$1.2-billion deal gets Mallinckrodt late-stage pipeline of product candidates for orphan diseases.

Maryland-based acquire Sucampo Pharmaceuticals, a company with branded constipation and ophthalmic drugs and a pipeline of candidates targeted rare diseases, agreed to be acquired by specialty pharmaceutical firm Mallincrodkt for $1.2 billion.

The transaction has been approved by the boards of directors of both companies. Mallinckrodt subsidiary Sun Acquisition Co. will make a cash tender offer to purchase all of the outstanding shares of Sucampo Pharmaceuticals' common stock for $18.00 per share. Mallinckrodt is expected to fund the purchase by borrowing under its existing revolving credit facility, establishing a new secured term loan facility, and/or cash on hand. The deal 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. 

Mallinckrodt was attracted by Sucampo’s late-stage pipeline of candidates for the treatment of orphan diseases. One leading candidate is VTS-270 for the treatment of Niemann-Pick disease Type C, a rare progressive genetic disorder. The drug is 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. It has also been granted a breakthrough therapy designation in the US.

Separately, Sucampo has an exclusive option for the North American rights to CPP-1X/sulindac, a drug for the treatment of adenomatous polyposis, an inherited disorder characterized by cancer of the large intestine (colon) and rectum. This candidate has been granted orphan drug designation in the US. and is in Phase III development. 

Products already commercialized by Sucampo include Amitiza (lubiprostone), which is approved in the US for the treatment of 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, and Rescula (unoprostone isopropyl ophthalmic solution), which is marketed in Japan for the treatment of ocular hypertension and open-angle glaucoma. Sucampo has submitted a supplemental new drug application in the US for Amitiza in children 6 to 17 years of age with pediatric functional constipation. FDA is reviewing this candidate under priority review, with a decision expected by the end of January.