Company (Location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Genzyme Corp. (Cambridge, Mass.)

Aubagio

Teriflunomide; once-daily oral drug

Multiple
sclerosis

Hit the two main clinical endpoints in a confirmatory pivotal Phase III trial: an annualized reduction in relapse rate and a reduction in the risk of sustained accumulation of disability

6/4/12

Immunomedics Inc. (Morris Plains, N.J.)

Epratuzumab

A humanized anti-CD22 antibody

Systemic lupus erythematosus

Data showed clinically meaningful improvements in health-related quality of life; it is in Phase III

6/11/12

CANCER

Ariad Pharmaceuticals Inc. (Cambridge, Mass.)

Ponatinib

Pan-BCR-ABL inhibitor

Chronic myeloid leukemia or Philadelphia-positive acute lymphoblastic leukemia

Pivotal data showed that 54% of chronic-phase CML patients, including 70% with the T315I mutation, achieved a major cytogenetic response

6/19/12

Celgene Corp. (Summit, N.J.)

Abraxane

Paclitaxel protein-bound particles for injectable suspension

Metastatic pancreatic cancer

Completed enrollment in a Phase III study, with 861 patients randomized to receive Abraxane plus gemctiabine vs. gemcitabine alone

6/7/12

Cell Therapeutics Inc. (Seattle)

Pixuvri

Pixantrone; aza-anthracenedione

Aggressive non-Hodgkin B-cell lymphomas

Phase III data were the basis for conditional marketing authroziation in the European Union

6/1/12

Genentech Inc. (South San Francisco; part of the Roche Group)

Perjeta

Pertuzumab

HER2-positive metastatic breast cancer

Patients lived significantly longer when treated with the combination of Perjeta, Herceptin and docetaxel chemotherapy, compared to Herceptin and docetaxel alone in the Phase III study

6/25/12

Genta Inc. (Berkeley Heights, N.J.)

Tesetaxel

Oral chemotherapy

Metastatic breast cancer

Reached an SPA agreement with the FDA for the proposed Phase III trial

6/19/12

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

MDV3100

Enzalutamide

Advanced prostate cancer

Completed enrollment of 1,680 patients in the Phase III study

6/7/12

Millennium: The Takeda Oncology Co. (Cambridge, Mass.)

MLN9708

An oral proteasome inhibitor

Relapsed and/or refractory multiple myeloma

Started a Phase III trial

6/29/12

NewLink Genetics Corp. (Ames, Iowa)

Algenpan-tucel-L

Hyperacute pancreas immunotherapy product candidate

Pancreatic cancer

Passed the midpoint in enrollment in its Phase III candidate

6/20/12

NovaRx Corp. (San Diego)

Lucanix

Belagenpuma-tucel-L

Non-small-cell lung cancer

Completed enrollment in its Phase III trial

6/21/12

Polynoma LLC (San Diego; subsidiary of CK Life Sciences International Inc.)

POL103A

A melanoma vaccine

Melanoma

Started a Phase III trial

6/5/12

Seattle Genetics Inc. (Bothell, Wash.)

Adcetris

Brentuximab vedotin

Relapsed or refractory Hodgkin lymphoma

Pivotal data showed that the median overall survival has not been reached after a 26.5-month median follow-up

6/15/12

Spectrum Pharmaceuticals Inc. (Henderson, Nev.)

Zevalin

Ibritumomab tiuxetan injection

Refractory/relasped aggressive lymphoma

Updated clinical data for Zevalin injection for intravenous use showed it resulted in a 91% two-year overall survival rate when administered in combination with BCNU, etoposide, cytarabine, melphalan therapy

6/19/12

Taiho Pharmaceutical Co. Ltd. (Tokyo)

TAS-102

Combination antimetabolite; oral nucleoside

Advanced recurrent colorectal cancer

It will initiate a global Phase III trial

6/1/12

Talon Therapeutics Inc. (San Mateo, Calif.)

Marqibo

Vincristine sulfate liposome injection

Philadelphia-chromsome-negative acute lymphoblastic leukemia

Talon reported enrollment and dosing of the first patient in a confirmatory Phase III trial

6/4/12

Ziopharm Oncology Inc. (New York)

Zymafos

Palifosfamide

Metastatic soft tissue sarcoma

Enrollment was completed in the Phase III trial of palifosfamide with doxorubicin vs. doxorubicin alone

6/5/12

Ziopharm Oncology Inc. (New York)

Zymafos

Palifosfamide

Small-cell lung cancer

Dosed its first patient in the Phase III pivotal trial

6/12/12

CARDIOVASCULAR

Chelsea Therapeutics (Charlotte, N.C.)

