Ark Therapeutics Plc said that the European Medicines Agency has accepted its application for a marketing authorisation to launch a novel gene therapy to treat brain cancer. The application is one of the first in a new group of advanced therapies that are being regulated under European legislation that took effect on 30 December 2008. Ark announced the start of the regulatory review of its product, Cerepro, on 6 January 2009.
Pfizer has decided to exercise its options under a previously-announced research and licensing agreement with Cytos Biotechnology AG of Switzerland, giving it exclusive rights to develop, manufacture and commercialise a group of novel vaccines. The decision has triggered an undisclosed payment to Cytos. The total value of the agreement, including milestones and technology transfer fees, is estimated at CHF 150 million.
The European Medicines Agency (EMEA) has published a draft policy document in which it proposes to significantly increase the number of regulatory documents made available to the public once a decision on a medicine has been made.
The European Medicines Agency (EMEA) is recommending that six new medicines be approved for sale in Europe and that two others be given broader indications. This follows an analysis of the product data by the agency’s Committee for Medicinal Products for Human Use at a meeting from 15 to 18 December 2008. The European Commission will formally issue the marketing authorisations.
The European Commission did not cite any wrongdoing by specific companies in its preliminary report on 28 November 2008 into whether certain practices have stifled pharmaceutical innovation in Europe and/or prevented generic medicines from reaching the market in a timely fashion. However, enforcement action cannot be ruled out later, according to lawyers familiar with the investigation. This will only be known when the Commission issues its final report which is expected in late March or early April 2009.
Novartis has agreed to pay $20 million upfront for the exclusive right to an investigational cytomegalovirus (CMV) vaccine which is being developed by the privately-held AlphaVax Inc of Research Triangle Park, North Carolina. The total value of the deal, which includes an optional equity investment, milestones and royalties, was not disclosed.
Arpida AG has announced plans to reduce its workforce by three-quarters and stop two clinical-stage drug programmes following an unexpected negative opinion on its candidate antibiotic for skin infections by an advisory committee of the US Food and Drug Administration. The restructuring measures were announced on 16 December 2008.
Antisoma Plc said that a randomised Phase 2 trial of its small-molecule drug, ASA404, in non-small cell lung cancer (NSCLC) has shown that patients in the treatment group had a median survival of 14 months.
GlaxoSmithKline said that it has formed a strategic alliance to develop aptamer therapeutics with the privately-held US biopharmaceutical company, Archemix Corp. The deal is valued at up to $1.4 billion and will focus on developing products to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. It was announced on 23 December 2008.
Novozymes A/S of Denmark has entered into a licensing and collaboration agreement with sanofi-aventis to develop a new antibiotic for severe infections caused by the bacteria, Staphylococcus and Streptococcus. Financial terms were not disclosed.