Hanmi Pharmaceutical said today it will partner with Johnson & Johnson’s Janssen Pharmaceuticals to develop the Korean pharma’s Phase II-ready diabetes and obesity candidate HM12525A (LAPSGLP/GCG) and other oxyntomodulin-based therapies. The collaboration could generate up to $915 million for Hanmi.
HM12525A is a biologic GLP-1/Glucagon dual receptor agonist that, according to the companies, has potential to be a once-weekly therapy and the best-in-class among oxyntomodulin-based treatments. The candidate has shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity, Hanmi and Janssen said.
At the European Association for the Study of Diabetes (EASD) 51st Annual Meeting, held September 14-18 in Stockholm, Sweden, Hanmi presented a poster detailing positive Phase I safety and tolerability results for HM12525A compared with placebo in 40 healthy volunteers over a 56-day study period.
“The confirmed long half-life after a single dose supports the potential use of HM12525A for weekly or longer injection intervals,” Hanmi concluded. “Further investigation in T2DM [type 2 diabetes mellitus] patients will explore the synergistic potential of this LAPSGLP/GCG dual agonist to provide for a beneficial and effective therapeutic regimen.”
HM12525A is expected to enter Phase II studies next year.
Janssen agreed to obtain exclusive worldwide rights—except for Korea and China—to develop and commercialize HM12525A.
In return, Janssen agreed to pay Hanmi $105 million upfront, and up to $810 million in payments tied to achieving potential clinical development, regulatory, and sales milestones. Hanmi would also be eligible for tiered double-digit royalty payments if HM12525A is successfully commercialized.
“Through this agreement, we look forward to accelerating the development of HM12525A, to provide an innovative treatment option to patients suffering with diabetes and obesity,” Hanmi CEO/President Gwan Sun Lee, Ph.D., said in a statement.
The exclusive license and collaboration agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, Hanmi said.
Hanmi’s deal with Janssen is the Korean biopharma’s second diabetes collaboration with a pharma giant launched in less than a week. On Thursday, Hanmi and Sanofi announced an up-to-$4.2 billion partnership to develop long-acting diabetes treatments based on Hanmi’s Long Acting Protein/Peptide Discovery (LAPSCOVERY) platform.
Diabetes and obesity constitute one of Hanmi’s three areas of therapeutic focus. The other two are novel targeted agents against cancer and autoimmune disorders; and fixed-dose combination programs.
Earlier this year, Hanmi signed agreements initiating an up-to-$730 million-plus alliance with Boehringer Ingelheim to develop the Phase II HM61713 for EGFR mutation-positive lung cancer; and an up-to-$690 million collaboration with Eli Lilly to develop Hanmi’s Phase I compound HM71224 for autoimmune and other diseases.