Chapter 17 485
42. a. Each student will have a different answer. No solution is provided. Selected ex-
cerpts from the 2008 Genentech 10-K:
p. 16: Additionally, we may be unable to maintain regulatory approval for Raptiva, or
we may be subject to other regulatory requirements or actions that significantly restrict
the use of Raptiva, due to cases of PML in Raptiva patients. On February 19, 2009, the
pp. 36-37: On October 2, 2008, we announced that we issued a Dear Healthcare Pro-
vider letter to inform physicians of a case of progressive multifocal leukoencephalopa-
thy (PML) in a 70-year-old patient who had received Raptiva for more than four years
for treatment of chronic plaque psoriasis. The patient subsequently died. On October 16,
2008, revised prescribing information for Raptiva was approved by the FDA. A boxed
inform physicians of a second case of PML that resulted in the death of a 73-year old pa-
tient who had received Raptiva for approximately four years for treatment of chronic
plaque psoriasis. On February 10, 2009, a Dear Healthcare Provider letter was sent to
physicians to inform them of a third case of PML in a 47-year-old patient who had re-
ceived Raptiva for more than three years for the treatment of chronic plaque psoriasis.
FDA issued a public health advisory regarding Raptiva, which provided warnings
about PML and the use of Raptiva, and advised physicians to periodically re-evaluate
patients treated with Raptiva and to consider other approved therapies to control pa-
tients’ psoriasis. Based on the medical information available for the PML cases, we be-
withdrawal of regulatory approval for Raptiva.
p. 43: As of December 31, 2008, we held approximately $130 million of Raptiva
work-in–process and finished goods inventory. If future FDA actions or other events or