Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Amgen Inc.
(AMGN) and
Wyeth

Enbrel (FDA-approved)

Etanercept; anti-tumor necrosis factor-alpha antibody

Plaque psoriasis

European regulators recommended approval for treating adults with moderate to severe disease for whom other treatments have been inadequate (7/30)

Centocor Inc. (unit of Johnson & Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Psoriatic arthritis

European regulators recommended approval of expanded label to include treatment, with methotrexate, of active and progressive PA in patients who responded inadequately to other drugs (7/30)

Y's Therapeutics
Ltd.*
(Japan)

YSIL6

Agent designed to inhibit TNF-alpha and IL-6 production, and to inhibit T-cell proliferation and migration

Rheumatoid arthritis

Plans Phase II trial in Germany to assess safety and clinical effect (7/26)

CANCER

Atrix
Laboratories
Inc.
(ATRX)

Eligard (FDA-approved)

Leuprolide acetate for injectable suspension

Prostate cancer

Licensee Sanofi-Synthelabo filed for approval of six-month, 45-mg formulation in Canada (7/19)

Immuno-
Designed
Molecules*
(France)

Mepact

Immune system stimulant designed to activate macrophages

Osteosarcoma

The product was granted orphan designation in Europe in that indication (7/8)

PharmaMar SA* (Spain)

Kahalalide F

Peptides isolated from the Hawaiian mollusk, Elysia rufescens

Non-small-cell lung cancer and melanoma

Began Phase II trials in Europe in each indication to measure response rates and other endpoints (7/19)

Progen Industries
Ltd.
(Australia; PGLAF)

PI-88

Anti-angiogenesis drug also designed to inhibit tumor-promoting factors

Primary liver cancer

Asian collaborator Medigene Bio- Technology Corp. began fourth and largest Phase II trial of drug, in 340 patients in Taiwan (7/13)

SuperGen
Inc.
(SUPG)

Dacogen

Decitabine for injection; a hypomethylating agent

Myelodysplastic syndromes

Published data from Phase II trials involving 170 patients in Europe showed platelet responses in 63% of patients, which correlated with survival (7/9)

SuperGen
Inc.
(SUPG)

Orathecin (rubitecan)

Topoisomerase-I inhibitor in capsule formulation

Pancreatic cancer

Filed MAA seeking approval in Europe for treating patients who have failed at least one regimen (7/1)

CARDIOVASCULAR

AOP Orphan
Pharmaceuticals
AG*
(Austria)

Thrombo-reductin

Anagrelide-containing medicinal product

Thrombocythemia

The orphan product was approved in Europe; AOP will complete ongoing Phase III Anahydret trial (7/19)

Biopure Corp.
(BPUR)

Hemopure
(HBOC-201)

Oxygen therapeutic consisting of bovine hemoglobin

Blood loss in trauma patients

Began Phase II trial in South Africa to test safety and tolerability in a hospital setting, as well as to assess efficacy parameters (7/28)

BioTime Inc.
(AMEX:BTX)

Hextend

Blood plasma volume expander

Blood loss during surgery

Partner CJ Corp. received approval in South Korea, and now will seek pricing approval (7/7)

Novogen Ltd. (Australia; NVGN)

Trans-NV-04

Antioxidant that inhibits smooth muscle cell growth in blood vessels

Cardiovascular disease

Began trial in Australia to test safety and tolerability in healthy volunteers at risk of cardiovascular disease (7/6)

CENTRAL NERVOUS SYSTEM

Manhattan Pharmaceuticals
Inc.
(OTC BB:MHTT)

--

Lingual spray formulation of propofol

Sedation

UK Phase I trial in 12 healthy volunteers demonstrated feasibility of oral mucosal delivery (7/14)

NeuroSearch
A/S
(Denmark;
CSE:NEUR)

NS1209

Water-soluble, glutamate AMPA antagonist

Long-lasting seizures

Began two Phase II trials in Denmark, Sweden and Finland to test the agent on 60 patients with refractory status epilepticus (7/20)

INFECTION

Avant Immuno- therapeutics
Inc.
(AVAN)

Rotarix

Oral, two-dose, live attenuated vaccine developed from a single human strain

Rotavirus infection

Partner GlaxoSmithKline plc got approval in Mexico for preventing gastroenteritis caused by rota- virus infection; it was the first approval of the vaccine (7/15)

Chiron Corp.
(CHIR)

