Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
4SC AG* |
SC12267 |
Small molecule designed to inhibit pyrimidine synthesis |
Autoimmune diseases |
Phase I trial demonstrated safety, tolerability and a good pharmacokinetic profile (3/24) |
CANCER | ||||
Adherex |
Exherin (ADH-1) |
Cadherin antagonist; small-peptide, tumor/ vascular-targeting agent |
Various cancers |
Began Phase II trial in Canada to test the drug in eight tumor types in 60 patients whose tumors express N-cadherin (3/24) |
Alfacell Corp. |
Onconase |
Ranpirnase; cytotoxic ribonuclease |
Malignant mesothelioma |
The product was granted orphan designation in Australia in that indication (3/28) |
Bioenvision |
Clofarabine |
Second-generation purine nucleoside analogue |
Pediatric and adult acute leukemia |
Presented data from ongoing trials that confirm positive data from previous studies (3/21) |
GammaCan |
GCAN 101 |
Therapy based on intravenous immuno- globulin |
Cancers |
Began Phase II trial in up to 30 patients with metastatic melanoma, metastatic prostate or colon cancers (3/14) |
Genzyme |
Thyrogen |
Thyrotropin alfa for injection; a recombinanthuman thyroid- stimulating hormone |
Ablation of remnant thyroid tissue |
The European Commission approved the product for use with radio-iodine (3/3) |
Maxim |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Acute myeloid leukemia |
The product was granted orphan designation in Europe in that indication (3/9) |
OSI |
Tarceva (FDA-approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor |
Advanced non- small-cell lung cancer |
The product was approved in Switzerland for treating locally advanced or metastatic disease; F. Hoffmann-La Roche Ltd. has marketing rights in Europe (3/22) |
Oxford |
TroVax |
Vaccine that delivers an antigen (5T4) using a poxvirus vector |
Metastatic colorectal cancer |
The primary endpoints of safety and immunological responses were achieved in Phase II trials with chemotherapy in 25 patients; clinical benefit also was seen; in another trial all eight evaluable patients mounted immune responses (3/2) |
Praecis |
Plenaxis (FDA-approved) |
Abarelix for injectable suspension; gonadotropin- releasing hormone antagonist |
Prostate cancer |
German authorities had questions about the MAA that could impact future labeling (3/24) |
Psiron Ltd. |
CVA21 |
Coxsackie A21 (common cold) virus |
Advanced melanoma |
Began initial human testing of the product in two patients; initial data showed it was well tolerated (3/15) |
CARDIOVASCULAR | ||||
GTC |
ATryn |
Recombinant human antithrombin |
Hereditary antithrombin deficiency |
The EMEA has questions on the MAA, which was filed in February 2004, delaying the expected time to launch (3/16) |
NicOx SA |
NCX 4016 |
Nitric oxide-donating derivative of aspirin |
Cardiovascular complications |
Phase IIa trial in 40 patients showed drug was more effective than aspirin and placebo at prventing platelet activation induced by acute hyperglycemia in diabetic patients (3/1) |
United |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Pulmonary hypertension |
French officials issued an approval letter for treating NYHA Class III primary PH, and said the mutual recognition process in the EU would begin in May (3/8) |
CENTRAL NERVOUS SYSTEM | ||||
Axonyx |
Phenserine |
Inhibitor of acetylcholin- esterase and beta-amyloid precursor protein |
Alzheimer's disease |
Company released additional details from Phase III trial in 375 patients in Europe that failed to demonstrate statistical significance, and halted additional recruitment in Phase III trials; a Phase IIb trial continues (3/11) |
Cara |
CR665 |
Selective peripheral kappa opioid receptor agonist |
Pain |
Began Phase I trial in the UK to test safety, tolerability and pharmacokinetics in healthy volunteers (3/24) |
LAB International |
Fentanyl Taifun |
Fentanyl formulation delivered via the company's dry powder inhaler platform |
Pain in cancer patients |
Began Phase II trial in 112 patients to evaluate safety and efficacy (3/29) |
Prana |
PBT2 |
Small molecule that binds metal ions |
Alzheimer's disease |
Began Phase I trial in the Netherlands to examine safety and pharmacokinetics in volunteers (3/14) |
DIABETES | ||||
Speedel Group* |
SPP301 |
Once-a-day oral endothelin A receptor antagonist |
Diabetic nephropathy |
