Race Heats Up As Mallinckrodt Gets Bids

August 9, 2017
By Alex Keown, BioSpace.com Breaking News Staff

STAINES-UPON-THAMES, England– At least two companies are beginning to nibble on the bait of Mallinckrodt PLC ’s generics business a few months after the company announced it was exploring the possible divestment.

A CNBC-TV report posted on moneycontrol.com indicates that two India-based businesses, Aurobindo Pharma and Intas are interested in acquiring the generics business. The U.K.-based company could garner up to $2 billion for the generics operations. If one of these two companies bites, CNBC said it will mark the biggest ever overseas acquisition for any Indian drug maker.

Mallinckrodt announced in May that it was exploring the sale as a way to pivot toward its higher-margin branded drugs. The company has a long history with generics drugs, but branded pharmaceuticals comprises the bulk of its revenues, Reuters noted. But the company’s generics business has been “a drag” on Mallinckrodt, particularly because some of its products “include opiate-based pain killers, which have fallen out of favor with doctors due to their addictive potential,” Reuters said in May.

Mallinckrodt’s generics business saw revenue losses of about 18 percent, with sales declining approximately $1 billion. Mallinckrodt’s branded drugs climbed more than 40 percent to $2.3 billion.

While rumors swirl that the two Indian companies are in competition for Mallinckrodt’s generics business, the U.K. company has not provided any confirmation, according to the reports. Neither Aurobindo nor Intas provided any additional confirmation.

Aurobindo is India’s fourth-largest drugmaker by sales. CNBC noted that Mallinckrodt’s generics business will fit in well with Aurobindo’s existing offerings.

While Mallinckrodt is exploring the divestment of its generics business, the company has been filling out its pipeline. Most recently, the company announced it was acquiring privately-held InfaCare, a Pennsylvania-based company focused on therapies for neonatal and pediatric patient. The deal worth up to $425 million will provide Mallinckrodt with InfaCare’s stannsoporfin, a heme oxygenase inhibitor, used to treat elevated bilirubin levels that can cause severe jaundice in infants.

In addition to the acquisition, Mallinckrodt has also picked up some momentum from regulatory agencies. In July, the U.S. Food and Drug Administration designated Mallinckrodt’s Stratagraft skin-tissue replacement with the new designation of Regenerative Medicine Advanced Therapy. The company's investigational, tissue-based therapy is currently under evaluation in a Phase III trial to assess its efficacy and safety in the promotion of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements (also known as deep partial thickness burns).

Also in July, the FDA granted Mallinckrodt’s experimental Duchenne muscular dystrophy drug, MNK-1411, with the Orphan Drug Designation. MNK-1411 (cosyntropin injection) is a depot formulation of tetracosactide, a synthetic 24 amino acid melanocortin receptor agonist. It is expected to begin Phase II trials later this year.