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Pharma/Fine Chemicals Roundup – June 28
8:31 AM MDT | June 28, 2011 | By DEEPTI RAMESH
FDA UNVEILS GLOBAL STRATEGY TO ENSURE SAFETY OF IMPORTED PRODUCTS
The U.S. Food and Drug Administration (FDA) says it has unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply. The four key elements of the strategy are - the FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; the coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; the FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology; and the FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
“Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” says Margaret A. Hamburg, Commissioner of Food and Drugs. “There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”
FDA regulated imports have quadrupled since 2000, and today a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world, the agency says. Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.
REPORT: INDUSTRIAL BIOTECHNOLOGY MARKET HAS HIGH GROWTH POTENTIAL
The white biotechnology or the industrial biotechnology market has high growth potential and is expected to see strong growth in the next decade, says a report by market research firm Companies and Markets (London). Key end use industries include pharmaceuticals, biofuels, food and feed, personal care and bioplastics, and each industry segment is currently at different levels of development. The pharmaceutical ingredients sector has historically been dependant on white biotechnology for product development. However, strong growth is expected, particularly with the increase in application of bio catalysis in the active pharmaceutical ingredients segment and the advancements in biopharmacuticals, the report says.
White biotechnology has high penetration levels in a majority of applications in the food and feed ingredients sector, and as a result, the food and feed ingredients market lies at the upper end of the market life-cycle curve, the report says. The biofuels and bioplastics sectors have seen strong growth in the past, and this trend is likely to continue, with the introduction of more government initiatives and increasing consumer awareness. The application of white biotechnology in the personal care sector is in its early growth stage and it is expected to gain momentum over the next decade.
ENZYMICALS AND LONZA SIGN LICENSE AGREEMENT
Enzymicals (Greifswald, Germany), a company that specializes in the enzymatic production of fine and specialty chemicals and the production of biocatalysts, says it is brining newly developed (R)-selective transaminases as a screening kit to the biotechnology market for broad implementation. The basis of this technology is a license agreement for global use of these enzymes on a laboratory scale in patented processes of Lonza. Enzymicals has extended its enzyme portfolio by a class of enzymes which can be used for the synthesis of chiral amines for active pharmaceutical ingredients (APIs), agchems and their chiral intermediates.
The market for chiral active APIs and agchems accessible with this technology is very large at this time, Enzymicals says. Chiral amines are important building blocks for APIs such as anti-influenza agents or cholesterol blockers. Other applications are for the treatment of diabetes, thyroid disfunction, ADHD- or Parkinson disease. In the latter case, most of the APIs are derived from the class of L-dopamine-decarboxylase inhibitors.
Chiral amine APIs have a market volume of millions of U.S. dollars. It is expected that the importance of the (R)-enantiomers will increase as they have been difficult to access until now with existing technologies.
PHARMA R&D SPENDING FALLS FOR THE FIRST TIME
By Alex Scott
Savage spending cuts by big pharma companies has led to the global pharma industry’s first ever annual fall in R&D spending, according to research by Thomson Reuters. The sector’s R&D spending fell by nearly 3% to $68 billion in 2010, when compared with the year earlier. The trend is set to continue again this year, Thomson Reuters says.
The drop in R&D expenditure reflects a fall in innovation for each dollar invested. Research spending by drug companies accounting for 80% of the industry's total R&D has increased by more than 50% since 2000, and yet the number of new medicines has fallen. The industry introduced 21 new original drugs, known as new molecular entities (NME), in 2010, down from 26 in 2009. Only one third of the 21 are owned by major drug makers with annual R&D budgets extending to more than $2 billion/year, Thomson Reuters states.
Pfizer is among the big pharma companies making the most severe cuts. The company plans to cut about one quarter of its R&D spending during the next two years with activities including the closure of the company’s flagship research site at Sandwich, U.K. with the loss of 2,400 jobs.
A similar trend appears to be taking place in the agchems sector. Johannes Lubosch, head of procurement for Bayer CropScience, at the Chemspec 2011 expo in Geneva, Switzerland earlier this month raised concerns that return on investment into innovation across the agchems sector is diminishing.