IRVING, Texas—Building on a two-year partnership to developan antioxidant inflammation modulator (AIM) compound, Abbott Laboratories andReata Pharmaceuticals are casting a wider net on the therapeutic potential ofReata's AIM portfolio in a 50/50 profit-sharing agreement announced by thecompanies in December.
In September 2010, Abbott agreed to pay Reata $450 million inupfront and near-term cash payments in exchange for the exclusive rights todevelop and commercialize Reata's pivotal-stage chronic kidney disease (CKD)candidate, bardoxolone methyl, worldwide, excluding the United States andcertain Asian markets. Those efforts are deeply entrenched in a Phase IIIclinical trial called Bardoxolone methyl EvAluation in patients with Chronickidney disease and type 2 diabetes: the Occurrence of renal eveNts—or BEACONstudy— a multinational, double-blind, placebo-controlled study designed toassess the impact of bardoxolone methyl on patients with stage 4 chronic kidneydisease and type 2 diabetes.
Per the newly expanded agreement, which is global in nature,the companies will explore a large number of molecules in a broad range oftherapeutic areas, including pulmonary, central nervous system disorders andimmunology. Abbott and Reata will equally share costs and profits for all newAIMs in all newly licensed indications except for rheumatoid arthritis andselect other autoimmune diseases, in which Abbott will take 70 percent of costsand profits and Reata will take 30 percent. The deal also includes a researchagreement in which the companies will work together to discover new moleculesthat exhibit the same pharmacology as the AIMs already in Reata's pipeline.
Reata will earn an additional $400 million in the form of aone-time license payment. The companies expect the first compound in thiscollaboration to enter human clinical trials sometime this year.
"This partnership allows Abbott to enhance its promisingresearch pipeline across multiple therapeutic areas," said Dr. John Leonard,senior vice president of pharmaceuticals, research and development at Abbott,in a statement announcing the expanded partnership. "Accumulating data hasestablished the potential for antioxidant inflammation modulators inneuroscience and immunology, and we look forward to expanding our knowledgethrough further research."
AIMs are potent activators of the transcription factor Nrf2.Nrf2 controls the body's production of hundreds of antioxidants and isassociated with protection against a broad range of diseases of inflammationand oxidative stress. Suppression of Nrf2 and activation of NF-κB have beenassociated with numerous chronic diseases, including multiple sclerosis,rheumatoid arthritis, chronic kidney disease, neurodegenerative disease and chronicobstructive pulmonary disease. Therefore, it's Reata's contention that agentsthat activate Nrf2 and inhibit NF-κB may be beneficial in the treatment ofthese chronic diseases.
Beyond Reata's lead program in kidney disease, a large bodyof literature has demonstrated activity of the company's AIMs in models ofautoimmune, respiratory, cardiovascular, metabolic and central nervous systemdiseases, as well as organ transplants.
"Abbott understood, as we did, that these compounds had thepotential for much broader applications outside of the renal and cardiovascularspace," says the company's CEO, Warren Huff. "About a year ago, we initiateddiscussions about entering into a broader collaboration where we generatedsecond-generation molecules and tested them in a broad range of conditionswhere inflammation played a role in pathology. This was the basis of our secondtransaction."
Huff characterizes the deal as a "true, integratedcollaboration where we are really trying to share the developmentresponsibility in a way that adds the most value and makes the most progress inthe shortest amount of time."
The partnership will also enable Reata to build a globalcommercial presence, he adds.
Founded in 2002 out of the University of Texas M.D. AndersonCancer Center, Reata currently has 150 employees.
"Our deal with Abbott is structured much like an agreementbetween two pharma companies, not a small biotech," Huff says. "There aremillions of people around the world with metabolic and diabetic disease. Theseare cases of great human suffering as well as an incredible expense to healthsystems around the world. We view this deal as something that could beenormously valuable to patients, health systems and us."