Janssen, a subsidiary of Johnson & Johnson, has decided to return the development rights of antidiabetic obesity treatment (HM12525A) that the Belgium-based drugmaker in-licensed from Hanmi Pharmaceutical in 2015.
“In two phase-2 trials that Janssen conducted, the drug achieved the primary endpoint of weight reduction, but its blood glucose control in obese patients accompanying diabetes fell short of Janssen’s internal standards. So, Janssen sent us such notice,” Hanmi Pharmaceutical said in a public filing on Wednesday.
Hanmi does not have to return the upfront payment of $105 million that it had already received from Janssen.
On Nov. 9, 2015, Hanmi inked an out-licensing deal with Janssen, valued at $915 million, over the investigational obesity drug. Janssen has been conducting global clinical trials on the drug candidate with exclusive rights in the global market, except for Korea and China.
Despite Janssen’s drop of the deal, the experimental drug proved efficacy as an obesity drug in phase-2 trials, Hanmi said.
“In phase-2 studies, the treatment showed excellent efficacy in reducing weight in obese people with or without diabetes. We will have an internal review on the matter and confirm our plan for development as soon as possible,” an official at Hanmi Pharmaceutical said. “We are aware that it is not easy to develop a new drug but will not stop challenging to commercialize Korea’s first successful new drug in the overseas market.”
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