Company* (Country; Symbol) Product Description


Status (Date)


Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland)


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

Multiple sclerosis

FDA advisory panel unanimously recommended reintroduction of drug as a treatment for relapsing forms of MS (3/8); the FDA extended its review by 90 days; action is expected by June 28 (3/22)


Amgen Inc. (AMGN)


Fully human monoclonal antibody directed against the epidermal growth factor receptor

Metastatic colorectal cancer

Completed rolling BLA submission that seeks approval for treating metastatic disease in patients who have failed prior chemotherapy (3/30)

Amgen Inc. (AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Chemotherapy-induced anemia

The FDA approved new every-three-week dosing schedule (3/27)

Celgene Corp. (CELG)


Lenalidomide; derivative of Thalomid (thalidomide)

Advanced multiple myeloma

The FDA granted priority review to the sNDA seeking approval for treating relapsed or refractory MM; the PDUFA date is June 30 (3/3)

ChemGenex Pharmaceuticals Ltd. (Australia; CXSP)


sHHT; homoharringtonine; apoptosis inducer and angiogenesis inhibitor

Chronic myeloid leukemia

The FDA granted orphan designation to the drug in that indication (3/19)

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

Rituxan (FDA-approved)

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

Non-Hodgkin's lymphoma

Filed supplemental BLA seeking approval as first-line treatment with chemotherapy in patients with low-grade or follicular, CD20-positive, B-cell NHL (3/30)

Genta Inc. (GNTA)


Oblimersen sodium; inhibits function of bcl-2 protein

Advanced chronic lymphocytic leukemia

The FDA accepted for review NDA seeking approval of the drug with chemotherapy for treating refractory/relapsed disease; the PDUFA date is Oct. 28 (3/1)

ImClone Systems Inc. (IMCL)

Erbitux (FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Head and neck cancer

The FDA approved second indication, for use with radiation therapy for treating advanced squamous cell carcinoma of the head and neck, and as a single agent in advanced disease not responsive to platinum-based treatment (3/1)

Pharmion Corp. (PHRM)

Vidaza (FDA-approved)

Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions

Myelodysplastic syndromes

Filed supplemental NDA with FDA seeking approval to allow for I.V. administration (3/30)

SciClone Pharmaceuticals Inc. (SCLN)


Synthetic preparation of thymosin alpha-1

Malignant melanoma

The FDA granted orphan designation to the product for treating Stage IIb through IV disease (3/20)


Cardiome Pharma Corp. (Canada; CRME)


Intravenous formulation of drug designed to selectively block ion channels in the heart

Atrial fibrillation

Cardiome and partner Astellas Pharma US Inc. submited an NDA seeking approval to market the intravenous formulation (3/31)

Encysive Pharmaceuticals Inc. (ENCY)


Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

The FDA issued an approvable letter outlining various concerns; it called for additional clinical work (3/24)

Myogen Inc. (MYOG)


Oral endothelin receptor antagonist

Pulmonary arterial hypertension

The FDA granted fast-track status to the product in that indication, for which Phase III trials are on-going (3/9)

United Therapeutics Corp. (UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary arterial hypertension

The FDA approved supplemental NDA based on Phase IV studies required under accelerated approval guidelines (3/21)


Avicena Group Inc. (OTC BB:AVGO)


Agent that incorporates ultra-pure form of creatine

Huntington's disease

The FDA granted orphan designation to the product in that indication (3/22)

Cephalon Inc. (CEPH)


New formulation and dosage of modafinil, the active ingredient in the approved product Provigil

Attention deficit/hyperactivity disorder

An FDA advisory committee recommended against approval, finding the drug was effective but saying more safety data were needed (3/23)

Medivation Inc. (OTC BB:MDVN)


Oral agent that's been used in Russia for more than 20 years

Huntington's disease

The FDA requested additional toxicology studies prior to the start of a proposed human clinical trial (3/1)

Nabi Bio-pharmaceuticals (NABI)


Nicotine conjugate vaccine

Nicotine addiction

The FDA granted fast-track designation for treating nicotine addiction (3/9)

Prestwick Pharmaceuticals Inc.*

Xenazine (tetrabenazine)

Dopamine depletor that works by selectively blocking the VMAT2 transporter

Chorea associated with Huntington's disease

The FDA issued an approvable letter that said certain undisclosed conditions must be met before it could be approved (3/31)


Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co.

Byetta (FDA-approved)

Exenatide; incretin mimetic

Type II diabetes

Filed supplemental NDA seeking approval as add-on therapy to thiazolidinediones in those not achieving acceptable blood sugar control (3/1)


Cerexa Inc.*


Next-generation, broad-spectrum, cephalosporin antibiotic

Complicated skin and skin structure infections

The FDA granted fast-track status to the drug for treating cSSSIs caused by methicillin-resistant Staphylococcus aureus (3/14)

Cubist Pharmaceuticals Inc. (CBST)

Cubicin (FDA-approved)

Daptomycin for injection; a bactericidal antibiotic

S. aureus bacteremia and endocarditis

The FDA issued an approvable letter on supplemental NDA; approval is subject to an agreement on labeling (3/24); submitted response to FDA (3/27)

Gilead Sciences Inc. (GILD)

Viread and Truvada (both FDA-approved)

Viread is a nucleotide reverse transcriptase inhibitor; Truvada combines Viread and Emtriva


The FDA granted traditional approval status to both products; accelerated approval for Viread was granted in October 2001 and for Truvada in August 2004 (3/8)

Medarex Inc. (MEDX) and PharmAthene Inc.*

Valortim (MDX-1303)

Fully human antibody that targets the Bacillus anthracis protective antigen

Anthrax infection

The FDA granted orphan designation to the product in that indication (3/6)

Transave Inc.*

SLIT Amikacin

Inhaled, sustained-release liposome formulation of amikacin

Pseudomonas aeruginosa infections

The FDA granted orphan designation to the product for treating bronchopulmonary P. aeruginosa infections in cystic fibrosis patients (3/23)


Aastrom Biosciences Inc. (ASTM)

Tissue Repair Cells

Autologous bone marrow-derived adult stem and progenitor cells


The FDA granted orphan designation to the product in that indication, for which studies were being planned (3/23)

BioDelivery Sciences International Inc. (BDSI)


Buccal tablet formulation of the approved agent prochlorperazine

Severe nausea and vomiting

The FDA issued non-approvable letter stating that additional information is needed (3/1)

NPS Pharmaceuticals Inc. (NPSP)


Recombinant human parathyroid hormone


The FDA issued approvable letter that calls for additional clinical information on hypercalcemia,and on the injection device (3/10)

PTC Therapeutics Inc.*


Oral agent that targets nonsense mutations

Duchenne muscular dystrophy

The FDA granted fast-track designation to the product for treating DMD due to a nonsense mutation in the dystrophin gene (3/30)

Savient Pharmaceuticals Inc. (SVNT)


Polyethylene glycol conjugate of uricase


Reached agreement with FDA on SPA for Phase III trials to test drug for controlling hyperuricemia in 200 nonresponding patients with symptomatic gout (3/21)


* 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.

OTC BB = Over-the-Counter Bulletin Board; NYSE = New York Stock Exchange.