Mallinckrodt plc, a specialty pharmaceutical company, and www.sucampo.com, a biopharmaceutical company, have entered into an agreement under which Mallinckrodt will acquire Sucampo, including its commercial and development assets. The transaction was approved by the boards of both companies.

Sucampo Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of highly specialized medicines. Mallinckrodt develops, manufactures, markets, and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products.

“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,” said Mark Trudeau, chief executive officer and president of Mallinckrodt. “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.”

Amitiza (lubiprostone), a product in the branded constipation market, is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic idiopathic constipation (CIC) in adults, irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older, and opioid-induced constipation (OIC) 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 (PFC). The sNDA received a Priority Review designation and has a user fee¹ goal date of January 28, 2018.

The transaction 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.

If the acquisition is approved, Mallinckrodt 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.

At launch, patient access to the treatment options would also be supported by Mallinckrodt’s relationships with insurance companies and group purchasing organizations, according to the company. Mallinckrodt’s existing infrastructure of clinical and medical affairs personnel also would support approval and launch of both products.
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¹ Prescription Drug User Fee Act

(Source: Mallinckrodt plc)