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- Giotrif competitor Vizimpro close to receiving reimbursement
- by Eo, Yun-Ho Sep 15, 2020 06:27am
- Sources report, Pfizer Korea is speeding up the procedure to introduce epidermal growth factor receptor (EGRF) tyrosine kinase inhibitors (TKI) into the market. According to the industry sources, a fifth EPGF TKI Vizimpro (dacomitini) has passed the Health Insurance Assessment and Review Service (HIRA) Cancer Deliberation Committee in last July, and it is waiting for Drug Reimbursement Evaluation Committee’s (DREC) deliberation in October. Although the DREC deliberation was initially scheduled be convened in September, the deliberation was delayed due to the resurging number of confirmed COVID019 cases. Currently, the first generation EGFR TKI ‘Iressa (gefitinib)’ by AstraZeneca and Tarceva (erlotinib) by Roche, and the second generation Giotrif and the third generation Tagrisso (osimertinib) by AstraZeneca are prescribed in South Korea. As its direct competitor Giotrif (afatinib) has already settled in the market already, Vizimpro chose the drug pricing negotiation exemption track. As a result, its launch would be able to convince the product from then on in the second half of the year. Vizimpro’s efficacy has been confirmed in Phase III ARCHER 1050 trial. The study compared Vizimpro and the first-generation Iressa head-to-head with total 452 patients fighting against non-small cell lung cancer (NSCLC). In the trial, the medicine reduced the risk of progression-free survival (PFS) by 41 percent than Iressa, when Vizimpro patient group’s median PFS was at 14.7 months and Iressa group’s was at 9.2 months. The study reported Vizimpro lowered the risk of progression or death by 41 percent against Iressa, and the median progression-free survival (PFS) was 14.7 months in the Vizimpro group and 9.2 months in the Iressa group. Nevertheless, Vizimpro showed worse cases of adverse reactions. In the Vizimpro group, the frequently demonstrated severe adverse reactions included dermatological issues with pimple (14 percent) and diarrhea (8 percent), whereas changes in liver enzymes (8 percent) were significant in the Iressa group. Around 60 percent of Vizimpro patient group had to adjust their medication dose due to adverse reaction. Vizimpro is a second-generation targeted therapy indicated to treat patients with EGRF-mutation-positive NSCLC. The U.S. Food and Drug Administration (FDA) approved the anticancer treatment in September 2018 after granting Priority Review in January same year. Currently, the drug is approved and used in the U.S., EU and Japan. In Korea, the medication has been approved as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, and it is also indicated treat patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations, who has not been treated before.
- Company
- The sales of antiemetic drug Nasea plummeted
- by Kim, Jin-Gu Sep 15, 2020 06:26am
- Nasea Sales in the domestic market declined after three types of domestic copyright rights, including the antiemetic drug Nasea (Ramosetron), were transferred from Astellas to Daiichi Sankyo, a Japanese pharmaceutical company. According to IQVIA, a drug research institute, Nasea's sales in the first half of this year were ₩12.7 billion, down 30% from ₩18.3 billion in the first half of last year. Compared to the second half of last year (₩16.4 billion), it also decreased by 22%. This is in contrast to the 50% increase in sales of other Ramosetron-based treatments from ₩10.2 billion to ₩15.4 billion over the same period. In addition to Nasea, Treatments including Ramosetron are ▲Boryung's Naseron ▲ Hana's Ramset ▲Parvis Korea’s Ramea ▲Astellas' Irribow ▲Kyongbo’s Ramocan, etc. In the case of Naseron, sales increased 63% from ₩6.1 billion in the first half of 2019 to ₩9.9 billion in the first half of this year. During the same period, Ramset increased 37% from ₩2.7 billion to ₩3.7 billion, and Ramea decreased 24% from ₩800 million to ₩600 million. Half-annual sales of Nasea and Ramosetron-based antiemetics (unit: ₩ billion, data from IQVIA) Nazea is a leading item in the antiemetics market with annual sales of over ₩30 billion. However, as sales declined significantly, the gap with the second-largest Ramosetron (Naseron) narrowed. The difference in sales between Nasea and Naseron in the first half of last year was ₩12.2 billion, but the gap has decreased to ₩2.8 billion in the first half of this year. Previously, Daiichi Sankyo Korea received three types of copyrights, including Nasea, Oldeca, and Perdipine sold by Astellas Korea from December last year. In the case of Perdipine, only injections were transferred to Daiichi Sankyo. On July 31, last year, Daiichi Sankyo headquarters signed a transfer agreement for the three drugs sold by Astellas in six Asian countries, including Korea, and the domestic copyright also changed. There was no significant change in the other two items except for Nasea. Oldeca posted sales of ₩900 million in the first half of last year and the first half of this year. In the case of Perdipine injection, the market size was very small, with semiannual sales of less than ₩100 million. It was a 15% decrease from ₩18.35 million in the first half of last year to ₩15.61 million in the first half of this year.
