Company* (Country; Symbol)




Status (Date)


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

Antegren (natalizumab)

Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class

Multiple sclerosis

The FDA designated the BLA for priority review; the BLA was submitted in May (6/28)


Allos Therapeutics Inc. (ALTH)

RSR13 (efaproxiral)

Small molecule designed to sensitize hypoxic areas of tumors prior to radiation

Brain metastases

FDA issued approvable letter for treating metastases from breast cancer; Allos must show efficacy in Phase III ENRICH trial (6/2)

Amgen Inc. (AMGN)


Recombinant human keratinocyte growth factor

Oral mucositis

Submitted BLA seeking approval for treating the condition in patients undergoing chemotherapy followed by a bone marrow trans- plant (6/24)

Genetronics Biomedical Corp. (AMEX:GEB)

MedPulser Electroporation System

System that applies a defined electric field to target cells

Head and neck cancer

The FDA granted fast-track designation to the product, which is in Phase III trials in that indication (6/7)

ILEX Oncology Inc. (ILXO)


Second-generation purine nucleoside analogue

Refractory/relapsed acute leukemia in children

The FDA accepted for review the NDA; ILEX filed the final section in March (6/3)

Medarex Inc. (MEDX)


Fully human anti-CTLA-4 antibody


The FDA granted orphan desig- nation to the product in Stages II-IV melanoma, in which a pivotal trial is being planned (6/9)

OSI Pharmaceuticals Inc. (OSIP) and Genentech Inc. (NYSE:DNA)


Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Non-small-cell lung cancer

The NDA was accepted for the FDA's Pilot 1 Program for Continuous Marketing Applications, designed to expedite the rolling application (6/29)

PharmaMar SA* (Spain)


Antitumor agent derived from the marine tunicate Aplidium albicans

Acute lymphoblastic leukemia

The FDA granted orphan designation to the product in that indication (6/24)

Praecis Pharmaceuticals Inc. (PRCS)


Methionine aminopeptidase Type 2 inhibitor

Non-Hodgkin's lymphoma

FDA lifted a clinical hold it put on Phase I trial in March; Praecis satisfied the agency's concerns (6/22)

SuperGen Inc. (SUPG)


Decitabine for injection

Myelodysplastic syndromes

SuperGen submitted the first section of its NDA, and plans to complete the filing in the third quarter (6/1)

TopoTarget A/S* (Denmark)

Topotect (ICRF-187)

Catalytic inhibitor of topoisomerase II

Preventing tissue damage in cancer patients

The FDA granted orphan designation for preventing tissue dam- age following extravasation of chemotherapeutics (6/28)


Alexion Pharmaceuticals Inc. (ALXN) and Procter & Gamble Pharmaceuticals Inc.


Monoclonal antibody; terminal complement inhibitor

Coronary artery bypass graft surgery and acute myocardial infarction

Reached agreement with FDA under special protocol assessment process on separate pivotal trials in each indication; the AMI trial involves patients treated with primary percutaneous intervention (6/4)

CV Therapeutics Inc. (CVTX)

Ranexa (ranolazine)

Partial inhibitor of fatty-acid oxidation

Chronic angina

Reached agremeent under FDA special protocol assessment on 500-patient trial that would sup- port approval if successful (6/2)

Discovery Laboratories Inc. (DSCO)


Engineered version of natural human lung surfactant

Respiratory distress syndrome in premature infants

The FDA acecpted the NDA filing and designated it for standard review (6/15)

Dyax Corp. (DYAX)


Recombinant small protein designed to inhibit human plasma kallikrein

Hereditary angioedema

The FDA lifted a hold it had put on a Phase II trial a week earlier; the trial is resuming (6/4)

Inotek Pharmaceuticals Corp.*


Inhibitor of the nuclear cell death enzyme poly (ADP-ribose) polymerase

ST-elevated myocardial infarction

The FDA granted fast-track designation in STEMI patients undergoing percutaneous coronary intervention (6/23)

The Medicines Co. (MDCO)

Angiomax (FDA-approved)

Bivalirudin; direct thrombin inhibitor

Not disclosed

The FDA rejected supplemental filing that sought to amend the product's labeling; the FDA said new trials would be needed (6/3)


DOV Pharmaceuticals Inc. (DOVP)


Agent that modulates a subset of GABA-A receptors


FDA lifted hold it placed on start of Phase III trial in October subject to review of a revised protocol, which will include more frequent liver enzyme testing (6/28)

Pozen Inc. (POZN)

MT 100

Combination of metoclopramide and naproxen


The FDA issued a not-approvable letter for the drug, citing potential safety issues and saying it failed to demonstrate superiority to naproxen (6/1)

Sepracor Inc. (SEPR)


Eszopiclone tablets


Resubmitted NDA on the product; the FDA issued an approvable letter in February (6/16)


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


Incretin mimetic; synthetic exendin-4

Type II diabetes

Filed NDA with FDA seeking approval in treating Type II diabetes (6/30)

Depomed Inc. (DEPO) and Biovail Corp. (Canada)

Glumetza 500 mg and 1,000 mg

Once-daily, extended- release formulations of the approved drug metformin

Type II diabetes

The FDA accepted for review the NDA, which was filed in April (6/24)


Basilea Pharmaceutica AG (Switzerland; SWX:BSLN)


Broad-spectrum cephalosporin antibiotic

Hospital- acquired pneumonia

The FDA granted fast-track designation to the product in that indication, the second for which it has that designation (6/16)


Adolor Corp. (ADLR) and GlaxoSmithKline plc (UK)

Entereg (alvimopan)

Mu opioid antagonist

Post-operative ileus

Adolor submitted the second portion of its NDA for Entereg, which has fast-track status (6/1); completed NDA submission (6/28)

Barrier Therapeutics Inc. (BTRX)


Agent designed to block retinoic acid metabolism

Congenital ichthyosis

The FDA granted orphan designation in that indication, which encompasses a group of skin disorders (6/22)

Cardiome Pharma Corp. (Canada; TSE:COM)


Xanthine oxidase inhibitor that is the active metabolite of allopurinol


FDA issued approvable letter saying additional clinical and manufacturing data are needed (6/24)

Cellegy Pharmaceuticals Inc. (CLGY)


Nitroglycerin ointment

Pain from anal fissures

Cellegy submitted an NDA based on new trial data, about two years after withdrawing its initial submission (6/30)

Eyetech Pharmaceuticals Inc. (EYET)


Pegaptanib sodium; pegylated vascular endothelial growth factor inhibitor

Wet age- related macular degeneration

Eyetech and Pfizer Inc. completed filing of NDA; an advisory panel will review the NDA Aug. 27 (6/17)

ISTA Pharmaceuticals Inc. (ISTA)


Liquid formulation of the beta-blocker timolol


The FDA approved the product for treating glaucoma (6/7)

Miravant Medical Technologies Inc. (OTC BB:MRVT)


Photodynamic therapy that uses a light- activated drug to destroy abnormal blood vessels

Wet age-related macular degeneration

The FDA accepted for review the NDA application, which was filed in March, and designated it for priority review (6/1)

RegeneRx Bio- Pharmaceuticals Inc. (OTC BB:RGRX)

Thymosin beta-4

Naturally occurring peptide with multiple mechanisms of action

Epidermolysis bullosa

The FDA granted the product orphan designation in that indication (6/4)

Santarus Inc. (SNTS)


Immediate-release powder formulation of the proton pump inhibitor omeprazole


The FDA approved the product for treating heartburn and other symptoms associated with gas- troesophageal reflux disease, for healing erosive esophagitis, and for treating duodenal ulcers (6/15)


* Privately held

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