The Acucela approach has been shown in animals to stop the natural accumulation of A2E, a molecule that’s toxic to retinal cells and believed to play a role in age-related vision loss. The first patient in a clinical trial received the drug in June, the company said. The trial is expected to enroll 36 patients on the drug or a placebo, on a single dose.
Acucela plans to finish the early-stage trial “as soon as possible” so it can move on to a proof-of-concept Phase II study in 2009, Kubota said in an email from Japan. Acucela currently has about 30 employees in Bothell, and plans to add some new hires in clinical development, although “we will continue to operate as efficiently as possible,” Kubota says.
Acucela (ack-you-cell-uh) made its first big splash on the Seattle biotech scene back in 2004, when it raised $13.4 million in a first-round financing from a group of 10 investment firms from Japan and Singapore, including Softbank. It raised an additional $25 million in April 2007 from another Japanese-led investment group, which included Otsuka. The new partnership enables the company to advance toward the marketplace without having to raise more capital in the forseeable future, Kubota says.
Besides the macular degeneration deal, Acucela also found a way to negotiate for a piece of another drug further along in Otsuka’s pipeline. The two companies will collaborate on the final stage of development for Rebamipide, an experimental drug Otsuka is developing for dry eye. Acucela will be responsible for the regulatory strategy to win approval of that drug from the FDA, while Otsuka will continue to pay all development costs, and expenses for future commercialization. Acucela will get a cash payment upfront, milestone payments on success in development, and royalties on sales, all of which were undisclosed. Once the drug is approved, Acucela may be able to negotiate terms to co-promote the product in the U.S.
Acucela was advised in both transactions by Posada & Associates, and its legal counsel was Wilson, Sonsini, Goodrich and Rosati.
