Company (Location) |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Genzyme Corp. (Cambridge, Mass.; unit of Sanofi SA) |
Lemtrada |
Alemtuzumab |
Relapsing multiple sclerosis |
Submitted a supplemental BLA to the FDA and an MAA to the EMA seeking approval |
6/13/12 |
CANCER | |||||
Arno Therapeutics Inc. (Flemington, N.J.) |
AR-42 |
A broad-spectrum deacetylation inhibitor of histone and nonhistone proteins |
Meningioma and schwannoma |
Was granted orphan drug status by the EMA |
6/8/12 |
Astellas Pharma Inc. (Tokyo) |
MDV3100 |
Enzalutamide |
Metastatic castration-resistant prostate cancer |
Submitted a European MAA |
6/28/12 |
Celgene International Sarl (Boudry, Switzerland) |
Revlimid |
Lenalidomide |
Newly diagnosed multiple myeloma |
Withdrew its marketing submission in Europe to package together more mature data |
6/22/12 |
CARDIOVASCULAR | |||||
Erytech Pharma (Lyon, France) |
Enhoxy |
Human erythrocytes encapsulating inositol hexaphosphate |
Sickle cell disease |
The European Committee for Orphan Medicinal Products adopted a positive opinion to grant orphan designation |
6/14/12 |
CENTRAL NERVOUS SYSTEM | |||||
Orexo AB (Uppsala, Sweden) and Meda AB (Goteborg, Sweden) |
Edluar |
A sublingual formulation of zolpidem |
Insomnia |
Received European regulatory approval for Edluar |
6/19/12 |
ProtAffin AG (Graz, Austria) |
PA401 |
A modified form of human chemokine IL-8 |
Steroid-resistant inflammation |
Started dosing healthy volunteers in a Phase I trial in the UK |
6/28/12 |
PsychoGenics Inc. (Tarrytown, N.Y.) |
Eltoprazine |
Selective 5-HTIA/IB partial agonist |
Levodopa-induced dyskinesia in Parkinson's disease |
The randomized, dose-finding study was conducted at two sites in Sweden; it met the primary objective by exhibiting a statistically significant reduction in LID, without adversely affecting levodopa efficacy; it was well tolerated |
6/13/12 |
DIABETES | |||||
Generex Biotechnology Corp. (Worcester, Mass.) and Shreya Life Sciences Pvt. Ltd. (Mumbai, India) |
Oral-lyn |
Buccal insulin spray |
Diabetes |
Shreya plans to complete the Phase III trial in India by the end of July; to date, 125 patients have completed the study |
6/26/12 |
pSivida Corp. (Watertown, Mass.) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Vision impairment associated with chronic diabetic macular edema |
Portugal's National Authority of Medicines and Health Products granted marketing authorization |
6/6/12 |
INFECTION | |||||
Gilead Sciences Inc. (Foster City, Calif.) |
Elvitegravir |
An integrase inhibitor |
HIV |
European Medicines Agency validated its MAA |
6/20/12 |
Medigene AG (Martinsried, Germany) |
Veregen |
Contains a concentrate of catechins with a complex defined composition extracted from green tea leaves |
Genital warts |
Obtained marketing approval in Serbia |
6/1/12 |
Theratechnologies Inc. (Montreal) and Sanofi SA (Paris) |
Tesamorelin |
Oral therapy |
Excess abdominal fat in HIV patients with lipodystrophy |
Submitted marketing authorizations in Colombia and Venezuela; withdrew the MAA in Europe after the CHMP cited a lack of data on cardiovascular risk markers; the company also received a notice of noncompliance regarding its submission in Canada, and regulatory trouble in Brazil regarding technical deficiencies with a third-party manufacturing site |
6/5/12 |
MISCELLANEOUS | |||||
AMAG Pharmaceuticals Inc. (Lexington, Mass.) |
Rienso |
Ferumoxytol; an intravenous iron therapy |
Iron deficiency anemia in adults with chronic kidney disease |
European Commission granted marketing authorization |
6/25/12 |
Kythera Biopharmaceuticals Inc. (Los Angeles |
ATX-101 |
A facial injectable |
Submental fat |
Results from two pivotal European Phase III studies showed it met its primary endpoints of statistically significant reduction of submental fat compared to placebo and statistically significant percentage of subjects achieving a pre-defined categorical change using a seven-point subject self-rating scale, compared to placebo |
6/12/12 |
NPS Pharmaceuticals Inc. (Bedminster, N.J.) |
Revestive |
Teduglutide |
Short bowel syndrome |
CHMP recommended approval |
6/25/12 |
Osiris Therapeutics Inc. (Columbia, Md.) |
Prochymal |
Remestemcel-L |
Acute graft-vs.-host disease |
Received approval in New Zealand to market it for children |
6/15/12 |
Protalix BioTherapeutics Inc. (Carmiel, Israel) and Pfizer Inc. (New York) |
Elelyso |
Taliglucerase alfa |
Type I Gaucher disease |
EMA's CHMP recommended against marketing authorization due to Shire plc's marketing exclusivity for Vpriv, but acknowledged that Elelyso has a positive risk-benefit profile |
6/25/12 |
PTC Therapeutics Inc. (South Plainfield, N.J.) |
Ataluren |
An oral small molecule |
Duchenne's/Becker muscular dystrophy |
Started an open-label study in the European Union, Israel, Australia and Canada |
6/28/12 |
|
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. | |||||