Company (Location)

Product

Description

Indication

Status (Date)#


AUTOIMMUNE

Almirall SA (Barcelona, Spain)

Sativex

Endocannabinoid system modulator

Spasticity in multiple sclerosis

Made regulatory submissions to a number of European countries, including Belgium, Finland, Iceland, Ireland, Luxemburg, the Netherlands, Norway, Poland, Portugal and Slovakia (2/8)

Genzyme (Cambridge, Mass.; unit of Sanofi SA)

Teriflunomide

Oral therapy

Multiple sclerosis

European Medicines Agency accepted for filing the MAA (2/24)

CANCER

Access Pharmaceuticals Inc. (Dallas) and Rhei Pharmaceuticals HK Ltd. (Hong Kong)

MuGard

Mucoadhesive oral wound product

Oral mucositis

Received marketing approval from Chinese regulators (2/27)

Cell Therapeutics Inc. (Seattle)

Pixuvri

Pixantrone dimaleate

Non-Hodgkin's B-cell lymphomas

The CHMP gave a positive opinion on conditional approval (2/21)

DCPrime BV (Amsterdam, the Netherlands)

DCP-001

A therapeutic vaccine

Acute myeloid leukemia

DCPrime received orphan drug designation in Europe for DCP-001 (2/7)

Plexxikon Inc. (Berkeley, Calif.)

Zelboraf

Vemurafenib

Metastatic melanoma

European Commission approved Zelboraf as a monotherapy in adults with BRAFV600 mutation-positive unresectable or metastatic melanoma (2/22)

CARDIOVASCULAR

CSL Behring LLC (King of Prussia, Pa.; subsidiary of CSL Ltd.)

rVIIa-FP

Recombinant fusion protein linking coagulation Factor VIIa with albumin

Congenital hemophilia

Received orphan drug designation from the FDA (2/17)

CENTRAL NERVOUS SYSTEM

Somaxon Pharmaceuticals Inc. (San Diego) and Paladin Labs Inc. (Montreal)

Silenor

Doxepin

Insomnia

Filed a new drug submission that has been accepted for review by Health Canada (2/24)

DIABETES

Amylin Pharmaceuticals Inc. (San Diego) and Eli Lilly and Co. (Indianapolis)

Byetta

Exenatide twice-daily

Type II diabetes

CHMP issued a positive opinion for expanded use of Byetta (2/21)

pSivida Corp. (Watertown, Mass.)

Iluvien

Fluocinolone acetonide intravitreal insert

Diabetic macular edema

UK's Medicines and Healthcare Products Regulatory Agency accepted for review the MAA (2/29)

MISCELLANEOUS

Catalyst Pharmaceutical Partners Inc. (Coral Gables, Fla.)

CPP-115

A GABA aminotransferase inhibitor

West syndrome

European Commission granted orphan designation (2/14)

Clinuvel Pharmaceuticals Ltd. (Melbourne, Australia)

Scenesse

Afamelanotide 16-mg implant

Erythropoietic protoporphyria

Submitted an MAA to the EMA (2/7)

Furiex Pharmaceuticals Inc. (Morrisville, N.C.)

Prilogy

Dapoxetine 30-mg and 60-mg doses

Premature ejaculation

European Commission endorsed a positive opinion (2/2)

Nymox Pharmaceutical Corp. (Hasbrouck Heights, N.J.) and Recordati SpA (Milan, Italy)

NX-1207

Investigational therapy for BPH

Benign prostatic hyperplasia

Started activities aimed at preparing for a European Phase III trial (2/22)

PregLem SA (Geneva)

Esmya

Ulipristal acetate

Uterin fibroids

European Commission granted approval (2/28)

Uluru Inc. (Addison, Texas)

Altrazeal

A powder formulation

Wound healing

Was approved in Australia (2/24)


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.