Novartis announced on Jan. 6 that it had reached an option agreement with two small pharmaceutical companies to license two investigational cardiovascular medications.
Ionis Pharmaceuticals and Akcea Therapeutics have developed AKCEA-APO(a)-LRX and AKCEA-APOCIII-LRX to reduce cardiovascular risk in patients with high levels of lipoproteins. Neither of the drugs is FDA-approved.
Ionis and Akcea said in a news release that they are eligible to receive $225 million in near-term payments, including an immediate $75 million up-front option payment and a $100 million equity investment in Ionis.
The agreement provides Novartis with the option to license and commercialize both medications before phase 3 studies begin. Ionia and Akcea plan on conducting phase 2 dose-ranging studies for each drug.
If Novartis exercises the option, the company will pay Ionis and Akcea a $150 million license fee, launch a phase 3 cardiovascular outcomes study in high-risk patients and be responsible for developing and commercializing both products throughout the world.
Ionis and Akcea said the companies would also be eligible to receive up to $315 million and $265 million, respectively, in development and regulatory milestone payments for APO(a)-LRX and AKCEA-APOCIII-LRX, as well as up to $285 million and $265 million in commercialization milestone payments for each drug. The companies said they would be eligible for tiered royalties in the mid-teens to low 20 percent range on the net sales of each drug.
In addition, Novartis is obligated to make a $50 million equity investment in the next 18 months in either company.
In a phase 1/2a study, healthy patients with elevated lipoprotein(a) who received AKCEA-APO(a)-LRX had a mean 79 percent reduction in lipoprotein(a) after only one dose and a mean 92 percent reduction in lipoprotein(a) after multiple doses.
By midday on Jan. 6, Ionis’s stock price was up 2.38 percent to $48.21 per share, while Novartis’s stock price was down 0.65 percent to $73.59 per share.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.