Company* |
Product |
Description |
Indication |
Status |
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Ankylosing spondylitis |
Filed application with European officials seeking approval in that indication(10/4) |
Apollo Life |
-- |
Topical TNF blocker |
Plaque psoriasis |
Began Phase Ib trial to evaluate safety and tolerability in volunteers and patients (10/18) |
BioMS |
MBP8298 |
Synthetic peptide |
Multiple sclerosis |
Monitors reviewing safety recommended continuation of pivotal Phase II/III trial in secondary progressive MS (10/27) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Plaque psoriasis |
The product was approved in Europe for treating moderate to severe plaque psoriasis (10/6) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Psoriasis |
EXPRESS trial in 378 patients in Europe showed a 75% or better improvement in symptoms in 80% of patients vs. 3% for placebo (10/13) |
Serono SA |
Raptiva (FDA-approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Plaque psoriasis |
The product was approved in Canada for treating moderate to severe chronic plaque psoriasis in adult patients (10/31) |
CANCER | ||||
Allos |
Revaproxyn (efaproxiral) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
Withdrew European MAA for use as an adjunct to whole-brain radiation therapy after regulators said data were insufficient (10/11) |
Amgen Inc. |
Kepivance (FDA-approved) |
Palifermin; recombinant human keratinocyte growth factor |
Oral mucositis in cancer patients |
The product was approved in the European Union in patients under-going blood and bone marrow transplants (10/28) |
Antisoma plc |
AS1404 |
Small molecule derived from xanthenone acetic acid; vascular disrupting agent |
Lung cancer |
Preliminary data from 47 patients in Phase II trial showed more tumor responses and a lower frequency of progressive disease than chemotherapy alone (10/17) |
Ark |
Cerepro |
Adenoviral-mediated gene medicine designed to induce thymidine kinase expression |
Malignant glioma |
Filed MAA with European regulators; the application was accepted for review (10/28) |
Ark |
Vitor |
Small molecule originally developed for high blood pressure; it is on patients the market in Japan |
Cachexia in cancer effect regardless of cancer type |
Trial in 200 terminal patients showed a positive treatment (10/28) |
AVAX |
M-Vax |
Autologous, hapten- modified melanoma vaccine |
Melanoma |
The product was approved in Switzerland, where it will be sold by Pro Vaccine AG (10/10) |
Celgene Corp. |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Myelodysplastic syndromes |
The EMEA accepted for review the MAA filing, which was submitted in August (10/26) |
ChemGenex |
Ceflatonin |
sHHT; homoharringtonine |
Chronic myeloid leukemia |
Began Phase II trial in the UK and France in 13 resistant patients; the trial then could be expanded to include 14 to 50 more patients (10/5) |
Cytos |
CYT004- MelQbG10 |
Therapeutic vaccine designed to activate cytotoxic T cells |
Malignant melanoma |
Began Phase IIa trial in 20 patients in Switzerland and Germany to evaluate safety, tolerability and immunogenicity (10/20) |
Genzyme |
Campath |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
Refractory B-cell chronic lymphocytic leukemia |
Phase II combination study with Fludara showed an overall response rate of 83%; began Phase III trial comparing combination to fludarabine as second-line therapy (10/21) |
OncoGenex |
OGX-011 |
Second-generation anti- sense drug designed to inhibit the production of clusterin, a cell-survival protein |
Prostate cancer |
Began Phase II trial in Canada to test the drug with chemotherapy in hormone-refractory disease (10/12) |
OncoGenex |
OGX-011 |
Second-generation anti- sense drug designed to inhibit the production of clusterin, a cell- survival protein |
Prostate cancer |
Began Phase II trial in Canada with docetexel to test safety and efficacy in up to 42 patients (10/25) |
Oncolytics |
Reolysin |
Formulation of the human reovirus |
Malignant glioma |
Drug appeared well tolerated in a Phase I trial in Canada; the maximum dose was not reached (10/19) |
Oxford |
TroVax |
Vaccine that delivers an antigen (5T4) using a poxvirus vector |
Metastatic colorectal cancer |
Final Phase II data confirmed ear-lier conclusions showing safety, immunogenicity and clinical benefit (10/17) |
PharmaMar |
PM02734 |
Marine-derived agent; depsipeptide of the kahalalides family |
Solid tumors |
Began a Phase I trial to evaluate safety, tolerability and dosing in patients (10/4) |
Provectus |
PV-10 |
Agent designed to be retained in tumor cells while leaving normal tissue unharmed |
Recurrent breast cancer |
Started Phase I trial in New Zealand to evaluate safety and preliminary efficacy in five patients (10/5) |
pSivida Ltd. |
BrachySil |
Micron-sized particle in which the isotope 32 phosphorus is immobilized |
Inoperable liver cancer |
Began Phase IIb trial to test safety, responses and survival in 50 patients in Singapore, Malaysia and Vietnam (10/31) |
Viventia |
Proxinium |
Antibody fragment conjugated with a cancer-killing payload |
Refractory head and neck cancer |
Got OK to expand Phase II trial into Canada (10/5) |
Viventia |
Vicinium (Proxinium) |
Antibody fragment conjugated with a cancer-killing payload |
Bladder cancer |
