Dive Brief:
- A wholly-owned subsidiary of Strongbridge Biopharma plc has snapped up the North American rights to Aeterna Zentaris Inc.'s lead product, Macrilen. While it's a relatively small deal, it was enough to push Aeterna Zentaris' stock up, closing over 16% higher.
- Aeterna Zentaris will get a much needed $24 million upfront, and royalties for the patent life of the drug, at a rate of 15% for sales up to $75 million and 18% above $75 million. After patent expiry, royalties will drop to 5%.
- Strongbridge will also pay milestone payments of up to $179 million on sales targets and on a pediatric U.S. approval, and will fund 70% of pediatric development costs.
Dive Insight:
In May 2017, Aeterna Zentaris was dealt a crippling blow. Its lead cancer candidate, Zoptrex (zoptarelin doxorubicin), failed to meet its primary and secondary endpoints in a Phase 3 trial in locally advanced, metastatic or recurrent endometrial cancer. The program was axed, and stock tumbled by around 60%.
In August, Aeterna Zentaris filed a claim against its former CEO David Dodd and former general counsel Philip Theodore over "breaches of fiduciary duties and unauthorized disclosure of confidential and highly proprietary information." This was based around allegations of a conspiracy between the two men and a shareholder activist, Graeme Roustan, to take control of the company and gain U.S. rights to the company's lead drug, Macrilen (macimorelin). Dodd and Theodore have filed a counterclaim.
The company has had other personnel shifts too. In September, Geneviéve Lemaire, VP of finance and CAO left, to be replaced by interim CFO Jeffrey Whitnell. In turn, Whitnell left in December and the company is seeking a new principal financial officer.
By the end of the year, things were starting to look up, with cost-containment measures having improved the company's cash reserves. After shifting its focus to Macrilen for adult growth hormone deficiency (AGHD) and resubmitting the new drug application, the agent gained approval on its second attempt. Launch is planned during the first quarter of 2018.
During 2017, Aeterna Zentaris also put a new CEO in place, Michael Ward, and began a review to look at strategic and financial alternatives, including potential changes to management and governance. The deal with Strongbridge Biopharma has resulted from this strategic review.
"We look forward to exploring the various alternatives to monetizing our rights to macimorelin outside the United States and Canada," said Ward.