Roche. Roche Pharmaceuticals is investing roughly CHF 2 billion ($1.6 billion) in manufacturing infrastructure projects, which includes
CHF 800 million ($659 million) in major biotechnology facilities to produce the APIs in "Avastin" (bevacizumab) and "Herceptin"
(trastuzumab) in Basel, Switzerland, and Penzberg, Germany, which are scheduled to be operational by 2009. Roche also is investing
in new formulation, filling, packaging, and logistics facilities for injectable and infusable medicines in Kaiseraugst, Switzerland,
and Mannheim, Germany, and in a facility in Toluca, Mexico, for the formulation of highly potent drugs such as "Xeloda" (capecitabine).
Roche Carolina Inc., a pharmaceutical process development and bulk API manufacturing affiliate of Roche Holding Ltd., plans
to expand its pharmaceutical manufacturing facility in Florence, South Carolina, by investing $60 million in a new multipurpose
production unit within an existing manufacturing building. Construction is scheduled to begin in mid-2007 to be completed
by the end of 2008.
Roche also announced earlier this year that it has sufficient production capacity for its antiviral drug "Tamiflu" (oseltamivir)
for treating the H5N1 avian-influenza virus. Its manufacturing network for the drug includes eight Roche sites and 19 external
manufacturing partners located in nine countries, giving it annual production capacity of more than 400 million courses. Roche
has government orders for 215 million treatments and is tailoring its production schedule while maintaining stocks of intermediates
and APIs. It said gearing production up to full capacity will be triggered by one of two events: Roche inventories of oseltamivir,
the API in Tamiflu, dropping below target levels or the World Health Organization declaring the pandemic has evolved to phase
4 (human-to-human transmission).
Eli Lilly. Eli Lilly is investing in its biologics-manufacturing facility to support its emerging biotechnology pipeline that is anticipated
to produce one new product per year, on average, beginning in 2010. Biotechnology-based programs and drug candidates now make
up more than 30% of the company's drug portfolio and pipeline.
Specific biotechnology investments include an expansion of its site in Kinsale, Ireland, to manufacture APIs for future biotechnology
products. Lilly is also expanding its Indianapolis, Indiana, parenteral operations so that the site can convert the biotechnology
APIs made in Kinsale into their final-dosage forms. Both expansions are part of a $1.5-billion investment in the company's
biotechnology capabilities announced during the past five years.
In October 2006, Eli Lilly completed the first phase of a $560-million expansion to its biotechnology complex in Indianapolis,
which included the opening of a bioproducts pilot-manufacturing plant that makes small-scale amounts of drugs for use in clinical
trials and a research-support facility. Construction of a third facility, a bioproducts R&D laboratory, was completed earlier
this year. These investments follow the recently completed $1-billion expansion of its Puerto Rico manufacturing operations
in August 2006, which includes new bulk capacity for "Humalog" (insulin lispro [rDNA origin] injection).
Eli Lilly is also adding a new assembly line at the company's device-assembly operation in Indianapolis. One of the first
products made on the assembly line will be its new prefilled insulin pen, "HumalogMirioPen." The product is currently under
FDA review and is expected to be launched later this year.
Also, in response to excess capacity in Lilly's small-molecule API operations, a voluntary exit program was offered to 250
employees at Lilly's Tippecanoe manufacturing site in Lafayette, Indiana. About 1000 employees work at the site, and 200 accepted
Eli Lilly is also closing its manufacturing plant in Basingstoke, United Kingdom, effective April 2008. The site now produces
56 million packs of finished product per year with an annual volume of 1.5 billion does. The site manufactures the finished
product for "Cialis" (tadalafil), "Evista" (raloxifene), "Strattera" (atomoxetine), and "Zyprexa" (olanzapine).