Company (Location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Biogen Idec Inc.(Weston, Mass.)

BG-12

Dimethyl fumarate

Multiple sclerosis

FDA and EMA accepted its marketing applications for review

5/11/12

CANCER

AVEO Pharmaceuticals Inc. (Cambridge, Mass.)

Ficlatuzumab

A humanized IgG1 antibody

Non-small-cell lung cancer

Phase II data of ficlatuzumab and Iressa to Iressa alone in previously untreated Asian subjects showed encouraging signals of activity in subsets of patients based on EGFR mutation status and c-Met expression levels

5/3/12

Cell Therapeutics Inc. (Seattle)

Pixuvri

Pixantrone

Refractory aggressive non-Hodgkin B-cell lymphomas

Received conditional marketing authorization from the European Commission

5/11/12

Curis Inc. (Lexington, Mass.) and Roche AG (Basel, Switzerland)

Erivedge

Vismodegib

Basal cell carcinoma

Submitted an application seeking approval in Australia

5/8/12

Seattle Genetics Inc. (Bothell, Wash.)

Adcetris

Brentuximab vedotin

Relapsed Hodgkin lymphoma and systemic anaplastic large-cell lymphoma

Completed its validation period for Adcetris, and Health Canada has accepted its NDA for review

5/24/12

Sunesis Pharmaceuticals Inc. (South San Francisco)

Vosaroxin

A first-in-class quinolone derivative

Acute myeloid leukemia

European Commission granted orphan drug designation

5/4/12

CARDIOVASCULAR

Emmaus Medical Inc. (Torrance, Calif.)

L-glutamine

Sickle cell disease treatment

Sickle cell disease

Received a positive opinion recommending orphan designation by the European Committee for Orphan Medicinal Products

5/31/12

CENTRAL NERVOUS SYSTEM

Allergan Inc. (Irvine, Calif.)

Botox

Botulinum toxin type A

To prevent headache in adults with chronic migraine

UK's National Institute for Health and Clinical Excellence recommended it for approval

5/14/12

Genentech Inc. (South San Francisco)

Crenezumab

Targets the beta-amyloid pathway

Alzheimer's disease

Company is starting a Phase II trial in healthy members of a large extended Colombian family who are likely to develop Alzheimer's due to their genetic history

5/17/12

DIABETES

pSivida Corp. (Watertown, Mass.)

Iluvien

Second-line treatment; a sustained-release intravitreal insert

Vision impairment associated with chronic diabetic macular edema

UK granted marketing authorization

5/8/12

INFECTION

Gilead Sciences Inc. (Foster City, Calif.)

Cobicistat

Pharmaco-enhancing agent to increase blood levels of protease inhibitors

HIV

Filed an MAA with the EMA

5/25/12

Ligand Pharmaceuticals Inc. (San Diego) and GlaxoSmithKline plc (London)

Promacta/Revolade

Eltrombopag

Hepatitis C virus infection

Submitted regulatory applications in the U.S. and Europe

5/31/12

MISCELLANEOUS

Ampio Pharmaceuticals Inc. (Greenwood Village, Colo.)

Ampion

A nonsteroidal anti-inflammatory candidate

Knee injury

A planned analysis of the day 84 data of the Australian study showed the change from baseline was statistically significant at both 30 days and 84 days with Ampion, compared to no statistical significance with placebo

5/1/12

Arno Therapeutics Inc. (Flemington, N.J.)

AR-42

A broad-spectrum deacetyelation inhibitor

Neurofibro-matosis Type 2

EMA granted orphan drug status

5/14/12

Halo Therapeutics LLC (Newton, Mass.)

HT-100

Small-molecule formulation of halofuginone

Duchenne's muscular dystrophy

European Commission granted orphan designation

5/4/12

Kythera Biopharma-ceuticals Inc. (Los Angeles)

ATX-101

A facial injectable

To reduce submental fat

Two European Phase III trials resulted in a statistically significant reduction in submental fat relative to placebo

5/8/12

Ocera Therapeutics Inc. (San Diego)

Zysa

Spherical carbon adsorbent

Diarrhea-predominant irritable bowel syndrome

Received a CE Mark

5/21/12

Osiris Therapeutics Inc. (Columbia, Md.)

Prochymal

Allogeneic stem cell treatment

Graft-vs.-host disease

Health Canada approved it

5/23/12

Uluru Inc. (Addison, Texas)

Altrazeal

Powder formulation

Wound healing

Expanded its 60-patient study to include 500 patients to support the launch of the drug in Australia and New Zealand

5/4/12

Vertex Pharmaceuticals Inc. (Cambridge, Mass.)

Kalydeco

Ivacaftor

Cystic fibrosis

Received a positive opinion from the CHMP for its use in those age 6 and older with at least one copy of the G551D mutation

5/29/12


Notes:

CHMP = Committee for Medicinal Products for Human Use; EMA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

The date indicated refers to the BioWorld Today issue in which the news item can be found.