Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)#

AUTOIMMUNE

Active Biotech (Sweden) and Teva Pharmaceutical Industries Ltd.

Laquinimod

Oral therapy

Relapsing-remitting multiple sclerosis

Hit the primary endpoint in its two-year Phase III study, demonstrating significant reduction in annualized relapse rate compared to placebo (12/10)

Immunomedics Inc. and UCB SA (Belgium)

Epratuzumab

A monoclonal antibody targeting CD22

Moderate to severe systemic lupus erythematosus

Launched two Phase III studies (12/15)

CANCER

Amgen Inc.

Xgeva

Denosumab

Skeletal-trelated events in bone metastases; prostate cancer

Xgeva was superior to Zometa in delaying the time to first on-study skeletal-related event by 18% and time to first and subsequent on-study event by 22% (12/14); it improved median bone metastasis-free survival by 4.2 months in men with castrate-resistant prostate cancer vs. placebo (12/15)

Bavarian Nordic AS (Denmark)

Prostvac

Therapeutic vaccine

Castration-resistant

prostate cancer

Reached an SPA with the FDA for a Phase III registration study (12/9)

Biogen Idec Inc. and Roche AG (Switzerland)

Rituxan

Rituximab

Follicular lymphoma

Phase III data showed that patients who are given two years of maintenance therapy with Rituxan after immunochemotherapy have significantly better progression-free survival and higher response rates compared to those who do not receive that intervention (12/22)

BioVex Inc.

OncoVEXGM-CSF

Oncolytic virus designed to selectively kill tumor cells

Advanced squamous cell carcinoma of the head and neck

Started a Phase III pivotal study, which will enroll 528 previously untreated patients (12/13)

Cel-Sci Corp.

Multikine

Immunotherapy

Head and neck cancer

Started a Phase III trial (12/30)

Eli Lilly and Co.

Tasisulam

A small-molecule anticancer compound

Unresectable or metastatic melanoma

Suspended its global Phase III study (12/15)

EpiCept Corp.

Ceplene

Histamine dihydrochloride

Acute myeloid leukemia

Results of a new subset analysis of 190 patients showed a difference in overall survival was in favor of Ceplene plus IL-2 compared to the standard of care, with a median overall benefit of 36 months (12/13)

Halozyme Therapeutics Inc.

Herceptin

Subcutaneous formulation

HER2-positive breast cancer

Completed enrollment for a Phase III study with 595 patients (12/8)

Medivation Inc. and Astellas Pharma Inc. (Japan)

MDV3100

A triple-acting oral androgen receptor antagonist

Advanced prostate cancer

Completed patient enrollment in the Phase III study (12/1)

Sunesis Pharmaceuticals Inc.

Vosaroxin

A first-in-class quinolone derivative

Acute myeloid leukemia

Launched its Phase III trial (12/22)

CARDIOVASCULAR

Amarin Corp. plc (Ireland)

AMR101

Prescription grade omega-3 fatty acid drug; ethyl icosapentate

For high triglycerides

Completed randomization for its ANCHOR Phase III trial (12/17)

Gilead Sciences Inc.

Letairis

Ambrisentan

Idiopathic pulmonary fibrosis

Phase III data showed a lack of efficacy so Gilead is halting work on Letairis (12/27)

Pfizer Inc.

Thelin

Sitaxentan

Pulmonary arterial hypertension

Pfizer is voluntarily pulling it from the market in Europe, Canada and Australia and is discontinuing clinical studies worldwide due to a potential life-threatening idiosyncratic risk of liver injury associated with Thelin (12/13)

Shire plc (Ireland)

Firazyr (icatibant)

Bradykinin B2 recptor antagonist

Hereditary angioedema (HAE)

Top-line results from Phase III FAST-3 showed that patients receiving treatment experienced a significantly faster time to onset of symptom relief from individual and combined cutaneous and abdominal HAE symptoms, compared to placebo (12/2)

CENTRAL NERVOUS SYSTEM

BioDelivery Sciences International Inc.

Buprenor-phine

Opioid analgesic delivered with BEMA

Chronic pain

Enrolled and dosed the first patient in its Phase III trial (12/10)

Medivation Inc.

