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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.

FundingEU

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Stock marketNetherlandsUKBelgium

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M&AUKIreland

08.07.2014 Abbvie is determined to bring home British rare disease specialist Shire in a merger worth £30.1bn (€37.9bn). So far, Shire has rejected all offers from the US company.

M&ASwitzerland

04.07.2014 Genentech, a member of Swiss Roche Group, is set to acquire US-biotech Seragon Pharmaceuticals Inc. With the move, Genentech will obtain the rights to investigational breast cancer treatments.

M&AFranceGermany

03.07.2014 Nicox S.A. is stretching beyond the European market: The French eye health specialist is set to acquire Aciex Therapeutics Inc., a US-based pharma company with several ophthalmic therapeutics nearing market maturity.

FinanceBelgium

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BioeconomyBelgiumUK

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InvestmentGermanyNetherlands

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InvestmentNetherlands

20.06.2014 Tomtom founder Pieter Geelen invests in Dutch biotech Ocello, the company behind a 3D mapping technology used for predicting drug behaviour in patients.

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No liability assumed, Date: 11.07.2014