Company
(location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Biogen Idec Biotech India Ptvt. Ltd. (Haryana, India)

Tecfidera

Dimethyl fumarate

Relapsing-remitting multiple sclerosis

Gained approval in India

2/17/15

Celsus Therapeutics plc (London)

MRX-6

Cream 2%

Mild to moderate atopic dermatitis

Failed to demonstrate a difference in mean change from baseline to day 28 in children with mild to moderate atopic dermatitis in the phase II trial, called C012013

2/18/15

Hospira Inc. (Lake Forest, Ill.)

Inflectra

Infliximab; biosimilar monoclonal antibody (Remicade; Johnson & Johnson)

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis

Launched Inflectra in major European markets for the treatment of inflammatory conditions

2/18/15

Hospira Inc. (Lake Forest, Ill.)

Inflectra

Biosimilar Remicade (infliximab, Johnson & Johnson)

Crohn's disease and ulcerative colitis

Patients treated with Remicade and Inflectra in Hungary showed comparable induction and maintenance of remission

2/20/15

CANCER

Alethia Biotherapeutics Inc. (Montreal)

AB-16B5

A fully humanized monoclonal antibody that inhibits epithelial to mesenchymal transition

Solid tumors

Submitted a clinical trial application with Health Canada to initiate a phase I trial

2/18/15

Celgene International Sarl (subsidiary of Celgene Corp.; Summit, N.J.)

Abraxane

Nab-paclitaxel

Metastatic pancreatic cancer

Abraxane, in combination with gemcitabine, received a positive recommendation by the Scottish Medicines Consortium within the National Health Service (NHS) Scotland

2/11/15

Celgene International Sarl (subsidiary of Celgene Corp.; Summit, N.J.)

Revlimid

Lenalidomide

Multiple myeloma (MM)

European Commission approved Revlimid to treat adult patients with previously untreated MM who are not eligible for transplant

2/24/15

Northwest Biotherapeutics Inc. (Bethesda, Md.)

Dcvax-L

Dendritic cell-based vaccine

Glioblastoma multiforme brain cancer

Ongoing phase III trial of Dcvax-L for glioblastoma multiforme brain cancer was approved to proceed in Canada, has completed the approval processes at two sites and is under way screening patients for enrollment

2/20/15

Theravectys SAS (Paris)

Vaccine

Candidate for a rare malignancy caused by the human T-cell lymphotropic virus type 1

Adult T-cell leukemia/lymphoma

EMA has granted orphan drug designation

2/5/15

Tolero Pharmaceuticals Inc. (Salt Lake City)

Alvocidib

A small-molecule inhibitor of cyclin-dependent kinases

Relapsed/refractory and front-line intermediate or high-risk acute myeloid leukemia

EMA granted orphan designation

2/27/15

CARDIOVASCULAR

Prometic Life Sciences Inc. (Laval, Quebec)

PBI-4050

Orally active antifibrotic candidate

Idiopathic pulmonary fibrosis

Was cleared by Health Canada to start a phase II trial

2/5/15

CENTRAL NERVOUS SYSTEM

Arena Pharmaceuticals Inc. (San Diego) and Ildong Pharmaceutical Co. Ltd. (Seoul, South Korea)

Belviq

Lorcaserin HCl

Weight management

South Korea's Ministry of Food and Drug Safety approved Belviq

2/4/15

Eisai Co. Ltd. (Tokyo)

Zonegran

Zonisamide; anti-epileptic drug

Partial seizures

The Transparency Commission of the French National Authority for Health has published advice approving of the expanded use of Zonegran for the treatment of partial seizures in adolescents and children from 6 years of age

2/19/15

Zambon SpA (Milan) and Newron Pharmaceuticals SpA (Milan)

Xadago

Safinamide

Idiopathic Parkinson's disease

European Commission approved the use of Xadago

2/27/15

DIABETES

Hua Medicine Ltd. (Shanghai)

Sinogliatin

A fourth-generation glucokinase activator

Type 2 diabetes

Clinical data showed it has overcome issues to provide 24-hour glucose control in diabetics with the potential to improve pancreatic beta cell function

2/13/15

GASTROINTESTINAL

Infant Bacterial Therapeutics (subsidiary of Biogaia AB; Stockholm, Sweden)

Unnamed therapy

N/A

To prevent necrotizing enterocolitis

Obtained orphan drug designation in Europe

2/24/15

Sucampo Pharmaceuticals Inc. (Bethesda, Md.)

