Pharmaceutical manufacturing: news in brief

By Staff Reporter

- Last updated on GMT

Related tags: Cardinal health, Pharmacology brings you a selection of recent
headlines from around the pharmaceutical manufacturing industry.

Sanofi-Aventis and Regeneron Pharmaceuticals have entered into a collaboration agreement to discover, develop and commercialise fully-human therapeutic antibodies using Regeneron's VelociSuite of technologies. ​ As a result of the agreement, Sanofi-Aventis will see the company increasing its ownership of Regeneron's outstanding common stock from four per cent to 19 per cent through the purchase of 12 million newly issued shares. Under the terms of the agreement, Sanofi-Aventis will make an $85m upfront payment to Regeneron and will fund up to $475m of research over the next five years. The research could be extended for a further three years. Development costs will be shared between the two companies. The first therapeutic antibody to enter clinical development under the collaboration is an antibody to the Interleukin-6 receptor (IL-6R) which has started clinical trials in rheumatoid arthritis. VelociSuite of technologies includes VelocImmune, which increases the speed and efficacy of fully-human therapeutic monoclonal antibody development and is currently being used to generate antibodies to address clinically relevant targets of interest. Cardinal Health has been told to temporarily cease activities at its Auburn, Washington, distribution centre as of December 3. ​ The US Drug Enforcement Administration (DEA) will temporarily suspend the company's license to distribute because Cardinal Health "failed to maintain effective controls against the diversion of a particular controlled substance"​. The agency cited the sale of hydrocodone to one pharmacy that allegedly dispensed excessive amounts of the drug based on illegitimate prescriptions from internet pharmacy websites. Cardinal Health released a statement saying the suspension affected only the Washington facility. The company said the security of the pharmaceutical supply chain is among its highest priorities and it will co-operate fully with the DEA to resolve the suspension and steps were being taken to ensure the continuity of service to its customers. Oakwood Laboratories' Chroniject sustained release delivery technology is being used in the formulation of Japan-based Santen Pharmaceutical's injectable steroidal treatment for macular edema which is entering Phase I/IIa trials. ​ The microsphere formulation and sterile filling was done at Oakwood's Cleveland manufacturing facility. "Oakwood is very pleased to have been able to solve some difficult technical issues in order to bring this product to commercial manufacturing scale, and to the point of clinical use,"​ Oakwood president Mark Smith said. China Aoxing Pharmaceutical Company has been granted the designated manufacturer status to produce Tilidine tablets and capsules. ​ The drug, a prodrug, which, after oral administration, is converted to the active analgesic metabolite nortilidine, is a highly regulated narcotic drug used in cancer pain management and is currently not available in China. Under the China State Food and Drug Administration regulations, the company will have a five-year exclusivity in the China market. Abbott has received the annual Illinois Governor's Pollution Prevention Award for outstanding environmental excellence for the sixth time in the last seven years. ​ The company was recognised for implementing pollution prevention projects at its pharmaceutical fermentation manufacturing operations in North Chicago in 2006. This included making changes to two manufacturing processes that saved more than three million gallons of water a year. Abbott also adjusted another process to reduce the use of solvents and, in a different project, was able to segregate isopropyl alcohol (IPA) from other process materials for reuse, thereby minimising the amount of IPA in the waste stream. The award recognises Illinois businesses for significant achievements in protecting the environment and strengthening the economy.

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