Times have changed at Ionis Pharmaceuticals Inc. since it spun out Akcea Therapeutics Inc. in 2015. The company’s evolution is such that Ionis is now ready to bring Akcea back into the fold by acquiring the remaining 24% of its affiliate.

“We were in a different place when we founded Akcea four, five years ago,” Brett Monia, Ionis’ CEO, founder and director, told investors on the company’s Aug. 5 earnings call. “And it was a good strategy at the time – it was a very good strategy at the time to maximize the commercial value of certain rare disease assets in the pipeline while preserving the innovation that is at our core at Ionis and proving and validating the technology, not just clinically but also commercially, which we've now done. We're in a different place today.”

Brett Monia, CEO, founder and director, Ionis

Monia added that Ionis’ culture can endure and actually synergize with the creation of its own pipeline and building commercial capabilities to maximize the pipeline’s value. With that in mind, Ionis said on Aug. 31 that it will acquire Akcea’s remaining common stock for $18.15 per share in cash, bringing the total transaction value to about $500 million.

With the deal, Ionis gets full access to Akcea’s products plus its roughly $390 million cash on hand and future cash flows. Akcea brings much to the table as it is advancing six medicines from the Ionis platform.

While Carlsbad, Calif.-based Ionis’ stock (NASDAQ:IONS) nudged slightly upward 3.24% on Aug. 31, Boston’s Akcea (NASDAQ:AKCA) closed up a whopping 60.6%, with shares ending the day at $18.28.

Damien McDevitt, Akcea’s CEO and director, said on the company’s Aug. 4 investor call that Akcea is looking to expand its portfolio by “closely collaborating with Ionis to identify and potentially license a novel rare disease medicine from our wholly owned pipeline. … And we are searching for potential third-party medicines that complement our rare diseases focus and capabilities.”

The transaction is expected to be completed in the fourth quarter of 2020. Goldman Sachs & Co. LLC and Stifel, Nicolaus & Co. Inc. are financial advisors to Ionis and Cowen is financial advisor to the affiliate transactions committee of Akcea's board.

The two companies also presented data on a phase II study of antisense therapy vupanorsen that hit its primary endpoint of significant triglyceride-level reductions at the virtual European Society of Cardiology on Aug. 29. Vupanorsen, an investigational antisense therapy being developed to treat certain cardiovascular diseases, also hit multiple secondary endpoints compared to placebo, with a favorable safety and tolerability profile. About 105 patients with hypertriglyceridemia (fasting plasma TG levels >150 mg/dL), type 2 diabetes and nonalcoholic fatty liver disease were randomized to three dosing cohorts in a 3-to-1 ratio (vupanorsen: placebo) within each cohort. Dosing cohorts had different doses and dose regimens vs. placebo as patients received either 40 mg or 80 mg every four weeks or 20 mg every week. Participants received either vupanorsen or placebo by subcutaneous injection.

The phase II study showed statistically significant dose-dependent reductions in fasting triglycerides at all dose levels. The highest mean reduction of 53% was seen with the dose of 80 mg every four weeks (44% mean reduction compared to placebo, p<0.0001)

Akcea and Ionis also presented data at the European Society of Cardiology from the phase II study of AKCEA-APOCIII-LRx, which hit its primary and key secondary endpoints with significant triglyceride and apoC-III levels. The data showed patients with hypertriglyceridemia experienced dose-dependent reductions in triglyceride levels and apoC-III, as well as significant reductions in atherogenic lipoproteins. The study of 114 randomized patients in four cohorts at a 4-to-1 ratio within each cohort. The study showed a 62% reduction at the highest dose, which was 50 mg every four weeks, while 91% of the patients achieved triglyceride levels of less than 150 mg/dL (≤1.7 mmol/L) at that dose at six months.

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