Company
(Location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Biogen Idec Inc. (Weston, Mass.)

BG-12

Dimethyl fumarate

Relapsing-remitting multiple sclerosis

Phase III data showed statistically significant and clinically relevant effects of BG-12 in reducing MS relapses and progression of disability

10/15/12

CANCER

AB Science SA (Paris)

Masitinib

An oral tyrosine kinase inhibitor

Pancreatic cancer

Phase III data showed that masitinib in combination with Gemzar significantly extended overall survival by six months in pancreatic cancer patients

10/31/12

ArQule Inc. (Woburn, Mass.)

ARQ 197

c-Met-targeted cancer drug tivantinib

Nonsquamous non-small-cell lung cancer

An independent data safety monitoring committee terminated the Phase III MARQUEE trial, following data that the statistically significant improvement in progression-free survival did not extend to overall survival

10/3/12

ArQule Inc. (Woburn, Mass.)

Tivantinib

A selective MET inhibitor

Hepatocellular carcinoma

Reached an SPA agreement with the FDA for a pivotal Phase III trial

10/17/12

Cancer Research UK (London)

Tarceva

Targeted therapy; erlotinib

Advanced non-small-cell lung cancer

Phase III data showed that elderly patients who developed a rash within 28 days of receiving Tarceva survived an average of 6.2 months, compared to 4. 1 months for patients who received placebo

10/16/12

Celgene Corp. (Summit, N.J.)

Abraxane

Paclitaxel protein-bound particles for injectable suspension

Metastatic melanoma

Met the primary endpoint of progression-free survival in a Phase III trial

10/3/12

Celgene Corp. (Summit, N.J.)

Pomalidomide

Immunomod-ulatory agent

Multiple myeloma

Phase III study met the primary endpoint of progression-free survival

10/24/12

NewLink Genetics Corp. (Ames, Iowa)

Algenpan-tucel-L

HyperAcute Pancrease immunotherapy

Pancreatic cancer

Launched a Phase III study with 280 subjects who will receive standard-of-care FOLFIRINOX plus or minus algenpantucel-L

10/11/12

OncoGenex Pharmaceuticals Inc. (Bothell, Wash.)

Custirsen

Based on Isis Pharmaceuticals Inc.'s second-generation antisense technology

Non-small-cell lung cancer

Entered another Phase III study, this one in NSCLC patients whose disease has progressed despite chemotherapy

10/1/12

Onyx Pharmaceuticals Inc. (South San Francisco)

Carfilzomib

Single-agent

Relapsed and refractory myeloma

Completed enrollment in the Phase III study

10/16/12

Pharmacyclics Inc. (Sunnyvale, Calif.)

PCI-32765

Ibrutinib

Chronic lymphocytic leukemia/small lympocytic lymphoma

Phase III trial of ibrutinib in combination with bendamustine and rituximab enrolled the fifth patient

10/16/12

Threshold Pharmaceuticals Inc. (South San Francisco)

TH-302

A hypoxia-targeted drug

Metastatic or locally advanced unresectable pancreatic cancer

FDA reached agreement with Threshold's partner, Merck KGgA, for an SPA for a Phase III trial

10/17/12

XBiotech Inc. (Austin)

Xilonix

Antibody (MABp1)

Cachexia in cancer and other diseases

Launched its first Phase III trial

10/5/12

CENTRAL NERVOUS SYSTEM

Omeros Corp. (Seattle)

OMS302

Designed to be added to standard irrigation solution used during intraocular lens replacement procedures

To maintain intraoperative mydriasis and reduce postoperative pain

Enrolled the last patient in its second Phase III trial

10/4/12

TauRx Therapeutics Ltd. (Singapore)

LMTX

Tau aggregation inhibitor

Alzheimer's disease

Recruited the first patients to two Phase III trials

10/31/12

DIABETES

Dompe Group (Milan, Italy)

Reparixin

Shown to improve efficacy of transplantation of insulin-producing pancreatic islets

Type I diabetes

Enrolled the first patient in a Phase III trial

10/24/12

MannKind Corp. (Valencia, Calif.)

Afrezza

Insulin human [rDNA origin]

Diabetes

Finished recruiting patients for two Phase III studies

10/8/12

Reata Pharmaceuticals Inc. (Irving, Texas)

Bardoxolone methyl

An antioxidant inflammation modulator

Stage IV chronic kidney disease and Type II diabetes

Ended a Phase III trial after an independent data monitoring committee pointed to safety signals in the treatment arm

10/19/12

INFECTION

Circassia Ltd. (Oxford, UK)

ToleroMune

T-cell vaccine

Rhinoconjuc-tivitis

Started a pivotal Phase III study

10/5/12

Durata Therapeutics Inc. (Morristown, N.J.)

Dalbavancin

A long-acting intravenous lipoglycopeptide

Acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria

Reached its target enrollment in a Phase III trial

10/26/12

Trius Therapeutics Inc. (San Diego)

Tedizolid

Tedizolid phosphate

Acute bacterial skin and skin structure infections

Data showed that the incidence of platelet counts below the lower limit of normal was significantly lower in patients receiving tedizolid vs. Zyvox

10/22/12

MISCELLANEOUS

Amgen Inc. (Thousand Oaks, Calif.)

Prolia

Denosumab

To increase bone mineral density (BMD)

Phase III data showed continued increases in BMD and low fracture incidence over six years

10/16/12

Depomed Inc. (Menlo Park, Calif.)

Serada

Nonhormonal extended-release formulation of gabapentin

Menopausal hot flashes

Phase III data suggested it may help manage menopausal hot flashes

10/4/12

Genzyme Corp. (Cambridge, Mass.)

Eliglustat tartrate

Oral therapy

Gaucher disease Type I

Met its primary endpoint in previously untreated patients in a Phase III trial

10/3/12

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

MLN9708

Once-weekly oral therapy

Relapsed or refractory light chain AL amyloidosis

Started a Phase III trial

10/22/12

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

Gattex

Teduglutide therapy

Short bowel syndrome

Data suggested patients achieving independence from intravenous fluids tend to have colon in continuity and lower baseline needs than typical patients

10/23/12

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

Natpara

Recombinant human parathyroid hormone

Hypopara-thyroidism

Phase III data showed Natpara initiated bone remodeling as demonstrated by significant increases in bone turnover markers

10/16/12

Noven Pharmaceuticals Inc. (Miami; subsidiary of Hisamitsu Pharmaceutical Co. Inc.)

LDMP

Low-dose mesylate salt of paroxetine

Severe vasomotor symptoms associated with menopause

Data from two Phase III trials showed it achieved statistical significance for all co-primary endpoints testing weekly reductions in the frequency and severity of symptoms

10/4/12

SARcode Bioscience Inc. (Brisbane, Calif.)

Lifitegrast

Ophthalmic solution 5%

Dry eye syndrome

Phase III data showed it hit its primary endpoint

10/23/12


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.