Akcea is also getting Ionis' second-gen drug for hereditary TTR amyloidosis, the experimental IONIS-TTR-LRx.
A spokesperson followed up with him, noting, "After a thoughtful evaluation of all the possibilities, we arrived at the conclusion that this transaction with Akcea met all three of our key partnering goals: to rapidly deliver inotersen to the patients who desperately need this treatment, to maximize the commercial success of inotersen, and to optimize our commercial participation in our TTR franchise".
Commercial profits and losses from inotersen will be divided 60% to Ionis and 40% to Akcea until the initialcommercial sales of AKCEA-TTR-LRx, following which the profits and losses will be shared equally. AKCEA-TTR-LRx is planned to enter clinical development in 2018. Regulatory clearance of inotersen and AKCEA-TTR-LRx in the USA and European Union will trigger milestone payments to Ionis of $50 million and $40 million, respectively, with more payouts due upon approval of both programs in various other geographies. "The potential to add commercial revenue from both inotersen and volanesorsen to our growing Spinraza® royalties helps us achieve our goal of being a multiproduct, profitable company".
Analysts await Akcea Therapeutics, Inc.
Motivating Ionis to ensure a rapid launch of inotersen is the looming competitive threat from rival drugmaker Alnylam Pharmaceuticals Inc.
When the arrangement is complete, Ionis' ownership in Akcea will increase by 7 percent, from 68 percent to 75 percent, totaling about 64.1 million shares.
Money or stock is exchanging hands - in a manner of speaking, as Ionis carries Akcea on its books, according to its recent annual report. The costs of the development of AKCEA-TTR-LRx and the profits from its commercialization will be shared 50-50, and the license for the pair of drugs includes sales milestone payments of up to nearly $1.3 billion.
Ionis' commercial team for inotersen will transfer to Akcea, and Sarah Boyce, now Ionis' chief business officer, will join Akcea as president. The license for the two drugs also includes various sales milestone payments of up to almost $1.3 billion. As per Friday, March 16, the company rating was maintained by Stifel Nicolaus.
Under the terms of the agreement, Akcea will pay Ionis an upfront licensing fee of $150M in the form of Akcea shares.
The transaction should close next quarter. Novartis Pharma AG, one of Akcea's largest shareholders, has agreed to vote in favor of the proposal with its shares of common stock, representing approximately 9.4% of the issued and outstanding shares. Inotersen is a treatment used in people with hereditary transthyretin amyloidosis or hATTR, which can be fatal.
Currently, Inotersen is under regulatory review for marketing authorization in the U.S. and European Union (EU).
Spinraza is marketed for spinal muscular atrophy by Biogen Biogen licensed global rights to Spinraza from Ionis in August 2016, which was approved by the U.S. Food and Drug Administration (FDA) on December 23, 2016. The progressive accumulation of TTR amyloid deposits in these tissues and organs leads to sensory, motor and autonomic dysfunction often having debilitating effects on multiple aspects of a patient's life. The Company is focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders.
Akcea Therapeutics, Inc is a biopharmaceutical company.