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Hanmi Pharm rejects rumors of clinical trial setback on Janseen project
Collected
2016.12.08
Distributed
2016.12.09
Source
Go Direct
South Korea’s Hanmi Pharmaceutical Co. which has reasons to be jumpy about more bad news denied rumors of interruption in a clinical trial of its investigational drug JNJ-64565111, saying the program remains underway although patient recruitment is on suspension.

Hanmi Pharm signed a license deal with Janssen over the drug to treat diabetes and obesity. Hanmi shares tumbled 10.76 percent to close at 311,000 won on Wednesday despite the denial statement.

The official website of the clinical trial says “this study has suspended participant recruitment,” but patient recruitment suspension happens commonly in the process of a clinical trial and the program will be resumed, Hanmi Pharm added.

It also said its partnership with Janssen remains intact. Hanmi Pharm said it cannot guarantee when the clinical study is back on because the study is controlled by Janssen and it is working on the release of regulatory disclosure in Korea.

Market watchers say the recruitment suspension can happen because of negative developments or happen commonly in the process of updating clinical trial information, but Janssen remains silent.

JNJ-64565111 is another project name for HM12525A over which Hanmi Pharm signed a license deal with Janssen for $915 million in total late last year. Janssen announced it began a phase I study in July and suspended patient recruitment on Nov. 30.

Hanmi Pharm has already lost face and investors’ confidence following the cancellation of a major out-licensing deal with Boehringer Ingelheim. The company is under damage suit by hundreds of minority shareholders that had been burned by the deferred announcement of the license termination. Its company employees have been indicted on insider trading charges.

By Shin Chan-ok

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