Company* |
Product | Description | Indication |
Status (Date) |
| | ||||
| AUTOIMMUNE | ||||
Centocor Inc. |
Remicade |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Crohn's disease |
The FDA accepted supplemental BLA filing and designated it for priority review (4/4) |
Pozen Inc. |
PN 200 |
Agent combining a proton pump inhibitor with a non- steroidal anti-inflammatory drugs |
Various conditions |
Reached agreement with FDA on SPA for pivotal trial, in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondyli- tis at risk for developing NSAID-associated gastric ulcers (4/20) |
Serono SA |
Rebif (FDA-approved) |
Interferon beta-1a |
Multiple sclerosis |
Submitted supplemental BLA with FDA seeking approval of a new formulation of Rebif (4/4) |
CANCER | ||||
Cephalon Inc. |
CEP-701 (lestaurtinib) |
Oral indolocarbazole agent that inhibits certain tyrosine kinases |
Acute myeloid leukemia |
The FDA granted orphan designation to the agent in that indication, for which Phase II/III trials are ongoing (4/4) |
Genentech |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Advanced non-small-cell lung cancer |
Filed supplemental BLA seeking approval in combination with platinum- based chemotherapy for first-line treatment of advanced, non-quamous NSCLC (4/11) |
MGI Pharma |
Saforis |
Oral formulation of glutamine in company's delivery system |
Oral mucositis in cancer patients |
Filed NDA with FDA, seeking approval of the product (4/13) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib; RAF kinase and VEGF inhibitor |
Liver cancer |
The FDA granted orphan designation to the product for treating hepatocellular carcinoma, or liver cancer (4/26) |
CARDIOVASCULAR | ||||
Speedel Holding |
SPP100 (aliskiren; Rasilez) |
Oral renin inhibitor |
Hypertension |
Partner Novartis AG filed an NDA with the FDA, seeking approval in that indication (4/19) |
CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. |
Vivitrol |
Long-acting, injectable form of naltrexone |
Alcohol dependence |
The FDA approved the once- monthly product; Cephalon Inc. has primary marketing and sales responsibility(4/13) |
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Pseudobulbar affect |
The FDA accepted NDA filing and granted it priority review; action is expected by July 30 (4/4) |
Cephalon |
Sparlon |
New formulation and dosage of modafinil, the active ingredient in the approved product Provigil |
Attention deficit hyperactivity disorder |
The FDA extended its review period to Aug. 22, following the company's submission of new safety data (4/24) |
Cortex |
CX717 |
Ampakine analogue; designed to improve brain cell signaling |
Attention deficit hyperactivity disorder |
The FDA placed CX717 trials on hold due to concerns over pre-clinical animal data (4/3) |
Noven |
Daytrana |
Transdermal patch containing methylphenidate |
Attention deficit hyperactivity disorder |
The FDA approved the drug for treating ADHD in 6- to 12-year- olds; Shire plc will market the product (4/6) |
TheraQuest |
Tramadol ER (TQ-1017) |
Extended-release, abuse- deterrent formulation of tramadol |
HIV-associated neuropathy |
The FDA granted fast-track desig- nation to the product in that indication, for which a Phase I trial has been completed (4/18) |
INFECTION | ||||
Acambis plc |
ACAM2000 |
Second-generation vaccine derived from the Dryvax smallpox vaccine |
Smallpox infection |
Completed submission of BLA with FDA; the rolling submission began in January (4/18) |
Accentia Bio- |
SinuNase |
Intranasal amphotericin B formulation |
Chronic sinusitis |
The FDA granted fast-track status in that indication, for which Phase III trials were being planned (4/12) |
Gilead Sciences |
-- |
Once-daily tablet combining the anti-HIV drugs Sustiva and Truvada |
HIV |
Submitted NDA seeking approval of the product; Gilead's Truvada is a fixed-dose product containing Viread and Emtriva (4/27) |
| MISCELLANEOUS | ||||
BioSante |
Bio-E-Gel |
Estradiol transdermal gel |
Hot flashes |
NDA filed with FDA in February was accepted for review (4/19) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature infants |
The FDA issued a second approvable letter; it asks for additional information on drug specifications (4/5); company said a manufacturing issue could lead to a potentially significant delay in the approval process (4/24) |
Edison |
EPI-A0001 |
Agent believed to target electron shuttling and energy production |
Respiratory chain diseases |
The FDA granted orphan designation to the agent for treating inherited mitochondrial respiratory chain diseases (4/4) |
Genzyme |
Myozyme |
Recombinant human acid alpha-lucosidase enzyme |
Pompe disease |
The FDA granted approval to the product in that indication; it marks the first treatment ever approved for the disease (4/28) |
Neurochem |
Fibrillex |
Glycosaminoglycan mimetic with anti- amyloid properties |
Amyloid A amyloidosis |
NDA filing completed in February was granted priority review; the PDUFA date is Aug. 13 (4/18) |
TopoTarget A/S (Denmark; |
Totect (Savene) |
Dexrazoxane; inhibitor of topoisomerase II |
Antidote to anthracyline extravasation |
The FDA accepted for review the NDA filing and granted it priority review status (4/12) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange. | ||||
