The US Food and Drug Administration has recommended that the breast cancer indication be removed from Avastin (bevacizumab), which is used in combination with paclitaxel, because the treatment does not prolong overall survival. However, the European Medicines Agency said it will allow the indication to remain because there is still clinical benefit based on progression free survival.
Evotec AG has entered into a licensing agreement with the AstraZeneca Plc subsidiary, MedImmune, to generate biological factors that play a role in beta cell regeneration. The deal includes a €5 million upfront payment to Evotec.
ImmunoGen Inc of Waltham, Massachusetts has reported initial data from two early clinical trials of its antibody-drug conjugate for first-line treatment of breast cancer patients which showed meaningful response rates when the product, trastuzumab-DM1, was used as a single agent, or in combination with a monoclonal antibody. Data from a Phase 1b/2 trial, which was reported on 10 December, showed that 57.1% of patients with HER2 metastatic breast cancer responded to treatment with the drug, plus the antibody (pertuzumab). The study consisted of 21 patients who had not received prior systemic anticancer therapy for metastatic disease. In a separate Phase 2 study, 47.8% of 137 patients receiving trastuzumab-DM1 as a single agent responded to treatment. This compared with a response rate of 41.4% of patients treated with Herceptin and a taxane. The ImmunoGen antibody-drug conjugate consists of trastuzumab plus a cytotoxic agent and a linker.
The management of Genzyme Corp has again asked shareholders to reject an all-cash $69 per-share-offer from Sanofi-Aventis SA saying that it substantially undervalues the company. Sanofi has extended its offer for Genzyme until 21 January 2011.
Bavarian Nordic A/S has reached an agreement with the US Food and Drug Administration on the design of a Phase 3 trial for its candidate vaccine for prostate cancer, Prostvac. The Special Protocol Assessment was announced on 8 December.
Cephalon Inc is to pay $130 million upfront for access to stem-cell technology developed by Mesoblast Ltd of Australia as part of an alliance to develop and commercialise adult mesenchymal precursor stem cell therapeutics for disease.
Merck & Co Inc is making a public offering of $2 billion in senior unsecured notes in order to support general corporate operations. The offering consists of $850 million of 2.25% notes due in 2016 and $1.15 billion of 3.875% notes due in 2021.
Johnson & Johnson Inc has launched its recommended offer for Crucell NV at €24.75 per share for all of the shares it does not already own. The price is the same as that announced on 17 September, 2010 when the offer was first disclosed.
AstraZeneca Plc has signed a research agreement with the Joslin Diabetes Center in Boston, Massachusetts to use stem cells to generate new research tools for investigating the causes of Type 2 diabetes.
A public-private consortium that is investigating biomarkers for Alzheimer’s disease said data from a just-completed proteomics study which used plasma samples from a neuroimaging project is now available to download from a public website.