Northera

Droxidopa

Neurogenic orthostatic hypotension

Phase III data showed patients experienced improvements in their symptoms of neurogenic orthostatic hypotension and a number of individual symptoms

6/22/12

Orexigen Therapeutics Inc. (San Diego)

Contrave

Naltrexone SR/bupropion SR

Weight loss

Started enrollment in its long-term research study

6/7/12

Theratechnologies Inc. (Montreal)

Tesamorelin

A synthetic analogue of human growth hormone-releasing factor

Muscle wasting in chronic obstructive pulmonary disease

Data presented at the ENDO 2012 meeting in Houston showed it selectively reduced visceral adipose tissue in the abdominal area, without significant effects on subcutaneous adipose tissue; it also was shown to improve triglycerides, C-reactive protein and carotid intima medial thickness, without aggravation glucose

6/28/12

CENTRAL NERVOUS SYSTEM

Alkermes plc (Dublin, Ireland) and Janssen Research & Development LLC (unit of Johnson & Johnson)

Invega Sustenna

Paliperidone palmitate; once-monthly injectable

Schizophrenia

Initiated a Phase III program

6/13/12

DIABETES

Amylin Pharmaceuticals Inc. (Houston)

Metreleptin

Analogue of leptin

Diabetes and/or hypertriglyceridemia

Ongoing expanded access protocol clinical study showed treatment reduced blood glucose and triglyceride levels

6/26/12

MISCELLANEOUS

Aeterna Zentaris Inc. (Quebec City)

AEZS-130

Oral ghrelin agonist

Adult growth hormone deficiency

Phase III data showed it was safe and effective

6/27/12

AMAG Pharmaceuticals Inc. (Lexington, Mass.)

Feraheme

Ferumoxytol

Iron deficiency anemia

The global Phase III program will conclude this year

6/27/12

Amgen Inc. (Thousand Oaks, Calif.)

Sensipar/Mimpara

Cinacalcet

Secondary hyperparathyroidism and chronic kidney disease

Top-line Phase III data showed patients experienced numerically fewer composite events when compared to placebo, though the study fell short of statistical significance

6/11/12

Auxilium Pharmaceuticals Inc. (Malvern, Pa.)

Xiaflex

Collagenase clostridium histolyticum

Peyronie's
disease

Top-line Phase III data showed that the co-primary endpoints met statistical significance, with a 37.6% mean reduction in penile curvature deformity

6/5/12

Canyon Pharmaceuticals Inc. (Parsippany, N.J.)

Desirudin

Anticoagulant

Orthopedic surgery in chronic kidney disease

Results of an analysis comparing enoxaparin with desirudin found that blood clots and postoperative bleeding were reduced with use of desirudin

6/21/12

Cleveland Biolabs Inc. (Cleveland)

CBLB502

Polypeptide derived from the flagellin protein

Radiation exposure

Showed a nearly threefold increase in overall survival among rats exposed to a 70% lethal dose of radiation; this is being developed under the FDA's animal rule and the next step is a BLA filing

6/5/12

Finox Biotech AG (Burgdorf, Switzerland)

Afolia

A biosimilar recombinant follicle-stimulating hormone

For assisted reproduction technology

Pivotal Phase III data showed it met its primary endpoint, demonstrating clinical and statistical equivalence to reference product Gonal-f

6/7/12

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

MuDelta

JNJ-27018966

Diarrhea-predominant irritable bowel syndrome

The first patient has been dosed in its Phase III placebo-controlled studies

6/21/12

NPS Pharmaceuticals Inc. (Bedminster, N.J.)

Natpara

Recombinant human parathyroid hormone

Hypoparathyroidism

Phase III data showed it resulted in significant reductions in calcium and active vitamin D supplements

6/26/12

Omeros Corp. (Seattle)

OMS302

PharmacoSurgery candidate

For use in lens replacement surgery

Began a pharmacokinetic substudy in its Phase III program

6/1/12

ProFibrix BV (Leiden, the Netherlands)

Fibrocaps

A dry powder topical tissue sealant

For spine, liver and soft-tissue surgery

Began a Phase III trial

6/7/12

PTC Therapeutics Inc. (South Plainfield, N.J.)

Ataluren

An investigational new drug

Nonsense mutation cystic fibrosis

Phase III data demonstrated positive trends in lung function

6/11/12

Veloxis Pharmaceuticals A/S (Horsholm, Denmark)

LCP-Tacro

A once-daily formulation of the immunosuppressive drug tacrolimus

Kidney transplant

A Phase III subgroup analysis showed that African-American stable kidney transplant patients may be safely converted from twice-daily Prograf to once-daily LCP-Tacro

6/1/12

Ventrus Biosciences Inc. (New York)

VEN 309

Iferanserin ointment

Hemorrhoidal disease

Phase III trial failed to demonstrate improvement over placebo in either treatment arm, for any of the endpoints

6/26/12

XOMA Corp. (Berkeley, Calif.)

Gevokizumab

Monoclonal antibody that allosterically modulates its target, interleukin-1 beta

Noninfectious uveitis

Enrollment is open in a Phase III study in noninfectious uveitis and a Phase II trial in erosive osteoarthritis of the hand

6/28/12


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.