- Company
- Listed pharma companies financially sound despite COVID-19
- by Kim, Jin-Gu Sep 14, 2020 06:16am
- Apparently, major South Korean pharmaceutical and bio companies have been maintaining the level of financial soundness from late last year for the first half of this year. One of their financial soundness indicators, net liabilities, showed similar level as late last year, which the experts analyze the industry is performing relatively well, regardless of COVID-19. According to Financial Supervisory Service (FSS) on Sept. 14, 30 listed Korean pharmaceutical companies’ net liabilities reached 7.63 trillion won as of the end of first half of the year. Compared to 7.61 trillion won as of same time last year, the figure was slightly increased by 0.3 percent (24.1 billion won). Technically, the net liabilities have not changed much. The net liabilities indicate a company’s financial liquidity. The less net liabilities, the better financial soundness is. The net liabilities are the difference between the total current liabilities and the total current assets accounting only cash or cash equivalents. In other words, it is the value of the debt a pharmaceutical company has minus the total sum of all liquidatable cash (or cash equivalent assets). On paper, the 30 pharmaceutical companies’ total debt has surged, but their total assets have also increased as much and canceled out the inclined the net liabilities. The total liabilities of the 30 pharmaceutical companies, as of late June, were 10.65 trillion won, growing 9 percent (841.5 billion won) from last year same time at 9.81 trillion won. In the same period, the total cash and cash equivalent assets grew by 37 percent (817.4 billion won) from 2.20 trillion won to 3.17 trillion won. The cash and cash equivalents are assets without real estate, stock, intellectual property and some of financial assets, and most of them are operating profit. As for financial instruments, only the ones that acquire the income in three months (or expire) are accounted. The 30 companies’ sales and operating profit have reportedly improved over 40 percent in the first half of the year, regardless of COVID-19. The overall change in total liabilities, cash and cash equivalents and net liabilities in 30 listed pharmaceutical companies (Unit: KRW 100 million) Source: FSS Also some companies have significantly improved their financial soundness by decreasing the net debt. Hugel has apparently improved its financial soundness the most with its net liabilities dropping by 203.1 billion won. Also, Yuhan (154.8 billion won), Dong Hwa Pharm (71.8 billion won), Daewoong Pharmaceutical (56.9 billion won) and Dong-A ST (37.3 billion won) were able to reduce the net liabilities. Particularly, Hugel and Dong Wha Pharm have recorded negative net liabilities as of late June. Basically, the two companies can pay off their debts with the cash they can immediately liquidate. Meanwhile, Dong Kook Pharmaceutical (90.3 billion won), Samsung Biologics (88.6 billion won), GC Pharma (74.5 billion won), Celltrion (41.8 billion won), Hanmi Pharmaceutical (41 billion won), Kyung Dong Pharm (36 billion won) and JW Life Science (35.8 billion won) had their net liabilities increased. Overall, 22 companies out of the 30 companies had their net liabilities increased. The total liabilities, cash and cash equivalents and net liabilities in 30 listed pharmaceutical companies (Unit: KRW 100 million) Source: FSS The experts analyze the top listed pharmaceutical companies were able to maintain the net debt level on par with last year, because the industry is relatively thriving despite COVID-19 pandemic. A credit rating agency’s report found most of industries including, semi-conductor, automobile, distribution, display, hospitality and duty free, airline, shipbuilding and steel, have worsened their financial soundness in the first half of the year.
