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Pfizer (PFE) Ends Vupanorsen Development, Returns Rights to Ionis

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Pfizer (PFE - Free Report) and partner Ionis Pharmaceuticals (IONS - Free Report) announced that they are discontinuing the clinical development program for vupanorsen (PF-07285557), which was being developed to treat potential indications in cardiovascular (CV) risk reduction and severe hypertriglyceridemia (SHTG).

Pfizer’s decision to discontinue the vupanorsen clinical development program was based on its detailed analysis of a phase IIb study (TRANSLATE-TIMI 70), which evaluated the therapy against placebo in statin-treated participants with dyslipidemia.

Last November, both Pfizer and Ionis Pharmaceuticals announced that the TRANSLATE-TIMI 70 study achieved its primary endpoint of a statistically significant decline in non-high-density lipoprotein cholesterol (non-HDL-C). The study also achieved its secondary endpoints of statistically significant decline in triglycerides (TG) and angiopoietin-like 3 (ANGPTL3).

Yet, Pfizer’s review of the TRANSLATE-TIMI 70 study revealed that the magnitude of the reduction seen in non-HDL-C and TG endpoints did not support the continuation of the development program for CV risk reduction and SHTG indications. Although the study did achieve its primary and secondary endpoints, treatment with the therapy also led to an increase in liver fat, with higher doses of the drug increasing liver enzymes alanine aminotransferase and aspartate aminotransferase.

Pfizer also stated that it would return rights for vupanorsen to Ionis Pharmaceuticals. Ionis Pharmaceuticals out-licensed rights to Pfizer as part of an exclusive global agreement for vupanorsen in 2019.

Shares of Pfizer declined 3% following the announcement. Yet, the stock has surged 50.6% in the trailing 12 months in comparison with the industry’s 17.9% rise.

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We note that vupanorsen is an antisense therapy developed by Ionis Pharmaceuticals using its proprietary technology platform.

This is already the second pipeline setback faced by Pfizer this year. Earlier in January, Pfizer announced that the FDA issued a complete response letter to Pfizer and partner OPKO Health’s (OPK - Free Report) biologics license application for somatrogon for the treatment of growth hormone deficiency in pediatric patients. Both Pfizer and OPKO Health are currently evaluating the FDA’s comments and looking to work with the regulatory body to decide the best path forward for somatrogon.

We remind investors that both Pfizer and OPKO Health signed the global deal for somatrogon in 2014. Per the deal terms, OPKO Health is mainly responsible for clinical development, while Pfizer will take care of commercializing the product.

Zacks Rank & Another Key Pick

Pfizer currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the same sector is Eli Lilly (LLY - Free Report) , which sports a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Eli Lilly’s earnings per share estimates for 2022 have increased from $8.42 to $8.45 in the past 30 days. Shares of Eli Lilly have risen 24.2% in the past year.

Earnings of Eli Lilly missed estimates in three of the last four quarters while beating the mark in one, delivering a surprise of 0.5%, on average.

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