Dimebon

Latrepirdine

Alzheimer's

disease

Completed enrollment in its Phase III trial evaluating dimebon plus Aricept (12/8)

QRxPharma Ltd. (Australia)

MoxDuo IR

A fixed-dose combination of morphine plus oxycodone

Pain in patients who have undergone total knee replacement surgery

Completed patient enrollment in a pivotal Phase III trial (12/7)

Sunovion Pharmaceuticals Inc.

Latuda

Lurasidone HCL

Schizophrenia

Phase III data showed statistically significant improvement compared to placebo (12/10)

UCB SA

Vimpat

Lacosamide

Uncontrolled partial-onset seizures

After a year of Vimpat treatment, patients reported significant improvements in all aspects of seizure severity and across almost all health-related quality-of-life assessments (12/7)

DIABETES

Generex Biotechnology Corp.

Generex Oral-lyn

A buccal insulin spray product

Diabetes

A 31-subject study showed that treatment with an aggregate of 12 sprays resulted in a 29.6% decrease in plasma glucose at two hours and a 26.8% decrease at three hours (12/14)

INFECTION

Anacor Pharmaceuticals Inc.

AN2690

A topical antifungal candidate

Onychomycosis

Started enrollment in its Phase III program (12/17)

Medivir AB (Sweden) and Meda AB (Sweden)

Xerese

Acyclovir and hydrocortisone cream

Cold sores

Phase III data showed it was well tolerated and did not give rise to acyclovir-resistant virus (12/9)

Topaz Pharmaceuticals Inc.

Ivermectin

Topical cream

Head lice

Completed its two pivotal Phase III trials, and Topaz plans to submit an NDA in 2011 (12/8)

MISCELLANEOUS

Adamis Pharmaceuticals Corp.

Savvy

Contraceptive

To prevent pregnancy

Completed its Phase III trial, which met its primary endpoint showing the gel was not inferior to Conceptrol; it also was well tolerated (12/8)

Aeterna Zentaris Inc. (Canada)

Solorel

AEZS-130, macimorelin

Adult growth hormone deficiency

Reached agreement with the FDA on a Phase III trial (12/21)

Auxilium Pharmaceuticals Inc.

Xiaflex

Collagenase clostridium histolyticum

Dupuytren's contracture

Phase III data showed that 67% of patients experienced a clinically significant result (12/7)

Bellus Health (Canada) and Celtic Therapeutic LLLP

Kiacta

Eprodisate

AA amyloidosis

Started a confirmatory Phase III study (12/16)

Corcept Therapeutics Inc.

Corlux

Mifepristone; a cortisol receptor antagonist

Cushing's syndrome

Phase III data showed a response rate of 60% for glucose-intolerant patients and 43% for patients with hypertension (12/23)

Ikaria Inc.

Lucassin

Terlipressin

Hepatorenal syndrome type 1

Enrolled the first patients in a pivotal Phase III trial (12/1)

Incyte Corp.

INCB18424

JAK1/2 inhibitor

Myelofibrosis

Hit the primary endpoint of reducing spleen size in patients in a Phase III trial (12/22)

Inspire Pharmaceuticals Inc.

Denufosol

Inhaled therapy

Cystic fibrosis

Patients, age 5 and older, had better lung exhalation rates than those in the placebo group at the end of 24 weeks in a Phase III trial (12/20)

Keryx Biopharma-ceuticals Inc.

Zerenex

Ferric citrate

Hyperphospha-temia

Met the primary and key secondary endpoints in a short-term Phase III trial in dialysis patients (12/1)

PTC Therapeutics Inc.

Ataluren

An oral small

molecule

Nonsense mutation cystic fibrosis

Completed enrollment in a Phase III trial (12/22)

Regeneron Pharmaceuticals Inc. and Bayer AG (Germany)

VEGF Trap-Eye

Aflibercept

Macular edema

Phase III trials met the primary endpoint, with 56.1% of patients on drug gaining at least 15 letters of vision from baseline, compared to 12.3% of patients on placebo (12/21)

Vivus Inc.

Avanafil

A phosphodiesterase 5 inhibitor

Erectile dysfunction

It met all primary endpoints in a Phase III study (12/7)

Notes:

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.

SPA = Special Protocol Assessment.