Amitiza (lubiprostone) has the approvals of the US Food and Drug Administration (FDA) for three constipation indications.
The first two indications for the drug as approved in the US are chronic idiopathic constipation (CIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women aged over 18 years.
The third indication is opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain which includes patients with chronic pain caused by prior cancer or its treatment, who would not need frequent opioid dosage escalation.
Through the acquisition, Mallinckrodt adds a second commercial asset from Sucampo which is Rescula (unoprostone isopropyl ophthalmic solution) 0.15%. Mallinckrodt will acquire global rights of this ophthalmic solution, which is currently marketed in Japan for the treatment of ocular hypertension and open-angle glaucoma in the country.
Sucampo chairman and CEO Peter Greenleaf said: “We believe that this transaction with Mallinckrodt represents significant value for shareholders.
“With the addition of its significant resources and expertise, we believe Mallinckrodt is a natural partner to accelerate the development of our rare disease assets in NPC and FAP, and to continue to provide AMITIZA for patients suffering from constipation-related disorders.”
Sucampo’s assets that are being developed are VTS-270 and CPP-1X/sulindac which are currently going through phase 3 studies. While VTS-270 is intended for the treatment of Niemann-Pick Type C, CPP-1X/sulindac is for the treatment of Familial Adenomatous Polyposis (FAP).
Mallinckrodt CEO and president Mark Trudeau said: “Mallinckrodt’s acquisition of Sucampo is the latest milestone towards our vision of becoming an innovation-driven specialty pharmaceutical growth company focused on improving outcomes for patients with severe and critical conditions.
“The acquisition brings near-term net sales and earnings accretion through AMITIZA and bolsters our pipeline in rare diseases with VTS-270 and CPP-1X/sulindac.”
The transaction, which has been approved by the boards of directors of both firms, is subject to customary closing conditions and approval of Sucampo’s shareholders.
Image: Through the deal, Mallinckrodt will add constipation drug Amitiza to its portfolio. Photo: courtesy of Stuart Miles/FreeDigitalPhotos.net.