Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Amgen Inc. (AMGN)

Enbrel (FDA-approved)

Etanercept; anti-TNF-alpha antibody

Ankylosing spondylitis

Partner Wyeth gained approval in Europe to sell the drug for those with severe, active disease (1/20)

Antisense Therapeutics Ltd. (Australia; ASX:ANP)

ATL1102

Second-generation antisense drug

Multiple sclerosis

Preliminary Phase I data were positive in terms of safety and pharmacokinetics (1/30)

CANCER

Bioenvision Inc. (AMEX:BIV)

Clofarabine

Next-generation purine nucleoside antimetabolite

Acute myelogenous leukemia

Phase II trial in the UK began involving older adults not suitable for intensive chemotherapy (1/14)

Biogen Idec Inc. (BIIB)

Zevalin (FDA-approved)

Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope

Non-Hodgkin's lymphoma

The product was approved in Europe for treating adults with CD20+ follicular B-cell NHL who are refractory to Rituxan; it will be sold there by Schering AG (1/22)

MediGene AG (Germany; FSE:MDG)

Eligard 22.5 mg

Leuprolide acetate for injectable suspension

Prostate cancer

German authorities approved the product, which was developed by Atrix Laboratories Inc. (1/26)

Millennium Pharmaceuticals Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

European regulators recommended approval under exceptional circumstances for treating patients whose disease has progressed under prior treatments (1/22)

Munich Biotech AG* (Germany)

MBT-0206

Anti-neovascular agent containing paclitaxel and a lipid-based carrier

Metastatic breast and pancreatic cancer

Company started Phase II trial in each indication; the pancreatic trial is for first-line treatment in combination with gemcitabine in 70 patients; the breast cancer trial is a second- or third-line monotherapy trial in 60 patients (1/16)

Oxford BioMedica plc (UK; LSE:OXB)

TroVax

Vaccine that delivers an antigen (5T4) using a pox virus vector

Colorectal cancer

Company got approval for Phase II study in UK of 20 patients who are undergoing surgery for resectable liver metastases (1/16)

Wilex AG* (Germany)

WX-UK1

Synthetic small-molecule inhibitor of serine proteases

Head and neck cancers

Company started a Phase Ib trial in Germany to assess safety, toler- ability and biological activity as a monotherapy (1/14)

CARDIOVASCULAR

GTC Biotherapeutics Inc. (GTCB)

ATryn

Recombinant human antithrombin product produced in the milk of goats

Hereditary antithrombin deficiency

GTC submitted an approval application in Europe; the indication in HD patients is prophylaxis of deep-vein thrombosis and thromboembolism in clinical-risk situations (1/26)

Jerini AG* (Germany)

Icatibant (JE049)

Bradykinin-2 receptor antagonist

Hereditary angioedema

Company said angioedema symptoms resolved rapidly in all eight patients in the Phase II European trial (1/13)

United Therapeutics Corp.(UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary arterial hypertension

French officials issued an action letter requesting additional information before product could be approved (1/6)

CENTRAL NERVOUS SYSTEM

Labopharm Inc. (Canada; TSE:DDS)

--

Once-daily formulation of the analgesic tramadol

Pain

French authorities sent a letter asking for clarification on the approval request there (1/28)

NiCox SA (France; Nouveau Marche: NICOX)

NCX 4016

Nitric oxide-donating derivative of aspirin

Peripheral arterial obstructive disease

NiCox said Phase IIa trial in Italy reached its primary efficacy end- point of reversing endothelium dysfunction induced by physical exercise (1/8)

Pain Therapeutics Inc. (PTIE)

Remoxy

Capsule formulation of oxycodone, designed to be abuse-resistant

Pain

Company started a Phase I trial to assess safety and pharmacokinetics against placebo and active drug in healthy volunteers in the UK (1/15)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN)

Symlin

Pramlintide acetate; an analogue of human amylin

Diabetes

Swiss officials said they would not approve the product based on data received; Amylin withdrew its approval application (1/7)

Avant Immunotherapeutics Inc. (AVAN)

CholeraGarde

Single-dose oral vaccine

Cholera

Avant released positive preliminary results from Phase II trial in 70 adults in Bangladesh; vaccine was well tolerated and more than 70% of adults had a favorable immune response (1/20)

Sinovac Biotech Inc.* (China; OTC BB:SNVBF)

--

Vaccine for severe acute respiratory syndrome

SARS

Company gained approval to initiate clinical trials in 30 subjects in China (1/20)

Stratus Research Labs Inc.*

A-221-HIV

Drug designed to target HIV-infected cells and put them in a nondividing state

HIV

Company said it was about to begin human trials in Latin Amer- ica (1/30)

VaxGen Inc. (VXGN)

rPA102

Recombinantly produced anthrax vaccine

Anthrax

The FDA granted fast-track status to the product, for which VaxGen has government contracts to develop (1/21)

MISCELLANEOUS

Aastrom Biosciences Inc. (ASTM)

Tissue Repair Cell

Stem and progenitor cells produced from samples of a patient's own bone marrow

Leg fractures

Company began trial in Germany in combination with a synthetic bone graft matrix in 10 patients with serious fractures (1/22)

Biolipox AB* (Sweden) and NiCox SA (France; Novuea Marche: NICOX)

NCX 1510

Agent delivered via nasal spray

Allergic rhinitis

Biolipox started a Phase IIa trial in 36 patients in Sweden to look at efficacy in an out-of-season allergen-provocation study (1/21)

Enhance Biotech Inc. (OTC BB:EBOI)

LI 301

Existing undisclosed drug

Premature ejaculation

Company said Phase IIa trial in Europe showed positive effect vs. placebo (1/27)

Genzyme Corp. (GENZ)

Fabrazyme (agalsidase beta)

Enzyme replacement therapy

Fabry's disease

Genzyme received approval to market the product in Japan as soon as officials there establish a price (1/29)

Proskelia SAS* (France)

PSK 3471

Selective estrogen receptor modulator

Osteoporosis

Company started a Phase IIa trial (1/28)**

Notes:

* Privately held.

** Denotes the date item ran in BioWorld International.

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