News

The following is an update of recent European and US regulatory decisions.

Privately-owned NovImmune SA of Geneva, Switzerland has raised an additional CHF 20 million (€15.7 million) from a syndicate led by BZ Bank Aktiengesellschaft to advance its monoclonal antibody development programmes.

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.

The following is an update of recent alliance and deal activity among biopharmaceutical companies and research institutions.

H. Lundbeck A/S of Denmark has signed agreements with Zenobia Therapeutics Inc of La Jolla, California and Vernalis Plc of the UK to research inhibitors for a family of kinases relevant to diseases of the central nervous system. Specifically, the Danish company is investigating the Leucine-rich repeat kinase 2 (LRRK2) as a target for a potential treatment for Parkinson’s disease. Lundbeck will collaborate with Zenobia to explore the structure and chemistry of the target using Zenobia’s protein expression and x-ray crystallography technology. In a separate agreement with Vernalis, the two companies will identify candidate compounds that can inhibit LRRK2. Financial terms were not disclosed. LRRK2 is an enzyme that is encoded by the LRRK2 gene. Mutations in this gene represent a risk for Parkinson’s disease. LRRK2 inhibition is potentially neuroprotective as it appears the gene is expressed at high levels in dopamine-producing neurons, Lundbeck said.

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.

A team of scientists from the Cincinnati Children’s Hospital Medical Center have reported generating functioning human intestinal tissue in the laboratory from pluripotent stem cells. The findings were reported online in Nature on 12 December.

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.