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Why did Janssen Postpone Critical Tests for a New Medicine for Diabetic Released by Hanmi Pharmaceutical?Possibility of dose change…labeled ‘terminated’ when it is stopped because of side effects
  • By Lee Hye-seon
  • Published 2016.12.13 07:20
  • Updated 2017.02.20 16:37
  • comments 0

Hanmi Pharmaceutical Co., Ltd has been under controversy because the contract to export a new medicine was cancelled. Now, Hanmi is in trouble again because the a clinical test of the new medicine is postponed. Last November, the news that clinical test status of new bio medicine for diabetic and obesity, ‘HM12525A(JNJ-64565111’, had been changed to ‘suspended’ resulted from stopping clinical tests. The contract of this medicine was worth of $9.15m­illion (including milestone).

The news and the case to return the development right of Olita grow uncertainty in market and Hanmi stock price sharply dropped to 11,000won level on July 31st.

But officials at Hanmi and experts say postponing the clinical test doesn’t mean completely stop of the test.

The company says “the exact meaning of ‘suspended’ is ‘suspended participant recruitment’ and it is a temporary action. Therefore, the clinical test can be restarted. There is no problem in partnership with Janssen”.

Experts also point out it isn’t a common thing to change the status to ‘suspended’ in the middle of a clinical test, but this doesn’t mean complete stop of the test as well as can’t lead to failure.

A professor at internal medicine department of a university hospital says “‘suspended participant recruitment’ isn’t common. But it doesn’t make sense it predicts the failure of the clinical test. If there is highly likely to stop a clinical test because of side effects, the label will be ‘terminated participant recruitment’” He goes to say “I need to see clinical design, but if the test is the first stage( the cause of delaying the clinical test) there is highly possibility of dose change”

The first stage is designed to evaluate a new medicine for a few participants in a clinical test and collects information on safety, safe dose, and pharmacodynamic reaction.

Hanmi made a contract to export new bio medicine ‘HM12525A’(JNJ-64565111) for diabetic and obesity with Jassen worth of $9.15million(including milestone) in November last year.

The medicine has dual treatment logic to vitalize GLP-1 that helps insulin release and appetite control and Glucagon that increases energy metabolism rate. LAPSCOVERY developed by Hanmi to maintain medicine effect is applied. And Hanmi has developed it as new treatment to cure diabetic and obesity given one shot a week. But on 30th, Jassen changed the clinical test status of JNJ-64565111 to ‘suspended’, which led to controversy.

An official at Hanmi explains “I feel sorry about this issue. Late last month, the status was changed and the site is frequently used by other countries. And on 6th, the report was released from stock industry, but rumor is going around in stock industry, which affects market.”

But Korea Exchange (KRX) says it will verify the possibility of unfair trade and the controversy will continue for the time being.

lhs@docdocdoc.co.kr

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