Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
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AUTOIMMUNE | ||||
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Active Biotech AB (Sweden; SSE: ACTI) |
Laquinimod (SAIK-MS) |
Small-molecule immunomodulatory agent |
Multiple sclerosis |
Phase IIb trial in relapsing-remitting MS patients met its primary endpoint of reducing inflammatory disease activity (9/5) |
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Avidia Inc.* |
C326 |
Inhibitor of interleukin-6 |
Crohn's disease |
Began Phase I trial in Australia to evaluate safety, tolerability and pharmacokinetics in adults with Crohn's disease (9/20) |
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Debiopharm Group* (Switzerland)
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Debio-0513 (PTR-262) |
Dual-altered ligand peptide analogue of the myasthenogenic epitopes of the acetylcholine receptor |
Myasthenia gravis |
The product was granted orphan designation in Europe in that indication (9/21) |
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Nitec Pharma AG* (Switzerland) |
Lodotra |
Modified-release tablet formulation of prednisone |
Rheumatoid arthritis |
Phase III trial in 288 patients in Europe showed significantly reduced morning stiffness; an MAA seeking European approval was filed in August (9/28) |
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CANCER | ||||
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Abraxis BioScience Inc. (ABBI) |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection; albumin-bound |
Breast cancer |
The EMEA accepted for review the application seeking approval in Europe (9/28) |
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Active Biotech AB (Sweden; SSE:ACTI) |
TASQ |
Tumor angiogenesis suppression by quinolines |
Hormone-refractory prostate cancer |
Interim data from Phase I trial in Sweden showed a reduced rate of PSA increase in all 10 patients evaluated (9/20) |
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Adherex Technologies Inc. (AMEX:ADH) |
Eniluracil |
Oral dihydropyrimidine dehydrogenase inhibitor |
Liver cancer |
Began Phase I/II trial in patients in Asia to evaluate drug with 5-FU (9/28) |
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Antisoma plc (UK; LSE:ASM) |
AS1404 |
Small molecule derived from xanthenone acetic acid; vascular disrupting agent |
Non-small-cell lung cancer |
Final data from Phase II trial showed median survival of 14 months vs. 8.8 months in the chemotherapy-only arm (9/28) |
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Astex Therapeutics Ltd.* (UK) |
AT9283 |
Inhibitor of the Aurora A and B kinases |
Leukemias |
Began Phase I/IIa trial to evaluate safety, tolerability and preliminary efficacy (9/26) |
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BioAlliance Pharma SA (France; Euronext:BIO) |
Doxorubicin Transdrug |
Nanoparticle formulation of doxorubicin |
Liver cancer |
Phase I/II trial in 20 patients in France showed five partial responses and seven disease stabilizations (9/19) |
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Bioenvision Inc. (BIVN) |
Evoltra (FDA-approved) |
Clofarabine; second-generation purine nucleoside analogue |
Pediatric acute lymphoblastic leukemia |
New data from ongoing study in Europe confirmed a significant response rate in a difficult-to-treat patient population (9/21) |
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Gendux AB* (Sweden) and Introgen Therapeutics Inc. (INGN) |
Advexin |
Adenoviral vector containing the p53 tumor-suppressor gene |
Li-Fraumeni syndrome |
The product was granted orphan designation in Europe in that indication (9/7) |
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lmmutep SA* (France) |
ImmuFact IMP321 |
Human T-celI immuno-stimulatory factor |
Melanoma |
Began Phase I trial in Belgium to evaluate HLA-A2 melanoma peptide antigens with or without IMP321 and/or Montanide (9/25) |
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Peregrine Pharmaceuticals Inc. (PPHM) |
Bavituximab (formerly Tarvacin) |
Anti-phosphotidylserine immunotherapeutic |
Cancers |
Is starting a Phase I trial in India to evaluate safety and tolerability with chemotherapy regimens (9/11) |
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CARDIOVASCULAR | ||||
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Alexion Pharmaceuticals Inc. (ALXN) |
Soliris (eculizumab) |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Submitted MAA with the EMEA, seeking approval of the product in Europe (9/26) |
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Biopure Corp. (BPUR) |
Hemopure | Oxygen therapeutic consisting of bovine hemoglobin |
For use in surgery procedures |
MAA filed in the UK in July was accepted for review; approval is being sought in acutely anemic adult orthopedic surgery patients younger than 80 (9/12) |
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Genfit SA* (France) |
GFT505 |
Activator of peroxisome proliferator-activated receptors |
Cardiometabolic disease |
Began a Phase I trial of the drug candidate (9/19) |
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Speedel Group (Switzerland; SWX:SPPN) and Novartis AG |
SPP100 (Rasilez) |
Oral renin inhibitor |
Hypertension |
The EMEA accepted for review Novartis' submission seeking European approval of drug as both a monotherapy and as part of combination therapies (9/28) |
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ThromboGenics NV (Belgium; Euronext:THR) |
Microplasmin |
Truncated form of the human protein plasmin |
Acute ischemic stroke |
Began Phase IIa MITI IA trial in Germany to evaluate drug in up to 20 patients with vertebro-basilar artery occlusion (9/22) |
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CENTRAL NERVOUS SYSTEM | ||||
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EpiCept Corp. (EPCT) |
LidoPAIN SP |
Patch designed to provide sustained topical delivery of lidocaine |
Pain |
Phase III trial in Europe in 440 patients who underwent hernia repair surgery failed to demonstrate efficacy vs. placebo (9/5) |
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GW Pharmaceuticals plc (UK; LSE:GWP) |
Sativex |
Spray formulation of cannabis extract |
Spasticity in multiple sclerosis patients |
Filed for approval under the decentralized procedure in the UK, Spain, Denmark and the Netherlands; the UK is the reference member state (9/5) |