- Company
- Expectations on Zejula are high
- by Sep 14, 2020 06:15am
- “The biggest burden on recurrent ovarian cancer patients is definitely 'relapse'. Zejula can play an important role for patients by preventing recurrence through primary maintenance therapy. In particular, it can be used as an All-comer. The appearance of Zejula is likely to make a big difference in the treatment of ovarian cancer.” Soo-Young Hur, a professor of obstetrics and gynecology at Seoul St. Mary's Hospital, said at an online press conference for PARP inhibitor Zejula (Niraparib) on the 10th, about Zejula's significance of expanding the indications for primary ovarian cancer maintenance therapy. Takeda Korea's ovarian cancer drug Zejula is the first PARP inhibitor that can be used regardless of whether the BRCA gene has been mutated. It was approved for the first time in Korea in March 2019 as ‘a single maintenance therapy for adult patients with platinum-sensitive recurrent highly serous ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have fully or partially responded to platinum-based chemotherapy at least 2nd order’ Since then, the indications have been expanding. In December last year, it became available for 4 or more monotherapy, and in August, it also acquired indications for first-line maintenance therapy. Soo-Young Hur, a professor of obstetrics and gynecology at Seoul St. Mary This online meeting was set up to explain the clinical research and treatment significance that served as the basis for the expansion of the indications for the primary maintenance therapy of In the case of ovarian cancer, recurrence occurs within 1-3 years in most patients after chemotherapy. After chemotherapy, the progression-free survival (PFS) is very short, ranging from 8 to 14 months, so maintenance therapy is selected to prolong it. Maintenance therapy options include Bevacizumab, a VEGF inhibitor, and PARP inhibitors such as Olaparib , Veliparib, and Niraparib. According to Professor Antonio González-Martín (The University Clinic of Navarra, Spain), the principal of PRIMA's clinical study, which was the basis for the expansion of the indications for the first-line maintenance therapy of Zejula, "The results of the PRIMA study show that the median PFS of Zejula in the HRd group is 21.9 months, and the placebo group (10.4 months). Also he said. "It also showed an effect in the HRp patient group." In particular, although the PRIMA study mainly included patients with high risk of recurrence, it was explained that it was effective in all patient groups regardless of biomarkers such as HRd or BRCA mutation. As for the safety profile, hemologic adverse reactions were observed in some patients, but they were manageable through dose reduction or suspension of medication, he added. In particular, he said about a comparative analysis with the combination therapy of Olaparib (Lynparza) + Bevacizumab (Avastin), which was approved as the first line maintenance therapy for HRd ovarian cancer patients regardless of BRCA mutation in the United States. "The PAOLA study shows that the combination with Olaparib is better than Bevacizumab alone, and this only appeared in the HRd patient group." However, he commented, "It is not clear how much additional value added to Bevacizumab plus Olaparib provides." He added, “When deciding on a treatment option that is suitable for a patient, we need to consider both options, as we need to consider several factors including clinical factors. There will be some patients in the group where Bevacizumab is not suitable, and also in the HRp group. Zejula is the only drug that has proven its effectiveness.” Professor Hur also focused on the fact that Zejula shows effects regardless of biomarkers. He said, "Olaparib can only be used when there is a BRCA mutation, but among ovarian cancer patients, the BRCA mutation is a small proportion of about 20%. In addition, Bevacizumab does not require a biomarker, but it is used depending on the patient's stage, and there are concerns about side effects such as toxicity." In addition, he said, "Zejula can be used as an all-comer, and if the dose is adjusted according to individual patients, the effect can be maintained while reducing side effects." He said, "I expect that Zejula can be used as an all-commer after ovarian cancer treatment, which will bring about a huge change." And he added that the indications have recently been expanded, and due to restrictions on reimbursement, there is not much experience in prescribing Zejula as the first maintenance therapy. As data accumulates in the future, it will be of great help to patients as a first-line maintenance therapy.
