Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term, despite the transfer of equipment across its sterile injectables network.
Hikma announced it was acquiring Bedford Laboratories in May for a potential $300m (€220m), and the firm was granted the first option to buy the accompanying sterile injectables manufacturing business, Ben Venue Laboratories.
Described at the time by Hikma CEO Said Darwazah as “one of the largest sterile injectable manufacturing sites in the world,” owners Boehringer Ingelheim closed down the site last year after years of cGMP problems and regulatory enforcement left the facility unsustainable.
Quality concerns and product recalls drove a temporary halt in operations in November 2011 which led to shortages for a number of drugs. In January 2013 the site was hit with a US Food and Drug Administration (FDA) consent decree, and in October the company said it was closing the plant permanently due to spiralling remediation costs.
Sterile injectables business growth
Ben Venue consists of four manufacturing plants and a Quality and Development Centre – including an R&D pilot plant – and Hikma said last week it “will transfer certain modern, advanced equipment, including lyophilisers and filling lines, to its other global manufacturing facilities in the US and Europe.”
Hikma has remained a key player in the sterile injectables industry despite offers last year from Novartis and Amgen worth up to $2bn. “Retaining and continuing to invest in this business is the best option for shareholder,” Darwazah said at the time, and the firm said last week the Ben Venue acquisition will “significantly” increase its current injectable manufacturing capacity and capabilities.
Hikma has not announced its plans for the actual site, which first opened in 1941, and did not respond to questions by phone and email. However, the company said in a statement that over time it “will evaluate the potential to partially reactivate the site to support the delivery of its medium and long term growth plans.”
Janssen ensures Doxil supply
Though Ben Venue halted operations in December, Johnson & Johnson’s Janssen – which suffered shortages of its cancer drug Doxil (doxorubicin HCl liposome injection) due to Ben Venue being its sole manufacturer - stepped in and assumed manufacturing responsibility for Doxil at the facility in order to ensure supply.
“Our lease agreement concluded at the end of June 2014, and we did not extend it,” Janssen spokesperson Linda Davis told this publication. “Currently, for the US. market, we have sufficient supplies of Doxil to last more than nine months, based on current demand and worldwide product utilization.”
Furthermore, “additional inventory of Doxil that has been produced through an alternative manufacturing approach at the leased facility will be available on a lot-by-lot basis via FDA regulatory discretion for release in the US. In addition, plans are progressing well to establish two manufacturing sites for global supply.”