A large proportion of that investment (around $750m) is for Merck’s new production facility in Durham, North Carolina, but the firm is also injecting funds into facilities in West Point, Pennsylvania, and Carlow in Ireland.
For example, Merck has been trying to put right some significant deviations from current good manufacturing practice (cGMP) at its West Point facility, which led to the recall of two products (PedvaxHIB and Comvax) at the end of 2007.
Shortages in these childhood combination vaccines – both of which protect against the meningitis-causing organism Haemophilus influenzae type B - remain to this day, and the firm is also finding it hard to meet demand for hepatitis B vaccine Recombivax HB, hepatitis A vaccine Vaqta and the measles, mumps, rubella and varicella vaccine ProQuad.
The current projection for the return of PedvaxHIB and Comvax to the US marketplace is mid-2009, according to the US Food and Drug Administration’s website.
“One of our top priority is addressing supply issue for our vaccines,” said Clark. “Our vaccine manufacturing is inherently complex; we are prioritising our vaccine production based on the public health needs.”
The $1bn investment will help Merck ensure it has “consistent, robust manufacturing practices and processes that meet existing demands for our vaccines,” said Clark.
The funds are also aimed at expanding Merck’s capacity to meet demand for the next generation of vaccines under development at the company, said Clark.
Clark’s comments were made against a financial backdrop which saw Merck reported $1.64bn in fourth-quarter net profit, reversing a $1.63bn loss a year ago in the wake of its multibillion settlement paid to people who claimed injury from taking its now-withdrawn arthritis drug Vioxx (rofecoxib).
Sales were down 3 per cent to $6bn, with sales of the cervical cancer vaccine Gardasil falling 16 per cent to $286m. Merck said it hopes to restore the fortunes of its biggest-selling vaccine product by pursuing new indications, including its use in older females, as well as in males to prevent genital warts and other lesions caused by human papillomavirus (HPV).