Company (Location)

Product

Description

Indication

Status (Date)#


AUTOIMMUNE

UCB SA (Brussels, Belgium)

C-Early

Certolizumab pegol

Rheumatoid arthritis

Started a Phase III trial of C-Early in combination with methotrexate for RA (2/23)

CANCER

Dendreon Corp. (Seattle)

Provenge

Sipuleucel-T

Prostate cancer

Data showed an estimated median overall survival of 7.8 months with the vaccine (2/2)

Gamida Cell Ltd. (Jerusalem)

StemEx

A cell therapy

Blood cancers

Enrolled the last of 100 patients in a pivotal, Phase III trial (2/15)

Medivation Inc. (San Francisco) and Astellas Pharma Inc. (Tokyo)

MDV3100

An oral androgen receptor signaling inhibitor

Advanced prostate cancer

MDV3100 extended life by nearly five months vs. placebo in a Phase III trial (2/28)

Onyx Pharmaceuticals Inc. (South San Francisco)

Carfilzomib

A next-generation proteasome inhibitor

Relapsed multiple myeloma

Completed enrollment in the Phase III trial (2/24)

CARDIOVASCULAR

Gentium SpA (Villa Guardia, Italy)

Defibrotide

The sodium salt of a complex mixture of single-stranded oligodeoxribonucleotides derived from procine mucosal DNA

To prevent hepatic veno-occlusive disease

Phase III data showed it led to a 40% reduction in the incidence of VOD 30 days after hematopoietic stem cell transplantation (2/28)

Ikaria Inc. (Hampton, N.J.)

Nitric oxide

Inhaled therapy

Broncho-pulmonary dysplasia

Enrolled the last patient in its pivotal Phase III trial (2/28)

Karo Bio AB (Huddinge, Sweden)

Eprotirome

Cholesterol-lowering agent

Heterozygous familial hypercholesterolemia

Company is terminating a Phase III pivotal trial after a toxicology study in dogs indicated that long-term exposure could result in cartilage damage (2/15)

CENTRAL NERVOUS SYSTEM

Forest Laboratories Inc. (New York) and Gedeon Richter plc (Budapest, Hungary)

RHG-188

Cariprazine; antipsychotic agent

Acute mania associated with bipolar I disorder

Top-line data from a Phase III trial showed patients experienced significant improvements in symptoms compared to those in the placebo arm (2/9)

Omeros Corp. (Seattle)

OMS302

Drug that combines an anti-inflammatory agent with one that causes mydriasis

For use during cataract surgery and to reduce postoperative pain

Positive clinical developments allowed it to revise the planned analysis for its ongoing Phase III study (2/8)

Orexigen Therapeutics Inc. (San Diego)

Contrave

Naltrexone HCl/bupropion HCl

Obesity

Orexigen agreed with the FDA on an SPA for the Contrave cardiovascular outcomes trial (2/7)

Titan Pharmaceuticals Inc. (South San Francisco)

Probuphine

A subcutaneous implant formulation of buprenorphine

Opioid dependence

Data from an open-label, six-month safety re-treatment study showed re-treatment was well tolerated (2/10)

DIABETES

Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.)

AVP-923 (Nuedexta)

Dextromethorphan with quinidine

Diabetic peripheral neuropathy

Phase III data showed efficacy, but the company is putting the indication on the back burner to focus on central neuropathic pain in multiple sclerosis (2/9)

ViroPharma Inc. (Exton, Pa.)

Plenadren

Hydrocortisone, modified-release tablet

Concomitant diabetes mellitus

Pivotal data suggested the once-daily dual-release tablet provided a more circadian-based serum cortisol profile resulting in reduced body weight, reduced blood pressure and improved glucose metabolism, compared to standard formulations of hydrocortisone (2/17)

Zealand Pharma A/S (Copenhagen, Denmark) and Sanofi SA (Paris)

Lixisenatide

A once-daily glucagon-like peptide 1 agonist

Type II diabetes

Top-line data from the GetGoal-P Phase III study showed it hit its primary efficacy endpoint of significantly reducing blood glucose levels compared to placebo (2/9)

INFECTION

Dynavax Technologies Corp. (Berkeley, Calif.)

Heplisav

HBV-10 vaccine

Hepatitis B virus

Pivotal Phase III data showed that a short, two-dose regimen of Heplisav over one month was well tolerated and superior to a three-dose regimen over six months (2/15)

Intercell AG (Vienna, Austria)

Ixiaro/Jespect

Vaccine

Japanese encephalitis

Completed a pivotal Phase III study in the Philippines and a second Phase III study in the European Union, U.S. and Australia, showing it was well tolerated and immunogenic in children (2/2)

MISCELLANEOUS

Protalix BioTherapeutics Inc. (Carmiel, Israel)

Taliglucerase alfa

A plant-cell expressed form of glucocerebrosidase

Gaucher's disease

Phase III extension data showed patients continued to demonstrate a statistically significant reduction in mean spleen volume after 24 months, with reductions of 54% in the 60 U/kg group and of 41% in the 30 U/kg group (2/10)

Salix Pharmaceuticals Ltd. (Raleigh, N.C.)

Xifaxan

Rifaximin; antibiotic

Irritable bowel syndrome with diarrhea

Started a Phase III trial to test rifaximin 550 mg three times daily for 14 days (2/22)

Santarus Inc. (San Diego)

Uceris

Budesonide tablets 9 mg

Ulcerative colitis

Began patient enrollment in a Phase IIIb trial (2/15)

Sucampo Pharmaceuticals Inc. (Bethesda, Md.) and Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Amitiza

Lubiprostone

Opioid-induced bowel dysfunction

Met the primary endpoint in a Phase III trial (2/3)

Tranzyme Pharma Inc. (Research Triangle Park, N.C.) and Norgine BV (Amsterdam, the Netherlands)

Ulimorelin

Intravenous ghrelin agonist

For gastrointestinal recovery in patients undergoing abdominal surgery

Completed patient enrollment in two Phase III studies (2/29)


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.