Novartis is making a big bet on two of Ionis’ cardio drugs.
The pharma giant $NVS is handing over $225 million in near-term payments, split between fees, an upfront and an equity stake, and promising $1.13 billion more in development and commercialization milestones for a worldwide option and collaboration pact on AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx — handled by Ionis’ subsidiary Akcea.
That’s $75 million upfront, $100 million in equity now at $61.30 a share and $50 million more for stock in 18 months. And another $300 million is up for grabs if Novartis agrees to take the license options.
Shares of Ionis jumped 7%.
For Novartis, the deal marks another opportunity to build up its all-important cardio portfolio as the early sales for Entresto continue to disappoint analysts. For Ionis $IONS, it’s a big win coming fast on the heels of an approval for Spinraza, a new drug they advanced and which Biogen is spearheading for spinal muscular atrophy at a controversial price of $750,000 for the first year.
Ionis has been on a roller coaster ride for the past year, afflicted by worries over adverse events but also backed by investors who believe that its RNAi platform can deliver significant new therapies for tough diseases. Cardio indications, though, are among the toughest conditions to get a new approval on, as regulators remain wary about any potential threat to large groups of patients.
AKCEA-APO(a)-LRx targets lipoprotein(a) or Lp(a), which has been linked to cardiovascular disease. An absence of the protein ApoC-III, meanwhile, has been tied to lower triglycerides and lower cardio risks. Both of these targets face an uphill climb in Phase III, where regulatory agencies will demand huge patient groups to prove efficacy as well as safety.
In the next step, Akcea will run two Phase II studies to set up a pivotal trial for each. If Novartis takes the option after the Phase II, they will pay $150 million as a licensing fee on each. And the pharma giant will be responsible for the Phase III studies.
Up to $315 million and $265 million in development and regulatory milestone payments are set aside for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx as well as up to $285 million and $265 million in commercialization milestone payments, for each drug.
In addition, Akcea will have co-commercialization rights for any drug that hits the market.
Said Akcea CEO Paula Soteropoulos:
This strategic partnership allows us to move more rapidly to Phase 3 cardiovascular outcomes studies with both therapies than our original development plan. Our ability to benefit from Novartis’ global commercialization resources and complement them with Akcea’s specialized sales force focused on lipid specialists should allow us to maximize the commercial potential of each drug.
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