News briefing: Eli Lilly completes $1B+ Prevail buyout; Elzonris approved in Europe for adults
Eli Lilly’s $1.04 billion takeover of Prevail Therapeutics is officially complete, the company announced Friday.
The sides had entered into the buyout agreement last month with Lilly focusing on Prevail’s pipeline of gene therapies, highlighting two AAV9 programs in Parkinson’s disease and frontotemporal dementia as potential winners. Lilly paid $22.50 per share, which amounted to an 82% premium over the previous day’s closing price and a 117% premium over Prevail’s 60-day average.
The deal also included a $4 contingent-value right (CVR) based on one of the AAV9 gene therapies receiving approval in one of the US, UK, Japan, France, Germany, Italy or Spain by the end of 2024. If that deadline isn’t met, the value of the CVR would drop by 8.3 cents each month before eventually expiring by the end of 2028.
It was Lilly’s second big M&A move in the last three months of 2020 after the pharma picked up Disarm Therapeutics and its SARM1 inhibitors in October for $135 million in cash, plus up to $1.225 billion in milestones.
Elzonris tacks on approval in Europe for adult patients
A little over two years after receiving FDA approval, Elzonris is now approved to use in Europe.
The European Commission formally OK’ed the drug late Thursday night, making it the first CD-123 therapy approved on the continent. In Europe, Elzonris is indicated as a monotherapy for the first-line treatment of adults with blastic plasmacytoid dendritic cell neoplasm.
US regulators greenlit the drug back in October 2018, and Elzonris is available for Americans aged two and older.
Stemline Therapeutics developed the drug, but the company is now a part of Italian pharmaceutical company The Menarini Group. Stemline invited controversy while the drug was still in clinical trials, failing to tip investors off about a patient death in the pivotal study.
The FDA nonetheless waved the drug through on a small set of data. Elzonris’ OK came after it posted widely varying results from two drug cohorts in a tiny single-arm study.
Humanigen signs deal to use BARDA manufacturing sites for lenzilumab in Covid-19
Humanigen, a former company of “Pharma Bro” Martin Shkreli, has been developing its lenzilumab candidate in conjunction with the Department of Defense for Covid-19 since November 2020. Now, the company has access to new manufacturing sites.
Humanigen’s deal with CRADA is now co-signed by BARDA, allowing the company to produce the experimental drug with BARDA’s sites. Lenzilumab is currently in a Phase III trial for Covid-19 and Humanigen is expected to seek an EUA in the near future.
Should the candidate work as planned, it will prevent and treat the cytokine storms associated with Covid-19. In October, the monoclonal antibody was also tapped by the NIAID to participate in the ACTIV-5 Big Effect Trial, evaluating its efficacy in combination with Gilead’s Veklury.