Bavarian Biotech Report 2011/2012 (7MB) - Bio M

PHASE II4SC: Hepatocellular carcinoma, Hodgkin’s Lymphoma,mild to moderate rheumatoid arthritis,Inflammatory bowel disease (IBD)Agennix: Diabetic foot ulcers, Severe SepsisBavarian Nordic: Small pox, Breast cancerCorimmun: Heart failure, Acute CoronarySyndrome/StrokeDonatur: PeriarthritisMediGene: Breast cancer, Pancreatic cancer,Rheumatoid ArthritisMicromet: adult r/r acute lymphoblastic Leukemia(relapsed/refractory), MRD-positive acute lymphoblasticleukemia, Solid tumorsMorphoSys (with Roche): Alzheimer's diseasesMorphoSys (with Centocor): Immunology, OncologyMorphoSys (with Novartis): OncologyMorphoSys (with Janssen): PsoriasisMorphoSys: Rheumatoid ArthritisScil Technology: Periodontal diseaseSuppreMol: Idiopathic Thrombocytopenic Purpura,Systemic Lupus ErythematosusTrion Pharma/Fresenius Biotech: Metastatic Breastcancer, Gastric cancer, Ovarian cancer, MalignantAscitesVasopharm: Traumatic brain injuryWilex: Advance non-metastatic pancreatic cancer,Breast cancerPHASE IIIAgennix: Non small cell lung cancerAntisense Pharma: GliomaBavarian Nordic: Advanced prostate cancerFresenius Biotech: Stem cell transplantation,Immunology therapyWilex: Non-metastatic clear cell renal cellcancerAPPROVEDFresenius Biotech: Transplantation(ATG-Fresenius S)MediGene: Genital warts (Veregen ® ),Prostate Cancer (Eligard ® ), Rosacea,inflammatory lesions (Oracea ® , sold)Trion Pharma/Fresenius Biotech:Malignant Ascites (EU, Removab ® )The number of all clinical studies in phase II did notchanged during the year 2011, but nevertheless severaldrug development companies has reached significantmilestones in clinical developement.Corimmun GmbH (Martinsried) has started a phase IIclinical trial with their key compound COR-1, a peptidedrug for the personalized therapy of congestive heartfailure. The trial represents a multi-centric, randomized,double blind, placebo-controlled study.Agennix AG (Munich) has started clinical phase II/IIIOASIS study with their key compound talactoferrin forsevere sepsis. In June 2011, the first patient has beendosed with talactoferrin. The OASIS study represents amulticenter, double-blind, randomized phase II/III trialevaluating the oral immunotherapy talactoferrin for thetreatment of severe sepsis.In September and October 2011, the US Food and DrugAdministration (FDA) and European Medicines Agency(EMA) have granted orphan drug designation to 4SC'slead oncology compound Resminostat in Hodgkin'slymphoma (HL). 4SC's lead oncologic compound,received in July 2011 a positive recommendation fororphan medicinal product designation in the EU in theindication hepatocellular carcinoma (HCC) and obtainedorphan drug status in the US for HCC as well.In November 2011, 4SC AG has announced their finalresults from its clinical Phase IIb COMPONENT study withits anti-inflammatory compound Vidofludimus inRheumatoid Arthritis. The compound Vidofludimus showsthe reduction of objective parameters and reveals substantialanti-inflammatory activity in combination with avery good safety profile. Moreover, the company has20