Vectura has found a new partner to step into the shoes of Sandoz, after the big generic company abruptly exited from their U.S. pact covering a lung treatment that bears a close resemblance to Advair. But the U.K. developer is not identifying which company agreed to pay it $10 million upfront with $35 million in milestones for a share of VR315, a combo therapy for asthma/COPD.
All a tight-lipped Vectura will say at this point is that the U.S. division of a leading international pharma company has snagged the U.S. rights to the drug. Vectura CEO Chris Blackwell says that the mystery partner has "a strong track record in respiratory product development and commercialization."
But analysts have been skeptical over the whole regulatory process that VR315 faces at the FDA, where a follow-on faces an uncertain future. And those doubts were heightened by Sandoz's decision last year to drop the U.S. end of their deal while hanging on to the European rights, where the regulatory path has been more clearly mapped out.
"It is not clear what the regulatory requirements will be and how much data the FDA will need to grant approval, but given the FDA's concerns over Long Acting Bronchodilators (LABAs), the approval process is likely to be challenging," noted Nomura Code analyst Michael King, according to Reuters. King estimated peak sales at $300 million while Advair earns $4 billion.
Adds Blackwell: "This is a major endorsement of the potential value of this product, Vectura's technology and product development expertise."'
- read the Vectura release
- here's the story from Reuters