Company* |
Product | Description | Indication |
Status (Date) |
| ||||
AUTOIMMUNE | ||||
Biogen Idec |
Tysabri (FDA-approved) |
Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
The product was approved in Canada for treating relapsing-remitting MS (10/4) |
ImmuPharma |
IPP-201101 |
Agent designed to modify CD4+ T cells |
Lupus |
Phase II trial in Europe met its primary endpoints related to surrogate biomarkers (10/17); additional data showed clinical improvements (10/30) |
Isotechnika |
ISA247 |
Immunosuppressive agent |
Psoriasis |
Final, 60-week data from Phase III SPIRIT trial in Canada demonstrated safety and efficacy (10/5) |
Isotechnika |
ISA247 |
Immunosuppressive agent |
Psoriasis |
Began pivotal Phase III ESSENSE trial in Germany, Poland and Canada to evaluate drug vs. placebo and cyclosporine in 500 patients (10/2) |
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
Withdrew MAA filing, following word from the EMEA that additional clinical data would be needed prior to approval (10/12) |
CANCER | ||||
Adherex |
ADH-1 |
Cadherin antagonist; small peptide, tumor/ vascular-targeting agent |
Solid tumors |
Began Phase I trial to evaluate drug in separate combinations, in up to 55 patients (10/3) |
Algeta ASA* |
Alpharadin |
Radiopharmaceutical based on the alpha particle emitter radium-223 |
Hormone- refractory prostate cancer |
Phase II trial in Europe showed statistically significant effects on biomarkers of bone turnover; PSA levels also were reduced (10/23) |
EpiCept |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Acute myeloid leukemia |
Filed MAA with EMEA, seeking approval in Europe for use with interleukin-2 for maintenance of first remission in AML patients (10/3) |
Gendux AB* |
Advexin |
Adenoviral vector containing the p53 tumor- suppressor gene |
Li-Fraumeni syndrome |
Reached agreement with the EMEA on plan to file for approval under exceptional circumstances provisions (10/31) |
Genta Inc.(GNTA) |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Stage IV malignant melanoma |
The product was granted orphan designation in Australia in that indication (10/17) |
Micromet |
MT201 |
Adecatumumab; fully human antibody targeting the epithelial adhesion molecule Ep-AM |
Relapsed prostate cancer |
Phase II trial in 84 patients in Europe showed a beneficial trend but failed to meet primary endpoint related to PSA levels (10/2) |
Micromet |
MT201 |
Adecatumumab; fully human antibody targeting the epithelial adhesion molecule Ep-CAM |
Metastatic breast cancer |
Phase II trial in 109 patients in Europe failed to show a clinical benefit rate of 25%; a benefit was seen in time to progression, a secondary endpoint (10/2) |
Peregrine |
Cotara |
Chimeric tumor-necrosis therapy antibody attached to iodine-131 |
Glioblastoma multiforme |
Began trial in India to evaluate safety and efficacy in up to 40 patients who have experienced their first relapse (10/12) |
Wilex AG* |
Rencarex (WX-250) |
Chimeric monoclonal IgG1 antibody that binds to the MN cell-surface antigen |
Metastatic renal cell cancer |
Phase II study with low-dose interferon alpha-2a showed a median survival of 30 months and a two-year survival rate of 57% (10/16) |
CARDIOVASCULAR | ||||
Speedel |
SPP635 |
Next-generation renin inhibitor |
Hypertension |
Began Phase IIa trial in Europe to evaluate safety and efficacy in 35 patients with mild to moderate hypertension (10/31) |
ThromboGenics |
-- |
Intraocular injection of recombinant microplasmin |
Back-of-the-eye diseases |
Phase IIa MIVI-I trial demonstrated tolerability and encouraging proof of concept (10/20) |
CENTRAL NERVOUS SYSTEM | ||||
Anesiva Inc. |
1207 |
Anesthetic that binds to fast sodium channel on both A and C nerve fiber |
Pain |
Began Phase I trial in Australia to evaluate safety and effects in 24 healthy male volunteers (10/25) |
Cortex |
CX717 |
Ampakine analogue; designed to improve brain cell signaling |
Attention deficit hyperactivity disorder |
The FDA lifted clinical hold it had placed on trial, but mandated dosing limits that would preclude development in ADHD (10/24 and 10/29) |
