J&J’s attempts to buy Actelion Ltd have succeeded, with the Big Pharma firm announcing today it has entered into a definitive transaction agreement to buy the Swiss biotech for $280 (€261) per share, or a total of $30bn.
J&J says it intends to spin-out Actelion’s R&D unit into a standalone public company, but while the addition of Actelion’s five marketed pulmonary arterial hypertension (PAH) and two specialty products – sales of which clocked in over $2bn in 2015 – expands subsidiary Janssen Pharmaceuticals’ portfolio, the firm has not yet divulged its integration plans.
Manufacturing networks
However, J&J will not have to deal with the deluge of manufacturing sites as often comes with deals this size (Pfizer and Hospira, Actavis and Forest, Merck & Co. and Schering-Plough, etc) as Actelion is a "virtual" biotech.
“Rather than manufacturing its own commercial drugs, Actelion outsources the process to contract manufacturers,” the firm says in its most recent sustainability report.
According to US FDA label information, one of the CMOs Actelion uses is Patheon, which makes the oral endothelin receptor antagonis Tracleer (bosentan) from its facility in Ontario, Canada, and Veletri (epoprostenol for injection) from its site in Monza, Italy.
J&J’s global network consists of 121 manufacturing facilities occupying approximately 21.3 million square feet of floor space, according to the firm’s 2015 annual report, though this includes sites operated by its consumer health and medical device businesses.
Pharma manufacturing sites total 26, including eight located in the US and eight Janssen production sites in Europe.
Taking in-house?
But whether J&J will retain Actelion’s network of third-parties or transfer some of the manufacturing in-house remains to be seen, and could come down to the complexity of the manufacturing.
Janssen has previously said it preferred to keep production of its more complex products – monoclonal antibodies, for example – in-house and would happily invest in such capabilities in order to control its supply chain.
But complex or not, it can easily be argued that continuing a certified supply chain would be much easier than cancelling contracts and transferring technologies and processes, as long as the contractors comply with J&J’s quality compliance standards.
In 2014, we spoke to the firm about its problems with the now defunct CMO Ben Venue Laboratories. Quality issues at the Ohio-based third-party led to an FDA consent decree and a shortage of Janssen’s ovarian cancer drug Doxil.
“There is certainly a perspective that if you go to outsourcing manufacturing, you lose control over it and you’ve got companies that maybe don’t have the same standards as yourself,” the firm’s general manager of supply chain, Ireland, Kyran Johnson told us at the time.
“But I think that’s changing," he continued, adding CMOs need to demonstrate they have the same capability – technically and in compliance with cGMP – as at J&J’s internal sites.
But just last week Janssen-Cilag announced a temporary change to its supply chain citing unspecified “production and supply problem with the Swiss preparation Haldol solution for injection.”
Thus whether Actelion's current network will continue as is under J&J's scrutiny remains to be seen.