Takeda Pharmaceutical has struck a deal which fuels its ambitions for growth in immunology. The Japanese drugmaker and Seattle-based startup Resolve Therapeutics have agreed to terms for a partnership for Resolve's pre-clinical program targeting lupus, an autoimmune disease that afflicts more than a million women in the U.S. and some 5 million patients worldwide.
New therapies have been slow to reach the market, leaving patients with limited options to combat the chronic inflammation and tissue damage from the disease. Resolve's lead compound, the key asset in its Takeda deal, could advance treatment of lupus with its novel mechanism that attacks triggers of the disease called immune complexes.
Takeda agreed to fork over $8 million initially to Resolve as the startup works toward the start of first human studies in 2013 for the lead compound, RSLV-132, a nuclease Fc fusion protein. The deal includes backup compounds as well. And if planned Phase 1b/2a work for the front runner goes as hoped, Takeda could use its exclusive option from the deal and take over global development and commercialization of the compound, leading to up to $247 million in development payments to Resolve, which also stands to pick up royalty payents on potential drug sales.
Resolve CEO James Posada says the Takeda deal validates the lean corporate strategy and asset-focus of his company, which operates as an LLC with all its 15 or so workers employed as contractors--including him.
"What we've heard from Takeda and other pharma companies is that this is the sort of asset that they seem to be more interested in now," Posada told FierceBiotech. "Rather than buying a company with a ton of infrastructure, they're looking for compounds and these single-asset companies that are focused on developing a single compound or group of compounds."
Founded in 2010, Resolve is a big bet on RSLV-132 and the technology from Keith Elkton and Jeff Ledbetter at the University of Washington School of Medicine, Posada says. The company has raised shy of $8 million from investors and burned through only $3 million so far, a testament to the agile structure and strategy of the company.
The main drug is the company's version of an enzyme designed to degrade or digest immune complexes linked with lupus. The complexes--which are made of the body's autoantibodies attached to components in the blood that the immune system has mistaken as pathogens--activate interferon, touch off inflammation, and damage tissue in organs such as the skin and kidneys.
Resolve's drug is intended to act at an earlier step in the disease than GlaxoSmithKline's ($GSK) lupus drug Benlysta, an antibody therapy that homes in on B cells involved in inflammation. Though RSLV-132 has the potential to provide a better blockade against inflammation than Benlysta in patients with lupus, which primarily afflicts women, Resolve hasn't even begun to test the candidate in humans and it's way too early to say that the company or Takeda has an edge over GlaxoSmithKline ($GSK) in this market.
Still, Takeda thinks the drug has enough of a shot at success to gamble $8 million up front this year in a deal that landed before planned human clinical trials. And Japan's No. 1 drugmaker has been open about its desire to strike deals that beef up its immunology business, which includes sales of Amgen's blockbuster Enbrel for rheumatoid arthritis in Japan.
- here's the release