Hanmi Pharmaceutical, Ahngook Pharmaceutical, Dasan Medichem, and Huons are speeding up the development of incrementally modified drugs (IMD), which have changed the base of Pradaxa (ingredient: dabigatran), an anticoagulant by Boehringer Ingelheim.
Also known as “me-too” drugs, IMDs have similar compounds and efficacy to originals but have changed the base of the latter to produce the same effectiveness.
Boehringer Ingelheim extended Pradaxa’s patent term by three years and five months, under the “patent term extension system.” The system allows a patent term’s extension up to five years to compensate disadvantages of the patentee whose pharmaceutical invention is patented for a shorter period than the inventions of other technologies.
However, 14 local drugmakers filed a trial with the Intellectual Property Trial and Appeal Board to nullify the extension of the patent term for Pradaxa and won the trial in September last year. The move was their strategy to advance the sale of their IMDs that changed the base of the original drug. Now, the four drugmakers can release their IMDs of Pradaxa from next month.
Dasan Medichem and Dasan Pharm received approval for phase-1 clinical trial to compare the safety and efficacy of DA-1602 and Pradaxa on healthy male volunteers, in February and November, respectively.
Ahngook also received the regulator’s nod on a phase-1 clinical trial on AG-1606 in June last year. Hanmi Pharm also obtained approval in December for a phase-1 clinical trial on HIP1404 to check the drug’s safety, tolerability, and pharmacokinetic characteristics in December.
This year, Huons has begun development of a similar drug. The Ministry of Food and Drug Safety Wednesday approved the company’s plan for a phase-1 clinical trial on RDG-17012.
However, the companies will likely be unable to launch IMDs in February, as Boehringer Ingelheim filed an appeals trial with the IPTAB to reverse the latest judgment, and Hanmi, Dasan Medichem, and Huons just started their trials, observers said.
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