- Company
- Kolmar shareholders agree to dispose CMO and Kolmar Pharma
- by Chon, Seung-Hyun Sep 14, 2020 06:15am
- Kolmar Korea’s shareholders have agreed to dispose of the corporate asset valued at 500 billion won. Kolmar Korea announced the shareholders have deliberated at a general meeting convened on Sept. 10 to pass the agenda of selling the company’s pharmaceutical CMO and Kolmar Pharma to IMM Private Equity (PE). Previously in last May, Kolmar Korea signed a deal to sell off its 62.1 percent share of Kolmar Pharma and the entire pharmaceutical CMO sector to IMM PE for 512.4 billion won The private equity firm was to take over the pharmaceutical CMO sector valued at 336.3 billion won and Kolmar Pharma at 176.1 billion won. Prior to their general shareholders’ meeting, one of the top shareholders, National Pension Service (NPS) voted against the asset disposal. Regardless, the general shareholders have agreed to dispose the asset as planned. Voting against the asset disposal, NPS recently said, “The asset’s transfer scope and value of shares have not been finalized for the shareholders to deliberate.” Currently, NPS owns 11.75 percent of Kolmar Korea’s shares. However, the proceeds from sale could be lessened due to the result of additional negotiation between Kolmar Korea and IMM PE. Kolmar Korea disclosed the business transfer notice stating “The company is currently undergoing additional negotiation with the transferee about the scope of transferring asset, and the proceeds from sale may be lowered up to 15 percent, depending on the negotiation result.” Kolmar Korea’s shareholders may exercise their appraisal right until Oct. 5. An appraisal right is the statutory right of a shareholder, who opposed to an issue that the majority voted for in the general shareholders’ meeting, to demand the company to acquire their shares. The obliged purchasing price of the share is at 42,556 won. As the price is lower than the share price recorded on the day of the shareholders’ meeting at 45,900 won, the shareholders are unlikely to exercise their rights.
- Company
- The issue is that the NHIS is entitled to indemnity or not
- by Kim, Jin-Gu Sep 14, 2020 06:14am
- A legal dispute has begun between the NHIS and 36 domestic pharmaceutical companies regarding Valsartan's claim for right to indemnity. At the first trial, the issue emerged as an issue whether the NHIS exercises the right to indemnit. The judiciary questioned whether they were eligible to claim from the NHIS, not from patients under the Product Liability Act. On the morning of the 10th, the 21st Division of Civil Affairs of the Seoul Central District Court proceeded to a lawsuit for the existence of a debt filed by 36 pharmaceutical companies, including Daewon Pharmaceutical, against the NHIS. It was the first trial on the right to indemnify Valsartan. Previously, the NHIS requested ₩2.1 billion worth of compensation from 69 pharmaceutical companies related to the Valsartan case in July last year. The reason was that the pharmaceutical company should take responsibility for the health care finances being invested due to Valsartan. Accordingly, 36 companies, including Daewon Pharmaceutical, filed a lawsuit against the NHIS for the existence of debt. The intention was that there was no need to fulfill the right to indemnify the NHIS. It was argued that impurities were detected irresistibly even though pharmaceuticals were manufactured in a legal process not only domestically but also globally, and it was excessive to ask pharmaceutical companies to be liable for compensation as the impurities were recognized with the development of science. In the first trial, the qualifications of the NHIS were the main issue. The judge asked, "If a pharmaceutical company sells medicines, the NHIS buys them directly?" It was a question asking whether the NHIS, not the direct buyer, was entitled to claim the right to indemnify. In response, the NHIS replied, "If a patient receives a diagnosis, prescription and takes medicines, it can be a buyer because it pays money in the form of reimbursement in the end." The plaintiff, Daewon Pharmaceutical, gave the NHIS tit for tat. Daewon Pharmaceutical said, "The defendant is said to be the final and ultimate buyer, but it is impossible under civil law. The NHIS is not entitled to claim." The judge asked again that it was only partially supported by the health insurance system for the patient's purchase of medicines according to the claims of the NHIS, and wasn't that the party?" Then, the NHIS said, “As the patient stopped taking medicines, they began to use generic substitution, and damage occurred to the NHIS accordingly. Under the Product Liability Act, the qualification to claim (reimbursement rights) is not a 'consumer' but a 'victim'. However, how to interpret the victims specified in the Product Liability Act was no longer covered in this trial. In the next trial, a fierce legal dispute between the plaintiff and the defendant is expected over the interpretation of the victim under the Product Liability Act. The next trial is scheduled for 11 AM on November 19th.