MeNZB

Meningococcal B vaccine designed for strain in New Zealand

Meningococcal
B disease

New Zealand regulators approved the vaccine for use there (7/7)

Intercell AG*
(Germany)

--

Vaccine based on virus-derived, T-cell-specific peptides formulated with the company's Polyarginine adjuvant

Hepatitis C

Reported positive data from a Phase II trial in interferon/ribavarin non-responders, setting the stage for further Phase II study (7/21)

Microscience
Holdings plc*
(UK)

spi-VEC

Hepatitis B antigen delivered via company's spi-VEC vaccine technology

Hepatitis B

Phase I trial in 30 subjects showed the vaccine was safe and immunogenic (6/29)

Neutec Pharma
plc
(UK; LSE:NTP)

Mycograb

Agent based on naturally occurring antibody against hsp90

Invasive
candidiasis

Multinational trial in 139 patients showed 84% response rate vs. 48% in placebo group, a statistically significant result (7/12)

Sinovac Biotech
Ltd.
(China;
OTC BB:SNVBF)

Healive

Hepatitis A vaccine that is sold in China

Hepatitis A

Filed registration applications in Brazil, Indonesia, Mexico, Malaysia, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam (7/22)

Tripep AB
(Sweden; SSE:TPEP)

AlphaHGA

Agent designed to inhibit the spread of the virus from the infected cell

HIV

Microdosing study showed the agent was orally bioavailable and had kinetic properties (7/21)

Vertex
Pharmaceuticals
Inc.
(VRTX)

Telzir (Lexiva; FDA-approved)

Fosamprenavir calcium; protease inhibitor

HIV

Vertex and GlaxoSmithKline plc gained approval in Europe for use in combination regimens (7/16)

Viral Genetics
Inc.
(OTC BB:VRAL)

VGV-1

Thymus nuclear protein

HIV

Trial in China showed decreased viral loads in treatment-naive patients receiving VGV-1 mono- therapy (7/23)

MISCELLANEOUS

Amgen Inc.
(AMGN)

Mimpara (FDA- approved as Sensipar)

Cinacalcet HCl; oral calcium calcimimetic

Secondary hyperpara- thyroidism

European regulators recommended approving the drug for HPT in chronic kidney disease patients on dialysis and for elevated calcium levels in patients with parathyroid carcinoma (7/29)

Ascend
Therapeutics
Inc.*

Andrin

Transdermal dihydro-
testosterone gel

Benign prostate hyperplasia

Began Phase II trial in 100 healthy men in Australia to evaluate safety and efficacy in preventing prostate growth (7/16)

Cellegy Pharmaceuticals
Inc.
(CLGY)

Rectogesic
(Cellegesic)

Nitroglycerin ointment

Pain from
anal fissures

Said approval in the UK expected in six months, following satisfactory responses to minor issues (7/7)

Dragon
Pharmaceutical
Inc.
(Canada;
TSE:DDD)

--

Recombinant erythropoietin product

Anemia due to renal failure and surgery

The product was approved in Ecuador, the sixth country to grant approval (7/16)

Genentech
Inc.
(NYSE:DNA),
Tanox Inc. (TNOX) and Novartis AG
(Switzerland)

Xolair
(FDA-approved)

Omalizumab; humanized monoclonal antibody to IgE

Asthma

Novartis submitted an application seeking approval in Europe (7/2)

Insmed Inc.
(INSM)

SomatoKine

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

Leprechaunism and primary lateral sclerosis

French officials authorized use in an infant with severe insulin resistance, and Italian officials OK'd use in a patient with PLS (7/12)

IsoTis
OrthoBiologics
SA
(Switzerland;
SWX:ISON)

Allox

Allogeneic product derived from human cells, in spray formulation

Wound treatment

Phase II trial in 110 patients with hard-to-heal ulcers showed 45% complete wound closure in the drug group vs. 33.3% among con-trols (7/9)

BioMarin
Pharmaceutical
Inc.
(BMRN)

6R-BH4

Enzyme co-factor; the active ingredient in the company's investigational agent

Phenylketonuria

The product was granted orphan status in Europe (7/20)

Y's Therapeutics
Ltd.*
(Japan)

YSTH2

Agent designed to inhibit T-cell proliferation and migration, and to inhibit matory cytokine production

Asthma

Plans Phase II trial in Germany to Th-2 type and proinflam- assess safety and clinical effect (7/26)


Notes:

* Privately held.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

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