Company* (Symbol) | Product |
Description |
Indication | Status (Date)** |
CANCER | ||||
Access Pharmaceuticals Inc. (OTC BB: AXCS) |
OraRinse |
0.5% mucoadhesive solution of amlexanox | Mucositis |
Received clearance to begin Phase II trial (1/27) |
AltaRex Corp. (Canada; TSE:AXO) | OvaRex MAb |
Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen |
Advanced-stage ovarian cancer |
Company developed a clinical plan in conjunction with FDA which, if successfully accomplished, would allow a substantially improved manufacturing process with cell culture production by Lonza Biologics (unit of Algroup; Switzerland) without having to repeat ongoing trials (1/3) |
AVAX Technologies Inc. (AVXT) | O-Vax | Haptenized autologous cell vaccine | Advanced-stage ovarian cancer |
Investigational new drug application (IND) accepted; FDA authorized AVAX to begin Phase II trials (1/18) |
Cell Pathways Inc. (CLPA) |
Aptosyn |
Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase | Regression and prevention of precancerous polyps in patients with familial adenomatous polyposis |
FDA advised it plans to evaluate the new drug application (NDA) without requiring input from the Oncologic Drugs Advisory Committee (1/11) |
Celltech Chiroscience plc (LSE:CCH) and Wyeth-Ayerst Laboratories (pharmaceutical division of American Home Products Corp. [NYSE:AHP]) |
Mylotarg (CMA-676) |
Gemtuzumab zogamicin; humanized recombinant antibody linked with a cytotoxic anti-tumor anti-biotic called calicheamicin, isolated by Wyeth researchers from a bacterium in caliche clay, a soil found in Texas; antibody portion is specific for CD-33 antigen, a protein commonly expressed by myeloid leukemia cells |
CD-33-positive relapsed adult acute myeloid leukemia | Wyeth received priority review status for NDA (1/5) |
EntreMed Inc. (ENMD) | Angiostatin |
Recombinant human anti-angiogenic protein |
Cancer | Received permission to begin Phase I clinical testing (1/31) |
Maxim Pharmaceuticals Inc. (AMEX:MMP) |
Maxamine Therapy |
H2 receptor agonist; combination therapy with low-dose interleukin 2 |
Acute myelogenous leukemia | FDA granted orphan drug status (1/5) |
CENTRAL NERVOUS SYSTEM | ||||
Boston Life Sciences Inc. |
Altropane |
Radioimaging probe for dopamine neurons | Diagnosis of attention deficit-hyperactivity disorder |
After discussions with FDA, company said it expects to initiate Phase II/III trial program at the end of 1Q:00 (1/25) |
Immunex Corp. (IMNX) |
Novantrone (FDA-approved) |
Mitoxantrone for injection concentrate |
Relapsing-remitting and secondary progressive multiple sclerosis | FDA's Peripheral and Central Nervous System Drugs Advisory Panel unanimously recommended approval (1/28) |
Chimeric Therapies Inc.* |
Graft engineering technology that processes donor bone marrow in such a way as to allow only a partial transplant |
Sickle cell anemia | Received clearance to begin clinical testing (1/31) |
|
NiCox SA (France; NM:NicOx) |
NCX 4016 | Nitric oxide-releasing derivative of acetylsalicylic acid, the active ingredient in aspirin | Pain and inflammation |
Submitted IND (1/27) |
Nouvel Pharma Inc. (subsidiary of NeoPharma Production AB; Sweden) |
Duodopa | Liquid preparation of levodopa/carbidopa for administration to the small intestine via intraduodenal infusion |
Advanced-stage Parkinson's disease |
Granted orphan drug status (1/25) |
INFECTION | ||||
BioCryst Pharmaceuticals Inc. (BCRX) and R.W. Johnson Pharmaceutical Research Institute (unit of Johnson & Johnson; NYSE:JNJ) | BCX-1812 | Oral small-molecule inhibitor of neuraminidase enzyme, which promotes spread of the influenza virus by breaking the chemical strands that hold new viruses to cell surfaces | Influenza infection | RWJ notified U.S. clinical investigators that discussions with the FDA are continuing, and that it expects to have more information in the coming weeks regarding the timing of U.S. trials (1/7) |
Enzon Inc. (ENZN) and Schering Plough Corp. (NYSE:SGP) |
PEG-Intron Powder for Injection |
Long-acting dosage form of Schering-Plough's Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol | Chronic hepatitis C virus infection in adult patients with compensated liver disease |
Submitted biologics license application (BLA) (1/5) |
Ribozyme Pharmaceuticals Inc. (RZYM) and Eli Lilly and Co. (NYSE:LLY) | LY466700 (formerly Heptazyme) | Synthetic ribozyme designed to selectively cut hepatitis C virus RNA and inhibit viral replication | Hepatitis C infection | Submitted IND (1/11) |
SYNSORB Biotech Inc. (Canada; SYBB) |
Synsorb Cd |
Product that binds to toxins secreted by bacteria in the gastrointestinal tract | Prevention of recurrence of Clostridium difficile-associated disease | Received formal notification of fast-track designation (1/11) |
MISCELLANEOUS | ||||
Alexion Pharmaceuticals Inc. (ALXN) | 5G1.1 |
Anti-inflammatory inhibitor of the fifth component of the complement cascade (C5) |
Severe psoriasis | Filed IND and commenced Phase Ib trial (1/11) |
Amgen Inc. (AMGN) |
NESP; novel erythropoiesis stimulating protein |
Renal disease | Submitted NDA (1/25) | |
Kineret |
Recombinant form of the cytokine interleukin-1ra, which selectively blocks the effects of IL-1, a cytokine released as part of the disease process in rheumatoid arthritis |
Rheumatoid arthritis |
Filed BLA (1/25) | |
Cellegy Pharmaceuticals Inc. (CLGY) |
Tostrelle | Transdermal testoster-one gel |
Postmenopausal testosterone deficiency | IND approved (1/6) |
Centocor Inc. (CNTO) | Remicade (FDA- approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha | Prevention of joint damage in patients with rheumatoid arthritis |
Priority review status granted (1/27) |
Corixa Corp. (CRXA) and Genesis Research & Development Corp. Ltd.* (New Zealand) | PVAC | Immunotherapeutic derivative of Mycobacterium vaccae |
Moderate to severe psoriasis |
Received FDA clearance to initiate Phase II trials (1/11) |
Inhale Therapeutic Systems (INHL) and Aventis Behring LLC (plasma protein business of Aventis Pharma AG (NYSE:AVE) |
Inhaleable formulation of alpha 1 proteinase inhibitor (human) | Congenital emphysema caused by alpha 1 antitrypsin deficiency | Received orphan drug designation and initiated Phase I trial (1/13) |
|
InKine Pharmaceutical Company Inc. (INKP) |
Diacol |
Sodium phosphate tablets |
Purgative agent for adults undergoing colonic cleansing for diagnostic procedures |
NDA accepted for filing (1/24) |
Unigene Laboratories Inc. (OTC BB: UGNE) |
Nasal calcitonin formulation |
Osteoporosis |
Filed IND (1/6) | |
Notes: | ||||
* Indicates a privately held company | ||||
** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NM = Nouveau Marche; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange; ND = Not disclosed | ||||
