Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Abbott
Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Early rheumatoid arthritis

Filed a Type II variation with the EMEA seeking approval in early RA (12/22)

Abbott
Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Psoriatic arthritis

Filed an MAA with the EMEA seeking approval in the additional indication of PA (12/16)

BioMS
Medical Corp.
(Canada; TSE:MS)

MBP8298

Synthetic peptide

Multiple sclerosis

Began pivotal Phase III trial in Canada and Europe in up to 553 patients to assess time to disease progression vs. placebo (12/8)

Isotechnika
Inc.
(Canada;
TSE:ISA)

ISA247

Immunosuppressive agent

Psoriasis

Company began a Phase III trial in Canada to test efficacy and other endpoints in 400 patients with severe disease (12/1)

CANCER

Active Biotech
(Sweden; SSE:ACTI)

TASQ

Tumor angiogenesis suppression by quinolines

Prostate cancer

Began a Phase I trial in Sweden to study safety and tolerability (12/13)

Australian
Cancer
Technology Ltd.
(Australia; ASX:ACU)

RP101

Antiviral drug marketed in Europe that down-regulates the STAT3 and APEX genes

Metastatic pancreatic cancer

Began Phase II trial in Germany to test drug and gemcitabine in 22 patients (12/14)

Bioenvision
Inc.
(BIVN)

Clofarabine

Second-generation purine nucleoside analogue

Acute myeloid leukemia

Trial in Europe demonstrated a threefold greater overall response rate in older patients than current standard of care (ASH)

Cell
Therapeutics
Inc.
(CTIC)

Trisenox (FDA-approved)

Arsenic trioxide

Myelodysplatic syndromes

Phase II trial in Europe showed the drug produced a hematologic response rate of 27% (ASH)

Diatos SA*
(France)

DTS-201

Doxorubicin conjugated to a peptide technology

Advanced solid tumors

Got regulatory clearance for a Phase I trial in France and Belgium (12/16)

Flamel
Technologies
SA
(France; FLML)

--

Medusa formulation of long-acting interleukin-2

Renal cancer

Began Phase I/II trial in France to compare drug to Proleukin (12/8)

GPC Biotech
AG
(Germany;
CPGB)

1D09C3

Anti-MHC Class II monoclonal antibody

B-cell lymphomas

Got OK for a Phase I trial in Switzerland to test safety, tolerability and dosing in patients with relapsed or refractory disease (12/9)

ILEX
Oncology Inc.
(merged with
Genzyme Corp.;
GENZ)

Campath (FDA-approved)

Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces

Peripheral T-cell non-Hodgkin's lymphoma

Trial in Germany showed an over- all response rate of 62% in 21 patients in first-line treatment (ASH)

ILEX
Oncology Inc.
(merged with
Genzyme Corp.;
GENZ)

Campath (FDA- approved)

Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces

B-cell chronic lymphocytic leukemia

Phase II trial with Fludara in Germany showed an overall response rate of 85% in the relapsed/refractory patients (ASH)

ILEX
Oncology Inc.
(merged with
Genzyme Corp.;
GENZ)

Campath (FDA-approved)

Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces

Chronic lymphocytic leukemia

Trial in Germany showed an overall response rate of 36% in 44 patients refractory to fludarabine (ASH)

OxiGene
Inc.
(OXGN)

OXi4503

Ortho-quinone prodrug

Advanced cancers

Began Phase I trial in the UK that will assess safety and gain further insight into the mechanism of action (12/21)

QLT Inc.
(Canada; QLTI)
and MediGene
AG
(Germany;
FSE:MDG)

Eligard (FDA-approved)

Leuprolide acetate for injectable suspension; LHRH agonist

Prostate cancer

Gained approval in 24 of 26 countries in Europe through the mutual recognition procedure for the one- and three-month formulations (12/21)

Vaxon-Biotech*
(France)

VX-001

Vaccine containing a peptide that targets tumors expressing the telomerase antigen

Tumors

Phase I trial in Greece produced immune responses in 13 of 14 patients, with disease stabilization in four patients (12/6)

