Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Ark Therapeutics Ltd. (UK)* | EG009 | Gene therapy product consisting of the gene HSV-tk, and the inactive prodrug ganciclovir | Glioma | Product was granted orphan drug designation in the European Union (3/27**) |
Cell Therapeutics Ltd. (subsidiary of Cell Therapeutics Inc.; CTIC) | Trisenox (FDA- | Arsenic trioxide injection | Relapsed/refractory acute promyelocytic leukemia | The European Commission granted marketing authorization (3/13) |
EpiTan Ltd. | Melanotan | A 13-amino-acid peptide that stimulates the production of melanin to produce normal tanning | To reduce sun exposure damage/ | Company completed its first Phase I/II trial in Australia (3/18) |
PhotoCure ASA (Norway; OSE:PH) | Metvix PDT | Cream that is absorbed into the cancer cells, followed by activation of the drug through illumination with a red light source called Curelight | Basal cell carcinoma | Company received German marketing authorization; it also has authorization in New Zealand, Sweden, Norway and Iceland (3/7) |
Procyon Biopharma Inc. (Canada; TSE:PBP) | PCK3145 | Synthetic peptide analogue of prostate secretory protein | Hormone-refractory prostate cancer | Company received approval from the UK regulatory authorities to begin a Phase IIa trial (3/11) |
CARDIOVASCULAR | ||||
Actelion Ltd. (Switzerland; SWX:ATLN) | Tracleer (FDA- | Orally available endothelin receptor antagonist | Pulmonary arterial | The Swiss regulatory authority approved Tracleer (3/11) |
Hemosol Inc. | Hemolink | Oxygen therapeutic; hemoglobin raffimer | Cardiac bypass grafting surgery | Health Canada said the new drug submission for Hemolink would not be approved (3/21) |
DIABETES | ||||
Biovitrum AB | BVT.3498 | A selective 11B HSD-1 inhibitor | Type II diabetes | Company entered Phase I studies (3/11) |
INFECTION | ||||
Gilead Sciences Inc. (GILD) and Hoffmann-La Roche Inc. | Tamiflu (FDA- | Oseltamivir phosphate | Influenza | The European Committee for Proprietary Medicinal Products recommended granting marketing authorization for the treatment of influenza in children and adults (3/21) |
Gilead Sciences | Adefovir dipivoxil 10 mg | Nucleotide reverse transcriptase inhibitor | Chronic hepatitis B | Company submitted a marketing authorization application in Europe (3/26) |
SciClone | Zadaxin | Monotherapy treatment; synthetic immunostimulant peptide | Hepatitis B | Phase III results from a trial in Japan showed that data on one-third of the 319 patients indicate that 24% had a successful interruption of viral replication (3/5); data of a 12-month follow-up to a study in Turkey showed that 71% of patients who used Zadaxin in combination therapy with interferon continued to show a sustained response vs. only 10% of the patients who used interferon alone (3/13) |
The Immune Response Corp. (IMNR) and Trinity Medical Group USA Inc. (OTC BB:TMGU) | Remune | Inactivated HIV-1 therapeutic vaccine | HIV | Company submitted an independent Remune study to the Thai Ministry of Public Health as part of its NDA; the study showed that Remune met its clinical endpoints (3/1) |
INFLAMMATION | ||||
Amgen Inc. | Kineret (FDA- | Anakinra; a direct and selective blocker of interleukin-1 | Rheumatoid arthritis | The European Commission approved Kineret for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate (3/13) |
MISCELLANEOUS | ||||
Biosearch Italia | BI-K0376 | Selective against Propionibacterium acnes, the causative agent of acne, but does not harm the normal bacterial flora | Acne | Company began a Phase I trial in the UK (3/27**) |
Cellegy Pharma- | Rectogesic | Nitroglycerin ointment | Pain associated with chronic anal fissures | Company filed a new drug submission in Canada (3/22) |
Cephalon Inc. (CEPH) | Provigil (FDA- | Modafinil; oral formulation of synthetic compound | Excessive daytime sleepiness in patients with obstructive sleep apnea | Company filed a marketing authorization application in the UK to expand the label (3/28) |
Modex Therapeutics Ltd. (Switzerland; SWX:MDXN) | EpiDex | Skin replacement product | Skin ulcers | Phase II data showed EpiDex had clinical superiority to the meshgraft in treating hard-to-heal skin ulcers (3/28) |
NexMed Inc. | Befar | Alprostadil cream combined with NexACT transdermal penetration enhancing technology | Erectile dysfunction | Befar was approved in Hong Kong (3/12) |
PowderJect | Dukoral | A drinkable vaccine | Cholera and travelers' diarrhea | Companies submitted a European marketing authorization application (3/11) |
Transkaryotic Therapies Inc. (TKTX) | Dynepo | Erythropoietin product; epoetin delta | Anemia in dialysis patients and renal patients | Dynepo was granted approval in Europe (3/26) |
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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; OSE = Oslo Stock Exchange; OTC BB = Over the Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange | ||||
