OSAKA, Japan—With their sights set on developing compoundsfor the treatment of systemic lupus erythematosus and possibly other autoimmunediseases, Takeda Pharmaceutical Co. Ltd. and Seattle-based Resolve TherapeuticsLLC announced at the end of February that they have entered into a partnershipfocused on Resolve's lead compound, RSLV-132, a novel nuclease Fc fusionprotein that will begin clinical development in 2013, probably around midyear.
Resolve also has several other autoimmune candidates thatare in the preclinical proof-of-concept stage. These compounds target thedegradation and elimination of autoantibody-containing immune complexes, whichare thought to be the most proximal pathophysiological trigger of lupus.
Resolve will conduct all development work under thecollaboration until completion of the first RSLV-132 Phase Ib/IIa trial in lupuspatients; after completion of the trial, Takeda has the exclusive option tolicense the lead compound and all other compounds from the Resolve platform.Should Takeda exercise its option, the Japanese company would assume leadresponsibility for worldwide development and commercialization of the Resolveproducts.
Although Resolve is responsible for bringing the compoundthrough the trial, the terms of the deal do call for Takeda to help fundcontinued development of RSLV-132 through an initial payment of $8 million toResolve in fiscal year 2012. If Takeda exercises its option, it would payResolve an option exercise fee, and Resolve would also enjoy the potential foradditional development milestones totaling $247 million, as well as royaltieson product sales if RSLV-132 makes it to market.
"This collaboration with Resolve is very exciting as itsinnovative pipeline of nuclease fusion proteins has the potential to provide anew approach to helping lupus patients," said Dr. Tetsuyuki Maruyama, generalmanager of the Pharmaceutical Research Division at Takeda, in a news releaseabout the deal. Maruyama was formerly known as Paul Chapman, but changed hisname legally when he became a Japanese citizen in July 2012.
"Last year, our board was looking at the markets, and wedecided it would make a lot of sense to bring on a pharma partner to help withthe investment that was required to get to the Phase Ib endpoint," Dr. JamesPosada, CEO of Resolve, tells ddn."Over the years, I've interacted with people at Takeda and Takeda Ventures, butI'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 treatingsickness, and the relationship grew into the deal we have today. Also, the newleadership at Takeda has created an environment that's pretty attractive forus. They've changed the way they approach development and they're placing a bigemphasis on inflammation and autoimmunity, which is good—it's important for usthat our drug reside in a development unit that's a high priority for thecompany."
In an investor note about the Takeda-Resolve deal, ZacksInvestment Research said nothing about the work between the two companies thatwasn't already noted in the news release about the deal, but did make a pointof noting that it wrote the previous month that Takeda suffered a setback whenthe company, along with partner Affymax Inc. of Palo Alto, Calif., recalled alllots of Omontys (peginesatide) voluntarily. This was prompted by data frompost-marketing studies that revealed fatal reactions such as anaphylaxis werefound to be associated with the use of the drug, which received approval in theUnited States in March 2012 for the treatment of anemia due to chronic kidneydisease in adult patients on dialysis. Zacks then went on to write that Takedastill carries a Zacks Rank #3 (Hold) rating and added that Philadelphia-basedLannett Co. Inc. and South San Francisco-based Cytokinetics Inc. "look moreattractive 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 toinflammation and considerable resources will give Resolve's compounds the bestpossible chance of success.
"Also, this deal is important because Takeda is fundingabout half of the development of the drug, and that's non-dilutive financing,which is attractive to our management and investors compared to the challengeof trying to seek out venture capital," Posada says, though it is worth notingthat late last year, Resolve was able to raise $5.8 million in a Series Bprivate-equity financing round to help fund development of RSLV-132.
"We also benefit from tappingTakeda's expertise in how to design trials, what you're looking for inendpoints and other important factors," Posada notes of the agreement with thecompany. "That input makes the probably of technical success higher and makesit more likely that they will exercise their option in the end."