Pharma/Fine Chemicals Roundup – December 20
5:07 AM MST | December 20, 2011 | By DEEPTI RAMESH
FDA AND EMA TO SHARE WORK ON MANUFACTURING SITE INSPECTIONS
The European Medicines Agency (EMA; London) says that EMA and the U.S. Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, which will start in January 2012, “will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate,” EMA says. The EMA is a decentralized agency of the European Union (EU), and it is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.
The initiative will apply to inspections of manufacturing sites of human or veterinary medicines in the European Economic Area and the U.S. It will focus on sites that are already known to the two authorities and have a history of compliance with good manufacturing practice (GMP) following previous inspections. The outcomes of the initiative will be reviewed after three years.
The initiative is expected to enable better use of the two authorities' inspection resources, reduce the burden of inspections for medicines manufacturers, and shift the authorities' inspection capacity to other regions.
This is the latest step in increased collaboration between European authorities and the FDA. The authorities, in August 2011, announced the completion of two pilot projects involving the sharing of information on inspections.
COVIDIEN PLANS TO SPIN OFF PHARMA BUSINESS, INCLUDING ITS API BUSINESS
Covidien (Dublin) says it plans to spin off its pharmaceuticals business into a standalone public company. “The spin off includes the company’s active pharmaceutical ingredients (API) business, which had revenue of about $416 million in the fiscal year ended September 30, 2011,” Covidien tells CW. Covidien manufactures and sells a range of product lines in three segments- medical devices, pharmaceuticals and medical supplies. The pharmaceuticals business of Covidien had sales of about $1.97 billion and the company had total sales of about $11.6 billion in the fiscal year ended September 30, 2011.
DSM SINOCHEM PHARMACEUTICALS TO BUILD MULTI-PRODUCT PLANT IN CHINA
DSM Sinochem Pharmaceuticals (DSP; Hong Kong), the former DSM Anti-Infectives, says it will build a multi-product plant at Zibo, China. DSP develops, produces, and sells raw materials, intermediates, and active pharmaceutical ingredients (APIs) for anti-infectives such as antibiotics; anti-fungals; and APIs for other therapeutic classes such as cholesterol-lowering medicines. The new facility will serve as a launch platform for new semi synthetic cephalosporines (SSCs) and facilitate pilot campaigns for new 2nd, 3rd and 4th generation SSCs, the company says. The facility is expected to start operating in early 2013, and will serve the Chinese and overseas markets. “This investment allows DSP to further drive its growth in China and it fits well in the company strategy of strengthening the beta-lactam business and broadening DSP’s portfolio of APIs,” the company says.
LONZA EXPANDS EARLY-PHASE MANUFACTURING CAPACITY IN CHINA
Lonza says it has expanded early-phase manufacturing capacity at the company’s production site at Nansha, China. The extended capabilities and infrastructure brought online this year will help Lonza continue to meet the growing demands of its global small molecule customers, Lonza says.
This investment speeds up the company’s efforts to establish the Lonza Nansha site as a base to “serve our global customer base for all material needs from gram-scale to metric tons,” says Stefan Stoffel, Head of Lonza’s chemical manufacturing business unit. “With this expansion, Lonza’s FDA-approved Nansha site now offers a fully integrated end-to-end development and manufacturing solution for small molecules.”
BAYER: FOUR POTENTIAL BLOCKBUSTERS IN PHARMA PIPELINE
Bayer says it plans to continue to invest in research and development and expects its pharmaceuticals business in particular to generate substantial sales with the new products that are scheduled to be launched in the next 18 months.
“We have achieved major progress with our pharma pipeline in 2011 and are therefore lifting our sales forecasts for several products,” says Marijn Dekkers, CEO of Bayer. “Overall, we believe that four of the drug products currently in advanced development have the potential to become blockbusters, meaning that each of these products can generate peak sales of €1 billion/year and more.”
They include the ophthalmological substance VEGF Trap-Eye and the cancer treatments alpharadin and regorafenib. For the thrombosis drug Xarelto, Bayer continues to expect peak sales of more than €2 billion/year following the granting of regulatory approval by the European Commission in the new indications this week. The combined peak sales potential of these products will therefore amount to a total of €5 billion/year, Bayer says.
Bayer currently has some 40 pharmaceuticals projects in total in clinical development.