Pfizer, Akcea enter licensing agreement for investigational antisense therapy AKCEA-ANGPTL3-LRx
New Delhi: Pfizer Inc. and Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc, recently announced that the companies have entered into a worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with certain cardiovascular and metabolic diseases.
As per a recent release by Akcea, under terms of the agreement, Akcea and Ionis will receive a $250 million upfront license fee, which will be split equally between the two companies. Akcea will settle its $125 million obligations to Ionis in Akcea common stock. The companies are also eligible to receive development, regulatory and sales milestone payments of up to $1.3 billion and tiered, double-digit royalties on annual worldwide net sales following marketing approval of AKCEA-ANGPTL3-LRx. Future milestone payments and royalties will be split equally between Akcea and Ionis.
Pfizer is responsible for all development and regulatory activities and costs beyond those associated with the ongoing Phase 2 study. Prior to a regulatory filing for marketing approval, Akcea has the right, at its option to participate in certain commercialization activities with Pfizer in the U.S. and certain additional markets on pre-defined terms and based on meeting pre-defined criteria.
AKCEA-ANGPTL3-LRx is designed to reduce the production of angiopoietin-like 3 (ANGPTL3) protein in the liver, a key regulator of triglycerides, cholesterol, glucose and energy metabolism. AKCEA-ANGPTL3-LRx is currently being evaluated in a Phase 2 study in patients with Type 2 diabetes, hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD).
“AKCEA-ANGPTL3-LRx has the potential to treat people suffering from certain cardiovascular and metabolic diseases. Given the unmet medical need for this patient population and the broad market potential, we believe Pfizer’s expertise and breadth of experience in cardiovascular and metabolic diseases makes it well suited to accelerate clinical development of AKCEA-ANGPTL3-LRx and to deliver it to patients in need of additional therapies for these life-threatening diseases,” said Damien McDevitt, Ph.D., interim chief executive officer at Akcea.
“Pfizer is committed to delivering breakthrough medicines to patients with unmet medical needs,” said Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research & Development and Medical, Pfizer.
“AKCEA-ANGPTL3-LRx is a novel therapy that will complement our clinical mid-stage internal medicine pipeline, and we believe that our deep expertise in cardiovascular and metabolic diseases will help allow this program to reach its maximum potential for patients, ” Dolsten added.
This transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.