- Company
- Korean drug industry prepares for Peramiflu generic
- by Kim, Jin-Gu Sep 11, 2020 06:29am
- Peramiflu supplied by GC Pharma South Korean pharmaceutical companies are speeding up the launch preparation for a flu drug Peramiflu (peramivir) generic. After filing trials for invalidation of original patent late last year, ten pharmaceutical companies recently applied for the generic approval. If Ministry of Food and Drug Safety (MFDS) approves the generic and the companies win the ongoing patent dispute, the Peramiflu generics would be accessible in the market from coming winter at earliest. The pharmaceutical industry sources reported on Sept. 11 that three Korean pharmaceutical companies have applied for approval on their Peramiflu generics in the last two months. Peramiflu is an influenza drug sold by GC Pharma in South Korea. GC Pharma licensed the drug from the U.S.-based BioCryst and received the Korean health authority approval in 2010. The drug has a valid substance patent that expires on Feb. 12, 2027. Apparently, 10 Korean companies have challenged Peramiflu’s patent by filing a patent nullification case in December last year. Ilyang Pharmaceutical, Penmix, JW Pharmaceutical, Kolon Pharma, Kolmar Korea, Kolmar Pharma, HK Inno N, Chong Kun Dang, and Hanmi Pharmaceutical are part of the case. Sources confirm three companies among the patent challengers have applied for the item approval so far. Apparently, all three companies have their own manufacturing facilities. The applications were submitted to MFDS on July 22, 30, and Aug. 14, respectively. As a result, the three companies have met two out of three prerequisite conditions (first to file patent trial and first to apply for approval) to win the preferential sales rights. Only one condition is left for them to achieve—they would need to win the patent trial. The patent trial proceeding has reportedly picked up its speed again after being delayed by COVID-19 for a while in the first half of the year. The industry expects the trial decision to be made by the end of the year at earliest. The industry insiders also predict the generic could be released in winter, if the companies win the patent trial. An official from a pharmaceutical company challenging the Peramiflu patent noted, "Currently, the patent dispute is actively progressing on paper. We are expecting the Intellectual Property Trial and Appeal Board to conclude the trial within this year," and “meanwhile, the company is proceeding with patent dispute and item approval to launch the generic in coming winter.” Peramiflu is an improved formulation of oseltamivir, a substance of the top selling influenza treatment Tamiflu. When Tamiflu has to be administered orally for five days, Peramiflu can be effective with only a single intravenous injection for 15 to 30 minutes. Boosted by its convenience, Peramiflu is rapidly growing in the flu treatment market. According to pharmaceutical market research firm IQVIA, Peramiflu has made 7.1 billion won last year. Compared to 2 billion won generated in 2017, the sales almost tripled in three years. In last two years, sometimes the supply was unable to keep up with demand and some regions experienced shortage.
