The facility, which was bought from US contract manufacturing organisation (CMO) Atlantic Pharma Services in 2002, produces four of Shire’s top sellers: Adderall XR and Vyvanse; the epilepsy treatment Carbatrol; and the ulcerative colitis drug Pentasa.
Shire will phase out operations over the next three years and outsource all production to DSM’s contract manufacturing unit in North Carolina, which has already been making the drugs on a contractual basis for several years.
Of the four products made at Owings Mills, the attention-deficit hyperactivity disorder treatment Adderall has been Shire’s biggest earner, generating revenue of $1.1bn (€833m) last year alone.
However, the drug has now lost patent protection and is likely to face considerable generic competition, which must surely have been a significant factor in the company’s decision.
Company spokesman Matt Cabery told in-PharmaTechnologist that the Owings Mills plant and the in-house manufacture of small molecule drugs “no-longer fit with Shire’s strategic plan.”
He said that the closure had not been influenced by the current global downturn and added that Shire plans to continue to “grow as a specialty pharmaceutical firm, expanding both its therapeutic range and geographic reach.”
Since 2003, the firm has more than doubled its workforce to 3,600 employees and tripled the number of international markets in which it operates through acquisitions and promotion partnerships.
The most recent of these co-promotion deals, signed last week with UK drug major GlaxoSmithKline (GSK), is focused on promoting Shire’s Adderall XR replacement Vyvanse in the US.
Enzyme therapy manufacture
While small molecule manufacture may no-longer be an interest for Shire, Carbery was keen to reiterate the firm’s ambitions for its Human Genetic Therapies (HGT) unit in the field of therapeutic enzymes.
HGT’s manufacturing facility in Massachusetts, where the firm makes its drugs Elaprase (idursulfase) and Replagal (agalsidase alfa), is currently undergoing considerable capacity expansion.
Carbery explained that because the production of this type of drug is so highly skilled and specialised, Shire is keen to retain and expand its in-house manufacturing expertise