Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)#

AUTOIMMUNE

Paladin Labs Inc. (Canada) and Isotechnika Pharma Inc. (Canada)

Voclera

Voclosporin

Psoriasis

Submitted a dossier for approval for the Canadian market (12/21)

CANCER

Allos Therapeutics Inc.

Folotyn

Pralatrexate injection

Peripheral T-cell lymphoma

EMA accepted the MAA for review (12/22)

EpiCept Corp.

Ceplene

Histamine dihydrochloride

Acute myeloid leukemia

The Israeli Ministry of Health has approved the marketing application for Ceplene (12/22)

Johnson & Johnson (which acquired developer Cougar Biotechnology Inc.)

Abiraterone acetate

An oral androgen biosynthesis inhibitor

Metastatic, advanced prostate cancer

Submitted a marketing application in Canada (12/27)

Lytix Biopharma A/S (Norway) and KAEL-GemVax Co. Ltd. (South Korea)

LTX-315

An adjuvant for the GV1001 peptide cancer vaccine

Cancer

Enrolled the first patient in the companies' joint study, which will include 20 patients total (12/7)

Pfizer Inc.

Sutent

Sunitinib malate

Pancreatic neuroendocrine tumors

European Commission has approved Sutent (12/3)

CARDIOVASCULAR

InterMune Inc.

Esbriet

Pirfenidone

Idiopathic pulmonary fibrosis

CHMP issued a positive opinion, positioning the company for a European approval in early 2011 (12/20)

CENTRAL NERVOUS SYSTEM

Vivus Inc.

Qnexa

Phentermine/topiramate controlled-release capsules

Obesity

Filed an MAA with the EMA (12/21)

Zogenix Inc.

and Desitin Pharmaceuticals GmbH (Germany)

Sumavel DosePro

Sumatriptan injection needle-free delivery system

Migraine attacks and cluster headache

The Danish Medicines Agency has approved the MAA for Sumavel DosePro (12/3)

INFECTION

BioMarin Pharmaceutical Inc.

BMN 110

N-acetylgalac-tosamine 6-sulfatase

Mucopoly-saccharidosis IVA

The Medicines and Healthcare Products Regulatory Agency in the UK accepted a Phase III trial (12/15)

Intercell AG (Austria)

Vaccine

Patch-based vaccine to protect against enterotoxigenic Escherichia coli strains

Traveler's

diarrhea

Failed to demonstrate efficacy in two studies, a Phase III trial in Central America and a Phase II pilot study in India; company is discontinuing development (12/14)

Mymetics Corp. (Switzerland)

MYMV101

Vaccine

HIV

Phase I data showed the vaccine was well tolerated and immunogenic at low and high doses; the trial was conducted in Belgium (12/1)

MISCELLANEOUS

Shire plc (UK)

Vpriv

Enzyme replacement therapy

Gaucher's disease

Health Canada approved Vpriv for long-term use in pediatric and adult Type I Gaucher's disease (12/2)

Sucampo Pharmaceuticals Inc. and Abbott

Amitiza

Lubiprostone

Chronic idiopathic constipation

Phase III data in Japanese patients showed it was safe and well tolerated and showed a statistically significant increase from baseline in the number of spontaneous bowel movements at the end of week one and a statistically significant increase from baseline in the number of rhythmic SBMs at the end of week one (12/1)

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.