All doses in a Phase IIa trial in 286 patients demonstrated statistic- ally significant decreases in albumin excretion rates (3/2) |
INFECTION | ||||
AEterna |
Impavido |
Oral miltefosine, an alkylphospholipid agent |
Cutaneous form of leishmaniasis |
The product was approved in Colombia; the approval also applies to the visceral form of leishmaniasis (3/23) |
Access |
Aphthasol |
Product containing amlexanox |
Canker sores |
The product was approved in 10 European Union countries follow- ing completion of the Mutual Recognition Procedure (3/3) |
Chiron Corp. |
Fluvirin (FDA-approved) |
Influenza vaccine |
Influenza |
UK officials lifted the license suspension for Chiron's Liverpool, UK, manufacturing facility (3/2) |
Enanta |
EP-013420 (S-013420) |
A bridged bicyclic ketolide |
Infections |
Partner Shionogi & Co. Ltd. began Phase I trials in Japan (3/14) |
Immtech |
DB289 |
Oral, dicationic antiviral agent |
African sleeping sickness |
All 26 patients from Phase IIb trial in the Congo remained clear of the parasite three months after concluding treatment (3/9) |
Medivir AB |
MIV-310 |
Alovudine; antiviral agent |
HIV |
Partner Boehringer Ingelheim stopped development after the drug did not show target efficacy in a Phase II trial (3/15) |
Neutec Pharma |
Mycograb |
Agent based on naturally occurring antibody against hsp90 |
Invasive candidiasis |
Began marketing application process in Europe for use in combination with amphotericin-B (3/14) |
Sinovac Biotech |
Split influenza vaccine |
Influenza |
The product was approved in China (3/15) |
|
The Immune |
Remune |
Immune-based therapy comprised of a whole-killed virus and an adjuvant |
HIV |
Phase II trial in Spain showed long-term treatment delayed virologic failure during antiretroviral treatment interruption; Phase II trial in Italy showed stabilization of CD4+ cell counts and positive trends in response markers (3/9) |
MISCELLANEOUS | ||||
Alizyme plc |
Colal-Pred |
A prednisolone derivative with Alizyme's colonic drug delivery technology |
Acute ulcerative colitis |
Got OK for Phase III trial in Europe that will compare the drug to conventional oral prednisolone in up to 670 patients (3/15) |
BioXell SpA* |
BXL628 |
Inhibitor of growth factor phosphorylation and bcl-2 |
Benign prostatic hyperplasia |
Additional data from Phase IIa trial showed 29% of patients experienced a reduction of prostate volume vs. 0% for placebo (3/19) |
Cambridge |
Trabio (CAT-152) |
Lerdelimumab; fully human monoclonal antibody that neutralizes transforming growth factor beta-2 |
Glaucoma |
A second pivotal Phase III trial failed to meet the primary end- point of improving the outcome of surgery for glaucoma; further development was stopped (3/22) |
Cellegy |
Rectogesic (Cellegesic) |
Nitroglycerin ointment |
Hemorrhoids |
Trial in 47 patients in Australia showed mean anal sphincter pressure was significantly decreased; improvements were seen in pain, bleeding and other endpoints (3/28) |
InKine |
Visicol (FDA-approved) |
Sodium phosphate tablets |
For use as a colonic purgative |
Partner Zeria Pharmaceutical Co. Ltd. filed for approval in Japan for use as a colonic purgative, bowel cleansing agent or laxative (3/29) |
Life Medical |
Repel-CV |
Bioresorbable, polymer- based adhesion barrier film |
Prevention of post- operative adhesions |
Began a trial to test the product at cardiac centers in Europe (3/21) |
Miravant |
Photrex (SnET2) |
Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels |
Wet age-related macular degeneration |
Said it will begin a confirmatory trial in Europe in 600 patients, as called for in a September 2004 FDA approvable letter (3/10) |
NicOx SA |
NCX 1020 |
Nitric oxide-donating derivative of budesonide, a corticosteroid |
Asthma |
Phase IIa trial in 12 patients in the UK showed a trend in protecting against bronchoconstriction (3/15) |
NPS |
Preotact (Preos) |
Recombinant human parathyroid hormone |
Osteoporosis |
Partner Nycomed Group submitted an MAA in Europe seeking approval for treating postmenopausal osteoporosis (3/11) |
Pharming |
rhC1INH |
Recombinant human C1 inhibitor |
Hereditary angioedema |
Presented clinical data showing rapid time to beginning of relief and time to complete resolution, as well as favorable evaluations by patients and physicians (3/15) |
| | ||||
Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange. | ||||
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