BioWorld Today Contributing Writer

Just in time for the New Year's weight loss resolution season, Sanford-Burnham Medical Research Institute and Takeda Pharmaceutical Company Ltd., of Osaka, Japan, have teamed up to tackle the growing, worldwide problem of obesity. Under terms of a new partnership agreement, which also includes Orlando-based Florida Hospital, the parties will pursue a bottom-up strategy of identifying metabolic pathways and signatures to develop new, more personalized treatments for obesity and its associated conditions.

Because of its strong mission in translational medicine, Sanford-Burnham expects the collaboration to be fertile ground for spinning out new companies.

"This is a true discovery collaboration, and we hope that we will be identifying a lot of exciting targets," Sanford-Burnham Vice President Paul Laikind told BioWorld Today. "While we hope to continue collaborating with Takeda to turn these into actual drugs, my expectation is that there will be a lot coming out of this and that could lead to new companies."

Although Sanford-Burnham is an academic research institution, its organizational culture is heavily invested in translational medicine. In fact, it is in the process of establishing an incubator at its California facility. The effort has been boosted by gifts from philanthropist Denny Sanford, hence the name change for the former Burnham Institute. The donations from Sanford, most recently $50 million, have allowed the Burnham Institute to build state-of-the-art scientific infrastructure, including high content screening facilities, that make it a good match for commercial partners.

The terms of the agreement have not been disclosed by either party, except the fact that it is a two-year partnership, with an option to extend if agreeable to both sides.

Laikind said Sanford-Burnham will tackle obesity by collecting samples from many subjects, including obese and lean subjects, and use its core facilities to characterize the samples and create metabolomic profiles to look for potential druggable targets. Sanford-Burnham scientists will be looking for new approaches to treating obesity, and avoiding those that have failed in the past.

"One of the things that does make this very interesting is the question of peripheral effects vs. central effects," Laikind said. "A lot of centrally acting agents, while effective, are very troublesome in side effects." A peripherally targeted agent that works in tissues such as skeletal muscle may be able to improve the action of insulin without causing, for example, the adverse cardiovascular effects that have torpedoed obesity drugs in the past.

A series of events including FDA rejections in the obesity space has cleared the runway for brand new therapeutic approaches.

Abbott voluntarily removed Meridia (sibutramine) from the market in October due to a risk of heart attack and stroke combined with very modest efficacy. (See BioWorld Today, Oct. 11, 2010.)

The bad news kept rolling. In October, the FDA shot down Arena Pharmaceuticals Inc.'s Lorqess (lorcaserin) in October, and Qnexa (phentermine/topiramate) by Vivus Inc. (See BioWorld Today. Nov. 1, 2010.)

Contrave, by Orexigen Therapeutics Inc., did meet the FDA's high standards for safety and received the support of its review panel for approval, but not without intense scrutiny of adverse events within its trials. (See BioWorld Today, Dec. 6, 2010, and Dec. 8, 2010.)

Takeda is an active player in that space, with high-stakes partnerships with Orexigen and Amylin Pharmaceuticals Inc. Takeda came in as a partner on Contrave when it was already under review by the FDA for $50 million up front and a marketing commitment of $1.05 billion. And Takeda acquired rights in 2009 to Phase II obesity compounds pramlintide/metreleptin and davanlintide from Amylin's pipeline for $75 million up front and more than $1 billion in milestones. (See BioWorld Today, April 23, 2009, Sept. 3, 2010.)

The Sanford-Burnham partnership is structured somewhat differently than Takeda's more conventional relationships with Orexigen and Amylin.

"The part of this partnership that is extremely exciting for all of us is the opportunity to work in a creative, innovative model where we go from partnering a major pharmaceutical company, and an institute with unparalleled biotechnology platforms, all the way to clinical investigation a very uncommon approach," Steven R. Smith, director of Translational Research Institute for Florida Hospital and Sanford-Burnham, told BioWorld Today.

Smith said that from a biotech perspective, obesity has "lots of room for innovation." Citing the one-in-three record of obesity drugs with the FDA this year, he added, "It's going to take a lot of shots on goal." And that leaves plenty of chances for players large and small.