For the purposes of the guidance, "spore-forming microorganism" or "spore-former" includes both the spore and vegetative forms
of the organism. The guidance applies to the manufacturing of biological intermediates and biological drug substances.
-Patricia Van Arnum
Amgen to Cut Staff, Close Facilities
Amgen (Thousand Oaks, CA) announced on Aug. 15 that it would cut 2200–2600 jobs as part of a plan to increase operational
efficiencies. The job cuts are the first ever for the company and will result in a 12–14% staff reduction. Amgen's plan also
includes closing certain production operations and reducing planned capital expenditures by approximately $1.9 billion during
"Recent changes in coverage rules and adjustments to Amgen's FDA-approved labels for 'Epogen' and 'Aranesp' have and will
adversely affect Amgen's revenue," explained Chairman and Chief Executive Officer Kevin Sharer in a release.
The company also changed its adjusted earnings per share guidance for 2007 from $4.28 to $4.13–4.23, excluding restructuring
charges. The change results from low sales of Amgen's "Aranesp" drug.
Amgen expects its initiatives to be completed by 2008 and to generate $1.0–1.3 billion in pretax savings. The cumulative pretax
restructuring charges associated with these changes are expected to be $600–700 million in 2007 and 2008, including $289 million
for asset impairment and related costs reported in the second quarter of 2008.
The company said it would implement the initiatives in a way that maintains its responsiveness to customers and patients.
Amgen also stated it would treat its staff fairly and minimize the workforce reduction's impact on its employees by using
attrition, hiring freezes, and a voluntary transition program. Affected staff will receive career counseling assistance in
securing new employment. -Erik Greb
Protein-Coated Nanowires Developed for Drug Delivery
A team of researchers from the University of Idaho and Seoul National University have designed a potential drug delivery system
by coating silica nanowires with the protein fibronectin. Their study, released Sept. 4 in Moscow, Idaho, found that the protein
coating enabled the nanowires to enter cultured human cells and deliver a lethal dose of toxin (called StxA1).
The nanowires reportedly could be coated with antibodies or other materials to deliver low doses of drug to targeted cells
without compromising healthy cells.
At press time, the study was scheduled for publication in the Sept. 12 issue of Nano Letters by the American Chemical Society. -Maribel Rios