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AcelRx (ACRX) Inks Agreement With Aguettant for Dzuveo in Europe

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AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) announced agreements with Laboratoire Aguettant (Aguettant), whereby the latter will obtain Aguettant with a license to commercialize Dzuveo in Europe.

Dsuvia (sufentanil sublingual tablet 30mcg), approved as Dzuveo in Europe, is indicated for use in adults in certified, medically supervised healthcare settings, such as hospitals, surgical centers and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.

In exchange, AcelRx will receive up to approximately $55 million in a combination of upfront and sales-based milestone payments at various annual sales levels from Aguettant. It is entitled to revenue share payments ranging from 35% to 45% of net sales. AcelRx will manufacture and supply the drug to Aguettant at an agreed supply price.

In addition, under the terms of a separate licensing agreement, AcelRx gains the rights to file new drug applications (NDAs) and commercialize two innovative pre-filled syringe product candidates — ready-to-use ephedrine and phenylephrine — in the United States.

This licensing agreement gives Aguettant the right to receive up to $24 million in sales-based milestone payments, at various annual sales levels up to $60 million, along with revenue share payments of 40-45% of the net sales of the two pre-filled syringe products, upon receiving a potential approval from the FDA.

The agreement allows AcelRx to commercialize two product candidates in the United States with a track record of success in Europe and enables it to build a complementary product portfolio with Dsuvia, while limiting the cost of development of a new product.

Shares of the company have gained 21.8% in the year so far against the industry’s decline of 9.8%,

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AcelRx’s other product, Zalviso (sufentanil sublingual tablet system, SST system, 15 mcg), is an investigational product in the United States. It is being developed as an innovatively designed patient-controlled analgesia (PCA) system for the reduction of moderate-to-severe acute pain in medically supervised settings. It is approved in Europe.

Zacks Rank & Stocks to Consider

AcelRx currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the sector include Zoetis Inc. (ZTS - Free Report) , Repligen (RGEN - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) , all carrying a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Zoetis’ earnings estimates are up 8 cents for 2021 and 9 cents for 2022 over the past 90 days. The stock has rallied 20.8% year to date.

Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 90 days. The stock has rallied 3.4% year to date.

Loss per share estimates for Acadia narrowed to $1.26 from $1.93 for 2021 in the last 90 days.