Roche runs for EU application of subcutaneous Herceptin

26.03.2012 - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer.

Roche said subcutaneous administration of Herceptin is less invasive and more convenient to patients, as it takes approximately five minutes instead of 30-90 minutes with the approved intravenous (IV) administration. The regulatory application is based on data from the Phase III HannaH trial presented on March 23 the at the European Breast Cancer meeting in Vienna. Subcutaneous Herceptin produced a complete pathologic response rate, the co-primary endpoints of pharmacokinetics and efficacy met their pre-specified criteria. The drug concentration in the blood measured just before surgery was at least as high for the SC as for the IV formulation (69.0 and 51.8 µg/mL, respectively). This is important in order to demonstrate comparable efficacy. In addition, efficacy, determined by pCR, in patients treated in the SC arm was in the same range as in patients who received the IV formulation (45.4 percent and 40.7 percent, respectively). Subcutaneous Herceptin is formulated using Enhanze recombinant human hyaluronidase (rHuPH20) drug delivery technology from Halozyme Therapeutics Inc.


09.10.2015 The US pricing controversy is reverberating halfway across the globe. Shield Therapeutics has taken its IPO plans off the table. Market conditions are too volatile, the company says.


07.10.2015 T-cell specialist Adaptimmune Therapeutics plc needs more space for its R&D in immuno-oncology. The expanding UK company is building a major facility that will house 200 staff.

Drug DiscoveryGermany

06.10.2015 Evotec has been hired by the US National Cancer Institute (NCI) to provide compound management services to the Chemical Biology Consortium. The goal: the discovery of new cancer treatments.

Drug DevelopmentUKBelgium

01.10.2015 Autoimmune disease specialist Apitope has raised €12m in a Series B financing round and is relocating its UK headquarters to Wales.

Drug DevelopmentFranceEUFinlandSpainItalyAustria

01.10.2015 Paris-based BEAM Alliance, a network of companies working on novel antibiotics founded earlier this year, has released its first position paper.


29.09.2015 Swiss CNS specialist Asceneuron SA has raised CHF30m (€27.5m) in a Series A financing, winning Paris-based Sofinnova Partners as its largest investor.


28.09.2015 US company Aduro Biotech has acquired Dutch monoclonal antibody discovery and development firm BioNovion for €29m plus milestones.


24.09.2015 Nutrition company Nestlé is teaming up with biopharmaceutical company AC Immune SA to develop a Tau diagnostic assay for early Alzheimer’s.


22.09.2015 Bayer has taken another step in its restructuring and development as a life sciences company after splitting from all its chemical divisions.


18.09.2015 AstraZeneca has partnered up with the US Department of Health in order to accelerate the development of new antibiotics. The goal: to be prepared for multi-resistant bugs – and for bioterrorism.


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No liability assumed, Date: 09.10.2015