Amitiza

Lubiprostone

Chronic idiopathic constipation

Disclosed the successful completion of the European mutual recognition procedure (MRP) for Amitiza for the treatment of chronic idiopathic constipation in select European countries, resulting in a recommendation for marketing authorization

2/2/15

INFECTION

Biotime Inc. (Alameda, Calif.)

Renevia

Delivery matrix for a patient's own fat-derived cells

HIV-associated lipoatrophy

The first patient was successfully treated in a pivotal trial in Europe

2/25/15

Enanta Pharmaceuticals Inc. (Watertown, Mass.) and Abbvie Inc. (North Chicago)

Ombitasvir/paritaprevir/ritonavir

Once-daily dosed, all-oral, ribabirin-free and interferon-free, 12-week, two direct-acting antiviral treatment

Genotype 1 chronic hepatitis C virus infection

Has submitted an NDA to the Japanese Ministry of Health, Labor and Welfare seeking approval

2/13/15

Medigene AG (Martinsried, Germany)

Veregen

Sinecatechins ointment

Genital warts

Approved for marketing in eight additional European countries within the mutual recognition procedure, including two of the biggest EU markets, the UK and Italy

2/23/15

INFLAMMATORY

Cipher Pharmaceuticals Inc. (Mississauga, Ontario)

Beteflam Patch

Self-adhesive medicated plaster containing 0.1% betamethasone valerate

Inflammatory skin conditions such as chronic plaque psoriasis

The Beteflam Patch (previously called the Betesil Patch) has been accepted for review by Health Canada

2/13/15

Crystalgenomics Inc. (Seoul, South Korea)

Acelex

Polmacoxib; once-a-day non-sterioidal anti-inflammatory drug

Osteoarthritis

South Korean authorities approved it

2/13/15

MISCELLANEOUS

Atyr Pharma Inc. (San Diego)

Resolaris

Company's first Physiocrine-based product candidate

Facioscapulo-humeral muscular dystrophy

European Commission granted orphan designation

2/19/15

Biospecifics Technologies Corp. (Lynbrook, N.Y.) and Swedish Orphan Biovitrum AB (Stockholm)

Xiapex

Collagenase clostridium histolyticum

Peyronie's disease

Received approval from the European Commission to market Xiapex

2/3/15

Biotie Therapies Corp. (Turku, Finland)

BTT1023

A fully human monoclonal antibody targeting vascular adhesion protein 1

Primary sclerosing cholangitis

EMA's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug designation

2/18/15

Cytori Therapeutics Inc. (San Diego)

Cytori

Cell therapy

Traumatic meniscal injuries in the knee

The first patient was enrolled and treated in a single-arm, open-label, investigator-initiated trial in patients undergoing surgery for traumatic meniscal injuries in the knee at the Orthopedic Institute of Hospital Quiron in Barcelona

2/11/15

Cytori Therapeutics Inc. (San Diego)

ECCS-50

Contains adipose tissue-derived stromal vascular fraction cells derived from Cytori's Celution System

Scleroderma

EMA's Committee for Orphan Medicinal Products issued a positive opinion toward Cytori's application for an orphan drug designation

2/25/15

Kythera Biopharmaceuticals Inc. (Westlake Village, Calif.)

ATX-101

Deoxycholic acid

Submental fat

Submitted a drug application to Australia's Therapeutic Goods Administration

2/6/15

Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.)

Eylea

Aflibercept

Visual impairment due to macular edema

Was approved by the European Commission

2/27/15

RESPIRATORY

Galapagos NV (Mechelen, Belgium) and Janssen Pharmaceutica NV (unit of Johnson & Johnson; Brunswick, N.J.)

GLPG1690

Experimental pulmonary disease therapy

Pulmonary disease

Phase I data demonstrated engagement with an as-yet undisclosed target, a good safety profile and favorable drug properties; the randomized, double-blind, placebo-controlled, single-center study was conducted in 40 healthy volunteers in Belgium

2/18/15


Notes

BLA = Biologics license application; CHMP = Committee for Medicinal Products for Human Use; 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.

For more information about individual companies and/or products, see Thomson Reuters Cortellis.