YM Biosciences
Inc.
(Canada;
TSE:YM)

TheraCIM h-R3

Humanized anti-epidermal growth factor receptor monoclonal antibody

Nasopharyngeal carcinoma

Phase II pivotal trial in 130 patients showed complete responses of 90.6% with radiation vs. 51.5% in the radiation-only group (12/21)

CARDIOVASCULAR

Alexion
Pharmaceuticals
Inc.
(ALXN)

Eculizumab

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Two-year, 11-patient extension study in the UK showed statistically significant reductions in hemolysis and the need for blood transfusions (ASH)

Cangene Corp.
(Canada; TSE:CNJ)

WinRho SDF (FDA-approved)

Antibody to certain types of red blood cells

Hemolytic disease of the newborn and ITP

Company completed the European Mutual Recognition Procedure, gaining approval in 10 European countries for hemolytic disease and immune thrombocytopenic purpura (12/20)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYTN)

CYT006-AngQb

Vaccine designed to produce an anti-angiotensin II antibody response

Hypertension

Began Phase I/II trial in 88 patients to evaluate safety, tolerability and efficacy (12/7)

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin

Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

Phase III STRIDE-4 trial showed a lower dose was not as effective as a higher dose, and not superior to placebo; trial was in 98 patients in Latin America, Poland and Spain (12/20)

CENTRAL NERVOUS SYSTEM

Arena
Pharmaceuticals
Inc.
(ARNA)

APD125

Antagonist at the 5-HT2A serotonin receptor

Insomnia

Began Phase I trial in France to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (12/1)

GW
Pharmaceuticals
plc
(UK; LSE:GWP)

Sativex

Spray formulation of cannabis extract

Spasticity in multiple sclerosis

UK regulators said another study would be needed because clinical relevance was uncertain (12/3)

GW
Pharmaceuticals
plc
(UK; LSE:GWP)

Sativex

Spray formulation of cannabis extract

Spasticity in multiple sclerosis

Canadian regulators issued a notice saying the product qualified to be considered for approval (12/21)

KetoCytonyx
Inc.*
(UK)

KTX 0101

Ketone agent designed to act as an alternative energy system for cells

Cognitive impairment

Completed Phase I trial in volunteers undergoing coronary artery bypass graft surgery that showed positive safety and pharmacodynamic effects (12/13)

Neurobiological
Technologies
Inc.
(NTII)

Ebixa (FDA-approved)

Memantine; NMDA receptor antagonist

Alzheimer's disease

H. Lundbeck A/S gained approval of the product in Canada (12/13)

DIABETES

Diamyd
Medical AB
(Sweden; SSE:DIAM)

Diamyd

Glutamic acid decarboxylase 65- based immunotherapy

Type I diabetes

Began a Phase II trial in Sweden in 70 children to test if remaining insulin-producing beta cells can be saved (12/15)

MannKind
Corp.
(MNKD)

Technosphere Insulin

Pulmonary insulin formulation delivered via company's inhaler

Diabetes

Began Phase III trial in Europe (12/22)

INFECTION

AEterna
Zentaris Inc.
(Canada; AEZS)

Impavido

Oral miltefosine, an alkylphospholipid agent

Visceral and cutaneous leishmaniasis

The product was approved in Germany (12/6)

Anadys
Pharmaceuticals
Inc.
(ANDS)

ANA380 (LB80380)

Oral prodrug of the nucleotide analogue ANA317 (LB80317)

Hepatitis B

Interim Phase II data showed a 99.9% reduction in viral load in two dosing groups (12/13)

Chiron Corp.
(CHIR)

Fluvirin

Influenza vaccine

Influenza

UK officials plan to continue the manufacturing suspension for a further three months, effective Jan. 4, 2005 (12/7)

Chiron Corp.
(CHIR) and
Cubist
Pharmaceuticals
Inc.
(CBST)

Cubicin (FDA-approved)

Daptomycin for injection

Complicated skin and soft-tissue infections

Companies filed MAA seeking approval in Europe for treating cSSTIs in which susceptible Gram-positive bacteria are confirmed or suspected (12/2)

