Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Genentech
Inc.
(NYSE:DNA)
and Biogen
Idec Inc.
(BIIB)

Rituxan
(FDA-approved)

Rituximab; antibody that targets and selectively depletes CD20- positive B cells

Rheumatoid arthritis

Filed supplemental BLA seeking approval in patients with active RA who inadequately respond to an anti-TNF therapy (8/31)

CANCER

Amgen Inc.
(AMGN) and
Abgenix Inc.
(ABGX)

Panitumumab

Fully human monoclonal antibody directed against the epidermal growth factor receptor

Metastatic colorectal cancer

The FDA granted fast-track designation to the product; a BLA filing is planned before the end of 2005 (8/1)

AmpliMed
Corp.*

Amplimexon

Imexon injection; a cyanoaziridine compound believed to disrupt mitochondria

Ovarian cancer

The FDA granted orphan designation to the product in that indication; it already had orphan status in three other cancer indications (8/30)

Antisoma plc
(UK; LSE:ASM)

AS1411

Anti-nucleolin aptamer

Renal cancer

The FDA granted orphan designation to the Phase I product in that indication (8/17)

Ariad
Pharmaceuticals
Inc.
(ARIA)

AP23573

Oral form of agent designed to inhibit cell-signaling protein mTOR

Soft-tissue and bone sarcomas

The FDA granted orphan designation to the drug in both indications (8/18)

Genentech
Inc.
(NYSE:DNA)
and Biogen
Idec Inc.
(BIIB)

Rituxan (FDA-approved)

Rituximab; antibody that targets and selectively depletes CD20-positive B cells

Non-Hodgkin's lymphoma

Filed supplemental NDA seeking approval in previously untreated patients with intermediate-grade or aggressive, CD20-positive, B- cell NHL, in combination with other chemotherapy regimens (8/17)

ImClone
Systems Inc.
(IMCL) and
Bristol-Myers
Squibb Co.

Erbitux (FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Head and neck cancer

Filed supplemental BLA seeking approval for use with radiaiton in advanced squamous cell carcinoma of the head and neck and as a monotherapy in platinum-based failures (8/30)

CARDIOVASCULAR

CoTherix Inc.
(CTRX)

Ventavis (FDA-approved)

Inhaled formulation of iloprost, a prostacyclin analogue

Pulmonary arterial hypertension

The FDA expanded the drug's label to include use with Tracleer and for use with the hand-held I-neb AAD device (8/30)

CENTRAL NERVOUS SYSTEM

Cognetix Inc.*

CGX-1160

Broad-spectrum non-opioid analgesic based on peptide synthesized from marine cone snails

Neuropathic pain

The FDA granted orphan status to the Phase Ib product for the intrathecal treatment of neuropathic pain associated with spinal cord injury (8/30)

CytRx Corp.
(CYTR)

Arimoclomol

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

Amyotrophic lateral sclerosis

The FDA requested additional information in order to release a clinical hold it placed on planned Phase II trials (8/10)

Pozen Inc. (POZN)
and GlaxoSmithKline
plc (UK)

Trexima (MT400)

Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen

Migraine

Pozen filed an NDA with the FDA seeking approval of the agent (8/8)

Pozen Inc.
(POZN)

MT 100

Metoclopramide hydro- chloride combined with naproxen sodium

Migraine

FDA advisory panel voted that potential risk for tardive dyskinesia would outweigh benefits; the FDA issued a not-approvable letter in June 2004; Pozen ended development of the drug (8/5)

TheraQuest
Biosciences*

TQ-1017

Abuse-deterrent, once-daily, extended-release tramadol

Postherpetic neuralgia

The FDA granted orphan designation to the product in that indication (8/11)

INFECTION

Arpida Ltd.
(Switzerland;
SWX:ARPN)

Iclaprim

Capsule formulation of broad- spectrum antibiotic infections

Complicated skin and skin- structure

The FDA granted fast-track status to the product in that indication (8/23)

Chiron Corp.
(CHIR)

Fluvirin (FDA-approved)

Influenza vaccine

Influenza

The FDA OK'd Chiron's manufacturing facility in the UK, allowing the company to provide the vaccine for the 2005-06 flu season (8/31)

Vicuron
Pharmaceuticals
Inc.
(MICU)

Anidulafungin

Broad-spectrum agent from the echinocandin class

Invasive candidiasis/candidemia

Filed NDA with the FDA seeking approval in that indication (8/18)

MISCELLANEOUS

BioMarin
Pharmaceutical
Inc.
(BMRN)

Orapred ODT

Prednisolone sodium phosphate tablets; new formulation of Orapred

Inflammation reduction

Submitted an NDA with the FDA (8/1)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

Oracea

Non-antimicrobial tetracycline derivative

Rosacea

Filed NDA with the FDA seeking approval in that indication (8/1)

Discovery
Laboratories
Inc.
(DSCO)

Surfaxin

Engineered version of natural human lung surfactant

Respiratory distress syndrome in premature infants

The FDA said Discovery needed to provide more information in its response letter to the approvable letter received in February (8/15); the questions center on chemistry and manufacturing (8/19)

Tercica Inc.
(TRCA)

Increlex

Mecasermin injection; recombinant human insulin-like growth factor-1

Short stature caused by IGF deficiency

The FDA approved the drug for long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone (8/31)

Large Scale
Biology Corp.
(LSBC)

--

Recombinant human lysosomal acid lipase

Various diseases

The FDA granted orphan designation to the product, which is targeted toward the metabolism of certain lipids (8/1)

Neurochem
Inc.
(Canada;
NRMX)

Fibrillex

Glycosaminoglycan mimetic with anti-amyloid properties

Amyloid A amyloidosis

Initiated rolling NDA submission with the FDA; complete filing is expected around year-end (8/22)

Unigene
Laboratories
Inc.
(OTC
BB:UGNE)

Fortical

A nasal calcitonin product

Osteoporosis

The FDA approved the product for treating postmenopausal osteoporosis; Upsher-Smith Laboratories Inc. will market it (8/15)


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.

LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange.

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