- Novartis has inked a worldwide collaboration option deal with Ionis Pharmaceuticals and its subsidiary Akcea Therapeutics for two cardiovascular drugs.
- Akcea's AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx are antisense therapeutics with potential to reduce cardiovascular risk in patients with elevated levels of lipoprotein Lp(a), a protein that clogs arteries, or apolipoprotein C3, which research suggests correlates with coronary heart disease. The drugs are in Phase 2 and Phase 1, respectively.
- The Swiss biopharma pledged a near-term payment of $225 million, including $75 million up front and $150 million in equity investments, for the option. The deal also includes license fees, milestone payments, and royalty payment percentages in the mid-teens to low twenties that could push its total price tag past $1.6 billion.
Ionis has maintained a strong track record with drug partnerships over the last month. The company trumpeted in December the news that AstraZeneca agreed to a licensing option for IONIS-KRAS-2.5Rx, an antisense drug for KRAS-linked cancers. Also in December, Ionis and Biogen's Spinraza (nusinersen) got an unexpectedly early approval in spinal muscular atrophy (SMA).
That record and the products at stake were likely attractive to Novartis. Though the company put a large focus on buttressing its oncology offerings and reviving its eye care business in 2016, its cardio-metabolic division — which rests almost entirely on the sale of two drugs, Galvus and Entresto — brought in $363 million in the third quarter, a 22% increase from the year before.
"Novartis is building a robust cardiovascular portfolio of targeted therapies to address unmet medical need of high-risk patients," the company's global head of drug development and CMO, Vasant Narasimhan, said in a Jan. 6 statement. "Lp(a) and ApoCIII are potent, genetically validated cardiovascular risk reduction targets. The importance of predictive biomarkers in achieving successful cardiovascular outcomes will also be essential in the future payer environment."
Specific financial terms hold that Novartis will pay $150 million for each drug should it decide to license them. Ionis could also fetch $600 million and $530 million in development, regulatory and marketing milestones for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx, respectively.
Novartis will decide on whether to pick up the individual licensing options after Akcea completes a Phase 2 dose-optimization study for each of the two drugs. Opting for the drugs will put Novartis in charge of pushing them through Phase 3, while Akcea will retain rights to co-commercialize the treatments.
While there are many drugs available with an aim to treat and prevent cardiovascular disease, Akcea is focusing on the niche of serious cardiometabolic lipid disorders, an area it sees as underserved.
"We believe that Novartis is the ideal partner for developing both drugs to their fullest potential," Akcea said in its own Jan. 6 statement. "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."