Flamel
Technologies
SA
(France; FLML)

--

Medusa formulation of long-acting interferon-alpha

Hepatitis and hepatitis C

Began Phase I/II trial in France to test safety, and to compare pharmacokinetic profile to Schering-Plough Corp.'s Viraferon (12/17)

Nabi Bio-
pharmaceuticals
(NABI)

StaphVAX

Staphylococcus aureus polysaccharide conjugate vaccine

To prevent S. aureus bacteremia

Filed MAA with the EMEA seeking approval in Europe to prevent the condition in patients with end- stage renal disease (12/21)

SciClone
Pharmaceuticals
Inc.
(SCLN)

Zadaxin

Synthetic preparation of thymosin alpha-1

Hepatitis C

Partner Sigma-Tau began a Phase III trial to test the drug with pegylated interferon-alpha and ribavirin in 500 patients in Europe (12/23)

Sinovac Biotech
Inc.
(China; AMEX:SVA)

--

Inactive vaccine for severe acute respiratory syndrome

Severe acute respiratory syndrome

Phase I trial showed induction of SARS-neutralizing antibodies in all 36 subjects in a Phase I trial (12/6)

MISCELLANEOUS

Adolor Corp.
(ADLR)

Entereg

Alvimopan capsules; mu opioid antagonist

Post-operative ileus

Phase III trial in Europe failed to meet the primary endpoint of gastrointestinal recovery vs. placebo; it did show statistical significance in secondary endpoints (12/23)

BioMarin
Pharmaceutical
Inc.
(BMRN)

Aryplase

Galsulfase; an enzyme-
replacement therapy

Mucopoly-
saccharidosis-VI

The company filed an MAA seeking approval in the European Union (12/6)

Cellegy
Pharmaceuticals
Inc.
(CLGY)

Tostrex

Transdermal testosterone gel product

Hypogonadism

The product was approved in Sweden; ProStrakan Group Ltd. has European marketing rights (12/30)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYTN)

CYT005- AllQbG10

Immunodrug carrier mixed with the natural allergen extract of house dust mites

Allergy

Began Phase II trial to test safety, tolerability and efficacy of the vaccine in 20 patients (12/2)

Genzyme
Corp.
(GENZ)

Myozyme

Recombinant human acid alpha- lucosidase enzyme

Pompe disease Europe (12/20)

The EMEA accepted the MAA that seeks approval of the drug in Europe (12/20)

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

Cumulase

Ex vivo formulation of recombinant human PH20 hyaluronidase

Treatment of oocytes

Received CE Mark approval for treating oocytes to facilitate certain in vitro fertilization procedures, allowing it sell the product in Europe (12/28)

Manhattan
Pharmaceuticals
Inc.
(OTC
BB:MHTT)

Oleoyl estrone

Oral therapeutic for weight loss

Obesity

Got approval in Switzerland to begin a safety and tolerability trial in obese volunteers (12/20)

Metabolic
Pharmaceuticals
Ltd.
(Australia;
ASX:MBP)

AOD9604

Oral peptide modeled on one section of the human growth hormone molecule

Obesity

Phase IIb trial demonstrated weight loss, tolerability and an improvement in cholesterol (12/13)

Pharmagene
plc
(UK; LSE:PGN)

PGN0052

Synthetic version of secretin

Cystic fibrosis

Phase IIa trial in 18 patients failed to show improvement in the ability of the lungs to clear secretions (12/22)

Pharming
Group NV
(the
Netherlands;
Euronext:PHARM)

rhC1INH

Recombinant human C1 inhibitor

Hereditary angioedema

European trial showed rapid time to beginning of relief and to complete resolution (12/17); also got approval to expand clinical development to the U.S. (12/21)


Notes:

* Privately held.

MAA = Marketing authorization application; EMEA = European Medicines Agency.

ASH = Data were presented at the American Society of Hematology meeting.

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange;

TSE = Toronto Stock Exchange.

No Comments