Janssen, Isis Pharma Ink Up-to-$835M Antisense Agreement

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Johnson & Johnson’s Janssen Biotech will use Isis Pharmaceuticals’ RNA-targeted technology platform to discover and develop antisense drugs to treat autoimmune disorders of the gastrointestinal (GI) tract, in a partnership that could generate up to $835 million for Isis.

The collaboration will also bring Isis Pharma access to Janssen’s expertise in autoimmune disorders and therapeutic formulation toward development of antisense drugs to treat autoimmune disorders in the GI tract through oral delivery and other forms of local administration.

Janssen’s expertise includes its already-marketed intravenous drug Remicade (infliximab), a tumor necrosis factor (TNF) inhibitor that is indicated for a variety of disorders—including Crohn’s disease in children and adults, ulcerative colitis in children and adults, rheumatoid and psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

Remicade is a blockbuster for Janssen and parent Johnson & Johnson. During the first nine months of 2014, Remicade racked up $5.196 billion in sales, up 4.7% from Q1-Q3 2013.

“This collaboration broadens the utility of our drug discovery technology to new targets in the GI tract and expands the administration of antisense drugs to local delivery, including oral delivery, to the gut,” B. Lynne Parshall, Isis Pharma’s COO, said in a statement.

The collaboration agreement covers three development programs. Janssen agreed to pay Isis Pharma $35 million upfront, including a payment to initiate human lead optimization on the first collaboration target.

Isis Pharma said it is eligible for another nearly $800 million in development, regulatory, and sales milestone payments, as well as license fees for these programs. Isis will also receive tiered royalties averaging double-digits on sales from any product that is successfully commercialized.

In return, Janssen has the option to license a drug from each of the programs once a development candidate is identified. If Janssen exercises its option, it will assume global development, regulatory, and commercialization responsibilities, Isis Pharma said.

Antisense drugs are small (12-21 nucleotides) DNA- or RNA-like compounds that are chemically modified to engineer favorable drug properties. Isis Pharma’s platform is designed to develop antisense drugs that interact precisely with their targets, namely specific sequences of RNA. According to Isis, many of the antisense drugs in its pipeline bind to messenger RNAs (mRNAs), and inhibit the production of disease-causing proteins.

The collaboration aims to expand Isis Pharma’s pipeline, now consisting of 34 drugs for treating  a variety of diseases within its key therapeutic areas of cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis’ lead product—Kynamro, for treatment of patients with homozygous FH—is being commercialized in the U.S. and other countries through the Sanofi subsidiary Genzyme.

Isis Pharma’s collaboration with Janssen comes less than two months after the company agreed to expand its nearly two-year-old research collaboration with AstraZeneca by launching a strategic alliance to discover and develop new delivery methods for antisense oligonucleotides. The value of that expanded collaboration was not disclosed.








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