UK contract bio manufacturer Eden Biodesign and Stealthyx Therapeutics have entered into an agreement to develop and produce Stealthyx' lead drug candidate, which is is part of a new class of biologics being evaluated by the company for a range of inflammatory diseases including rheumatoid arthritis. The product will incorporate Stealthyx' proprietary Prothyx technology, which the firm said harnesses the properties of a naturally occurring peptide to confer stability and disease targeting biological therapeutics resulting in improved efficacy and lower side effect profile. The project has been funded by the National Biomanufacturing Centre (NBC) Access Fund, which is administered by the Northwest Regional Development Agency (NWDA). It was set up help UK small and medium enterprises (SMEs) and research groups translate product ideas to the clinic. "The Stealthyx project is a very good example of how the NBC, and Eden as its operators, are helping to develop the biopharmaceutical product pipeline for UK companies", said Dr Linda Magee, NWDA Biotechnology Sector director. In other news, NicOx has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of the active pharmaceutical ingredient (API) of its Phase III osteoarthritis drug naproxcinod. The aim of this agreement is to generate enough of the drug to ensure an adequate supply when it is commercially launched. The filing of a new drug application (NDA) for naproxcinod with the US Food and Drug Administration (FDA) is anticipated in mid-2009. "We now have a large capacity producer, which is capable of supporting the high commercial potential of naproxcinod that has been suggested by our market research", said Michele Garufi, Chairman and CEO of NicOx, who is expecting to begin receiving the commercial deliveries of product from the fourth quarter of 2009 onwards. Archimica is installing dedicated equipment required to manufacture the API at its site in Springfield, Missouri, and although it will feature as a "significant component" of NicOx' supply chain for naproxcinod, it is unlikely to be the firm's only supplier.
As part of NicOx' strategy to maximise the commercial potential and economic value of naproxcinod, the firm said it may sign agreements with up to two additional suppliers. Meanwhile, Mumbai-based contract research and manufacturing services (CRAMS) firm Hikal is spending Rs 200 crore to set up two new manufacturing facilities in Bangalore and one in Mumbai along with a research and development centre in Pune to undertake contract work for "major" pharmaceutical companies. One of the manufacturing units in Bangalore is being set up to supply APIs for Pfizer under an agreement that was forged in January. Terms of the agreement were not disclosed, however, Jai Hiremath, vice chairman and managing director of Hikal said that it will have a "substantial impact" on its pharmaceutical business in the coming years.
The firm's existing API and pharmaceutical intermediates manufacturing facilities are situated in Jigani (Bangalore) and Panoli (Gujarat) respectively and Hikal is also establishing a new pharmaceutical intermediate manufacturing facility at Panoli near Mumbai.