Mallinckrodt, a global specialty biopharmaceutical company based in Dublin, through a subsidiary, will acquire Hampton, N.J.-based Ikaria, a privately held critical care company, from a Madison Dearborn-led investor group, in a transaction valued at approximately $2.3 billion.

Subject to customary closing conditions, the parties expect the transaction to be completed early in the second calendar quarter of 2015, Mallinckrodt's third fiscal quarter. Assuming this timing, the transaction is expected to add at least $150 million in net sales and be accretive to Mallinckrodt's fiscal year 2015 adjusted diluted earnings per share by at least $0.25 per share.

Ikaria is a global critical care company focused on development and commercialization of innovative therapies and delivery systems to address the needs of critically ill infants in hospital neonatal intensive care unit (NICU) settings. Approved by the FDA, Ikaria's lead product INOmax (Inhaled Nitric Oxide) is a vasodilator which, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in which it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

INOmax is distributed in combination with Ikaria's INOmax DS_IR delivery systems and INOmax Total Care. Independently cleared by the FDA, each INOmax delivery system model has been validated to work in tandem with 79 ventilatory devices commonly used in the ICU. INOMAX Total Care provides clinicians with the "24/7/365" operational support, rapid response logistic capabilities, regular preventative service and maintenance, and access to medical affairs, clinical specialists and technical experts required to meet the needs of critically ill patients. Focused on critical care in areas of high unmet medical need, Ikaria is exploring additional potential applications for INOmax and INOmax delivery systems, and also is advancing other pipeline assets in rare disease.  

Mallinckrodt is expected to significantly strengthen its footprint in hospitals, extending its presence from its current base of diagnostic radiology and multimodal pain management in surgical specialties to include critical care respiratory therapies in neonatal intensive care units.

The Ikaria transaction also builds potential diversity in Mallinckrodt's nephrology rare disease pipeline with terlipressin (for injection), a portfolio asset being investigated for the treatment of Hepato-Renal Syndrome Type 1 (HRS 1)—a rare life-threatening condition with no currently approved therapy in the U.S. Terlipressin is approved for use and recognized as the standard-of-care treatment for HRS 1 in countries outside the U.S., including several in Europe.

Assuming a close early in Mallinckrodt's fiscal third quarter, the transaction is expected to add at least $150 million in net sales and be accretive to Mallinckrodt's fiscal year 2015 adjusted diluted earnings by at least $0.25 per share. Mallinckrodt plans to provide updated financial guidance on its second fiscal quarter earnings call. With strong free cash flow generated by its growing portfolio, Mallinckrodt estimates its net debt-to-EBITDA leverage ratio to be approximately 3.6 at the close of this transaction. 

Mark Trudeau, president and CEO of Mallinckrodt said, "We continue to move decisively in line with our strategic roadmap—building on key growth platforms and using our unique ability to manage complexity to unlock untapped additional value from diverse products and environments. With this expansion into respiratory neonatal critical care, we expect to further broaden our touch points in the hospital market, and at the same time diversify our portfolio with durable assets that play vital roles in the treatment of vulnerable patient populations."