Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

CANCER

Adherex Technologies Inc. (AMEX:ADH)

Eniluracil

Oral dihydropyrimidine dehydrogenase inhibitor

Hepatocellular cancer

The FDA granted orphan designation to the drug with fluoropyrimidines for treating liver cancer (12/21)

Celgene Corp. (CELG)

Revlimid

Lenalidomide; derivative of Thalomid (thalidomide)

Myelodysplastic syndromes

The FDA approved the product for treating transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality (12/28)

Enzon Pharmaceuticals Inc. (ENZN)

Oncaspar (FDA-approved)

PEG-enhanced version of the naturally occurring enzyme L- asparaginase

Acute lymphoblastic leukemia

The FDA accepted supplemental BLA filing, which seeks approval of use of the pediatric product in first-line treatment (12/1)

Genentech Inc. (NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Relapsed, metastatic colorectal cancer

Filed supplemental BLA with the FDA seeking approval for use with 5-FU in treating relapsed, metastatic disease (12/19)

Genta Inc. (GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced chronic lymphocytic leukemia

Filed NDA with FDA seeking approval of drug with chemotherapy for treating refractory/relapsed disease (12/29)

GPC Biotech (Germany; FSE:GPC)

Satraplatin

Oral platinum compound

Hormone-refractory prostate cancer

GPC began rolling NDA submission for drug in combination with prednisone as a second-line chemotherapy treatment (12/15)

MGI Pharma Inc. (MOGN) and SuperGen Inc. (SUPG)

Dacogen

Decitabine for injection; a hypomethylating agent

Myelodysplastic syndromes

The FDA accepted resubmission of data as a complete response to approvable letter issued in September (12/15)

Onyx Pharmaceuticals Inc. (ONXX) and Bayer Pharmaceuticals Corp.

Nexavar (sorafenib)

RAF kinase and VEGF inhibitor

Advanced renal cell carcinoma

The FDA approved the product for treating advanced kidney cancer (12/20)

ViaCell Inc. (VIAC)

CB001

Hematopoietic stem cells selectively amplified from umbilical cord blood

Stem cell transplants in cancer applications

The FDA lifted clinical hold that was placed on company's Phase I trial (12/19)

CARDIOVASCULAR

The Medicines Co. (MDCO)

Angiomax (FDA-approved)

Bivalirudin; direct thrombin inhibitor

Anticoagulant

The FDA expanded the label to include patients with or at risk of heparin-induced thrombocytopenia and thrombosis syndrome undergoing percutaneous coronary intervention (12/1)

Nuvelo Inc. (NUVO)

Alfimeprase

Modified fibrolase delivered via catheter; thrombolytic agent

Acute peripheral arterial occlusion

Received SPA from the FDA for the second of two Phase III trials, NAPA-3, which will include 300 patients (12/14)

CENTRAL NERVOUS SYSTEM

Alkermes Inc. (ALKS) and Cephalon Inc. (CEPH)

Vivitrol (formerly Vivitrex)

Long-acting, injectable form of naltrexone

Alcohol dependence

The FDA issued an approvable letter, which calls only for labeling discussions and delivery of certain preclinical pharmacokinetic data (12/28)

BioAxone Therapeutic Inc.* (Canada)

Cethrin

Agent targeting Rho GTPase signaling; believed to have neuroprotective properties

Acute spinal cord injuries

The FDA granted orphan designation to the product in that indication (12/12)

New River Pharmaceuticals Inc. (NRPH)

NRP104

Prodrug of amphetamine

Attention deficit/hyperactivity disorder

Filed NDA with FDA seeking approval to market the drug for treating children aged 6 through 12 (12/7)

Noven Pharmaceuticals Inc. (NOVN)

Daytrana

Transdermal patch containing methylphenidate

Attention deficit/hyperactivity disorder

FDA advisory committee recommended approval of the drug (12/2)

INFECTION

Caprion Pharmaceuticals Inc.* (Canada)

caStx1 and caStx2

Therapeutic monoclonal antibodies

Shiga-toxin producing E. coli infections

The products were granted orphan drug status by the FDA (12/20)

MediGene AG (Germany; FSE: MDG)

Polyphenon E Ointment

Product from green tea leaves designed to block virus binding to cells

Genital warts

The FDA accepted for filing the NDA on the drug (12/1)

Oscient Pharmaceuticals Corp. (OSCI)

Ramoplanin

Naturally occurring antibiotic

Clostridium difficile-associated disease

Reached agreement with FDA on SPA for Phase III program, which will include two concurrent non-inferiority studies (12/21)

SIGA Technologies Inc. (SIGA)

SIGA-246

Oral compound that has shown antiviral activity in poxvirus disease

Smallpox

The FDA granted fast-track status to the product, which was entering Phase I trials (12/13)

Vertex Pharmaceuticals Inc. (VRTX)

VX-950

Oral HCV protease inhibitor

Hepatitis C

The FDA granted fast-track designation to the product in that indication, for which Phase II trials recently began (12/8)

MISCELLANEOUS

Barrier Therapeutics Inc. (BTRX)

Sebazole

Topical formulation of 2% ketoconazole, an antifungal agent

Seborrheic dermatitis

The FDA accepted for filing the NDA submission; the NDA was submitted in September (12/9)

Genentech Inc. (NYSE:DNA)

Lucentis

Ranibizumab; humanized antibody fragment designed to bind and inhibit VEGF-A

Wet age-related macular degeneration

Submitted BLA with the FDA, seeking approval for treating neovascular wet AMD (12/30)

Halozyme Therapeutics Inc. (AMEX:HTI)

Hylenex (formerly Enhanze SC)

Formulation of recombinant human hyaluronidase

For use as a spreading agent

The FDA approved the product for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs; Baxter Healthcare Corp. will market the product (12/5)

Insmed Inc. (INSM)

iPlex (SomatoKine)

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

Severe primary IGF-1 deficiency

The FDA approved the product for treating growth failure in children with severe primary IGF-1 deficiency (12/12)

Inspire Pharmaceuticals Inc. (ISPH)

Diquafosol tetrasodium

Ophthalmic solution; P2Y2 receptor agonist

Dry-eye disease

The FDA issued a second approvable letter, saying trials failed to demonstrate efficacy (12/2)

Lev Pharmaceuticals Inc. (OTC BB:LEVP)

C1-INH

C1-esterase inhibitor

Hereditary angioedema

The FDA granted fast-track designation to the product, which is in Phase III trials (12/19)

Osiris Therapeutics Inc.*

Prochymal

Intravenous formulation of mesenchymal stem cells

Acute graft-vs.-host disease

The FDA granted the product orphan designation in that indication (12/20)

Sepracor Inc. (SEPR)

Arformoterol

Long-acting beta-agonist formulated for inhalation; single isomer of formoterol

Chronic obstructive pulmonary disease

Sepracor filed an NDA with the FDA seeking approval in that indication (12/13)

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.

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