Company* (Symbol) |
Product |
Description |
Indication |
Status (Date) |
CANCER | ||||
AEterna Laboratories (Canada; AELA; TSE:AEL) |
Neovastat/AE-941 |
Angiogenesis inhibitor; orally bioavailable naturally occurring product that blocks VEGF and MMPs |
Multiple myeloma |
Company submitted applications to the FDA to begin a clinical trial; application also was submitted with the Health Protection Branch in Canada (10/25) |
Cell Therapeutics Inc. (CTIC) |
CT-2103 |
PG-TXL; links the cancer drug Taxol to the company's polyglutamate polymer |
Lung, ovarian, breast and colon cancers |
FDA granted approval for the company to start a clinical study (10/30) |
Coulter Pharmaceutical Inc. (CLTR) and SmithKline Beecham (NYSE:SBH) |
Bexxar |
Tositumomab, I-131 tositumomab |
Relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma |
FDA assigned priority review status to Bexxar (10/5) |
Ilex Oncology Inc. (ILXO) and Millennium Pharmaceuticals Inc. (MLNM) |
Campath |
Alemtuzumab; humanized monoclonal antibody that specifically targets and binds to CD52 cell surface antigen on lymphocytes |
B-cell lymphocytic leukemia |
FDA will review Campath at the panel's Dec. 13-14 meeting; BLA was submitted in December 1999 (10/26) |
Intracel Corp.* |
Keyhole Limpet Hemocyanin |
Immune stimulator |
Bladder cancer |
FDA gave Intracel permission to begin a Phase III trial (10/24) |
MacroMed Inc.* |
OncoGel |
Formulation of paclitaxel using ReGel, MacroMed's drug delivery system; intralesionaly administered chemotherapeutic |
Cancer lesions |
Company received FDA clearance to initiate clinical trials in cancer patients with lesions or for those who are not candidates for aggressive surgical intervention (10/16) |
Repligen Corp. (RGEN) |
CTLA4-lg |
T-cell regulatory protein |
Leukemia |
FDA granted the company approval to initiate a Phase II trial to determine if CTLA4-lg, in combination with T-cell depletion, can reduce the incidence or severity of graft-vs.-host disease (10/23) |
CARDIOVASCULAR | ||||
Actelion Ltd. (Switzerland; SWX:ATLN) |
Bosentan |
Orally active endothelin receptor antagonist |
Pulmonary hypertension |
Actelion gained FDA orphan status for bosentan (10/18**) |
Endovasc Ltd. Inc. (OTC BB:ENDV) |
Liprostin |
Liposomal encapsulated prostaglandin E-1 drug |
Critical limb ischemia |
Company submitted an IND to test the drug in patients who have lost cirulation in their lower limbs and are in danger of requiring amputation (10/3) |
United Therapeutics Corp. (UTHR) |
Uniprost (formerly UT-15) |
Prostacyclin; molecule produced within the body naturally |
Pulmonary hypertension |
Company filed an NDA (10/16); FDA granted priority review status (10/19) |
CENTRAL NERVOUS SYSTEM | ||||
Immunex Corp. (IMNX) |
Novantrone (FDA-approved) |
Mitoxantrone for injection concentrate |
Secondary progressive multiple sclerosis |
FDA approved Novantrone for reducing neurological disability and/or the frequency of clinical relapses in patients with secondary progressive, progressive relapsing or worsening relapsing-remitting MS (10/13) |
Orphan Medical Inc. (ORPH) |
Xyrem |
Sodium oxybate; oral formulation |
Narcolepsy |
Company submitted an NDA for Xyrem to treat the symptoms of narcolepsy (10/2) |
Pharmacia Corp. (NYSE:PHA) |
Parecoxib sodium |
Injectable COX-2 specific inhibitor, which can be administered intramuscularly or intravenously |
Acute pain |
Company submitted an NDA (10/30) |
INFECTION | ||||
Aviron (AVIR) and American Home Products Corp. (NYSE:AHP) |
FluMist |
Intranasal vaccine |
Influenza |
Companies filed a BLA with the FDA for FluMist to prevent influenza in children and adults (10/31) |
Human Genome Sciences Inc. (HGSI) |
Albuferon |
A protein created by fusing the gene for the human protein interferon alpha to the gene of another human protein, albumin |
Hepatitis C |
Company submitted an IND application to the FDA to initiate Phase I trials of Albuferon (10/18) |
