Pharmaceutical manufacturing: news in brief
headlines from around the pharmaceutical manufacturing industry.
Bioject Medical Technologies' needle-free injection device, Biojector2000, is being used in Vical's Phase I testing of its Vaxfectin formulated plasmid DNA pandemic influenza vaccine. Vical is conducting a clinical trial comparing vaccination by needle and syringe to vaccination with the Biojector2000. "Needle-free injection therapy systems provide enhancing technologies for vaccines and we are confident that Vical's pDNA vaccine clinical trial will reaffirm the significant benefits of Bioject's needle-free injection therapy systems," Bioject executive vice president and chief medical officer Richard Stout said. In May, Vical announced that in a recently completed animal study, a pDNA vaccine formulated with the company's patented Vaxfectin adjuvant and delivered by needle-free injection yielded significantly higher antibody responses than an unformulated pDNA vaccine delivered by needle and syringe. An inhaled immune system stimulant has been found to protect mice against pneumococcal pneumonia and other bacterial, viral and fungal lung infections. Researchers at The University of Texas M.D. Anderson Cancer Centre developed an Aerosolised Lung Innate Immune Stimulant (ALIIS) and found that mice treated with the product two hours before exposure to S. pneumoniae had an 83 per cent survival rate, while treatment between four and 24 hours before exposure saw a 100 per cent survival rate. The team found that giving the stimulant after infection also provided protection. ALIIS consists of a purified extract of the common bacterium, Haemophilus influenzae, which is essentially broken open, purified and administered as an aerosol. The stimulant works by increasing the body's innate immune response in the lung lining through the production of antimicrobial polypeptides that kill the pathogens "virtually on contact". The innate immune system also recruits the adaptive immune system to launch a pathogen-specific response, which often takes a couple of days to respond. The team got similar results testing ALIIS as a protectant against lethal doses of several other types of pneumonia, as well as influenza virus, the mould aspergillus, and the Class A bioterror agents anthrax, bubonic plague and tularaemia. Early clinical trials are at least a year away. A recent report within the Pharmaceutical Tracker has found the pharma industry expects to spend $21bn over 537 construction projects next year. The figure represents a $6.7bn increase over projects in 2007, with 30 per cent more projects expected next year than this year. The average total investment value for 2008 is $39m, up from $34.6m this year. The West Coast of the US will be the biggest project hub with $3.6bn distributed over 62 projects. Many of the projects are focussed on increasing R&D capacity but also cover annual production plant maintenance. Solvay and Shire are both expected to start construction on manufacturing facilities in Alabama and Massachusetts respectively. The report authors note that many of the projects taking place next year were originally expected to begin in 2007, but were unable to get off the ground for a variety of reasons. Packaging machine company IMA has acquired the freeze-drying machinery business of the BOC Edwards Pharmaceutical Systems Group for €36m ($52.6m). While IMA takes on 100 per cent of the freeze-drying machinery business it will also take on 50 per cent of the shares of the joint venture Edwards Tianli Pharmaceutical Systems located in China, subject to the pre-emption right of the Chinese shareholder. "Thanks to this new and important acquisition we intend to further strengthen our world leadership in the field of machines for the pharmaceutical industry, with the objective of achieving the main market share in the various segments in which we operate," IMA chairman and managing director Alberto Vacchi said. "The freeze-drying business promises to be one of the fastest growing in the entire pharmaceutical industry, with great potential in the field of biotechnologies . . . We will have at our disposal a second plant in the US, the main pharmaceutical market in the world, a new location in the Netherlands and, in case of completion of the transfer of the shares of the Chinese joint-venture, also an additional production facility in China, another fast growing market." The closing date of the acquisition is expected in early 2008.
