Embattled Acerus Loses U.S. Distribution Deal for Natesto With Endo International

Embattled Acerus Pharma Loses US Distribution Deal for Natesto With Endo Pharma
December 31, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Toronto, Ontario-based Acerus Pharmaceuticals Corporation announced today that its sales and distribution deal with Dublin-based Endo International plc to market Natesto in the U.S. and Mexico has been terminated.

Natesto is a testosterone nasal gel used as replacement therapy in men for symptoms related to a deficiency or absence of endogenous testosterone. Endo will continue to sell and distribute Natesto in the U.S. until the deal terminates officially on June 30, 2016.

“While we are disappointed with Endo’s previously announced strategic business decision to realign their U.S. branded resources from urology retail to their pain franchise, we are fully committed to the continued success of Natesto in the U.S.,” said Tom Rossi, president and chief executive officer of Acerus, in a statement. “Our immediate focus is on finding a new Natesto partner in the U.S., the largest market for testosterone replacement therapy. We are encouraged by the positive physician and patient feedback received on the product to date, and believe there will be strong interest from other companies to step in and continue to drive the launch of Natesto.”

On Nov. 20, Acerus announced that Health Canada had granted a Notice of Compliance (NOC) for a generic version of Estrace. Estrace is used to profile relief for women’s menopausal symptoms. Estrace has been available in Canada since 1975.

At its third-quarter financial report on Nov. 5, Acerus indicated that Estrace had continued double-digit growth in the third quarter. At that time the company was aware that Endo was realigning their business in light of the U.S. Food and Drug Administration (FDA)’s approval of Belbuca, with what Acerus referred to as “the de-prioritization of select brands including Natesto.”

Despite that, Acerus cited IMS data showing that Natesto prescriptions in the U.S. increased by 62 percent in the third quarter of 2015 compared to the second quarter.

The company reported $2.8 million of revenue in the third quarter compared to $1.7 million for the same period in 2014. It was also up slightly from $2.7 million for 2015’s second quarter.

Acerus has been on the decline for most of 2015. Its high of the year was $0.65 per share, which took place in February, and hit a low of $0.06 per share this month. Shares are currently trading for $0.09.

Acerus Pharmaceuticals was previously known as Trimel Pharmaceuticals. It was recently upgraded by Zacks Investment Research from “hold” to buy” after a research note on Dec. 29. It has given a price target of $0.25, and indicates a potential upside of 164.55 percent from its current price.

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