Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
Amgen Inc. (AMGN) |
Enbrel (FDA-approved) |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Rheumatoid arthritis |
Partner Wyeth gained approval of Enbrel in Europe for use with methotrexate in adult RA patients whose response to other drugs has been inadequate (5/26) |
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Abbott Laboratories |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Rheumatoid arthritis |
European regulators issued a positive opinion for a label extension to reduce progression of joint damage, in combination with methotrexate (5/6) |
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Biogen Idec Inc. (BIIB) |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Chronic plaque psoriasis |
Israeli authorities approved the drug there for moderate to severe disease; Biogen also received a positive opinion letter from Swiss regulators (5/3) |
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CANCER | ||||
Ardana Bioscience* (UK) |
Teverelix LA |
Sustained-release gonadotrophin-releasing hormone antagonist |
Prostate cancer |
Began a Phase IIa trial testing two doses in 28 patients (5/17) |
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Attenuon LLC* |
ATN-224 |
Second-generation version of tetrathiomolybdate, an angiogenesis inhibitor that binds to copper |
Solid tumors |
Began Phase I trial in the UK that will evaluate safety, tolerability and dosing in up to 16 refractory patients (5/24) |
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Genmab A/S (Denmark; CSE:GEN) |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Cutaneous T-cell lymphoma |
The product was granted orphan designation in Europe in that indication (5/25) |
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Oncolytics Biotech Inc. (Canada; ONCY) |
Reolysin |
Formulation of the human reovirus |
Advanced solid tumors |
Began Phase I trial in up to 40 refractory patients in the UK to test dosing and safety as well as immune responses and antitumor activity (5/26) |
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PharmaMar SA* (Spain) |
Aplidin |
Cyclodepsipeptide derived from the marine tunicate Aplidium albicans |
Small-cell lung cancer |
Began a Phase II trial in the U.S. and Europe to assess responses in patients who have relapsed or progressed; also expanded Phase II trial in melanoma after positive responses were seen (5/10) |
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Protherics plc (UK; LSE:PTI) |
NQ02 |
Small-molecule prodrug combining CB1954 with an enzyme co-substrate |
Solid tumors |
Began a Phase I trial in 40 patients (5/20) |
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Responsif GmbH* (Germany) |
-- |
Immunotherapy consisting of patient-derived tumor cells coated with Annexin |
Renal-cell carcinoma |
Began first trial of the product, a study in Germany to evalaute the tolerability of treatment (5/26) |
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CARDIOVASCULAR | ||||
Opperbas Holding BV* (the Netherlands) |
-- |
Pegylated liposomes delivering Factor VIII |
Hemophilia A |
Began a Phase II trial; details were not disclosed (5/28) |
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United Therapeutics Corp. (UTHR) |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
Product gained approval in Australia for treating patients with NYHA Class III and IV to diminish symptoms associated with exercise (5/21) |
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INFECTION | ||||
Acambis plc (UK; ACAM) |
ChimeriVax-West Nile |
Vaccine |
West Nile virus |
The number of subjects in Phase I trial was increased to 110 from 60 and a placebo arm was added after two adverse events were reported (5/25) |
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Bavarian Nordic A/S* (Denmark) |
Imvamune |
Third-generation smallpox vaccine candidate |
Smallpox infection |
Phase ll dose-finding trial in 165 healthy volunteers confirmed favorable safety and immunogenicity profile seen earlier (5/11) |
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Bavarian Nordic A/S* (Denmark) |
Imvamune |
Third-generation smallpox vaccine candidate |
Smallpox infection |
Company began Phase I trial in 60 subjects in Europe, including people suffering from atopic dermatitis (5/5) |
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Biosyn Inc.* |
C31G vaginal gel (1 percent) |
Gel designed to prevent sexual transmission of HIV |
HIV prevention |
Began pivotal Phase III trial that will include 2,200 at-risk women in Ghana; parallel study in Nigeria is expected to follow (5/20) |
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Hemispherx Biopharma Inc. (AMEX:HEB) |
Alferon LDO |
Low-dose, oral alpha-interferon cocktail |
HIV |
World Foundation Aids Research began a trial to assess viral load and immune effect in 40 patients in Africa (5/10) |
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NexMed Inc. (NEXM) |
NM100060 |
Marketed oral antifungal delivered with NexACT technology |
Toenail fungal infections |
Trial in 120 patients showed the product was well tolerated and produced encouraging efficacy results (5/5) |
Peninsula Pharmaceuticals Inc.* |
PPI-0903 |
Next-generation cephalosporin antibiotic |
Infections and pneumonias |
Began Phase I trial in the UK to assess safety and tolerability of intravenous PPI-0903 in healthy subjects (5/20) |
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Xcellentis (subsidiary of Innogentics NV; Belgium) |
LymphoDerm |
Human keratinocyte lysate in a topical formulation |
Hard-to-treat venous leg ulcers |
Final data from Phase II trial confirmed improved total wound closure for the drug group vs. control groups (5/13) |
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MISCELLANEOUS | ||||
Arakis Ltd.* (UK) and Vectura Ltd.* (UK) |
AD 237 |
Bronchodilator treatment containing marketed anti-muscarinic drug |
Chronic obstructive pulmonary disease |
Phase IIa study showed an optimized inhaled formulation was suitable for once-daily use (5/14) |
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Enzo Biochem Inc. (NYSE:ENZ) |
EGS21 |
Beta-D-glucosylceramide compound that acts on immune regulatory cells |
Various diseases |
Got approval to begin Phase I trial in Israel to test safety (5/20) |
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Pharmagene plc (UK; LSE:PGN) |
PGN0052 |
Human secretin |
Cystic fibrosis and asthma |
Two Phase I trials in healthy volunteers and one in patients with asthma showed the product was well tolerated and showed effects on respiratory function; a Phase IIa trial in the UK in 18 CF patients is under way (5/24) |
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Vectura Ltd.* (UK) |
VR004 |
Inhaled apomorphine |
Erectile dysfunction |
Early stage clinical trial showed product was tolerated and was rapidly and efficiently absorbed following inhalation (5/26) |
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Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Cophenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange. |
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