Hanmi Pharmaceutical

Hanmi Pharmaceutical (Korean: 한미약품) is a South Korean pharmaceutical company that is headquartered in Seoul.[1]

Hanmi was founded in 1973 by Lim Sung-ki, who was a pharmacist.[2] Hanmi started selling drugs in China in 1996.[3]

By around 2010, Hanmi's R&D had two areas of interest: developing longer-lasting peptide and protein therapeutics using its "Lapscovery" technology, and developing small molecule tyrosine-kinase inhibitors for cancer and autoimmune diseases. Its strategy was to developmental incremental modifications of existing drugs, create new combination drugs, and to develop novel drugs.[4][5]

In August 2014 Hanmi exclusively licensed rights in China for poziotinib, a small molecule EGFR inhibitor, to the Chinese company Luye Pharma; in February 2015 Hanmi licensed rights in the rest of the world outside of South Korea to Spectrum Pharmaceuticals.[4]

In March 2015 Hanmi and Lilly signed an exclusive license outside of Asia for Hanmi's small molecule Bruton's tyrosine kinase inhibitor in the field of autoimmune diseases; Lilly paid $50 million upfront and the deal included up to $640 million in milestones and royalties greater than 10%.[6]

In November 2015 Hanmi signed three agreements:

  • An exclusive license outside of South Korea and China with Sanofi for Hanmi's Glucagon-like peptide-1 receptor agonist drug candidates for diabetes; Sanofi paid $434 million upfront and up to $3.2 billion in milestones and royalties over 10%.[7] The deal included efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist; an insulin intended to be delivered once per week, and a fixed-dosed weekly GLP1-RA/insulin drug combination.[8]
  • An exclusive license outside of South Korea and China with the J&J subsidiary Janssen Pharmaceuticals for Hanmi's oxyntomodulin-analog metabolic disease programs, including HM12525A; J&J paid $105 million upfront and the deal included $810M in milestones and royalties higher than 10%[7]
  • An exclusive license in China with the Chinese company ZAI Labs for olmutinib.[3]

In April 2016 Hanmi announced that it had acquired land near Yantai in the Shandong province of China, where it would build a manufacturing plant and R&D facility; at that time it already had a facility in Beijing.[3] In July Hanmi said it intended to invest more heavily in developing candidate substances of promising new drugs at an early stage in new pharmaceutical and biotech related fields, including through a venture capital firm set up by Sung-ki and colleagues.

In May 2016 the Korean regulatory authority approved olmutinib as a second-line treatment for certain kinds of non-small cell lung cancer.[2]

On September 28 Hanmi and Zentec Pharmaceuticals agreed that Zentec would market Hanmi's small molecule cancer drug candidate, HM95573; Zentec paid $80 million upfront, with $830 million in milestones, and royalties.[9]

On September 29th, Hanmi and Roche's cancer subsidiary Genentech announced a deal for Hanmi's Phase I cancer drug candidate, HM95573, which targets the MAPK/ERK pathway; Roche agreed to pay $80 million upfront, and the deal included $830 million in milestones.[10]

On September 30, 2016, Korean regulatory authorities issued a safety alert about olmutinib in which it described two cases of toxic epidermal necrolysis, one of which was fatal, and a case of Stevens-Johnson Syndrome; Boeheringer announced the termination its deal with Hanmi the same day, citing that the decision came after a review of "all available clinical data" on the drug, and also referring to competing drugs.[11]

On the evening of September 29, 2016 in Korea, Hanmi announced the Roche deal, causing its stock to rise; Hanmi was notified by Boehringer that evening that Boehringer was terminating their deal, and the company announced the termination on the morning of the 30th, causing its stock to crash. Hanmi's offices were raided by Korean regulatory authorities in mid-October based on evidence that insider knowledge of the Boehringer termination was passed to third parties, who shorted the stock prior to the announcement on the 30th.[1][12] In December three Hanmi employees were among 17 people indicted for insider trading; 25 people were fined, and 45 people were found to have made illegal trades that took around 3.3 billion won ($2.83 million) in profits based on the information.[13][14]

In December 2016 the Sanofi deal was reduced in scope, with Hanmi receiving back rights to the once-weekly insulin and the combination GLP1-RA/insulin product, and agreeing to repay Sanofi $250 million of the $434 million upfront payment.[15]

In April 2018 Hanmi was found to have violated two laws in Korea by not disclosing adverse effects of olmutinib sooner.[16] In that month Zai said it was dropping olmutinib[17] and a few days later Hanmi said it was terminating development of the drug.[18]

See also

References

  1. 1 2 Ji-young, Sohn (17 October 2016). "Hanmi Pharmaceutical raided over alleged info leak". The Korea Herald.
  2. 1 2 Dong-chan, Jhoo (20 May 2016). "Hanmi Pharmaceutical introduced first domestically developed lung cancer drug". Korea Times.
  3. 1 2 3 Keenan, Joseph (April 14, 2016). "South Korea's Hanmi to spend $200M in China expansion". FiercePharma.
  4. 1 2 Kim, Marie (4 July 2016). "Hanmi Pharmaceutical to Step Up R&D Investment to Further Develop Core Technologies". BusinessKorea.
  5. ↑ "Research programme: long-acting conjugate therapeutics - Hanmi Pharmaceutical". AdisInsight. Retrieved 25 March 2017.
  6. ↑ Garde, Damian (March 19, 2015). "Lilly inks a $690M deal to get its hands on an autoimmune drug". FierceBiotech.
  7. 1 2 Lane, EJ (November 10, 2015). "Janssen the latest Big Pharma to join Hanmi's South Korea deal machine". FiercePharma.
  8. ↑ "Sanofi, Hanmi Ink Up-to-$4.2B Long-Acting Diabetes Drug Alliance". GEN -- Genetic Engineering & Biotechnology News. November 5, 2015.
  9. ↑ Terry, Mark (September 30, 3016). "Deaths Lead Boehringer Ingelheim to Cancel 730 Million Cancer Deal With Hanmi Pharma Hanmi Stock Tanks". Biospace. Check date values in: |date= (help)
  10. ↑ Taylor, Phil (September 30, 2016). "UPDATED: After patient fatality, Hanmi loses Boehringer, gains Roche in $800M-plus cancer-partner shuffle". FiercePharma.
  11. ↑ Carroll, John (October 1, 2016). "Following lethal tox report, Boehringer scraps plans for high-speed development, kills $730M Hanmi deal". Endpoints.
  12. ↑ Taylor, Phil (October 7, 2016). "Smarting from failed Boehringer deal, Hanmi faces more pain from insider trading probe". FiercePharma.
  13. ↑ Mi-jung, Bae; Tae-yang, Yoo (December 2, 2012). "Hanmi Pharm employees charged over insider trading". Pulse by Maeil Business News Korea (in Korean).
  14. ↑ Ji-young, Sohn (14 December 2016). "Prosecution charges 17 over Hanmi Pharmaceutical disclosure case". The Korea Herald.
  15. ↑ Chan-ok, Shin (29 December 2016). "Hanmi Pharm downsizes license deal with Sanofi over diabetes drugs". Pulse News (in Korean).
  16. ↑ Adams, Ben (April 17, 2017). "Hanmi hit over failure to disclose olmutinib cancer trial side effect". FierceBiotech.
  17. ↑ "Zai Lab returns China rights for olmutinib to Hanmi". BioWorld. April 11, 2018.
  18. ↑ Taylor, Phil (April 13, 2018). "Hanmi calls time on troubled Tagrisso rival olmutinib". FierceBiotech.
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