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 selectiveendothelin A receptor antagonist

Pulmonary arterial hypertension

Australian regulators approvedThelin (3/7)

 

Proteo Biotech AG (Germany; OTC BB:PTEO)

Elafin

Recombinant humanprotein; blocks elastaseand proteinase 3

Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

European Commission grantedorphan 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 pivotalPhase III trial in more than 500patients showed fewer anti-emetic drugs were required in M6Gpatients vs. morphine patients,and M6G had a long duration ofanalgesic action (3/7)

 

Medivation Inc. (AMEX:MDX)

Dimebon

Neuroprotectant agentthat's been on the marketin Russia since 1983

Alzheimer's disease

Six-month data from 183-patientPhase II trial in Russia showed drug patients were significantlyimproved vs. placebo on all fiveefficacy 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 theU.S. demonstrated tolerability and an increase in CD4 T cells (3/5)

 

The Immune Response Corp. (OTC BB:IMRP)

NeuroVax

A T-cell-receptor peptidevaccine

Relapsing-remittingmultiplesclerosis

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 ofgranulocyte-colonystimulating factor

To reduce infections associated withneutropenia

Started a Phase I/IIa study inEurope (3/27)

 

MediGene AG (Germany;  FSE:MDG)

Polyphenon E (FDA-approved)

Ointment; product fromgreen tea leaves designedto block virus binding to cells

Genital warts

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

 

Oculus Innovative Sciences Inc. (OCLS)

DermacynWound Care

Super-oxidized, water-based solution designedto treat a range ofpathogens

Diabeticfoot ulcers

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

 

MISCELLANEOUS

 

AM-Pharma BV* (the Netherlands)

---

Alkaline phosphatase

Acute renalfailure

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

 

Cytos Biotechnology AG (Switzerland; SWX:CYTN)

CYT003-QbG10

Virus-like particle packaged with animmunostimulatorysequence

Grass pollenallergy

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

 

Obecure Ltd.* (Israel)

OBE101

Agent containingbetahistine, a drug onthe market in somecountries outside the U.S.for treating vertigo

Weight management

Began Phase II trial in 78 subjectstaking 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 formulationdelivered via aninhalation device

Chronic obstructive pulmonarydisease

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

 

Sucampo Pharmaceuticals Inc.*

Amitiza(FDA-approved)

Lubiprostone capsules; selective chloride channelactivator

Chronicidiopathic constipation

Began Phase I trial in Japan to evaluate safety, tolerability andpharmacokinetics in subjectswith renal or hepatic impairment(3/13)

 

Topigen Pharmaceuticals Inc.*

TPI ASM8

Inhaled RNA-targetingdrug

Asthma

Began a second, expanded, 14-day Phase II trial in 60 patients inCanada (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.

AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange.