/7)

Millennium Pharmaceuticals Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Mantle cell lymphoma

FDA granted full approval of Velcade to treat patients who have received at least one prior therapy (12/8)

Pharmacyclics Inc. (PCYC)

Xcytrin

Motexafin gadolinium; inhibits the enzyme thioredoxin reductase

Non-small-cell lung cancer metastasized to the brain

Company submitted its NDA based on pooled data from two Phase III trials (12/22)

Biopure Corp. (BPUR)

Hemopure

Hemoglobin glutamer-250 (bovine)

Hemorrhagic shock resulting from traumatic injury

FDA committee voted against the U.S. Navy's proposed Phase II/III 10,100-patient study, suggesting a pre-hospital Phase II/IIb study be designed in a smaller patient population (12/15)

Cardiome Pharma Corp. (Canada; CRME; TSX:COM) and Astellas Pharma U.S. Inc. (PK:ALPMF)

Vernakalant hydrochloride

Intravenous formulation

For the acute conversion of atrial fibrillation

Resubmitted the NDA (12/19)

Encysive Pharmaceuticals Inc. (ENCY)

Thelin

Sitaxsentan sodium

Pulmonary arterial hypertension

FDA informed the company that its response to the July 24 approvable letter is not complete (12/14); FDA accepted for review the company's complete response and issued a new PDUFA date of June 15 (12/29)

Medicure Inc. (Canada; AMEX:MCU; TSX:MPH)

MC-1

Naturally occurring small molecule that protects cardiomyocytes

Coronary artery bypass surgery

Completed an SPA with the FDA for the Phase III study, which will include about 3,000 patients (12/12)

ZymoGenetics Inc. (ZGEN)

RhThrombin

Recombinant human thrombin

To control bleeding during surgery

Company submitted a BLA to the FDA (12/18)

Labopharm Inc. (Canada; TSX:DDS)

Tramadol

Once-daily, controlled-release analgesic

Pain

Company submitted a complete response to the approvable letter (12/20)

Memory Pharmaceuticals Corp. (MEMY)

MEM 3454

Nicotinic alpha 7 receptor partial agonist

Alzheimer's disease

FDA completed its review of the IND and released the clinical hold; the Phase IIa trial will start in the first quarter of 2007 (12/11)

New River Pharmaceuticals Inc. (NRPH) and Shire plc (UK)

Vyvanse

Lisdexamfetamine dimesylate (formerly NRP104)

Attention deficit hyperactivity disorder

FDA issued a second approvable letter; it did not request any additional studies (12/22)

Pozen Inc. (POZN)

Trexima

Drug combines sumatriptan with naproxen sodium in a single tablet

Migraine

FDA completed its initial review of the company's response to the June 8 approvable letter and requested additional analyses and supporting information relating to the data submitted (12/13)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN)

Byetta (FDA-approved)

Exenatide; incretin mimetic

Type II diabetes

Received FDA approval to broaden the use in diabetics who are using a thiazolidinedione alone or in combination with metformin but have not achieved adequate glycemic control (12/22)

INFECTION

ISTA Pharmaceuticals Inc. (ISTA)

Bepotastine

Eye-drop formulation

Allergic conjunctivitis

Company filed an IND with the FDA to start a Phase II/III trial in the first quarter (12/21)

Neurorecovery Inc.*

Ampydin

4-Aminopyridine; immediate release version

Guillain-Barre syndrome

Received orphan drug status for chronic functional motor and sensory deficits resulting from Guillain-Barre syndrome (12/20)

Panacos Pharmaceuticals Inc. (PANC)

PA-1050040

Second-generation HIV maturation inhibitor

HIV

Company filed an IND with the FDA and plans to begin Phase I trials in the first quarter (12/22)

SIGA Technologies Inc. (SIGA)

SIGA-246

Orally active antiviral agent

Smallpox

Received orphan drug designation (12/20)

Theravance Inc. (THRX)

Telavancin

A bactericidal injectable antibiotic; lipoglycopeptide

Skin and skin structure infections caused by Gram-positive bacteria

Filed for FDA approval (12/8)

Trillium Therapeutics Inc.*

TTI-1612

Small, orally available receombinatn protein

Necrotizing enterocolitis

FDA and the European Medicines Agency designated TTI-1612 an orphan drug (12/19)

VaxGen Inc. (PK:VXGN)

rPA102

Recombinant anthrax vaccine

Anthrax

FDA's Center for Biologics Evaluation and Research maintained a clinical hold on the second Phase II trial due to concerns about the vaccine's stability (12/18)

MISCELLANEOUS

BioSante Pharmaceuticals Inc. (AMEX:BPA)

Bio-E-Gel (Elestrin)

Estradiol; topical estrogen

To treat hot flashes

FDA approved the product to treat moderate-to-severe vasomotor symptoms associated with menopause (12/18)

Genzyme Corp. (GENZ)

Renvela

Sevelamer carbonate; an improved formulation of Renagel (sevelamer hydrochloride)

Chronic kidney disease

Company filed an NDA with the FDA for the control of serum phosphorus levels in chronic kidney disease patients on dialysis (12/21)

ICo Therapeutics Inc.* (Canada)

iCo-007

An antisense drug that inhibits c-Raf

Eye disease

Company submitted an IND with the FDA (12/21)

Indevus Pharmaceuticals Inc. (IDEV)

Sanctura XR

Trospium chloride; a once-daily formulation

Overactive bladder

FDA accepted for review its NDA (12/13)

Vivus Inc. (VVUS)

EvaMist

A once-a-day transdermal spray that delivers estradiol

Vasomotor symptoms associated with menopause

FDA accepted for review the NDA (12/12)

Notes:

* Privately held.

BLA = Biologics license 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; NYSE = New York Stock Exchange; PK = Pink Sheets; TSX = Toronto Stock Exchange