Company** |
Product |
Description | Indication |
Type Action (Date) |
CANCER | ||||
British Biotech plc (U.K.) | Marimastat | Oral matrix metallo proteinase inhibitor designed to inhibit blood flow to tumors | Ovarian cancer (as monotherapy) | Discontinued pivotal Phase III trial in Europe; design of trial insufficient for registration (12/16) |
Cel-Sci Corp. |
Multikine | Natural mixture of human cytokines, including interleukin-2 |
Treatment of head and neck cancer prior to surgery or radiation therapy |
Received permission to initiate Phase II trial in Hungary (12/3) |
Cytogen Corp. |
ProstaScint |
Monoclonal antibody that targets prostate-specific membrane antigen, conjugated with indium-111 |
In vivo imaging agent for diagnostic imaging of prostate cancer | Submitted new drug submission in Canada; product was assigned priority review status (12/1) |
Digene Corp. |
Hybrid Capture II HPV Test | Assay that detects DNA from 18 different human papillomavirus (HPV) types |
Cervical cancer screening |
Approved for marketing in Switzerland (12/2) |
Guilford Pharmaceuticals Inc. and RhonePoulenc Rorer Inc. (subsidiary of Rhone-Poulenc SA; NYSE:RP; France) |
Gliadel Wafer | Biodegradable polyanhydride polymer wafer containing carmustine (implant) |
Treatment of malignant brain cancer (glioblastoma multiforme) | Approved for marketing in Canada (for both 1st and recurrent surgeries) and in France (for recurrent surgeries) (12/22) |
Maxim Pharmaceuticals Inc. |
Maxamine Therapy |
H2 receptor agonist; combination therapy with low-dose interleukin-2 | Acute myelogenous leukemia (patients in remission) |
Presented updated results of Phase II trial (conducted in Sweden) at the American Society of Hematology meeting in Miami Beach, Fla. (12/7) |
Medarex Inc. |
MDX-210 | Bispecific antibody that targets HER-2 receptor | Late-stage prostate cancer (patients pretreated with granulocyte macrophage-colony stimulating factor) |
Reported interim results of Phase II U.K. trial (12/3) |
CARDIOVASCULAR | ||||
Diatide Inc. and Nycomed Amersham plc (U.K.) |
AcuTect | Small-molecule synthetic peptide designed to adhere to GPIIb/IIIa receptors on activated platelets, labeled with technetium-99m | In vivo imaging agent for acute deep-vein thrombosis | Companies temporarily withdrew European marketing authorization application; European Medicines Evaluation Agency requested additional information (12/10) |
CENTRAL NERVOUS SYSTEM | ||||
Chiroscience Group plc (U.K.) |
Chirocaine |
Levobupivacaine; chiral version of approved drug bupivacaine |
Broad usage in local, regional or spinal anesthesia and pain control, including for use in children |
Approved for marketing in Sweden (12/16) |
INFECTION | ||||
Agouron Pharmaceuticals Inc. |
AG 7088 |
Synthetic compound designed to inhibit human rhinovirus 3C protease (intranasal administration) | Treatment of common cold |
Initiated Phase I trial in U.K. (12/15) |
Aviron and CSL Ltd. (Australia) |
FluMist | Nasal spray formulation of influenza vaccine;attenuated, cold-adapted live virus vaccine |
Prevention of influenza infection | Initiated bridging study in Australia (designed to evaluate clinical equivalence of facility with that used in earlier trials) (12/10) |
BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (NYSE:GLX; U.K.) | Combivir | Combination of anti-retroviral drugs 3TC/Epivir (lamivudine) and AZT (Retrovir) in single tablet |
HIV infection and AIDS |
Approved for marketing in Canada (12/4) |
Medeva plc (NYSE:MDV; U.K.) | Hepagene | 3rd-generation recombinant vaccine that incorporates all 3 hepatitis B virus surface antigens (pre-S1, pre-S2 and S) |
Vaccine for hepatitis B virus infection |
Announced results of clinical trial conducted in the Pacific Rim (12/16) |
PowderJect Pharmaceuticals plc (U.K.) and Glaxo Wellcome plc (NYSE:GLX; U.K.) |
Hepatitis B DNA Vaccine |
Vaccine contains DNA that encodes the surface antigen of hepatitis B virus; delivered to skin as dry powder using needle-free delivery needle-free delivery system | Prophylactic vaccine for hepatitis B virus infection (to elicit protective immunity) | Announced results of Phase Ib trial (12/7) |
SciClone Pharmaceuticals Inc. | Zadaxin (thymosin alpha 1) | Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) | Influenza vaccine adjuvant; also therapy for hepatitis B virus and hepatitis C virus infections | Approved for marketing in Mexico (vaccine adjuvant) and Cambodia (hepatitis therapy) (12/16) |
Serono Canada Inc. (member of the Ares-Serono Group; Switzerland) | Serostim |
Somatotropin; recombinant human growth hormone (injection) | Treatment of AIDS wasting |
Approved for marketing in Canada (12/1) |
MISCELLANEOUS | ||||
Angiotech Pharmaceuticals Inc. (Canada) | |
Topical paclitaxel gel (yew tree-derived semi-synthetic taxoid; inhibits abnormal skin cell growth, inflammatory cell response and angiogenesis) | Mild to moderate psoriasis | Initiated Phase I/II trial in Canada (12/14) |
Biomatrix Inc. |
Synvisc | Elastoviscous hylan biopolymer; chemically modified version of natural hyaluronan |
Osteoarthritis of the knee | Approved for marketing in Australia, Malaysia, Singapore and Thailand (12/18) |
Celtrix Pharmaceuticals Inc. | SomatoKine recombinant version of complex formed by insulin-like growth factor-1 and its major binding protein | IGF-BP3 complex; | Treatment of severely osteoporotic patients recovering from hip fracture surgery |
Presented final results of Phase II trial (conducted in Belgium) at the joint meeting of the American Society for Bone and Mineral Research and the International Bone and Mineral Research Society in San Francisco (12/2) |
Hemispherx Biopharma Inc. (AMEX:HEB) |
Ampligen thetic RNA compound | Double-stranded synpoly I:poly C12U |
Chronic fatigue syndrome (a.k.a. myalgic encephalomyelitis) |
Submitted final marketing application to European Medicines Evaluation Agency (12/2) |
NOTES: | ||||
This chart is intended to provide a monthly update on the clinical and regulatory status of biotech and biotech-related products in development in countries other than the U.S., whether those products are being developed by U.S.-based or non-U.S.-based firms. | ||||
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 14-15. | ||||