Is expanding Phase I trial in Canada to Phase II with the addition of 30 patients (10/6) |
CARDIOVASCULAR | ||||
Aastrom |
Tissue |
Autologous bone marrow-derived adult stem and progenitor cells |
Limb ischemi |
Began trial in Germany to test safety and ability of the product to regenerate functioning blood vessels in the legs of diabetic patients (10/6) |
Ark |
Trinam |
VEGF gene in an adenoviral vector delivered with Ark's biodegradable collagen collar device |
Prevention of blood vessel blockage |
Phase II trial in six patients showed that access grafts continued to remain functional three times longer than previous procedures (10/18) |
Biopure |
Hemopure |
Oxygen therapeutic consisting of bovine hemoglobin |
Reducing heart damage |
Began Phase II trial in the UK to assess safety and feasibility in reducing heart damage and enhancing tissue preservation during cardiopulmonary bypass in 60 patients (10/27) |
Biopure |
Hemopure |
Oxygen therapeutic consisting of bovine hemoglobin |
Blood replacement |
Began Phase II trial in Belgium in coronary angioplasty patients and a Phase II trial in South Africa in patients undergoing lower limb amputation (10/19) |
CV |
Ranexa(ranolazine) |
Partial inhibitor of fatty- acid oxidation |
Chronic angina |
Withdrew MAA filing in Europeafter EMEA requested additionalpharmacokinetic information;a resubmission is anticipated(10/25) |
Xechem |
Niprisan(Nicosan/ Hemoxin) |
A phyto-pharmaceutical drug; a composition of four traditional plants |
Sickle cell disease |
The EMEA granted orphan designation to the product in the European Union (10/4) |
CENTRAL NERVOUS SYSTEM | ||||
Durect Corp. |
Saber- Bupivacaine |
Sustained-release formulation of bupivacaine delivered by Saber system |
Pain |
Phase II trial in 81 patients in Australia demonstrated positive safety, pharmacokinetic and efficacy results (10/18) |
Evotec AG |
EVT 201 |
Agent that acts on GABA-A receptors |
Insomnia |
Proof-of-principle trial in healthy volunteers demonstrated safety and positive effects on sleep (10/20) |
Javelin |
Dyloject |
Injectable diclofenac, an analgesic |
Post-surgical pain |
UK regulators accepted for review the MAA filing (10/24) |
LAB |
Fentanyl Taifun |
Fentanyl formulation delivered via the company's dry powder inhaler platform |
Pain |
Phase I comparative trial in 32 healthy volunteers produced positive pharmacokinetic data (10/26) |
DIABETES | ||||
Nektar |
Exubera |
Dry-powder, inhaled insulin formulation that uses Nektar technology |
Type I and II diabetes |
Sanofi-Aventis SA and Pfizer Inc. received a positive opinion on approval from regulators in Europe (10/13) |
INFECTION | ||||
BioAlliance |
Miconazole Lauriad |
Oral, bioadhesive buccal tablet containing the antifungal miconazole |
Oropharyngeal candidiasis |
Filed an MAA in France, initiating the approval process within the European Union (10/3) |
ID Biomedical |
FluINsure |
Nonliving, subunit vaccine for intranasal administration |
Influenza |
Is starting Phase II trial in Canada to evaluate safety and immuno-genicity in 160 healthy children (10/24) |
Novexel* |
NXL 103 |
Agent designed to inhibit protein synthesis in bacteria |
Bacterial respiratory infections |
Began a Phase I trial of the drug (10/3) |
Sinovac |
Anflu |
Split-flu type influenza vaccine |
Influenza |
Received a GMP certificate in China, the final approval required to sell the product there (10/27) |
MISCELLANEOUS | ||||
Ardana plc |
-- |
Testosterone cream |
Hypogonadism |
Phase I pilot trial demonstrated proof of concept; began Phase II dose-finding trial (10/31) |
Chelsea |
CH-1504 |
Orally available, inert antifolate |
Cancers and inflammatory diseases |
Phase Ia trial in 30 subjects in the UK demonstrated safety and tolerability (10/20) |
Dynogen |
DDP225 |
Noradrenaline reuptake inhibitor and a serotonin type 3 receptor (5-HT3) antagonist |
Irritable bowel syndrome |
Began Phase II trial in Canada to assess safety, pharmacodynamics and symptom-based endpoints in patients with diarrhea-predominant IBS (10/17) |
Genentech |
Xolair |
Omalizumab; humanized monoclonal antibody to IgE |
Asthma |
The European Commission approved the product for treating severe allergic asthma in all 25 EU member states; Novartis AG will market it there (10/27) |
Metabolic |
AOD9604 |
Oral peptide modeled on one section of the human growth hormone molecule |
Obesity |
Began Phase IIb trial in Australia that will measure weight loss and other endpoints in 480 obese men and women(10/18) |
Santhera |
SNT-MC17 |
Idebenone |
Duchenne's muscular dystrophy |
Began Phase IIa trial in Belgium to assess efficacy in 21 10- to 16- year-old boys with cardiac dysfunction related to DMD (10/19) |
Topigen |
ASM8 |
Inhaled dual antisense drug designed to block two pathways of the inflammation response |
Allergic asthma |
Completed Phase I trial and began Phase II trial that will evaluate efficacy, safety and tolerability in patients (10/18) |
Vectura Group |
NVA237(formerly AD 237) |
Bronchodilator treatment containing marketed anti-muscarinic drug |
Chronic obstructive pulmonary disease |
Began Phase IIb trial to evaluate efficacy, safety and dosing (10/17) |
Notes: | ||||
* Privately held. | ||||
MAA = Marketing authorization application; MRP = Mutual Recognition Procedure; EMEA = European Medicines Agency. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
