Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)

AUTOIMMUNE

Amgen Inc.
(AMGN)
and Wyeth

Enbrel (FDA-approved)

Etanercept; anti-tumor necrosis factor-alpha antibody

Psoriatic arthritis

The FDA approved an expanded indication, to improve physical function in PA patients; it was approved for treating PA in 2002 (6/1)

Genelabs
Technologies
Inc.
(GNLB)

Prestara

Prasterone; synthetic equivalent of dehydro- epiandrosterone

Lupus

The FDA said that preventing loss of bone mineral density in patients on glucocorticoids qualifies for orphan exclusivity under the original orphan designation (6/22)

CANCER

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Fodosine

Transition-state analogue inhibitor of the enzyme purine nucleoside phosphorylase

Relapsed/ refractory T-cell leukemia

The FDA granted fast-track status to the drug in that indication, for which Phase IIa trials are ongoing (6/20)

Callisto
Pharmaceuticals
Inc.
(AMEX:KAL)

Annamycin

Second-generation anthracycline

Acute lypho- blastomic leukemia and acute myeloid leukemia

The FDA granted orphan designation to the product in ALL (6/24); the product also gained orphan designation in AML (6/28)

Celgene Corp.
(CELG)

Revlimid

Lenalidomide; derivative of Thalomid (thalidomide)

Myelodysplastic syndromes

The FDA accepted for review the NDA seeking approval for transfusion-dependent MDS patients with deletion 5q chromosomal abnormality (6/7); the NDA was granted priority review (6/21)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Relapsed/ refractory chronic lymphocytic leukemia

Initiated submission of NDA seeking approval for use in combination with fludarabine plus cyclophosphamide (6/30)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

Virulizin

Immunotherapy agent designed to stimulate the immune system

Pancreatic cancer

The FDA accepted Lorus' plan on a rolling NDA submission (6/13)

CARDIOVASCULAR

DiaDexus
Inc.*

PLAC

Blood test that measures lipoprotein-associated phospholipase A2 test

Ischemic stroke

The FDA approved the test to aid in predicting risk for ischemic stroke associated with athero-sclerosis (6/17)

NitroMed Inc.
(NTMD)

BiDil

Nitric oxide-enhancing oral agent; combination of isosorbide dinitrate and hydralazine

Heart failure in African-Americans

FDA panel voted 9-0 in recommending approval of the drug (6/15); the FDAapproved the drug (6/23)

Penwest
Pharmaceuticals
Co.
(PPCO)

PW2101

Low-dose formulation of a beta blocker

Hypertension and angina

The FDA issued a non-approvable letter on the NDA, partly due to kinetic variability and beta blockade as a surrogate for efficacy was not demonstrated; Penwest is dropping the compound (6/29)

The Medicines
Co.
(MDCO)

Angiomax (FDA-approved)

Bivalirudin; direct thrombin inhibitor

Anticoagulant

The FDA expanded the label to include patients undergoing percutaneous coronary intervention (6/15)

CENTRAL NERVOUS SYSTEM

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Pseudobulbar affect

The company submitted the final modules of its rolling NDA filing (6/30)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Capsule form of a non- benzodiazepine agent that targets the GABA-A receptor

Insomnia

The FDA accepted for review the company's resubmitted NDA (6/14)

DIABETES

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

Glumetza

Once-daily, extended-release formulation of metformin hydrochloride

Type II diabetes

The FDA approved the product; Biovail, which has U.S. rights, is seeking a marketing partner (6/3)

INFECTION

Advancis Pharmaceutical Corp. (AVNC)

Amoxicillin Pulsys

Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology

Strep throat

Phase III trial in patients with pharyngitis/tonsillitis due to Group A streptococcal infections failed to achieve microbiological and clinical endpoints (6/15)

Vical Inc.
(VICL)

--

Bivalent formulation of the company's vaccine against cytomegalovirus

CMV viremia

The FDA designated the vaccine an orphan drug; it is nearing Phase II trials in hematopoietic cell transplant recipients (6/14)

MISCELLANEOUS

BioMarin
Pharmaceutical
Inc.
(BMRN)

Naglazyme

Galsulfase; an enzyme- replacement therapy

Mucopoly- saccharidosis-VI

The FDA approved the drug, which has orphan status in the U.S. (6/1)

Chiron Corp.
(CHIR)

Pulminiq

Cyclosporine inhalation solution

For use in patients getting lung transplants

An FDA advisory panel split 8-8 on whether the drug provides a survival benefit (6/6)

Insmed Inc.
(INSM)

SomatoKine

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

Growth hormone insensitivity syndrome

The FDA extended the user-fee date on the NDA three months to Oct. 3, 2005, to give it time to review response data (6/10)

Inspire
Pharmaceuticals
Inc.
(ISPH)

Diquafosol tetrasodium

Ophthalmic solution; P2Y2 receptor agonist

Dry-eye disease

Submitted amendment to an NDA filed in 2003; the filing includes data from two additional Phase III trials (6/1)

Neurochem
Inc.
(Canada;
NRMX)

Fibrillex

Glycosaminoglycan mimetic with anti- amyloid properties

Amyloid A amyloidosis

Neurochem intends to provide additional follow-up data from an open-label extension trial after the FDA said it would review an NDA based on Phase II/III data (6/30)

Santarus Inc.
(SNTS)

Zegerid

Immediate-release capsule formulation of the proton pump inhibitor omeprazole

Gastrointestinal disorders

The FDA accepted for filing the NDA, which is seeking approval for treating heartburn and symptoms of other conditions (6/28)


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; SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; TSE = Toronto Stock Exchange.

No Comments