Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

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)

CANCER

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)

Palifermin

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)

Clofarabine

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)

MDX-010

Fully human anti-CTLA-4 antibody

Melanoma

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)

Tarceva

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)

Aplidin

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)

PPI-2458

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)

Dacogen

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)

CARDIOVASCULAR

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

Pexelizumab

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)

Surfaxin

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)

DX-88

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.*

INO-1001

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)

CENTRAL NERVOUS SYSTEM

DOV Pharmaceuticals Inc. (DOVP)

Ocinaplon

Agent that modulates a subset of GABA-A receptors

Anxiety

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

Migraine

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)

Estorra

Eszopiclone tablets

Insomnia

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

DIABETES

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

Exenatide

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)

INFECTION

Basilea Pharmaceutica AG (Switzerland; SWX:BSLN)

BAL5788

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)

MISCELLANEOUS

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)

Liarozole

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)

Oxypurinol

Xanthine oxidase inhibitor that is the active metabolite of allopurinol

Gout

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

Cellegy Pharmaceuticals Inc. (CLGY)

Cellegesic

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)

Macugen

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)

Istalol

Liquid formulation of the beta-blocker timolol

Glaucoma

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

Miravant Medical Technologies Inc. (OTC BB:MRVT)

SnET2-PDT

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)

Rapinex

Immediate-release powder formulation of the proton pump inhibitor omeprazole

Heartburn

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)


Notes:

* Privately held

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

AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

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