New biosimilar edges towards Europe

India and Austria collaborate to bring a cheaper product to market.

A biosimilar product could offer a cheaper alternative for treating the negative effects that cancer chemotherapy can have on white blood cells. According to a clinical Phase I trial conducted jointly by Kwizda Pharma GmbH (Austria) and Intas Biopharmaceutical Ltd, Neukine is safe, and exhibits an identical pharmacokinetic and pharmacodynamic profile compared WITH a reference product. Upon completion of the clinical Phase III trial, both companies will lodge an application for approval in Europe and the market launch is planned for early 2010.

Neutropenia is a condition whereby the concentration of neutrophils in the blood is too low, which is a serious side-effect of cancer chemotherapy and can prevent the treatment from being successful. In india, Neukine has been approved for the treatment of Neutropenia since 2004. Mani Iyer, Director of Intas, says: "More than 3000 cancer patients have already been treated with Neukine in India. No severe adverse reactions were reported, other than those commonly associated with Filgrastim."

The study was a single-dose, randomized, double-blind, two-way crossover trial and used an active control. Dr Helmut Brunar, VP of Research and Business Development at Kwidza says: "Not only was Neukine cleared from the patients' blood plasma just as quickly as the reference, but the number of neutrophils also increased with identical kinetics after treatment."

The product uses a human protein that can reverse neutropenia by initiating the production of neutrophils. Recombinant forms of the protein have already been approved for the European market. However, because of the high costs involved, the European Medicines Agency is encouraging biosimilar applications.

http://www.kwizda.at/
http://www.intasbiopharma.co.in/

UK creates biomedical units

The UK government is investing £45 million (€56.3 million) in 12 new biomedical research units to examine critical health problems such as heart disease, asthma and obesity. The units, under the umbrella of the National Institute for Health Research, will focus on 'translational research' that will take advances in basic medical research out of the laboratory and into the hospital clinic, which should allow patients to benefit more quickly from scientific breakthroughs.

Professor Sally Davies, Director General of R&D at the Department of Health, says: "Each new unit is a partnership between a National Health Service Trust and a university, which will enable some of the best health researchers and clinicians to work together. I believe the funding will really help to develop this country's capacity to conduct translational research in key areas of unmet health need."

The facilities will complement the country's existing 12 NIHR Biomedical Research Centres in London, Oxford, Cambridge, Liverpool, Manchester and Newcastle. Each unit will receive £3.75 million (€4.68 million) during the next 4 years. "The new funding will also enable high quality research to flourish in smaller centres across the country," says Dawn Primarolo, the UK's Public Health Minister. "This will strengthen our drive to put the UK at the forefront of vital health research."

http://www.nihr.ac.uk/

Bird flu library offers insights

Researchers from Turkey and the US have created the first monoclonal antibody libraries against avian influenza, which could pave the way for a successful universal flu vaccine. The libraries were created using samples from survivors of the 2005/2006 bird flu outbreak in Turkey, and so far the research has yielded more than 300 unique monoclonal antibodies that are active against H5N1 strains.

While overwhelmingly confined to bird populations in Asia and Europe, the H5N1 avian flu virus has shown its ability to infect humans and has killed more than 230 people worldwide. Epidemiologists remain concerned that the virus will one day mutate and be able to spread more readily between people, sparking a global pandemic.

"Our libraries create a roadmap for improving the efficacy and specificity of therapeutic influenza antibodies," says Arun Kashyap, Director of Influenza and Antibody Libraries for Sea Lane Biotechnologies (CA, USA), which is leading the study. said. "As a result, we might be able to engineer the best features of different antibodies into a single antibody that may not only treat contemporary strains of influenza, but also future influenza strains which normally would escape through simple mutations."

http://www.scripps.edu/