July 19, 2016 (Last Updated: 1:56pm PT)
By Alex Keown, BioSpace.com Breaking News Staff
CARLSBAD, Calif. – Ionis Pharmaceuticals , which is developing RNA-targeting therapeutics, struck a licensing deal with Janssen Biotech , Inc. for its oral gastrointestinal treatment, IONIS-JBI1-2.5.
The deal, which covers three programs, is worth $810 million, Ionis said in a statement this morning, with the company already having been awarded $10 million. The remaining potential $800 million will be awarded to Ionis based on development, regulatory and sales milestone payments and license fees for these programs. Additionally, Ionis is expected to receive tiered royalties that on average are double-digits on sales from any product that is successfully commercialized. Under terms of the deal, Janssen will assume all global development, regulatory and commercialization responsibilities for IONIS-JBI1-2.5 upon completion of investigational new drug enabling studies.
Ionis’ GI treatment, IONIS-JBI1-2.5, is antisense drug designed to locally inhibit an undisclosed target in the gastrointestinal (GI) tract. The deal with Janssen marks the first time an antisense drug has entered development under the collaborative agreement between the two companies, B. Lynne Parshall, Ionis’ chief operating officer, said in a statement. The collaboration between the two companies is focused on the development and discovery of orally administered, locally acting RNA-targeted therapeutics for autoimmune diseases in the gastrointestinal tract.
“We are very pleased to have rapidly advanced this first drug candidate into development within a year and a half of initiating our collaboration with Janssen,” Parshall said in a statement.
Ionis, formerly known as Isis, has several RNA-targeting drugs in late-stage development, including volanesorsen for patients with either familial chylomicronemia syndrome or familial partial lipodystrophy. Ionis also has a collaborative deal with Biogen for the development of nusinersen for the treatment of infants and children with spinal muscular atrophy.
Earlier this year the company had a setback after its partner GlaxoSmithKline opted to not initiate a Phase III study of its CARDIO-TTR drug program for the treatment of patients with TTR amyloidosis. GSK’s move caused Ionis stock to plummet more than 35 percent. GSK’s move followed an April decision by the U.S. Food and Drug Administration to place an Ionis study of CARDIO-TTR on clinical hold as a result of safety findings. A separate Neuro-TTR study is currently underway and Ionis expects to be completed within the first half of 2017. Earlier this month the company announced positive results from two ongoing trials with IONIS-TTR.
Despite the positive results of those trials and the collaborative deal with Janssen, Ionis’ stock has yet to recover from the setback with GlaxoSmithKline. Ionis’ stock is currently trading at $26.68.
