Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Barrier Therapeutics Inc. (BTRX)

Xolegel

Ketoconazole topical gel

Seborrheic dermatitis

Gained marketing approval in Canada to treat immunocompetent adults and children 12 and older (3/8)

Centocor Inc. (unit of Johnson & Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor alpha

Rheumatoid arthritis

Gained European Commission approval of a label extension allowing for greater dosing flexibility, an increased dose in patients who had an incomplete response to initial combination treatment with methotrexate and Remicade (3/2)

Centocor Inc. (unit of Johnson & Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor alpha

Crohn's disease

CMPH issued a positive opinion recommending approval for treating severe, active Crohn's disease; it would cover treatment in patients ages 6 to 17 who have not responded to conventional therapies (3/26)

CANCER

Active Biotech AB (Sweden; SSE:ACTI)

TASQ

An oral agent; tumor angiogenesis suppression by quinolines

Prostate cancer

Phase Ib data showed five of six patients had a decrease in prostate-specific antigen velocity of more than 50% compared to prior treatment; study was done in Sweden (3/9)

Adherex Technologies Inc. (AMEX:ADH)

ADH-1

Cadherin antagonist; small peptide, tumor/vascular-targeting agent

Solid tumors

Phase Ib/II European trial showed tolerability, predictable pharmacokinetics and potential anti-tumor activity in five out of 30 patients (3/8)

Celgene Corp. (CELG)

Revlimid (FDA-approved)

Lenalidomide; derivative of Thalomid (thalidomide)

Multiple myeloma

Received a positive opinion from the EMEA's CMPH for use in combination with dexamethasone in patients who have received at least one prior therapy (3/23)

Cephalon Inc. (CEPH)

Fentora (FDA-approved)

Fentanyl effervescent buccal tablet

Breakthrough pain in cancer

Filed for European approval (3/27)

Genta Inc. (GNTA)

Genasense

Oblimersen sodium injection

Advanced melanoma

CMPH is expected to issue a negative opinion on the MAA (3/26)

Pain Therapeutics Inc. (PTIE)

A radio-labeled monoclonal antibody

Metastatic melanoma

Received approval in Israel to begin a Phase I trial (3/20)

Pharmexa A/S (Denmark; CSE:PHARMX)

GV1001

Peptide vaccine that targets telomerase

Pancreatic cancer

Investigator began Phase III trial in the UK to evaluate if vaccine used with gemcitabine and capecitabine extends survival in 1,100 patients with inoperable disease (3/15)

Pharmion Corp. (PHRM)

Revlimid (FDA-approved)

Lenalidomide; derivative of Thalomid (thalidomide)

Multiple myeloma

European Medicines Agency accepted for review the marketing application (3/1)

CARDIOVASCULAR

Encysive Pharmaceuticals Inc. (ENCY)

Thelin

Sitaxentan sodium; 100 mg tablets; a selective endothelin A receptor antagonist

Pulmonary arterial hypertension

Australian regulators approved Thelin (3/7)

Proteo Biotech AG (Germany; OTC BB:PTEO)

Elafin

Recombinant human protein; blocks elastase and proteinase 3

Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

European Commission granted orphan drug status (3/29)

CENTRAL NERVOUS SYSTEM

CeNeS Pharmaceuticals plc (UK; AIM:CEN)

M6G (M6G022)

Morphine-6-glucuronide peptide vector

Post-operative pain

Additional data from pivotal Phase III trial in more than 500 patients showed fewer anti-emetic drugs were required in M6G patients vs. morphine patients, and M6G had a long duration of analgesic action (3/7)

Medivation Inc. (AMEX:MDX)

Dimebon

Neuroprotectant agent that's been on the market in Russia since 1983

Alzheimer's disease

Six-month data from 183-patient Phase II trial in Russia showed drug patients were significantly improved vs. placebo on all five efficacy endpoints (3/19)

Cytheris SA* (France)

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Recombinant interleukin-7

HIV

Data from a Phase I/II trial in France and a Phase I trial in the U.S. demonstrated tolerability and an increase in CD4 T cells (3/5)

The Immune Response Corp. (OTC BB:IMRP)

NeuroVax

A T-cell-receptor peptide vaccine

Relapsing-remitting multiple sclerosis

The first patient was injected in a Phase II study being conducted in 200 patients in Central and Eastern Europe (3/8)

INFECTION

CoGenesys Inc.*

Neugranin

A long-acting form of granulocyte-colony stimulating factor

To reduce infections associated with neutropenia

Started a Phase I/IIa study in Europe (3/27)

MediGene AG (Germany; FSE:MDG)

Polyphenon E (FDA-approved)

Ointment; product from green tea leaves designed to block virus binding to cells

Genital warts

MediGene filed for approval in Germany, Austria and Spain (3/28)

Oculus Innovative Sciences Inc. (OCLS)

Dermacyn Wound Care

Super-oxidized, water-based solution designed to treat a range of pathogens

Diabetic foot ulcers

Trial in 18 patients in Italy showed Dermacyn with antibiotics and standard therapy improved healing time and reduced reinfections and amputations, vs. 15 historical control patients (3/13)

MISCELLANEOUS

AM-Pharma BV* (the Netherlands)

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Alkaline phosphatase

Acute renal failure

Data from 15-patient subgroup from a Phase IIa trial showed a statistically significant improvement in plasma creatinine clearance vs. placebo (3/12)

Cytos Biotechnology AG (Switzerland; SWX:CYTN)

CYT003-QbG10

Virus-like particle packaged with an immunostimulatory sequence

Grass pollen allergy

Phase IIa trial in 40 patients with allergic rhinitis showed significant improvements in allergy symptoms vs. placebo (3/13)

Obecure Ltd.* (Israel)

OBE101

Agent containing betahistine, a drug on the market in some countries outside the U.S. for treating vertigo

Weight management

Began Phase II trial in 78 subjects taking Zyprexa, an antipsychotic from Eli Lilly and Co.; the goal of the trial in Canada is prevention of weight gain (3/13)

Pharmaxis Ltd. (Australia; ASX:PXS)

Aridol

Mannitol formulation delivered via an inhalation device

Chronic obstructive pulmonary disease

Phase II trial in 79 patients in Australia did not demonstrate improved lung function, although improved hyper-responsive airways were seen in those with a positive Aridol challenge test (3/14)

Sucampo Pharmaceuticals Inc.*

Amitiza (FDA-approved)

Lubiprostone capsules; selective chloride channel activator

Chronic idiopathic constipation

Began Phase I trial in Japan to evaluate safety, tolerability and pharmacokinetics in subjects with renal or hepatic impairment (3/13)

Topigen Pharmaceuticals Inc.*

TPI ASM8

Inhaled RNA-targeting drug

Asthma

Began a second, expanded, 14-day Phase II trial in 60 patients in Canada (3/8)

Notes:

* Privately held.

CMPH = 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.

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