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Lexicon Genetics Inc. (LEXG) |
LX6171 |
Small-molecule inhibitor of a membrane protein expressed in the central nervous system |
Cognitive disorders |
Began Phase I trial in the UK to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (9/6) |
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Medivation Inc. (AMEX:MDV) |
Dimebon |
Neuroprotectant agent that's been on the market in Russia since 1983 |
Alzheimer's disease |
Phase II trial in 183 patients in Russia demonstrated statistical significance on primary and all secondary efficacy endpoints (9/21) |
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Metabolic Pharmaceuticals Ltd. (Australia; ASX:MBP) |
ACV1 |
Inhibitor of neuronal nicotinic acetylcholine receptors; derived from Australian cone snail |
Neuropathic pain |
Began Phase IIa trial in Australia to evaluate safety and efficacy in 40 patients with neuropathic sciatic pain (9/27) |
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Trophos SA* (France) |
TRO19622 |
Compound believed to promote the survival of a range of neurons |
Amyotrophic lateral sclerosis |
The product was granted orphan designation in Europe in that indication (9/5) |
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WEX Pharmaceuticals Inc. (Canada; TSX:WXI) |
Tectin |
Tetrodotoxin; non-narcotic agent |
Cancer-related pain |
Canadian regulators approved company's request to resume clinical trials of the drug (9/6) |
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YM BioSciences Inc. (Canada; TSX:YM) |
AeroLEF |
Aerosolized liposome-encapsulated fentanyl |
Pain |
Phase IIb trial will enroll the planned 99 patients after interim analysis on the first 67 did not demonstrate predefined significance (9/27) |
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DIABETES | ||||
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Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. |
Byetta (FDA-approved) |
Exenatide; incretin mimetic |
Type II diabetes |
The CHMP of the EMEA recommended approval of the drug in that indication (9/21) |
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Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. |
Byetta (FDA-approved) |
Exenatide; incretin mimetic |
Type II diabetes |
One-year data from trial in Europe showed drug was as effective as biphasic insulin aspart 30/70 in improving blood sugar levels in those with unacceptable blood sugar control (9/14) |
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ConjuChem Biotechnologies Inc. (Canada; TSX:CJB) |
PC-DAC: Exendin-4 |
Albumin-bound analogue of glucagon-like peptide-1 |
Type II diabetes |
Final data from Phase I/II trial confirmed tolerability, positive efficacy on glucose reduction and extended duration of activity (9/12) |
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Diamyd Medical AB (Sweden; SSE:DIAM) |
Diamyd |
Agent containing GAD65, the dominating autoantigen in autoimmune diabetes |
Type I diabetes |
Presented further data from Phase II trial in Sweden, showing positive efficacy and safety (9/18) |
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NicOx SA (France; Euronext:NICOX) |
NCX 4016 |
Nitric oxide-donating derivative of acetyl salicylic acid |
Type II diabetes |
Data from Phase II subgroup and Phase I trial in volunteers showed increase in glucose utilization and in glucose uptake, respectively (9/6) |
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INFECTION | ||||
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Idenix Pharmaceuticals Inc. (IDIX) and Novartis AG (Switzerland) |
Telbivudine |
Oral, once-daily nucleoside analogue |
Hepatitis B |
The drug was approved in Switzerland for treating chronic hepatitis B in compensated patients with viral replication and active liver inflammation (9/21) |
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PowderMed Ltd.* (UK) |
-- |
H3-based DNA vaccine |
Influenza |
Is starting trial in healthy volunteers in the UK to evaluate effectiveness against a flu challenge (9/21) |
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Nektar Therapeutics Inc. (NKTR) |
ABIP |
Amphotericin B inhalation powder |
Fungal infections |
The product was granted orphan designation in Europe for preventing pulmonary fungal infections in at-risk patients (9/18) |
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Novexel* (France) |
NXL101 |
Small-molecule bacterial topoisomerase/gyrase inhibitor |
Bacterial infections |
Began Phase I development of the compound (9/26) |
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XOMA Ltd. (XOMA) |
Neuprex |
Modified form of fragment of bactericidal/permeability increasing protein |
Meningococcal disease |
The product was granted orphan designation in Europe in that indication (9/6) |
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MISCELLANEOUS | ||||
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Ardana plc (UK; LSE:ARA) |
-- |
Testosterone cream |
Hypogonadism |
Open-label Phase II trial in 16 men showed product effectively restored testosterone levels to the normal range (9/11) |
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Ark Therapeutics Group plc (UK; LSE:AKT) |
EG005 |
Agent designed to increase the ability of mitochondria to produce energy |
Lipodystrophy in HIV patients |
Extension data from Phase II trial showed improvements in metabolic risk factors (9/5) |
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Can-Fite BioPharma Ltd. (Israel; TEL:CFBI) |
CF101 |
Agent that targets the A3 adenosine receptor |
Dry-eye syndrome |
Is starting a Phase II trial in Israel to evaluate the product in 50 patients (9/6) |
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Intercytex Ltd.* (UK) |
ICX-PRO |
Human dermal fibroblasts embedded in a fibrin gel |
Diabetic foot ulcers |
Began open-label Phase II trial in the UK to evaluate wound closure in up to 15 patients (9/5) |
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Neurochem Inc. (Canada; NRMX) |
Kiacta (formerly Fibrillex) |
Glycosaminoglycan mimetic with anti-amyloid properties |
Amyloid A amyloidosis |
The EMEA accepted for review application seeking approval of the product in Europe (9/28) |
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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; ASX = Australian Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TEL = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange. |