Company* |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Biogen Inc. |
Amevive |
Alefacept; novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells |
Plaque |
Company's application in Europe was rejected; Biogen withdrew the application and plans to generate more clinical data (2/20) |
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Centocor Inc. (unit of Johnson & Johnson) and Schering-Plough Corp. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha |
Ankylosing spondylitis |
The European Union's Committee for Proprietary Medicinal Products issued a positive opinion recommending approval of Remicade; it also recommended approval of an expanded Remicade label to include maintenance dos- ing for patients with severe, active Crohn's disease who have responded to infliximab therapy (2/21) |
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Medinox Inc.* |
MX-1094 |
A non-steroidal anti-inflammatory prodrug |
Arthritis |
Company completed a Phase I trial in Europe; the results showed it was well tolerated and exhibited the desired pharmacokinetic profile when compared to naproxen (2/24) |
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Serono SA (Switzerland; NYSE:SRA) |
Raptiva |
Efalizumab; humanized antibody |
Psoriasis |
Company submitted a marketing authorization application to the European Agency for the Evaluation of Medicinal Products for Raptiva (2/26) |
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CANCER | ||||
Clavis |
CP-4055 |
An elaidic acid (C181, unsaturated fatty acid) ester of cytarabine |
Solid tumors |
Company began Phase I/II trials in the UK and Norway (2/19) |
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Corixa Corp. (CRXA)
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Bexxar |
Tositumomab and iodine-131 tositumomab; an investigational radioimmuno-therapy |
Follicular lymphoma |
European Commission granted orphan medicinal product designation (2/25) |
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Millennium Pharmaceuticals Inc. (MLNM) |
Velcade |
Bortezomib; proteasome inhibitor |
Multiple myeloma |
Company submitted a marketing authorization application in Europe; (2/5); it was accepted for review (2/25) |
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PhotoCure |
Metvix PDT |
Photodynamic therapy; cream that is absorbed into cancer cells, followed by activation of the drug through illumination with a red light source called Curelight |
Actinic keratosis |
Australian authorities recommended approval for Metvix PDT (2/24) |
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SuperGen Inc. (SUPG) |
Decitabine |
Inhibits DNA methyltransferase activity |
Myelodysplastic syndrome |
European regulatory authorities granted orphan drug status for decitabine (2/28) |
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CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. (ALKS) and Janssen-Cilag SA (Spain) |
Risperdal Consta |
Long-acting injectable form of risperidone that was developed using Alkermes' Medisorb drug delivery technology |
Schizophrenia |
Companies received approval in Spain for Risperdal Consta (2/26) |
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INFECTION | ||||
Gilead |
Viread (FDA-approved) |
Tenofovir disoproxil fumarate |
HIV |
Company received a positive opinion to extend the indication of Viread to include use in anti- retroviral-naive HIV patients, from the European Union's Committee for Proprietary Medicinal Products (2/21) |
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Medivir AB* (Sweden) |
MIV-210 |
Antiviral; nucleoside analogue |
Infections |
Company began multiple dosing in healthy volunteers as part of its Phase I study of MIV-210 in the UK (2/7) |
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PowderJect Pharmaceuticals |
Dukoral |
Oral, liquid vaccine that protects against diarrhea caused by Vibrio cholerae and enterotoxigenic E. coli |
Cholera and travelers' diarrhea |
Canadian authorities approved Dukoral (2/25) |
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The Immune Response Corp. (IMNR) |
Remune |
HIV-1 immunogen |
HIV |
Phase II data from a trial in Spain showed sustained HIV-specific immune response (2/19) |
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MISCELLANEOUS | ||||
Emisphere Technologies Inc. (EMIS) and Novartis Pharma AG (Switzerland) |
-- |
Salmon calcitonin peptide; an oral tablet formulation delivered in combination with the Emisphere delivery agent |
Osteoporosis and osteopenia |
Data from a Phase IIa trial in Europe showed activity on bone markers (2/26) |
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IsoTis SA* (Switzerland) |
OsSatura BCP |
Synthetic bone substitute |
Orthopedic indications |
Product received approval in Europe (2/12**) |
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ZymoGenetics |
rFXIII |
Recombinant human factor XIII; a protein involved in the formation and stabilization of blood clots |
Genetic and acquired FXIII deficiencies |
Company began a Phase I trial in Europe and the U.S. (2/4) |
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Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OSE = Oslo Stock Exchange | ||||
