Company (Location)

Product

Description

Indication

Status (Date)#


AUTOIMMUNE

Biogen Idec Inc. (Weston, Mass.)

BG-12

Dimethyl fumarate

Multiple sclerosis

Submitted an NDA (2/29)

CANCER

Amgen Inc. (Thousand Oaks, Calif.)

Xgeva

Denosumab

Castration-resistant prostate cancer

The Oncologic Drugs Advisory Committee voted 12 to 1 that Xgeva did not demonstrate a favorable risk/benefit for the patient population (2/9)

Arno Therapeutics Inc. (Flemington, N.J.)

AR-42

An orally available, broad-spectrum deacetylation inhibitor of both histone and nonhistone proteins

Meningioma and schwannoma

Granted orphan drug designation by the FDA (2/22)

Astex Pharmaceuticals Inc. (Dublin, Calif.)

Dacogen

Decitabine

Acute myeloid leukemia

FDA's Oncologic Drugs Advisory Committee voted 10 to 3, with one abstention, that data provided did not support a favorable benefit/risk profile in patients ages 65 and older who are not considered candidates for induction therapy (2/10)

Can-Fite BioPharma Ltd. (Petah-Tikva, Israel)

CF102

Targets the A3 adenosine receptor

Hepatocellular carcinoma

FDA granted orphan drug status (2/24)

DelMar Pharmaceuticals Ltd. (Vancouver, British Columbia)

VAL-083

A small-molecule chemotherapeutic

Glioma

FDA granted orphan drug designation for VAL-083 (2/3)

Genentech Inc. (South San Francisco)

Pertuzumab

A humanized monoclonal antibody designed to inhibit HER2 receptor heterodimerization

HER2-positive metastatic or locally recurrent, unresectable breast cancer

FDA accepted the BLA and granted priority review (2/8)

CARDIOVASCULAR

Chelsea Therapeutics International Inc. (Charlotte, N.C.)

Northera

Droxidopa

Neurogenic orthostatic hypertension

FDA committee voted in favor of its approval to treat primary autonomic failure (2/24)

United Therapeutics Corp. (Silver Spring, Md.)

Treprostinil diethanolamine

Sustained-release tablets; oral treprostinil

Pulmonary arterial hypertension

FDA accepted its NDA (2/22)

ViroPharma Inc. (Exton, Pa.)

Cinryze

C1 esterase inhibitor

Hereditary angioedema

FDA issued a complete response letter regarding manufacturing expansion activities (2/8)

CENTRAL NERVOUS SYSTEM

Impax Pharmaceuticals (Hayward, Calif.)

IPX066

An extended-release capsule formulation of carbidopa/levodopa

Idiopathic Parkinson's disease

FDA accepted for filing its NDA (2/24)

NeurogesX Inc. (San Mateo, Calif.)

Qutenza

Capsaicin patch

Neuropathic pain

A briefing document cited statistical concerns regarding multiplicity and questioned the absence of replicated statistically significant results (2/8); FDA's Anesthetic and Analgesic Drug Products Advisory Committee did not recommend approval (2/13)

Vivus Inc. (Mountain View, Calif.)

Qnexa

Phentermine/topiramate

Obesity

FDA committee voted 20 to 2 to support FDA approval in individuals with a body mass index greater than 30 kg/m2 or greater than 27 kg/m2 with weight-related co-morbidities (2/23)

DIABETES

Depomed Inc. (Menlo Park, Calif.) and Merck & Co. Inc. (Whitehouse Station, N.J.)

Janumet XR

Sitagliptin and metformin extended-release tablets

Type II diabetes

FDA approved Janumet XR (2/7)

INFECTION

Gilead Sciences Inc. (Foster City, Calif.)

Truvada

Emtricitabine/tenofovir disoproxil fumarate

HIV

FDA accepted the sNDA and granted a six-month priority review (2/15)

MISCELLANEOUS

BioSante Pharmaceuticals Inc. (Lincolnshire, Ill.) and Teva Pharmaceuticals Industries Ltd. (Jerusalem)

Bio-T-Gel

A testosterone gel

Male hypogonadism

FDA approved it (2/16)

Columbia Laboratories Inc. (Livingston, N.J.) and Watson Pharmaceuticals Inc. (Parsippany, N.J.)

Progesterone

Vaginal gel 8%

To reduce the risk of preterm birth

Received a complete response letter because it did not meet the level of statistical significance generally expected to support approval (2/28)

Corcept Therapeutics Inc. (Menlo Park, Calif.)

Korlym

Mifepristone

Hyperglycemia in patients with Cushing's syndrome

FDA approved it (2/21)

Glenveigh Medical LLC (Chattanooga, Tenn.)

Digoxin immune fab

Ovine; existing biologic approved for use in cases of digoxin toxicity

Severe preeclampsia and eclampsia

FDA granted orphan drug designation (2/15)

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

Gattex

Teduglutide

Short bowel syndrome

FDA accepted for review its NDA (2/1)

Santarus Inc. (San Diego)

Uceris

Budesonide; a locally acting corticosteroid

Mild to moderate active ulcerative colitis

FDA accepted for filing its NDA (2/16)

Ultragenyx Pharmaceutical Inc. (Novato, Calif.)

UX003

A recombinant human beta-glucuronidase

MPS 7, an autosomal recessive lysosomal storage disorder

FDA granted orphan drug designation (2/29)

Vertex Pharmaceuticals Inc. (Cambridge, Mass.)

Kalydeco

Ivacaftor

Cystic fibrosis

FDA approved Kalydeco (2/1)


Notes:

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

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.