Alvogen has secured a low-risk shot at the treatment-resistant suicidal bipolar depression market. The deal gives the drugmaker the U.S. license to NRx Pharmaceuticals’ NRX-101—and it will only make the initial $10 million cash payment upon seeing positive data from a phase 2b/3 clinical trial of the candidate.
NRX-101 is a fixed-dose combination of the NMDA receptor regulator D-cycloserine and the bipolar depression drug lurasidone, marketed as Latuda. By adding a NMDA receptor regulator to an existing treatment for bipolar depression, NRx thinks it can reduce suicidal ideation while addressing core symptoms of the condition. Neither component of the combination has shown potential for abuse.
NRx began a phase 3 study in January and merged it with a phase 2 trial in a broader patient population in March. Cash is tight, though. NRx ended March with $16.5 million to hand, a sum it predicted would keep it going through the expected delivery of phase 2b/3 data in the fourth quarter.
Now, NRx has disclosed deals for NRX-101 and promptly tapped investors for more money. Alvogen has secured an exclusive worldwide license to NRX-101 as part of a deal that could be worth $330 million in milestones but will only start paying out for NRx once it delivers positive phase 2b/3 data and completes a meeting with the FDA. NRx will receive another $5 million once the FDA approves Alvogen’s application for approval.
Talking to investors on a conference call to discuss the deal, NRx CEO Stephan Willard said the agreement was the result of a “competitive process” involving Alvogen and one other potential partner. NRx felt “Alvogen was the right partner,” Willard said.
While the near-term sums are small and contingent on R&D success, the deal removes the question of how NRx, a company with a market cap of below $40 million, will fund the commercialization of the drug. The deal leaves NRx solely responsible for all regulatory matters up to the initial $10 million milestone. Once the milestone is paid, Alvogen will take over. Taiwan’s Lotus Pharmaceuticals will work with Alvogen on U.S. commercialization and acquire the international rights to the product.
“A company like ours could never talk seriously about, ‘we're going to go do a launch in those markets,’ because we don't know the regulatory environment, we don't know the commercial environment,” Willard said. “By bringing on a partner with international reach, there are many more possibilities.”
The success of work to grow sales in the U.S. and overseas will determine how much of the $330 million NRx receives. Willard said the “vast majority” of the milestones are based on sales of NRX-101, adding that the “agreement contemplates the possibility of blockbuster status.”