
Mallinckrodt updates spin-off plans; FDA expands Vraylar approval for Allergan; Juvenescence spawns Souvien Therapeutics
→ UK-based biopharmaceutical company Mallinckrodt $MNK — the maker of the controversial drug Acthar — has updated its plans for its new spin-off company, first announced last year. The new plan is to divide the company into two independent publicly traded companies: one encapsulating the specialty generics/active pharmaceutical ingredients side of the business, while the other will encompass the specialty branded pharmaceuticals business.
The specialty generics/API business will retain the Mallinckrodt name, be listed on the NYSE and assume the MNK ticker symbol, while the specialty brands company will continue to be listed on the NYSE, be renamed Sonorant Therapeutics, and adopt SRTX as its symbol.
The completed spin-off is projected to occur in the second half of 2019, and the company expects up to $300 million in fresh debt to be raised.
→ The FDA has expanded the use of Allergan’s $AGN Vraylar to treat depressive episodes of bipolar I disorder. Until now, Vraylar is an approved treatment in the US for schizophrenia in adults and for manic or mixed episodes associated with bipolar I disorder. The drug generated more than a 70% year-over-year sales jump in the first quarter. It is estimated that nearly 11 million adults in the US live with bipolar disorder.

→ Juvenescence’s new venture Souvien Therapeutics is creating innovative medicines to address neurodegenerative diseases. Souvien was founded “on the pioneering research of professor Li-Huei Tsai, director of The Picower Institute for Learning and Memory at MIT, and associate professor Stephen Haggarty, the director of the chemical neurobiology laboratory at Harvard Medical School/Massachusetts General Hospital, on the epigenetic underpinnings of neurodegeneration.”

“We have collected a substantial body of data implicating a critical epigenetic regulator of cellular aging in neurodegeneration” said Tsai in a statement.

CEO of Juvenescence, Greg Bailey, commented: “Dementia and neurodegenerative conditions are a tremendous burden on our healthcare system and economy, and we are excited by the potential for Souvien to have an impact on this unmet clinical need.”
→ CRISPR/Cas9 technology user Intellia Therapeutics $NTLA welcomed Laura Sepp-Lorenzino as its new executive vice president and CSO. Sepp-Lorenzino joins the company after a stint at Vertex Pharmaceuticals $VRTX as vice president, head of nucleic acid therapies, research leadership and a member of the external innovation team. Prior to Vertex, Sepp-Lorenzino developed and implemented the hepatic infectious disease strategy at Alnylam Pharmaceuticals $ALNY. Before that, she spent 14 years at Merck $MRK advancing RNAi as a novel therapeutic modality.
→ It’s time for Amarantus Bioscience {$AMBS } to go the strategic alternatives route. The penny stock biotech has brought in Evolution Venture Partners to check out potential business opportunities and strategic alternatives in the hemp sector. “The engagement is for a period of six months, during which time the company will continue to execute on its biopharmaceutical holding company financing and spinoff model,” the company said.