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November 9, Arrowhead Pharmaceuticals (NASDAQ:ARWR) and Royalty
Pharma (NASDAQ:RPRX) announced, Royalty
Pharma has secured royalties in Olpasiran and future milestones from Arrowhead for $250 million in cash upfront plus additional payments of up to $160 million subject to certain clinical, regulatory and sales milestones
.
Olpasiran, a siRNA therapy being developed by Amgen to reduce the risk of
cardiovascular disease.
Olpasiran is a small interfering RNA (siRNA) originally developed by Arrowhead using its proprietary targeted RNAi molecule (TRiM™).
To reduce levels of lipoprotein (a) (Lp(a)), an independent risk factor for genetically determined cardiovascular disease, and is entering a Phase 3 cardiovascular benefit study to determine whether olpasiran treatment reduces the risk of cardiovascular events in patients with atherosclerotic cardiovascular disease and high levels of
Lp(a).
The Phase 2 clinical findings of the OCEAN(a)-DOSE study were presented at the 2022 American Heart Association Scientific Meeting, in which olpasiran demonstrated a significant and sustained reduction
in Lp(a) levels over 36 weeks.
The data were published simultaneously in the New England Journal of Medicine on November 6
, 2022.
Data presented at the American Heart Association's 2022 Scientific Session found that lipoprotein A (Lp(a)) levels decreased by 95%
in patients with a history of atherosclerotic cardiovascular disease who took 75 mg or more every three months.
Arrowhead President and CEO Chris
Dr Azalone said: "We are delighted to enter into this agreement with Royalty Pharma, Royalty
Pharma is recognized as a leader
in life sciences innovation.
Olpasiran, a product we developed and licensed to Amgen for further clinical development and commercialization, has the potential to benefit
millions of patients worldwide by reducing the risk of cardiovascular disease.
The early monetization of this potential patent rights validates Olpasiran's great potential and enables us to continue investing in our TRiM™ platform and our diverse and growing pipeline of RNAi therapeutic candidates
.
" ”Royalty
Pablo, founder and CEO of Pharma
Legoreta said: "We are excited to partner with Arrowhead, a leader in RNA interference (RNAi) therapeutics, to help them achieve their strategic goals and fund
their attractive channels.
Despite some therapeutic advances, cardiovascular disease remains the most common cause of death worldwide, and new therapeutic targets are urgently needed
.
Olpasiran is a promising late-stage treatment with the potential to lower lipoprotein(a), and this agreement aligns with
our strategy to access innovative therapies in areas of high unmet patient need.
" ”Royalty
Pharma is acquiring Arrowhead's entire royalty interest in olpasiran, a double-digit royalty
on net sales worldwide.
Arrowhead will retain the right to
make $400 million development, regulatory and sales milestone payments that Amgen may be due for.
The deal is a clear demonstration of confidence in the market potential of olpasiran, which Amgen licensed from Arrowhead in 2016
.
The drug is designed to reduce the level of apolipoprotein (a), a key component of
lipoprotein a, through small interfering RNAs.
As part of the transaction, which included a licensing option for another undisclosed Arrowhead asset, Amgen made a $56.
5 million down payment and a $617 million milestone payment
.
But Amgen and Arrowhead are still catching up to Novartis, even as the data shows higher upside
.
Novartis previously reported that its cardiovascular drug pelacarsen showed a 72 percent
reduction in Lp(a) levels in patients taking 60 mg per month.
When taken at 20 mg per week, the drop jumped to 80%.
Pelacarsen, which Novartis licensed from Ionis in 2019, launched a Phase 3 clinical trial
in June.
As for olpasiran, Amgen expects to enroll about 6,000 patients in the Phase III trial
, which is scheduled to start in December.
This time, the primary goal was to evaluate olpasiran's ability to
reduce coronary heart disease deaths, myocardial infarction, or urgent coronary revascularization.