Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
Amgen Inc. |
Enbrel (FDA-approved) |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Plaque psoriasis |
European regulators recommended approval for treating adults with moderate to severe disease for whom other treatments have been inadequate (7/30) |
Centocor Inc. (unit of Johnson & Johnson) |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriatic arthritis |
European regulators recommended approval of expanded label to include treatment, with methotrexate, of active and progressive PA in patients who responded inadequately to other drugs (7/30) |
Y's Therapeutics |
YSIL6 |
Agent designed to inhibit TNF-alpha and IL-6 production, and to inhibit T-cell proliferation and migration |
Rheumatoid arthritis |
Plans Phase II trial in Germany to assess safety and clinical effect (7/26) |
CANCER | ||||
Atrix |
Eligard (FDA-approved) |
Leuprolide acetate for injectable suspension |
Prostate cancer |
Licensee Sanofi-Synthelabo filed for approval of six-month, 45-mg formulation in Canada (7/19) |
Immuno- |
Mepact |
Immune system stimulant designed to activate macrophages |
Osteosarcoma |
The product was granted orphan designation in Europe in that indication (7/8) |
PharmaMar SA* (Spain) |
Kahalalide F |
Peptides isolated from the Hawaiian mollusk, Elysia rufescens |
Non-small-cell lung cancer and melanoma |
Began Phase II trials in Europe in each indication to measure response rates and other endpoints (7/19) |
Progen Industries |
PI-88 |
Anti-angiogenesis drug also designed to inhibit tumor-promoting factors |
Primary liver cancer |
Asian collaborator Medigene Bio- Technology Corp. began fourth and largest Phase II trial of drug, in 340 patients in Taiwan (7/13) |
SuperGen |
Dacogen |
Decitabine for injection; a hypomethylating agent |
Myelodysplastic syndromes |
Published data from Phase II trials involving 170 patients in Europe showed platelet responses in 63% of patients, which correlated with survival (7/9) |
SuperGen |
Orathecin (rubitecan) |
Topoisomerase-I inhibitor in capsule formulation |
Pancreatic cancer |
Filed MAA seeking approval in Europe for treating patients who have failed at least one regimen (7/1) |
CARDIOVASCULAR | ||||
AOP Orphan |
Thrombo-reductin |
Anagrelide-containing medicinal product |
Thrombocythemia |
The orphan product was approved in Europe; AOP will complete ongoing Phase III Anahydret trial (7/19) |
Biopure Corp. |
Hemopure |
Oxygen therapeutic consisting of bovine hemoglobin |
Blood loss in trauma patients |
Began Phase II trial in South Africa to test safety and tolerability in a hospital setting, as well as to assess efficacy parameters (7/28) |
BioTime Inc. |
Hextend |
Blood plasma volume expander |
Blood loss during surgery |
Partner CJ Corp. received approval in South Korea, and now will seek pricing approval (7/7) |
Novogen Ltd. (Australia; NVGN) |
Trans-NV-04 |
Antioxidant that inhibits smooth muscle cell growth in blood vessels |
Cardiovascular disease |
Began trial in Australia to test safety and tolerability in healthy volunteers at risk of cardiovascular disease (7/6) |
CENTRAL NERVOUS SYSTEM | ||||
Manhattan Pharmaceuticals |
-- |
Lingual spray formulation of propofol |
Sedation |
UK Phase I trial in 12 healthy volunteers demonstrated feasibility of oral mucosal delivery (7/14) |
NeuroSearch |
NS1209 |
Water-soluble, glutamate AMPA antagonist |
Long-lasting seizures |
Began two Phase II trials in Denmark, Sweden and Finland to test the agent on 60 patients with refractory status epilepticus (7/20) |
INFECTION | ||||
Avant Immuno- therapeutics |
Rotarix |
Oral, two-dose, live attenuated vaccine developed from a single human strain |
Rotavirus infection |
