STAINES-UPON-THAMES, U.K. & ROCKVILLE, Md.—Mallinckrodt plc, a global specialty pharmaceutical company, and Sucampo Pharmaceuticals Inc., a global biopharmaceutical company, announced in December that they 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 directors of both companies and would total approximately $1.2 billion.
“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, CEO 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. We look forward to adding the Sucampo portfolio and welcoming members of its team to Mallinckrodt.”
“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,” added Peter Greenleaf, chairman and CEO of Sucampo.
Amitiza (lubiprostone), a leading global product in the branded constipation market, is approved by the U.S. Food and Drug Administration (FDA) for 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. The FDA is currently reviewing a supplemental New Drug Application for Amitiza in children 6 to 17 years of age with pediatric functional constipation.
Also in the mix would be Rescula (unoprostone isopropyl ophthalmic solution) 0.15 percent, which 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.
As far as development assets, VTS-270 is in Phase 3 development for Niemann-Pick Type C (NPC). NPC is a rare, neurodegenerative and ultimately fatal disease that can present at any age. NPC is caused by mutations in either the NPC1 or NPC2 genes, resulting in the disruption of the trafficking of intracellular cholesterol, leading to intracellular lipid accumulation in various tissues, including the brain, liver and spleen. The FDA granted VTS-270 its Orphan Drug Designation, and the resulting seven years’ exclusivity would be applied upon approval of the drug. The European Medicines Agency (EMA) also granted VTS-270 Orphan Drug status.
In addition, CPP-1X/sulindac is in Phase 3 development for familial adenomatous polyposis (FAP) under a collaborative agreement between Cancer Prevention Pharmaceuticals and Sucampo. FAP results from a genetic mutation leading to uncontrolled growth of hundreds to thousands of polyps in the lower digestive tract. Left untreated, there is almost a 100-percent lifetime risk of developing colorectal cancer. The FDA granted CPP-1X/sulindac its Orphan Drug Designation, as well as its Fast Track designation, a process designed to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Orphan Drug status was also granted to the therapy by the EMA.
“Both NPC and FAP are devastating conditions associated with substantial morbidity and mortality, and effective therapies are needed,” said Dr. Steven Romano, chief scientific officer and executive vice president of Mallinckrodt. “In addition to the current patient benefits provided by Amitiza, we look forward to bringing VTS-270 and CPP-1X/sulindac to patients with critical unmet medical needs.”
As Zacks Investment Research noted of the deal, “Mallinckrodt, like Valeant Pharmaceuticals International Inc., has always been on the lookout for acquisitions to expand/diversify its portfolio. However, the company has been under tremendous pressure in 2017 ... The company’s largest product, Acthar’s, sales declined in the third quarter as the payer environment has become increasingly complex for specialty drugs ... Though the addition of Amitiza will add to Mallinckrodt’s sales, it might not be enough to counter the decline in Acthar sales.”
