Company (Location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Protalex Inc. (Summit, N.J.)

PRTX-100

A highly purified form of Protein A

Rheumatoid arthritis

Enrolled the first patients in the fourth cohort of its Phase Ib dose-escalation trial in South Africa

7/27/12

SkyePharma plc (London)

Flutiform

Combines the corticosteroid fluticasone propionate with the LABA formoterol fumarate

Asthma

European Commission approved it

7/9/12

CANCER

Astex Pharmaceuticals Inc. (Dublin, Calif.) and Janssen-Cilag International NV (unit of Johnson & Johnson; New Brunswick, N.J.)

Dacogen

Decitabine

Newly diagnosed de novo or secondary acute myeloid leukemia

CHMP granted a positive opinion recommending approval

7/23/12

Celgene International Sarl (Boudry, Switzerland; subsidiary of Celgene Corp.)

Istodax

Romidepsin

Relapsed or refractory peripheral T-cell lymphoma

Company is requesting a re-examination of the negative opinion from the CHMP regarding Istodax

7/23/12

Cytheris SA (Paris)

CYT017

Glycosylated recombinant human interleukin-7

Progressive multifocal leukoencepha-lopathy

European Commission granted orphan designation

7/11/12

Seattle Genetics Inc. (Bothell, Wash.) and Millennium: The Takeda Oncology Co. (Cambridge, Mass.)

Adcetris

Brentuximab vedotin

Relapsed or refractory CD30-positive Hodgkin lymphoma and anaplastic large-cell lymphoma

Received a positive recommendation from the CHMP for antibody-drug conjugate Adcetris

7/23/12

CARDIOVASCULAR

Theravance Inc. (South San Francisco) and GlaxoSmithKline plc (London)

Fluticasone furoate/vilanterol

Once-daily therapy

Chronic obstructive pulmonary disease and asthma

Submitted regulatory filings in the European Union

7/17/12

CENTRAL NERVOUS SYSTEM

Alexza Pharmaceuticals Inc. (Mountain View, Calif.)

Adasuve

Staccato loxpaine

Schizophrenia or bipolar I disorder

Submitted its responses regarding the Adasuve MAA to the EMA

7/20/12

Arena Pharmaceuticals Inc. (San Diego)

Lorcaserin

Lorcaserin hydrochloride

Obesity

Filed an MAA with Swiss regulators

7/13/12

Emmaus Medical Inc. (Torrance, Calif.)

Levogluta-mide

L-glutamine

Sickle cell disease

European Commission granted orphan designation

7/18/12

DIABETES

Alimera Sciences Inc. (Atlanta)

Iluvien

Fluocinolone acetonide intravitreal insert

Vision impairment associated with chronic diabetic macular edema

France granted marketing authorization; Germany granted marketing authorization

7/19/12

INFECTION

BioAlliance Pharma SA (Paris) and Sosei Group Corp. (Tokyo)

SO-1105

A once-daily mucoadhesive buccal tablet

Oropharyn-geal candidiasis

Completed a Phase I trial in Japan

7/3/12

Optimer Pharmaceuticals Canada Inc. (Toronto)

Dificid

Fidaxomicin

Clostridium difficile infection

Canadian regulators approved it

7/6/12

MISCELLANEOUS

Albireo AB (Gothenburg, Sweden)

A4250

Ileal bile acid transporter inhibitor

Primary biliary cirrhosis, progressive familial intrahepatic cholestasis and Alagille syndrome

The EMA's Committee for Orphan Medicinal Products issued a positive opinion on an orphan application

7/25/12

Auxilium Pharmaceuticals Inc. (Malvern, Pa.)

Xiaflex

Collagenase clostridium histolyticum

Dupuytren's contracture

Granted Canadian approval

7/10/12

Hemispherx Biopharma Inc. (Philadelphia)

Ampligen

Rintatolimod

Chronic fatigue syndrome

Submitted an NDA in Argentina

7/19/12

Ipsen SA (Paris) and Teijin Pharma Ltd. (Tokyo)

Somatuline

Lanreotide

Acromegaly and pituitary gigantism

Received approval to market it in Japan

7/2/12

Ligand Pharmaceuticals Inc. (San Diego) and Pfizer Inc. (New York)

BZA/CE

Bazedoxifene/conjugated estrogens

Estrogen deficiency symptoms and osteoporosis in women at risk of fracture

EMA accepted for review the MAA

7/20/12

Medgenics Inc. (Misgav, Israel)

Epodure Biopumps

Delivers sustained doses of erythropoietin

Anemia in end-stage renal disease

Launched a Phase IIa trial in Israel

7/18/12

Ocular Therapeutix Inc. (Bedford, Mass.)

OTX-TP1

Sustained-release travoprost-loaded punctum plug

Glaucoma

Initial results from a trial in Singapore showed intraocular pressure decreased by 5.5 mm Hg three days following insertion and mean IOP was 6.5 mm Hg below baseline after 30 days of treatment

7/25/12

Sucampo Pharmaceuticals Inc. (Bethesda, Md.) and Abbott (Abbott Park, Ill.)

Amitiza

Lubiprostone

Chronic constipation

Received Japanese approval

7/6/12

uniQure BV (Amsterdam, the Netherlands)

Glybera

Gene therapy

Lipoprotein lipase deficiency

EMA approved it

7/23/12

Vertex Pharmaceuticals Inc. (Cambridge, Mass.)

Kalydeco

Ivacaftor

Cystic fibrosis

European Commission approved it for people older than 6 with at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator gene

7/30/12


Notes:

CHMP = Committee for Medicinal Products for Human Use; EMA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

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.