Pharmaceutical Technologist - July 2008 - (Page 6)

Industry highlights Waging the TB war Researchers fight drug-resistant tuberculosis Researchers in the UK have been awarded £700000 (€886360) funding to develop a drug to combat tuberculosis (TB) that will be quicker to use and able to deal with drug-resistant strains. Lydia Tabernero and her team at the University of Manchester are hoping to develop the new drug in the next 3–4 years. “Existing treatments are more than 40 years old,” says Tabernero. “To tackle drug resistance and prevent future epidemics, we need new approaches and novel anti-TB drugs.” The incidence and mortality of TB are growing worldwide, with more people dying of TB than any other curable infectious disease. In addition, the disease’s long history and the use of problematic previous treatments has resulted in multidrug-resistant strains. “Antibiotic resistance is the most serious obstacle in the cure and eradication of TB. This is partly because of a lack of compliance from patients during the complex and long treatment,” says Tabernero. “Multidrug-resistant TB now affects more than 50 million people, with an increasing percentage of cases evolving into extensively drug-resistant TB, which is extremely hard to treat.” The funding, awarded by the UK’s Medical Research Council, will be used to develop the new drug that will target a unique virulence factor called MptpB from the causing agent of TB. The team has already identified compounds that are potent inhibitors and the research will be developed in collaboration with researchers at the University of Illinois (IL, USA). Tabernero says: “To take our ambitions further, we must now develop some of the leads we have identified and be able to test them. This will only be possible in a nonprofit academic environment at this stage.” www.manchester.ac.uk Biosimilar collaboration A biosimilar product used to help treat neutropenia, a side-effect of cancer chemotherapy, could soon be available in Europe, Canada and the US. Kwizda Pharma (Austria) had been working on the product with Intas Biopharmaceuticals Ltd (India), but has now transferred all its rights to Apotex (Canada), which will continue to work with Intas. “It is part of our current business strategy to work together with non-European pharmaceutical companies to break into the European market,” says Helmut Brunar, VP Research and Business Development of Kwizda. “That is why we worked with Intas to successfully complete a Phase I clinical trial, and have transferred our rights in Intas’s G-CSF to Apotex, including initiation of a Phase III trial and approval of the product in Europe.” The product uses a human protein that can reverse neutropenia by the production of neutrophils. Recombinant forms of the protein have already been approved for the European market. However, The European Medicines Agency is encouraging biosimilar applications because of the high costs involved. Shri Mani Iyer, Executive Director of Intas, says: “Intas and Apotex are eyeing a significant share of the total G-CSF market in the US and Europe, which is currently estimated to be worth approximately $1.4 billion (€902 million). Although guidelines for biosimilar product registration in the US are not yet finalized, we anticipate there would be a clear pathway for biotech companies once legislation is in place. Intas and Apotex are keen to explore prospective business opportunities for more biosimilar products in the coming years.” www.apotex.com 6 JULY 2008 PHARMACEUTICAL TECHNOLOGIST LWA/Getty Images http://www.manchester.ac.uk http://www.apotex.com

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Pharmaceutical Technologist - July 2008 Contents Industry Highlights Morpheus Market Watch Overcoming the Barriers The Tide of Change Eight Steps to Improved Water Efficiency Q&A

Pharmaceutical Technologist - July 2008

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