- Company
- Qurient, expects a big deal for Q203, Q301, Q702, & Q901
- by An, Kyung-Jin Sep 11, 2020 06:28am
- There are high expectations for Qurient to sign a large technology transfer contract in the second half of the year. All four key tasks, including immune anticancer drugs, atopic dermatitis and multi-drug-resistant tuberculosis treatment, are all in the process of discussing technology export, and there is a possibility that at least one contract will be signed within this year. Qurient held IR(Investor Relations) on the 9th to 10th to introduce the status of the project. Qurient is a new drug development company established in July 2008. In February 2016, it was listed on the KOSDAQ market through a special listing of technology growth companies. Make full use of the project management-based network research and development (R&D) business model. It is a type of NRDO (No Research Development Only) that introduces promising initial tasks from outside and then entrusts them to external research institutes to conduct research and development. Qurient shared the development status of four key new drug tasks at IR on this day. ▲Immune anticancer drugs 'Q702' and 'Q901' ▲Multi-drug resistant tuberculosis treatment 'Q203' ▲Atopic dermatitis treatment 'Q301'. All four projects are in the process of negotiating technology exports with global pharmaceutical companies, and some have opened up the possibility of signing contracts within this year. Introduction of new drug projects held by Qurient (Source: Qurient IR) In terms of the speed of development, Qurient believes that two types of multi-drug-resistant tuberculosis treatment 'Q203' and atopic dermatitis treatment 'Q301' are the right time to transfer technology. Both types have secured successful initial clinical data. Multi-drug-resistant tuberculosis treatment 'Q203' (Telacebec) ended phase IIa clinical trial last December. As a result of drug treatment for 14 days, 'Q203' showed clear anti-tuberculosis efficacy compared to two commercially available resistant tuberculosis treatments. It is explained that the interest of Big Pharma increased as it was published in the New England Journal of Medicine, an internationally recognized academic journal earlier this year. Since it was previously designated as an orphan drug and a drug subject to rapid review, it predicted that it is possible to quickly enter the market through the conditional approval procedure after completing phase IIb clinical trial. Cream-typed atopic dermatitis treatment, 'Q301', also secured successful data in phase IIb, and ended last May. Although in the early stages, the immune anticancer drugs 'Q702' and 'Q901' are at the stage of successful technology export with a differentiated mechanism. Qurient said, "We are reviewing various business alliance plans such as technology export for all pipelines the company has. We can not comment on specific timing, but we expect rapid results." "In the long term, it was established in Dortmund, Germany earlier this year. "We plan to focus on the development of proteasome inhibitors through a joint venture, QLi5 Therapeutics."
- Company
- Hunterase by GC Pharma is entering the Chinese market
- by Chon, Seung-Hyun Sep 11, 2020 06:28am
- Hunterase by Green Cross is entering the Chinese market GC Pharma announced on the 9th that Hunterase, a treatment for Hunter syndrome, has obtained a license from the NMPA of China. This is the first time that a drug for Hunter syndrome has been approved in China. Hunterase by Green Cross GC Pharma applied for Hunterase's item license, July of last year in China, and was designated as a priority subject of review by the NMPA in September. The commercialization of Hunterase in China and other China region is undertaken by “CANBridge Pharmaceuticals,” which has signed an export contract. Hunter syndrome, referred to as 'type II mucopolysaccharide', is a rare congenital disease that shows various unpredictable symptoms such as skeletal abnormalities and decreased intelligence, and dies early around 15 years of age. In general, it occurs at the rate of 1 in 150,000 males, and one of the Greater China countries, about 1 in 50,000 to 90,000 cases occurs in Taiwan, and it is known that the incidence rate in East Asian countries is higher. Currently, more than 3,000 patients with Hunter syndrome in China are estimated. GC Pharma developed Hunterase as the world's second hunter syndrome treatment in 2012 and is now supplying it to 11 countries around the world. It is also planning for Hunterase to enter Japanese market. GC Pharma' partner, Clinigen K.K., applied for an item license of 'Hunterase ICV (intracerebroventricular)', a ventricular administration method, to the Japan Pharmaceutical and Medical Device Administration (PMDA) in March. Hunterase ICV is a novel formulation in which drugs are administered directly to the ventricle by inserting a device into the head. ICV has the advantage of overcoming the limitations of existing intravenous formulations that do not improve the symptoms of decreased intelligence because drugs can not penetrate the blood brain barrier (BBB). Eun Chul Huh, President at GC Pharma said, “It is of great significance in that we are able to provide new treatment environments and opportunities for patients with Hunter syndrome in China. I will do my best.” James Xue, CEO of CANbridge, said, "The approval of this product will be an important step forward in our efforts to commercialize the desperately needed treatment for rare diseases in China and around the world."
