Company* |
Product | Description | Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Ulcerative colitis |
The FDA approved the drug for patients with moderate to severe disease who had inadequate responses to conventional therapy (10/20) |
Human Genome |
LymphoStat-B |
Belimumab; human monoclonal antibody that inhibits activity of B- lymphocyte stimulator |
Lupus |
Reached agreement with FDA on SPA for Phase III program, which was expected to start later in 2006 (10/26) |
CANCER | ||||
Agennix Inc.* |
Talactoferrin |
Oral talactoferrin alfa solution |
Renal cell carcinoma |
The FDA granted orphan designation to the product in that indication (10/12) |
Agennix Inc.* |
Talactoferrin |
Oral talactoferrin alfa solution |
Non-small-cell lung cancer |
The FDA granted fast-track status to the product for first-line treatment of NSCLC (10/5) |
Alfacell Corp. |
Onconase |
Ranpirnase; cytotoxic ribonuclease |
Malignant mesothelioma |
Completed nonclinical section of rolling NDA submission with FDA; complete filing was expected in 2007 (10/2) |
Allos |
PDX |
Pralatrexate; anitfolate; dihydrofolate reductase inhibitor |
T-cell lymphoma |
The FDA granted fast-track status to the product in that indication, for which pivotal Phase II trials are ongoing (10/3) |
AVAX |
M-Vax |
Autologous, hapten- modified melanoma vaccine |
Metastatic melanoma |
Reached agreement with FDA on SPA for pivotal Phase III trial in up up to 387 patients with Stage IV melanoma (10/12) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced chronic lymphocytic leukemia |
The FDA extended review period on NDA 90 days, to Jan. 27, after Genta submitted additional data (10/30) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Chronic lymphocytic leukemia |
Reached agreement with FDA on a trial that would evaluate the drug with fludarabine and rituximab (10/6) |
IDM Pharma |
Junovan |
Synthetic lipophilic derivative of the muramyl dipeptide |
Osteosarcoma |
Filed NDA with FDA seeking approval for treating newly diagnosed resectable high-grade osteosarcoma patients following surgical resection, in combination with chemotherapy (10/26) |
MGI Pharma |
Saforis |
Oral formulation of glutamine in company's delivery system |
Oral mucositis in cancer patients |
The FDA issued an approvable letter that requests an additional Phase III efficacy trial (10/12) |
Reata |
RTA 744 |
Anthracycline derivative that crosses the blood-brain barrier |
Malignant gliomas |
The FDA granted orphan designation to the Phase I product in that indication (10/26) |
CARDIOVASCULAR | ||||
Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia in chronic kidney disease |
FDA issued an approvable letter that requests additional data for the once-monthly dosing regimen, including an additional clinical study (10/13) |
CENTRAL NERVOUS SYSTEM | ||||
Anesiva Inc. |
4975 |
Non-opioid, VR1 agonist that acts as a C-neuron anesthetic |
Interdigital neuroma |
The FDA granted orphan status to the product for treating those who fail conservative treatments (10/12) |
Avanir |
Zenvia (formerly Neurodex) |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Involuntary emotional expression disorder |
The FDA issued an approvable letter that calls for additional safety and efficacy data (10/31) |
Memory |
MEM 3454 |
Nicotinic alpha-7 receptor partial agonist |
Alzheimer's disease |
The FDA placed a hold on proposed Phase IIa trial due to questions on toxicology data (10/16) |
Cortex |
CX717 |
Ampakine analogue; designed to improve brain cell signaling |
Attention deficit/ hyperactivity disorder |
The FDA lifted a clinical hold it had placed on trial in March, allowing company to resume trials (10/9) |
New River |
NRP104 |
Prodrug of amphetamine; capsule formulation |
Attention deficit/ hyperactivity disorder |
FDA issued an approvable letter; approval was contingent only upon final scheduling by the Drug Enforcement Administration (10/6) |
DIABETES | ||||
MacroGenics |
MGA031 |
Humanized, Fc-engineered anti-CD3 monoclonal antibody |
Type I diabetes |
The FDA granted orphan designation to the product in recent-onset Type 1 diabetes (10/10) |
INFECTION | ||||
Idenix |
Tyzeka |
Telbivudine; oral, once- daily nucleoside analogue |
Hepatitis B |
The FDA approved the product for treating chronic hepatitis B (10/25) |
Intercell AG |
-- |
Inactivated vaccine against Japanese encephalitis virus |
Japanese encephalitis virus |
Began BLA filing process with the FDA; full submission was expected in early 2007 (10/12) |
Replidyne |
Faropenem medoxomil |
Ester prodrug derivative of the beta-lactam antibiotic faropenem |
Four adult indications |
The FDA issued a nonapprovable letter calling for additional trials in all four indications: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections (10/23) |
MISCELLANEOUS | ||||
Agennix Inc.* |
Talactoferrin |
Topical talactoferrin alfa gel |
Diabetic foot ulcers |
The FDA granted fast-track status to the product in that indication (10/5) |
Critical |
-- |
Controlled-release formulation of zileuton (Zyflo), a 5-lipoxygenase inhibitor |
Asthma |
The FDA accepted for filing the NDA that was submitted in July; the PDUFA date is May 31 (10/17) |
Indevus |
Sanctura XR |
Once-daily formulation of the approved product Sanctura |
Overactive bladder |
Filed NDA with FDA, seeking approval in that indication (10/12) |
Isolagen Inc. |
Isolagen Therapy |
Autologous cellular therapy |
Wrinkles |
Reached agreement with FDA on SPA for two pivotal Phase III trials of 200 patients each to evaluate efficacy and safety in nasolabial skin fold wrinkles (10/13) |
Vivus Inc. |
EvaMist |
Transdermal spray formulation of estradiol |
Vasomotor symptoms associated with menopause |
Filed NDA with the FDA, seeking approval in that indication (10/2) |
| | ||||
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; OTC BB = Over-the-Counter Bulletin Board; VSE = Vienna Stock Exchange. | ||||
