|
Company* (Country; |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Amgen Inc. |
Enbrel (FDA-approved) |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Ankylosing spondylitis |
German researchers presented data showing significantly more drug patients had regression of spinal inflammation vs. placebo (10/18) |
Biogen Idec |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Psoriasis |
Amevive was approved in Canada for treating those with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy (10/13) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriatic arthritis |
Remicade, in combination with methotrexate, was approved in Europe for treating active and progressive PA in patients who have responded inadequately to other drugs; Schering-Plough Corp. has rights in Europe (10/14) |
Cytos |
CYT007- TNFQb |
Therapeutic vaccine designed to produce a specific TNF-a response |
Psoriasis |
Began a Phase I/II trial that will include 48 patients with moderate to severe plaque psoriasis (10/25) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 antibody labeled with yttrium-90 |
Sjogren's syndrome |
A Phase I/II trial in Europe is ongoing (10/19) |
PharmaMar |
Kahalalide F |
Peptides isolated from the Hawaiian mollusk, Elysia rufescens |
Psoriasis |
Began a Phase II trial in patients in France and Spain with severe psoriasis (10/27) |
CANCER | ||||
Access |
AP5346 |
A DACH polymer platinate |
Tumors |
Phase I data on 19 patients in Europe showed two responses in 12 evaluable patients (10/1) |
Adventrx |
CoFactor |
Form of folic acid that is designed to enhance the antitumor effects of 5-FU |
Pancreatic cancer |
The EMEA granted orphan status to the drug in that indication (10/14) |
Bioenvision |
Clofarabine |
Second-generation purine nucleoside analogue |
Acute myeloid leukemia |
Updated results from trial using drug as first-line therapy in older patients showed a median duration of response of six months (10/13) |
Cell |
Trisenox (FDA-approved) |
Arsenic trioxide |
Relapsed/ refractory acute promyelocytic leukemia |
Licensee Nippon Shinyaku Co. received approval to market the product in Japan (10/25) |
Cell |
Trisenox (FDA-approved) |
Arsenic trioxide |
Acute promyelocytic leukemia |
Single-agent study in Iran showed 90% of 63 newly diagnosed patients experienced a complete remission; mean survival time stood at 34 months (10/4) |
Cougar |
CB7630 |
Abiraterone acetate; targeted oral therapy |
Prostate cancer |
Phase I trial in the UK showed treatment was well tolerated and suppressed testosterone levels (10/25) |
Human Genome |
HGS-ETR1 |
Agonistic human monoclonal antibody to TRAIL Receptor 1 |
Advanced colorectal cancer |
Began Phase II trial in Germany in up to 30 patients with refractory or relapsed disease to evaluate tumor response, tolerability and safety (10/13) |
SuperGen Inc. |
Dacogen |
Decitabine for injection; a hypomethylating agent |
Myelodysplastic syndromes |
The companies filed for approval in Europe; MGI has worldwide rights to the product (10/1); the EMEA accepted the application for review (10/25) |
CARDIOVASCULAR | ||||
Actelion Ltd. |
Tracleer (FDA-approved) |
Oral dual endothelin receptor antagonist; bosentan |
Pulmonary arterial hypertension |
Australian researchers reported VITAL trial in 177 patients with PAH related to connective tissue diseases showed significant quality-of-life improvements (10/21) |
Alliance |
Oxygent |
Synthetic PFC emulsion-based oxygen therapeutic |
For use in blood transfusions |
European regulators said the company should pursue an initial indication that would not require direct comparison to allogeneic blood transfusion (10/6) |
DeCode |
DG031 |
Small-molecule inhibitor of 5-lipoxygenase- activating protein |
Preventing heart attack |
Phase IIa trial with 172 patients in Iceland met its primary endpoint of reducing one or more biomarkers linked to arterial inflammation and risk of heart attack (10/19) |
Liponex Inc.* |
CRD5 |
Agent designed to increase HDL (good cholesterol) levels |
High cholesterol and atherosclerosis |
Phase I trial in 56 volunteers in Canada showed the drug was safe and well tolerated (10/19) |
CENTRAL NERVOUS SYSTEM | ||||
Durect Corp. |
SABER-bupivacaine |
Sustained-release formulation of bupivacaine delivered by SABER system |
Post-operative pain |
Began Phase II trial in up to 95 patients in Australia following repair of inguinal hernia (10/25) |
Durect Corp. |
-- |
Transdermal product containing the approved drug sufentanil |
Pain |
Began Phase I trial in Europe to evaluate pharmacokinetics in healthy volunteers (10/22) |