- Company
- Hanmi to turn efpeglenatide crisis around with new partner
- by An, Kyung-Jin Sep 10, 2020 06:24am
- Hanmi Pharmaceutical’s glucagon-like peptide-1 (GLP-1) agonist ‘efpeglenatide,’ initially licensed out to a global pharmaceutical company Sanofi in 2015, was ultimately returned to the South Korean company. Four months after when the global company indicated its intention to return the rights on the drug May, Sanofi has decided to suspend clinical studies on the antidiabetic treatment and officially informed each clinical institutes. Hanmi Pharmaceutical plans to take over all five Phase III clinical trials Sanofi was conducting, and look for new opportunities to commercialize efpeglenatide. Over the past three years, three global Phase III clinical trials on efpeglenatide have recruited 5,391 participants, and collected a vast amount of data. Various options are in discussion, such as finding a new commercialization partner in the antidiabetic treatment field, exploring new indications treating other metabolic diseases, and developing a combination therapy with the Korean company’s new drug pipeline. ◆Sanofi says “R&D strategy has changed,” and returns the rights over efpeglenatide after five years Apparently, the sign of the contract termination was looming from last year. CEO Paul Hudson at Sanofi, held an investors event to talk about R&D strategies in late last year. He declared the company "would halt researches in the diabetes and cardiovascular programs." His plan is to focus R&D investment in four areas, including oncology, blood disorders, rare disease, and neurology diseases. Even at the time, Sanofi had unchanged commitment to continue developing the long-lasting GLP-1 agonist efpeglenatide. The company was determined to complete the five Phase III clinical trials on efpeglenatide, but wanted find another commercialization partner to take charge of global sales and marketing activities after receiving the approval. CEO Paul Hudson affirmed, “It was the best decision for the successfully launch of efpeglenatide while maximizing the productivity of our research engine. It was irrelevant to efficacy and safety of the substance, and it would make no changes on license-in agreement with Hanmi Pharmaceutical." However, Sanofi overturned its initial position in just five months, and informed Hanmi Pharmaceutical of its intention to return the rights over efpeglenatide. The two companies concluded the efpeglenatide returning procedure on Sept. 8 (local time) after a 120-day negotiation period as stated on the contract terms. Hanmi Pharmaceutical would not take any legal actions like litigation for damage compensation the company has previously claimed. Sanofi is expected to hand over all data collected from the on-going Phase III clinical trials to Hanmi Pharmaceutical, and step away from the entire development process. Hanmi Pharmaceutical has also agreed to take over the one Phase III clinical trial to be completed in October. Including the compensation and research cost coverage, the conditions for breaching the contract were undisclosed. ◆Market competition intensified with oral GLP-1 agonist Rybelsus The pharmaceutical industry pin points the cause of Sanofi giving up on developing efpeglenatide lies on the pipeline growing unattractive for the market. The global GLP-1 agonist market is expanding rapidly. Nevertheless, the industry sees that the latecomers would struggle to enter the market as multinational pharmaceutical companies like Novo Nordisk and Eli Lilly are firmly dominating the market. (From left) Product image of Victoza, Ozempic, Rybelsus and Trulicity Eli Lilly's once-weekly subcutaneous injection Trulicity (dulaglutide) owns majority of the share in the single therapy market. In addition, Novo Nordisk is expanding its market presence as it added newly launched the world's first oral GLP-1 agonist Rybelsus (semaglutide) to its existing line up of once-daily subcutaneous injection 'Victoza (liraglutide)' and once-weekly injection 'Ozempic (semaglutide).'