CytRx Corp. |
Arimoclomol |
Small molecule designed to protect cells by activating molecular chaperone proteins |
Amyotrophic lateral sclerosis |
The product was granted orphan designation in Europe (10/31) |
GW |
Sativex |
Spray formulation of cannabis extract |
Pain in those with advanced cancers |
Filed for approval in Canada for treating pain not adequately relieved by opioids (10/19) |
KeyNeurotek |
KN 38-7271 |
Cannabiniod receptor agonist |
Traumatic brain injury |
Began Phase II trial in Europe to evaluate efficacy and tolerability in more than 100 patients (10/17) |
Prana |
PBT2 |
Small molecule that binds metal ions |
Alzheimer's disease |
Is starting Phase IIa trial in Sweden to evaluate safety, tolerability and signs of efficacy in patients with early AD (10/5) |
DIABETES | ||||
Karo Bio |
KB3305 |
Agent designed to antagonize glucocorticoid action in the liver |
Type II diabetes |
Is starting a Phase I trial in Sweden to evaluate the product in healthy volunteers (10/25) |
INFECTION | ||||
AB-Pharma |
Verum |
Alkaline phosphatase agent |
Severe sepsis |
Pilot study in 36 patients demonstrated tolerability; also, survival rates were increased (10/20) |
Acambis plc |
ChimeriVax-JE |
Single-dose vaccine against Japanese encephalitis virus |
Japanese encephalitis virus |
Pivotal Phase III safety trial showed comparable adverse events to placebo; early Phase III data on efficacy were positive (10/30) |
Bavarian |
MVA-BN polytope |
MVA-BN virus expressing 21 epitopes from killer T cells and 18 epitopes from helper T cells |
HIV |
Began Phase I and II trials in Europe to evaluate immunogenicity and safety in both healthy and HIV- infected subjects (10/23) |
BioAlliancePharma |
Loramyc (miconazole Lauriad) |
Bioadhesive buccal tablet containing the antifungal agent miconazole |
Oropharyngeal candidiasis |
The product was approved in France for treating OC in immuno-depressed patients (10/13) |
Gilead |
Atripla |
Once-daily, single tablet containing BMS' Sustiva and Gilead's Truvada |
HIV |
Submitted MAA with EMEA, seeking approval of the triple-combination drug (10/9) |
MISCELLANEOUS | ||||
Allergy |
Pollinex Quattro |
Short-course vaccine with TLR4-agonist adjuvant |
Ragweed allergies |
Dose-ranging trial demonstrated the product was immunogenic (10/13) |
BioMarin |
Aldurazyme (FDA-approved) |
Laronidase; enzyme replacement therapy |
Mucopoly- saccharidosis I |
The product was approved in Japan in that indication (10/31) |
Biovitrum AB |
BVT.28949 |
5-HT2A antagonist |
Glaucoma |
Began Phase II trial in Sweden and Ukraine to evaluate the product in 150 patients with elevated intraocular pressure (10/16) |
DUSA |
Levulan (FDA-approved) |
Aminolevulinic acid HCl; photodynamic therapy; used with light source |
Dermatology indications |
Partner Stiefel Laboratories Inc. gained approval of the product in Brazil (10/17) |
Genzyme |
Synvisc (FDA-approved) |
Hylan G-F20; an elastoviscous hylan therapeutic |
Osteoarthritis |
Received additional approval in Europe to include treatment of pain due to osteoarthritis of the ankle and shoulder (10/2) |
Renovo Group |
Juvista |
Therapeutic application of human recombinant TGF-beta3 |
Scarring |
Phase II trial showed statistically significant reductions in scarring in split-thickness skin-graft donor sites vs. placebo (10/24) |
Repros |
Proellex (Progenta) |
Agent designed to block progesterone without blocking adrenal hormones |
Endometriosis |
Three-month data from Phase II study in Europe showed a reduction of pain vs. Lupron (10/24) |
Spectrum |
Ozarelix |
Fourth-generation luteinizing hormone- releasing hormone |
Benign prostatic hyperplasia |
Phase II trial in 144 patients in Europe met its primary endpoint of improving clinical symptoms vs. placebo(10/3) |
| ||||
Notes: | ||||
* Privately held. | ||||
CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; AIM = Alternative Investment Market; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. |
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