Dive Brief:
- As a result of J&J's $30 billion acquisition of Actelion, the pharma giant's subsidiary Janssen will hand back global control of an insomnia treatment to small Waltham, MA-based Minerva Neurosciences, waiving its right to royalties on any future sales of the drug in that indication under a reworked development and licensing deal.
- Minerva will also repurchase the roughly 3.9 million company shares held by J&J Innovation at par value of $0.0001 per share — approximately $389. Both the licensing amendment and share buyback are contingent on the successful closing of J&J's deal for Actelion.
- The new terms also give Minerva a financial boost. Janssen will pay Minerva $30 million upfront, with the potential for another $40 million after development milestones tied to a Phase 3 trial of the candidate in insomnia are reached. Janssen will also waive the $13 million owed by Minerva for Phase 2 development of the compound.
Dive Insight:
Back in January, Johnson & Johnson announced its acquisition of Actelion, beating out Sanofi to pick up the Swiss biotech's leading portfolio of treatments for pulmonary arterial hypertension. As part of the transaction, Actelion is spinning out its drug discovery and early- to mid-stage pipeline candidates into a new biotech company, referred to by the placeholder name "R&D NewCo."
J&J will own 16% of the new biotech, with rights to an additional 16% through a convertible note. One of the drug candidates R&D NewCo looks set to inherit is a dual orexin receptor antagonist for the treatment of insomnia, currently in Phase 2 development.
As it happens, Minerva's candidate is also a orexin 2 receptor antagonist, likely prompting the decision to hand back rights to Minerva.
Under the new deal, Janssen will no longer have exclusive rights to MIN-202 outside of Minerva's territories in the European Economic Area and Switzerland. The J&J pharma unit will also lose its rights to royalties on MIN-202 insomnia sales in those territories.
In major depressive disorder (MDD) — another indication MIN-202 is being developed for — Janssen retains its rights to royalties on any future sales in Minerva territories.
Shares in Minerva climbed more than 20% Thursday on the news to close at $10 a share.
The financial resources accumulated through this new deal should be enough to support the planned Phase 3 trial of Minerva's lead candidate MN-101 in schizophrenia, as well as three Phase 2b trials for MN-202 in both insomnia and MDD. Minerva estimates the new money will extend its runway through the end of 2019.
Readouts from these studies are expected during that timeframe, along with trials of two other candidates in major depressive disorder and Parkinson's disease.