. Lily's Trulicity generated global sales of USD 4.23 billion (approximately 4.91 trillion won), surging by 29 percent compared to the previous year. The drug is expected to reach its new record in yearly sales as it made 2.50 billion dollars in the first half of this year. Novo Nordisk's three GLP-1 agonists have earned overall DKK 33.22 billion (approximately 6.26 trillion won). The Danish company’s first GLP-1 Victoza had a sales dip of 21.93 billion kroner, but the company had even more significant growth with the recently launched Ozempic sales increasing up to 11.24 billion kroner, and newly released Rybelsus making 50 million kroner. In the first six months of the year, the Ozempic sales grew up to 9.60 billion kroner, and surpassed Victoza sales reaching 9.23 billion kroner. Rybelsus marked six-month sales of 584 million kroner immediately after its release. The three drugs’ sales in total reached 19.4 billion kroner (approximately 3.65 trillion won) in the first half of the year. A GLP-1 agonist efpeglenatide has extended the administration term to once-weekly by incorporating Hanmi Pharmaceutical’s key platform technology, ‘Lapscovery’. However, the industry experts analyze the investigational drug’s competitiveness as a follow-on drug is faltering when Trulicity and Ozempic dominate the once-weekly injection market and even an oral option Rybelsus emerges. ◆Hanmi with 6,000 participants’ data, committed to rekindle efpeglenatide’s potential The industry experts address Sanofi’s three-year worth of abundant clinical data as an engine to bring efpeglenatide back to life. Sanofi has been operating five Phase III clinical trials since it signed the deal over efpeglenatide from Hanmi Pharmaceutical in 2015. Two years into the deal, a Phase III AMPLITUDE-M study that compared efpeglenatide against placebo on the blood glucose level reduction effect was initiated from late 2017, and four Phase III clinical studies have started as of last year. Following are the four Phase III trials; AMPLITUDE-D study compares efpeglenatide against Trulicity plus metformin combination therapy; AMPLITUDE-O study evaluates efpeglenatide’s effects on the cardiovascular system in type 2 diabetes patients; AMPLITUDE-L study administers efpeglenatide and other existing insuling treatment to type 2 diabetes patients; and AMPLITUDE-S additionally administers efpeglenatide to type 2 diabetes patients, who cannot control blood sugar level even after using metformin alone or metformin and sulfonylurea combination. AMPLITUDE-M, AMPLITUDE-D and AMPLITUDE-O studies have completed subject registration. Total 5,391 participants registered for the three studies. Considering the number of participants registered for the remaining two studies, the number would sum up to around 6,000. Hanmi Pharmaceutical plans to conduct and complete the AMPLITUDE-M study scheduled to end in October. AMPLITUDE-M study is the first Phase III clinical study initiated by Sanofi after it licensed in efpeglenatide. Companied called for participants from 56 research institutes in four countries including the U.S., Germany, Poland, and the U.K. from December 2017, and compiled the roster with 406 participants by early September last year. The endpoint of the study is to evaluate the change of goal is to evaluate the rate of change in hemoglobin A1c at week 30 of the treatment. The entire study is scheduled to conclude by next month after the participants’ visits and data collection. Based on the efpeglenatide data collected so far, Hanmi Pharmaceutical is determined to turn the crisis around with a plan to seek a new commercialization partner and also by opening options to explore new indications and research about combined treatment effect with other Lapscovery-based pipelines.