Partner GlaxoSmithKline plc got approval in Mexico for preventing gastroenteritis caused by rota- virus infection; it was the first approval of the vaccine (7/15) |
Chiron Corp. |
MeNZB |
Meningococcal B vaccine designed for strain in New Zealand |
Meningococcal |
New Zealand regulators approved the vaccine for use there (7/7) |
Intercell AG* |
-- |
Vaccine based on virus-derived, T-cell-specific peptides formulated with the company's Polyarginine adjuvant |
Hepatitis C |
Reported positive data from a Phase II trial in interferon/ribavarin non-responders, setting the stage for further Phase II study (7/21) |
Microscience |
spi-VEC |
Hepatitis B antigen delivered via company's spi-VEC vaccine technology |
Hepatitis B |
Phase I trial in 30 subjects showed the vaccine was safe and immunogenic (6/29) |
Neutec Pharma |
Mycograb |
Agent based on naturally occurring antibody against hsp90 |
Invasive |
Multinational trial in 139 patients showed 84% response rate vs. 48% in placebo group, a statistically significant result (7/12) |
Sinovac Biotech |
Healive |
Hepatitis A vaccine that is sold in China |
Hepatitis A | Filed registration applications in Brazil, Indonesia, Mexico, Malaysia, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam (7/22) |
Tripep AB |
AlphaHGA |
Agent designed to inhibit the spread of the virus from the infected cell |
HIV |
Microdosing study showed the agent was orally bioavailable and had kinetic properties (7/21) |
Vertex |
Telzir (Lexiva; FDA-approved) |
Fosamprenavir calcium; protease inhibitor |
HIV | Vertex and GlaxoSmithKline plc gained approval in Europe for use in combination regimens (7/16) |
Viral Genetics |
VGV-1 |
Thymus nuclear protein |
HIV | Trial in China showed decreased viral loads in treatment-naive patients receiving VGV-1 mono- therapy (7/23) |
MISCELLANEOUS | ||||
Amgen Inc. |
Mimpara (FDA- approved as Sensipar) |
Cinacalcet HCl; oral calcium calcimimetic |
Secondary hyperpara- thyroidism |
European regulators recommended approving the drug for HPT in chronic kidney disease patients on dialysis and for elevated calcium levels in patients with parathyroid carcinoma (7/29) |
Ascend |
Andrin |
Transdermal dihydro- |
Benign prostate hyperplasia |
Began Phase II trial in 100 healthy men in Australia to evaluate safety and efficacy in preventing prostate growth (7/16) |
Cellegy Pharmaceuticals |
Rectogesic |
Nitroglycerin ointment |
Pain from | Said approval in the UK expected in six months, following satisfactory responses to minor issues (7/7) |
Dragon |
-- |
Recombinant erythropoietin product |
Anemia due to renal failure and surgery |
The product was approved in Ecuador, the sixth country to grant approval (7/16) |
Genentech |
Xolair |
Omalizumab; humanized monoclonal antibody to IgE |
Asthma |
Novartis submitted an application seeking approval in Europe (7/2) |
Insmed Inc. |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Leprechaunism and primary lateral sclerosis |
French officials authorized use in an infant with severe insulin resistance, and Italian officials OK'd use in a patient with PLS (7/12) |
IsoTis |
Allox |
Allogeneic product derived from human cells, in spray formulation |
Wound treatment |
Phase II trial in 110 patients with hard-to-heal ulcers showed 45% complete wound closure in the drug group vs. 33.3% among con-trols (7/9) |
BioMarin |
6R-BH4 |
Enzyme co-factor; the active ingredient in the company's investigational agent |
Phenylketonuria |
The product was granted orphan status in Europe (7/20) |
Y's Therapeutics | YSTH2 |
Agent designed to inhibit T-cell proliferation and migration, and to inhibit matory cytokine production |
Asthma | Plans Phase II trial in Germany to Th-2 type and proinflam- assess safety and clinical effect (7/26) |
Notes: | ||||
* Privately held. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