Protherics plc (UK; LSE:PTI) |
CroFab |
Antivenom; consists of antibody fragments, derived by injecting rattlesnake venom into sheep and harvesting the antibodies, which will bind to the toxins of the rattlesnake's venom |
Rattlenake bites |
Company won FDA approval for CroFab as a treatment for rattlesnake bites (10/11**) |
MISCELLANEOUS | ||||
Allergan Inc. (NYSE:AGN) and Acadia Pharmaceuticals* |
AGN 195795 |
Gene-specific adrenergic agonist |
Glaucoma |
Allergan filed an IND application with the FDA (10/31) |
Alexion Pharmaceuticals Inc. (ALXN) |
5G1.1 |
Monoclonal antibody that inhibits the fifth component of the complement cascade |
Dermatomyositis |
FDA granted orphan drug status (10/6) |
Genelabs Technologies Inc. (CNLB) |
Aslera (FDA-approved) |
GL701 or prasterone |
Systemic lupus erythematosus |
FDA granted priority review status to the Aslera NDA (10/25) |
Genentech Inc. (NYSE:DNA) |
Alteplase |
Recombinant, a bioengineered version of the naturally occurring tissue plasminogen activator |
To open occluded central venous access devices |
Company submitted a supplemental BLA to restore function of devices necessary to withdraw or infuse vital fluids to ill patients (10/2) |
Gliatech Inc. (GLIA) |
ADCON-L |
Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) |
Post-surgical scarring and adhesions |
Gliatech withdrew its PMA supplement in response to the FDA's concerns and has proposed re-evaluating the MRI data (10/16) |
Inspire Pharmaceuticals Inc. (ISPH) |
INS37217 Respiratory |
Second-generation P2Y(2) agonist designed to enhance the lung's innate mucosal hydration and mucociliary clearance mechanisms |
Cystic fibrosis |
Company filed IND to begin clinical trials (10/3) |
Neurochem Inc. (Canada; TSE:NRM) |
Fibrillex |
Orally active antifibrillary agent |
Secondary amyloidosis |
Neurochem received IND status from the FDA, allowing it to begin Phase II/III trials (10/11) |
Novazyme Pharmaceuticals Inc. * |
NZ-1001 |
Highly phosphorylated enzyme replacement therapy |
Pompe disease |
FDA granted orphan drug status (10/5) |
Orphan Medical Inc. (ORPH) |
Xyrem |
Sodium oxybate; oral solution |
Narcolepsy |
FDA granted priority review status (10/17) |
Ortec International Inc. (ORTC) |
Composite Cultured Skin |
Cryopreserved (frozen) version of CCS |
Venous statis skin ulcers |
Company received FDA permission to begin a pivotal trial; trial expected to include up to 200patients (10/18) |
Q-Med AB* (Sweden) |
DEFLUX |
Copolymer between non-animal stabilized hyaluronic acid and dextranomer |
Vesicoureteral reflux |
An FDA advisory board recommended the approval of DEFLUX to treat vesicoureteral reflux in children (10/23) |
Serono Inc. (U.S. affiliate of Serono SA, Switzerland; NYSE:SRA) |
Ovidrel |
Choriogonadotropin alfa for injection |
Infertility |
FDA granted marketing approval (10/2) |
SkyePharma plc (UK; SKYE) |
Solaraze |
Uses Hyaluronan Induced Targeting transdermal delivery technology |
Acute keratosis |
FDA granted marketing approval (10/20) |
V.I. Technologies Inc. (VITX) |
PEN110 |
Inactine product |
To inactivate pathogens in red blood cells |
Company received FDA clearance to begin a Phase II trial (10/2) |
Vivus Inc. (VVUS) |
Alibra |
Urethral microsuppository of alprostadil and prazosin hydrocholoride |
Erectile dysfunction |
Company withdrew its NDA and plans to meet with the FDA to determine the additional data needed; company also plans to meet with the European Agency for the Evaluation of Medicinal Products concerning the pending European application (10/20) |
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. | ||||
AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; SWE = Switzerland Stock Exchange; TSE = Toronto Stock Exchange; VSE = Vancouver Stock Exchange | ||||
BLA = Biologics License Application | ||||
IND = Investigational New Drug | ||||
NDA = New Drug Application | ||||
ND = Not disclosed | ||||
PMA = Premarket Approval Application |