Specialty pharmaceuticals manufacturer Mallinckrodt has agreed to buy biopharmaceuticals producer Sucampo, including its commercial and development assets.  The transaction is subject to customary closing conditions, including expiration of the waiting period under the US Hart-Scott-Rodino Antitrust Improvements Act and the tender of a majority of the outstanding Sucampo shares.

US-founded Mallinckrodt, currently headquartered in Ireland, said its acquisition of Sucampo, which has its headquarters in the US state of Maryland, is the latest milestone toward its vision of becoming an innovation-driven specialty pharmaceutical growth company focused on improving outcomes for patients with severe and critical conditions.

Along with bolstering the drugmaker’s pipeline in rare diseases with VTS-270 and CPP-1X/sulindac, CEO Mark Trudeau said Sucampo will bring Mallinckrodt near-term net sales and earnings accretion through Amitiza (lubiprostone), a branded constipation drug approved for treatment of various types of the ailment, including opioid-induced constipation (OIC).

The US Food and Drug Administration (FDA) is currently reviewing a supplemental New Drug Application (sNDA) for Amitiza in children 6 to 17 years of age with pediatric functional constipation (PFC). The sNDA received a Priority Review designation and has a user fee goal date of January 28, 2018.

Mallinckrodt’s areas of focus include autoimmune and rare diseases in specialty areas such as neurology, rheumatology, nephrology, pulmonology and ophthalmology as well as immunotherapy and neonatal respiratory critical care therapies, in addition to analgesics and hemostasis products.

If the acquisition is approved, Mallinckrodt said it expects to build on the limited commercial infrastructure Sucampo has built for both VTS-270 and CPP-1X/sulindac with its sales organizations currently focused on rare diseases. Mallinckrodt added that its existing infrastructure of clinical and medical affairs personnel also would support approval and launch of both products.