Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

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 patients with moderate to severe disease who had inadequate responses to conventional therapy (10/20)

Human Genome
Sciences Inc.
(HGSI)

LymphoStat-B

Belimumab; human monoclonal antibody that inhibits activity of B- lymphocyte stimulator

Lupus

Reached agreement with FDA on SPA for Phase III program, which was expected to start later in 2006 (10/26)

CANCER

Agennix Inc.*

Talactoferrin

Oral talactoferrin alfa solution

Renal cell carcinoma

The FDA granted orphan designation to the product in that indication (10/12)

Agennix Inc.*

Talactoferrin

Oral talactoferrin alfa solution

Non-small-cell lung cancer

The FDA granted fast-track status to the product for first-line treatment of NSCLC (10/5)

Alfacell Corp.
(ACEL)

Onconase

Ranpirnase; cytotoxic ribonuclease

Malignant mesothelioma

Completed nonclinical section of rolling NDA submission with FDA; complete filing was expected in 2007 (10/2)

Allos
Therapeutics
Inc.
(ALTH)

PDX

Pralatrexate; anitfolate; dihydrofolate reductase inhibitor

T-cell lymphoma

The FDA granted fast-track status to the product in that indication, for which pivotal Phase II trials are ongoing (10/3)

AVAX
Technologies
Inc.
(OTC BB:AVXT)

M-Vax

Autologous, hapten- modified melanoma vaccine

Metastatic melanoma

Reached agreement with FDA on SPA for pivotal Phase III trial in up up to 387 patients with Stage IV melanoma (10/12)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced chronic lymphocytic leukemia

The FDA extended review period on NDA 90 days, to Jan. 27, after Genta submitted additional data (10/30)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Chronic lymphocytic leukemia

Reached agreement with FDA on a trial that would evaluate the drug with fludarabine and rituximab (10/6)

IDM Pharma
Inc.
(IDMI)

Junovan

Synthetic lipophilic derivative of the muramyl dipeptide

Osteosarcoma

Filed NDA with FDA seeking approval for treating newly diagnosed resectable high-grade osteosarcoma patients following surgical resection, in combination with chemotherapy (10/26)

MGI Pharma
Inc.
(MOGN)

Saforis

Oral formulation of glutamine in company's delivery system

Oral mucositis in cancer patients

The FDA issued an approvable letter that requests an additional Phase III efficacy trial (10/12)

Reata
Pharmaceuticals
Inc.*

RTA 744

Anthracycline derivative that crosses the blood-brain barrier

Malignant gliomas

The FDA granted orphan designation to the Phase I product in that indication (10/26)

CARDIOVASCULAR

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Anemia in chronic kidney disease

FDA issued an approvable letter that requests additional data for the once-monthly dosing regimen, including an additional clinical study (10/13)

CENTRAL NERVOUS SYSTEM

Anesiva Inc.
(ANSV; formerly
Corgentech Inc.)

4975

Non-opioid, VR1 agonist that acts as a C-neuron anesthetic

Interdigital neuroma

The FDA granted orphan status to the product for treating those who fail conservative treatments (10/12)

Avanir
Pharmaceuticals
Inc.
(AVNR)

Zenvia (formerly Neurodex)

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Involuntary emotional expression disorder

The FDA issued an approvable letter that calls for additional safety and efficacy data (10/31)

Memory
Pharmaceuticals Corp.
(MEMY)

MEM 3454

Nicotinic alpha-7 receptor partial agonist

Alzheimer's disease

The FDA placed a hold on proposed Phase IIa trial due to questions on toxicology data (10/16)

Cortex
Pharmaceuticals
Inc.
(AMEX:COR)

CX717

Ampakine analogue; designed to improve brain cell signaling

Attention deficit/ hyperactivity disorder

The FDA lifted a clinical hold it had placed on trial in March, allowing company to resume trials (10/9)

New River
Pharmaceuticals
Inc.
(NRPH)

NRP104

Prodrug of amphetamine; capsule formulation

Attention deficit/ hyperactivity disorder

FDA issued an approvable letter; approval was contingent only upon final scheduling by the Drug Enforcement Administration (10/6)

DIABETES

MacroGenics
Inc.*

MGA031

Humanized, Fc-engineered anti-CD3 monoclonal antibody

Type I diabetes

The FDA granted orphan designation to the product in recent-onset Type 1 diabetes (10/10)

INFECTION

Idenix
Pharmaceuticals
Inc.
(IDIX)

Tyzeka

Telbivudine; oral, once- daily nucleoside analogue

Hepatitis B

The FDA approved the product for treating chronic hepatitis B (10/25)

Intercell AG
(Austria;
VSE:ICLL)

--

Inactivated vaccine against Japanese encephalitis virus

Japanese encephalitis virus

Began BLA filing process with the FDA; full submission was expected in early 2007 (10/12)

Replidyne
Inc.
(RDYN)
and Forest
Laboratories Inc.

Faropenem medoxomil

Ester prodrug derivative of the beta-lactam antibiotic faropenem

Four adult indications

The FDA issued a nonapprovable letter calling for additional trials in all four indications: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections (10/23)

MISCELLANEOUS

Agennix Inc.*

Talactoferrin

Topical talactoferrin alfa gel

Diabetic foot ulcers

The FDA granted fast-track status to the product in that indication (10/5)

Critical
Therapeutics
Inc.
(CRTX)

--

Controlled-release formulation of zileuton (Zyflo), a 5-lipoxygenase inhibitor

Asthma

The FDA accepted for filing the NDA that was submitted in July; the PDUFA date is May 31 (10/17)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Sanctura XR

Once-daily formulation of the approved product Sanctura

Overactive bladder

Filed NDA with FDA, seeking approval in that indication (10/12)

Isolagen Inc.
(AMEX:ILE)

Isolagen Therapy

Autologous cellular therapy

Wrinkles

Reached agreement with FDA on SPA for two pivotal Phase III trials of 200 patients each to evaluate efficacy and safety in nasolabial skin fold wrinkles (10/13)

Vivus Inc.
(VVUS)

EvaMist

Transdermal spray formulation of estradiol

Vasomotor symptoms associated with menopause

Filed NDA with the FDA, seeking approval in that indication (10/2)


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; OTC BB = Over-the-Counter Bulletin Board; VSE = Vienna Stock Exchange.

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