Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)

AUTOIMMUNE

Aspreva
Pharmaceuticals
Corp. (Canada;
ASPV)

CellCept

Mycophenolate mofetil; an immunosuppressant

Lupus

Concluded SPA agreement on Phase III trial in 358 patients that began in July (9/29)

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

Tysabri

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

Multiple sclerosis

They filed a supplemental BLA with the FDA; the product was taken off the market in February due to safety concerns (9/26)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Ulcerative colitis

The FDA approved the drug for reducing signs and symptoms, achieving clinical remission and mucosal healing and eliminating corticosteroid use in patients with moderately to severely active UC who don't respond to conventional therapy (9/16)

CANCER

Celgene Corp.
(CELG)

Revlimid

Lenalidomide; derivative of Thalomid (thalidomide)

Myelodysplastic syndromes

FDA advisory panel recommended full approval of drug for treating transfusion- dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality (9/14)

GTx Inc.
(GTXI)

Acapodene

Toremifene citrate; small- molecule non-steroidal selective estrogen receptor modulator

Prostate cancer

Reached agreement on SPA with FDA for Phase III trial that began in January; the trial will include 1,260 patients (9/14)

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

Dacogen

Decitabine for injection; a hypomethylating agent

Myelodysplastic syndromes

FDA issued approvable letter that calls for review of transfusion requirements from Phase III trial, labeling discussions and certain other data submissions (9/1)

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

Sorafenib (BAY 43-9006)

RAF kinase and VEGF inhibitor

Advanced kidney cancer

The FDA accepted NDA for review and granted it priority-review status; the NDA was filed in July (9/14)

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

Tarceva (FDA-approved)

Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Advanced pancreatic cancer

FDA advisory panel voted 10-3 in favor ofrecommending approval of drug with gemcitabine in patients with advanced disease who have not received previous chemotherapy (9/13)

CARDIOVASCULAR

Medicure
Inc. (Canada;
TSE:MPH)

MC-1

Naturally occurring small molecule that protects cardiomyocytes

Cardiovascular and cerebrovascular events

The FDA granted orphan designation to the drug for treating those events associated with ischemic and/or ischemic reperfusion injury in various patient groups (9/21)

CENTRAL NERVOUS SYSTEM

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

Vivitrex

Long-acting, injectable form of naltrexone

Alcohol dependence

The PDUFA date on the NDA filed in May was pushed back to Dec. 30 from Sept. 30 (9/20)

Amarin Corp.
plc (UK; AMRN)

Miraxion

Compound that inhibits certain enzymes, including phospholipases and caspases

Huntington's disease

Reached agreement with FDA on SPA for two pivotal Phase III trials that together will assess efficacy in up to 540 patients (9/12); began trials (9/21)

Avanir
Pharmaceuticals
Inc. (AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Pseudobulbar affect

Action on the NDA filed in June will be delayed following the FDA's request for additional information (9/22)

Cephalon
Inc. (CEPH)

Actiq (FDA-approved)

Oral transmucosal fentanyl citrate; sugar-free formulation

Pain in cancer patients

The FDA approved the sugar-free formulation of the already-approved drug (9/12)

Cephalon
Inc. (CEPH)

OraVescent Fentanyl

Fentanyl formulated with transmucosal delivery technology

Breakthrough cancer pain

Filed NDA with FDA seeking approval for managing pain in patients already receiving opioid therapy (9/6)

CytRx Corp.
(CYTR)

Arimoclomol

Small molecule designed to provide cellular protection by activating molecular chaperone proteins

Amyotrophic lateral sclerosis

The FDA granted fast-track designation to the product in ALS, for which Phase II trials recently began (9/26)

Noven
Pharmaceuticals
Inc. (NOVN)

--

Generic fentanyl transdermal system

Pain

The FDA stopped its review on abbreviated NDA, saying it would not approve the product (9/28)

DIABETES

DiObex Inc.*

--

Very-low-dose glucagon

Hypoglycemia in diabetics

The FDA granted fast-track status to the drug for preventing hypoglycemia associated with insulin intensification in Type I diabetes (9/28)

Nektar
Therapeutics
Inc. (NKTR)

Exubera

Dry-powder, inhaled insulin formulation that uses technology from Nektar

Type I and II diabetes

FDA advisory panel recommended approval of the product, from Sanofiventis Group and Pfizer Inc. (9/8)

INFECTION

Cubist
Pharmaceuticals
Inc. (CBST)

Cubicin (FDA-approved)

Daptomycin for injection; a bactericidal antibiotic

Bacteremia

Filed supplemental NDA with the FDA seeking approval to treat patients with bacteremia with known or suspected endocarditis caused by Staphylococcus aureus (9/26)

Incyte Corp.
(INCY)

Reverset

Nucleoside analogue reverse transcriptase inhibitor

HIV

FDA did not agree with company's plan to move into Phase III trials; Incyte will conduct another Phase II trial (9/28)

MedImmune
Inc. (MEDI)

CAIV-T

Trivalent vaccine; next generation of FluMist; refrigerator-stable formulation

Influenza

Submitted supplemental BLA seeking approval in preventing influenza in healthy people aged 5 to 49 (9/19)

MISCELLANEOUS

Alteon Inc.
(AMEX:ALT)

Alagebrium

A.G.E. crosslink breaker

Erectile dysfunction in diabetics

The FDA maintained its hold on the Phase IIa EMERALD trial pending further preclinical liver data (9/30)

Critical
Therapeutics
Inc. (CRTX)

Zyflo (FDA-approved)

Zileuton tablets; 5-lipoxygenase inhibitor

Asthma

The FDA approved supplemental NDA covering new manufacturing process (9/28)

Halozyme
Therapeutics
Inc. (AMEX:HTI)

Hylenex (formerly Enhanze SC)

Formulation of recombinant human hyaluronidase

For use as a spreading agent

The FDA said it would not meet its PDUFA action date on the NDA, which was filed in March (9/26)

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 issued an approvable letter asking for more information on the chemistry, manufacturing and controls section of the NDA (9/28)

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.

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

AMEX = American Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange.