Eyeing a drug that it believes holds peak annual sales potential of $12 billion in the U.S. alone, Zenas BioPharma has struck a licensing deal with China-based InnoCare Pharma that could be worth more than $2 billion.
The Massachusetts company, which launched just four years ago, is spending up to $100 million upfront and in near-term expected milestone payments to co-develop and possibly commercialize multiple sclerosis (MS) treatment orelabrutinib outside of China and Southeast Asia. The deal also encompasses two autoimmune candidates, which are expected to enter phase 1 testing next year.
The agreement also includes 7 million shares of Zenas' common stock, which is usable upon the achievement of another milestone expected early next year. InnoCare could also net more than $2 billion biobucks in regulatory and commercial milestones.
On top of that, the 10-year-old Beijing biotech could receive tiered royalties in the high teens on net sales of the products.
The prize of the deal is a Bruton’s Tyosine Kinase (BTK) inhibitor called orelabrutinib, an oral treatment which Zenas believes can address compartmentalized inflammation and disease progression in MS.
“Preventing disability progression is the highest unmet medical need in multiple sclerosis, a need unfortunately for patients which has been overlooked historically,” Zenas' Chief Scientific Officer, Haley Laken, Ph.D., said in a conference call on Wednesday.
A phase 3 trial of orelabrutinib in primary progressive MS (PPMS) is underway, and another phase 3 study of the therapy in secondary progressive MS (SPMS) is expected to kick off in the first quarter of next year.
In a phase 2 trial of patients with relapsing-remitting MS (RRMS), orelabrutinib showed significant reductions in inflammatory activity and achieving endpoints that indicate its ability to reduce disease progression.
Of MS patients, roughly 20% have SPMS and 10% to 15% have PPMS, Zenas said. Roche’s blockbuster Ocrevus is the only approved therapy for PPMS, but most of its sales are for relapsing MS (RMS) as it is “less impactful at delaying progression in PPMS,” Laken added.
As for SPMS, Sanofi’s investigational BTK inhibitor tolebrutinib has scored in a phase 3 trial, showing its ability to slow disease progression, and awaits an FDA decision by the end of this year.
“We believe we have a best-in-class product candidate,” Zenas founder and CEO Lonnie Moulder said during the conference call. “While tolebrutinib has a head start, history shows that many blockbuster therapies were not first to market, but succeeded by being differentiated.”
Orelabrutinib has been approved in China to treat four types of blood cancer. In the licensing deal, InnoCare did not surrender its rights to orelabrutinib in any oncology indications.
“The partnership with (Zenas) represents a significant milestone in our journey, and we will continue to enhance and advance our globalization efforts in the future,” said Jasmine Cui, Ph.D., co-founder and CEO of InnoCare in a release. “We are confident in Zenas’ management team, given their exceptional track record of successful drug development, global regulatory approvals and commercial launches, and their commitment to driving innovation for autoimmune diseases.”
Last month, Zenas secured up to $300 million from Royalty Pharma in return for a cut of potential sales of the company’s autoimmune candidate obexelimab, which is in phase 3 testing for IgG4-related disease and systemic lupus erythematosus.