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Takeda and Resolve pair up on autoimmunity
OSAKA, JapanóWith their sights set on developing compounds for the treatment of systemic lupus erythematosus and possibly other autoimmune diseases, Takeda Pharmaceutical Co. Ltd. and Seattle-based Resolve Therapeutics LLC announced at the end of February that they have entered into a partnership focused on Resolve's lead compound, RSLV-132, a novel nuclease Fc fusion protein that will begin clinical development in 2013, probably around midyear.
Resolve also has several other autoimmune candidates that are in the preclinical proof-of-concept stage. These compounds target the degradation and elimination of autoantibody-containing immune complexes, which are thought to be the most proximal pathophysiological trigger of lupus.
Resolve will conduct all development work under the collaboration until completion of the first RSLV-132 Phase Ib/IIa trial in lupus patients; after completion of the trial, Takeda has the exclusive option to license the lead compound and all other compounds from the Resolve platform. Should Takeda exercise its option, the Japanese company would assume lead responsibility for worldwide development and commercialization of the Resolve products.
Although Resolve is responsible for bringing the compound through the trial, the terms of the deal do call for Takeda to help fund continued development of RSLV-132 through an initial payment of $8 million to Resolve in fiscal year 2012. If Takeda exercises its option, it would pay Resolve an option exercise fee, and Resolve would also enjoy the potential for additional development milestones totaling $247 million, as well as royalties on product sales if RSLV-132 makes it to market.
"This collaboration with Resolve is very exciting as its innovative pipeline of nuclease fusion proteins has the potential to provide a new approach to helping lupus patients," said Dr. Tetsuyuki Maruyama, general manager of the Pharmaceutical Research Division at Takeda, in a news release about the deal. Maruyama was formerly known as Paul Chapman, but changed his name legally when he became a Japanese citizen in July 2012.
"Last year, our board was looking at the markets, and we decided it would make a lot of sense to bring on a pharma partner to help with the investment that was required to get to the Phase Ib endpoint," Dr. James Posada, CEO of Resolve, tells ddn. "Over the years, I've interacted with people at Takeda and Takeda Ventures, but I've never done a collaboration with them before, so this is a first for me. But in talking with them, we found we thought a lot the same way about treating sickness, and the relationship grew into the deal we have today. Also, the new leadership at Takeda has created an environment that's pretty attractive for us. They've changed the way they approach development and they're placing a big emphasis on inflammation and autoimmunity, which is goodóit's important for us that our drug reside in a development unit that's a high priority for the company."
In an investor note about the Takeda-Resolve deal, Zacks Investment Research said nothing about the work between the two companies that wasn't already noted in the news release about the deal, but did make a point of noting that it wrote the previous month that Takeda suffered a setback when the company, along with partner Affymax Inc. of Palo Alto, Calif., recalled all lots of Omontys (peginesatide) voluntarily. This was prompted by data from post-marketing studies that revealed fatal reactions such as anaphylaxis were found to be associated with the use of the drug, which received approval in the United States in March 2012 for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. Zacks then went on to write that Takeda still carries a Zacks Rank #3 (Hold) rating and added that Philadelphia-based Lannett Co. Inc. and South San Francisco-based Cytokinetics Inc. "look more attractive in the pharma sector. Both carry a Zacks Rank #1 (Strong Buy)."
Posada is bullish on Takeda's role with his company, though, saying that he feels strongly that Takeda's expertise, commitment to inflammation and considerable resources will give Resolve's compounds the best possible chance of success.
"Also, this deal is important because Takeda is funding about half of the development of the drug, and that's non-dilutive financing, which is attractive to our management and investors compared to the challenge of trying to seek out venture capital," Posada says, though it is worth noting that late last year, Resolve was able to raise $5.8 million in a Series B private-equity financing round to help fund development of RSLV-132.
"We also benefit from tapping Takeda's expertise in how to design trials, what you're looking for in endpoints and other important factors," Posada notes of the agreement with the company. "That input makes the probably of technical success higher and makes it more likely that they will exercise their option in the end."