Mallincrodkt, a specialty pharmaceutical company, has agreed to acquire Sucampo Pharmaceuticals, a Bethesda, Maryland-headquartered biopharmaceutical company, for $1.2 billion, which includes Sucampo’s commercial and development assets.

Sucampo’s product in the branded constipation market, Amitiza (lubiprostone), reported global sales of $456 million in 2016. The drug is approved by the US Food and Drug Administration (FDA) for treating chronic idiopathic constipation in adults, irritable bowel syndrome with constipation in women 18 years of age and older, and opioid-induced constipation in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation. The FDA is currently reviewing a supplemental new drug application (sNDA) for Amitiza in children 6 to 17 years of age with pediatric functional constipation. The sNDA received a priority review designation and has a user fee goal date of January 28, 2018.

Sucampo’s drug Rescula (unoprostone isopropyl ophthalmic solution) 0.15%, is indicated for ocular hypertension and open-angle glaucoma, and marketed in Japan. Mallinckrodt will acquire global rights to the product, with annual net sales of approximately $9 million.

Sucampo has a late-stage pipeline of product candidates for orphan disease areas, including VTS-270, a mixture of 2-hydroxypropyl-B-cyclodextrins with a specific compositional fingerprint that has been granted orphan designation in the US and Europe and is in a Phase II/III clinical trial for treating Niemann-Pick disease Type C, a rare progressive genetic disorder. VTS-270 has also been granted breakthrough therapy designation in the US. Sucampo has an exclusive option for the North American rights to CPP-1X/sulindac, which is in Phase III development for treating familial adenomatous polyposis, an inherited disorder characterized by cancer of the large intestine (colon) and rectum and has been granted orphan drug designation in the US.

Sun Acquisition Co., a subsidiary of Mallinckrodt, will commence a cash tender offer to purchase all of the outstanding shares of Sucampo Pharmaceuticals’ common stock for $18.00 per share. The total transaction value (including anticipated payments in respect of Sucampo’s debt) is approximately $1.2 billion. The acquisition is expected to be funded through borrowings under Mallinckrodt’s existing revolving credit facility, a new secured term loan facility, and/or cash on hand. Following the transaction, Mallinckrodt says it intends to use its cash generation to focus on reducing outstanding debt over time.

The transaction, which has been approved by the boards of directors of both companies, is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and the tender of a majority of the outstanding Sucampo shares.

Source: Mallinckrodt