Newron |
Ralfinamide |
Compound that blocks TTXr and TTXs sodium currents |
Neuropathic pain |
Phase II trial in 26 patients in Austria demonstrated tolerability and encouraging efficacy data (10/26) |
INFECTION | ||||
Advanced |
-- |
Topical formulation of antibodies to interferon- gamma |
Herpes simplex virus |
Pilot study in Russia demonstrated encouraging results in patients with Type I HSV (10/11) |
Altachem |
ACP-HIP |
Natural compound thought to be active against the causative viral agent |
Kaposi's sarcoma |
Phase I trial demonstrated safety and tolerability in AIDS-KS patients (10/14) |
BioPartners* |
-- |
Interferon-alpha product |
Hepatitis C |
Company submitted a marketing authorization application seeking approval in Europe (10/25) |
Chiron Corp. |
Fluvirin |
Influenza vaccine |
Influenza |
UK regulators suspended the manufacturing license for the vaccine and denied its release for the 2004-05 season (10/5) |
Corixa |
Fendrix |
Vaccine that includes the GSK Bio Hepatitis B antigen with the addition of Corixa's MPL adjuvant |
Hepatitis B |
The EMEA issued a positive opinion on the marketing application filed in Europe by GSK (10/26) |
Enzon |
PEG-Intron |
Pegylated form of recombinant interferon alfa-2b |
Hepatitis C |
Schering-Plough Corp.'s subsidiary gained approval in Japan for use in combination with ribavirin for treating chronic disease (10/22) |
Immtech |
DB289 |
Oral, dicationic antiviral agent |
Malaria |
Phase I trial in volunteers in France demonstrated appropriate blood levels were reached (10/14) |
Metabasis |
Remofovir |
Prodrug of the approved HBV drug adefovir (Gilead Sciences Inc.'s Hepsera) |
Hepatitis B |
Trial in 45 Asian patients showed serum HBV DNA level decreases with each dose tested (10/5) |
Migenix Inc.* |
MX-3253 |
Celgosivir; oral agent designed to inhibit the mammalian cell enzyme alpha-glucosidase |
Hepatitis C |
Began Phase II trial in Canada to assess viral loads and safety in 60 treatment-naïve or interferon- intolerant HCV patients (10/13) |
MISCELLANEOUS | ||||
Aastrom |
Tissue |
Stem and progenitor cells produced from a patient's own bone marrow |
Sinus lift bone graft |
Began a trial in Spain to test the safety and efficacy of the product in maxillary sinus lift bone graft procedures that are used in dental implants (10/21) |
Aastrom |
Tissue Repair Cells |
Stem and progenitor cells produced from a patient's own bone marrow |
Bone grafting |
Trial will be expanded following Phase I data in Spain from five patients undergoing bone graft repair of severe long bone nonunion fractures (10/18) |
Altus |
TheraCLEC |
Oral enzyme-replacement therapy designed to replace digestive enzymes |
Pancreatic insufficiency |
The product was granted orphan status in Europe for treating mal-absorption due to exocrine pan- creatic insufficiency (10/12) |
Amgen Inc. |
Mimpara (FDA- approved as Sensipar) |
Cinacalcet HCl; oral calcium calcimimetic |
Secondary hyperpara- thyroidism |
The product was approved in Europe for treating SHPT in patients with chronic kidney disease on dialysis and for treating elevated calcium levels in patients with cancer of the parathyroid gland (10/28) |
Arexis AB* |
BSSL |
Human enzyme-replacement therapy; bile salt-stimulated lipase |
Fat malabsorption in cystic fibrosis patients |
Phase II trial showed good effect, that drug was well tolerated and was superior to the current treatment (10/15) |
Basilea |
BAL4079 |
Alitretinoin; naturally occurring vitamin A derivative |
Chronic hand dermatitis |
Began Phase III program in Europe designed to enroll 2,000 patients and measure response rates vs. placebo (10/28) |
Columbia |
Striant |
Testosterone buccal system |
Testosterone replacement |
The product was approved in Europe as a testosterone-replacement therapy in men with hypogonadism (10/27) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature infants |
Submitted a marketing authorization application seeking approval in Europe (10/5); the EMEA validated the application (10/27) |
Enhance |
LI 301 |
Existing, undisclosed drug |
Premature ejaculation |
Began a Phase III trial to test efficacy in up to 80 couples in Europe (10/1) |
Insmed Inc. |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Extreme insulin resistance |
The product was granted orphan designation in Europe for that indication (10/25) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
EMEA = European Medicines Agency; MAA = Marketing authorization application. | ||||
AMEX = American Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; VSE = Vancouver Stock Exchange. | ||||
