Hanmi Pharm did it again. The 1 trillion-sized technology export contract, announced on the 4th, of LAPSGLP/GCG(HM12525A) between Hanmi Pharm and MSD is regarded as an opportunity to revive the stagnant atmosphere caused by the recent history of new drug development. It is said that its resilience has unblocked the pipeline of innovative new drugs that have been nearly buried due to global constraints, setting another milestone in the history of new drug development in South Korea. Especially under similar circumstances, more attention is being paid to the fact that it can be a sign of the revival of the ‘epiglenatide’, the peak of Hanmi Pharm's technology export.
Some said that this technology export of Hanmi Pharm is of great significance because it has achieved the “precision” of R&D development of "as one sows, so shall he reap". Regarding R&D investment, Hanmi Pharm, the representative of Korea, has played a pioneering role such as the export of advanced new drugs, complex new drugs, and innovative new drugs. However, it has suffered several frustrations during the recent phase 3 clinical trials. In this sense, this 1 trillion technology export has reconfirmed the potential of Hanmi Pharm and raised people's expectations for innovative new drugs. What is even more pleasant about this technology export is that it will greatly contribute to changing the atmosphere of new drug development in Korea, which is almost stagnant. It is true that in recent years, there have been more discouraging news. Particularly the clinical phase 3 has been regrettable, for such a global pharmaceutical company that has been in charge of global clinical practice to give up and return a large number of new drug development failures on the grounds that they "did not achieve the expected results". In addition to the news of the phase 3 failure, the pharmaceutical company had to experience the difficulty of shaking up the entire company due to the stock price plunge and distrust of the development process itself. Some pharmaceutical officials shared their feelings of walking on a thin ice plate ahead of the phase 3 clinical trials. Despite continuous investment, frequent failure news are making it more difficult for the company to develop new drugs, and skepticism about investment has also emerged.
Meanwhile, Hanmi Pharm is said to have set a new milestone for new drug developers in Korea through this technology export. It is of great significance that it revived the innovative new drug pipeline that once received a “death sentence” with a global pharmaceutical company returning the development rights. In the case of technology export "LAPSGLP/GCG (HM12525A)", the technology was exported to the multinational pharmaceutical company Janssen in November 2015 for a total of $880 million (at the time, 9372 billion Korean won), but the rights were returned in July last year after 4 years. At the end of phase 2 clinical trials, Janssen tried to develop a treatment for obesity and diabetes simultaneously, but finally returned it on the grounds that "the goal of weight loss has been achieved, yet the blood sugar control in obese patients with diabetes did not meet internal standards." In this case, development itself is likely to be frustrated, but Hanmi Pharm succeeded in finding a technology partner and succeeded in a technology export contract larger than that of Janssen. Hanmi Pharm has signed a $860 million (about 1.273 trillion won) contract with MSD, a multinational pharmaceutical company headquartered in the United States, to develop "LAPSGLP/GCG (HM12525A)" into Nonalcoholic Steatohepatitis (NASH) therapeutic drug for development, manufacture and commercialization. Since Hanmi Pharm needs to be able to simultaneously improve various indicators that are the basis for evaluating the effectiveness of NASH treatment in order to be licensed as an innovative new drug for NASH treatment, people are racing to develop the acting LAPSGLP/GCG dual worldwide. It is expected that it can be developed as the best new drug among NASH treatments. If a new drug candidate that has been exported to a global pharmaceutical company fails in the clinical process, its rights will be returned, which is considered as a “death sentence" though it could be a mistake in the development direction of the pharmaceutical company such as clinical design, the responsibility lies in the domestic pharmaceutical company that exports its technology. The misconception that global pharmaceutical companies have always been right still persists. However, this case suggests that there may be mistakes in the judgment of global pharmaceutical companies. This means that the level of new drug development in Korea has also improved.
This case is also a matter of concern. Five global phase 3 clinical trials are being conducted on the diabetes treatment injection "epiglenatide", which is injected once a week, and this will affect the relevant negotiation with Sanofi, thus attracting much attention. It is no exaggeration to say that epiglenatide is the flower of Hanmi technology export. In November 2015, the technology was exported to Sanofi at a total price of 4.33 trillion won, but in May this year, it was told that the rights were returned. After 120 days of negotiation, it finally entered the confirmation stage. It should be noted that both Sanofi and Hanmi said that they had nothing to do with the efficacy or safety of "epiglenatide". When global pharmaceutical companies receive a new drug technology, they'll decide whether to continue to develop drugs based on the objective evaluation and analysis after the clinical trials are completed. However, Sanofi has ignored the "currently ongoing" clinical trial involving more than 5,000 patients and expressed its intention to return the rights. In related industries, some even criticized Sanofi for taking patients as hostages in an attempt to "shake the negotiations" so as to reduce its investment in global clinical phase 3. Criticism is whether Hudson, the new president of Sanofi, who is from sales marketing, is focusing on immediate profits rather than mutual trust to build his achievements in "company revenue." Some critics believe that Hanmi Pharm is looking for new partners under better conditions for the technology export return pipeline, creating a favorable situation for negotiations with Sanofi on the return of epiglenatide for upcoming 40 days. Source: Medical News