Mallinckrodt plans spin-off biz for generics, APIs, and Amitiza

By Flora Southey contact

- Last updated on GMT

(Image: Getty/pichet_w)
(Image: Getty/pichet_w)

Related tags: Generic drugs, Strategic management

Under the Mallinckrodt name, its specialty generics business will be spun-off to shareholders and listed on the New York Stock Exchange.

Mallinckrodt has announced plans to create two independent pharmaceutical companies: one focused on innovative, specialty pharmaceutical brands; the other comprised of generic products, active pharmaceutical ingredients (APIs), and non-promoted pharmaceuticals.

The spun-off, specialty generics company is expected to employ approximately 1,600 staff, maintain the Mallinckrodt name, and be led by the company’s current CFO, Matthew Harbaugh.

Headquartered near St. Louis, Missouri, the firm’s portfolio will include an acetaminophen business, API and generic finished dose drugs, niche generic candidates, and US manufacturing capabilities.

Amitiza (lubiprostone), a chloride channel activator approved by the US Food and Drug Administration to treat certain adult patients with constipation, will also be included in the specialty generics portfolio.

“The inclusion of the Amitiza product in the non-promoted assets to be spun off brings added manufacturing facilities and employees in Japan [where the product is marketed by alliance partners], and diversified revenues further,” ​according to Mallinckrodt.

The specialty pharmaceutical brands company will be led by Mallinckrodt’s current CEO, Mark Trudeau, under a new, yet to be announced business name. Global headquarters will be maintained in the UK, alongside its network of offices and facilities in the US, Australia, Canada, Ireland, Japan, Luxembourg and Switzerland.

The spin-off will help enable the ‘remaining’ firm “become an innovation-driven, pure-play, specialty pharmaceutical brands growth company,” ​said Trudeau on a conference call.

“We believe this separation will further enhance our strategic focus and strengthen our balance sheet. It should also provide us with additional liquidity to support investments in our in-line brands and development portfolio and strategically allocate capital,” ​he added.

If approved by the board, the spin-off is expected to be completed in the second half of next year.

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