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- 2026-03-18 10:27:55
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- Will P-CABs take over PPIs in GERD treatment market?
- by Whang, byung-woo May 12, 2021 05:58am
- With HK Inno.N’s K-Cab increasing its influence in the potassium-competitive acid blocker (P-CAB) market, the introduction of new P-CAB products raises the question of whether the products may increase the P-CABs' share in the market. In addition to Daewoong Pharmaceutical’s Fexuprazan, which is expected to be approved in Korea within this year, there are expectations that the already-approved Takeda Pharmaceuticals Korea’s Vocinty (vonoprazan) may also be released this year. Since its introduction, P-CABs were regarded as the next-generation drug that would replace proton pump inhibitors (PPIs) in the market. P-CABs have been known to have resolved most of PPIs' limitations, including the slow onset of action, varied effect according to mealtime, inter-individual variability according to CYP2C19 genotype, and drug interaction concerns. In particular, HK Inno.N’s K-Cab is the world's first P-CAB that received approval for all major indications of gastric acid blockers including erosive and non-erosive Gastroesophageal reflux disease (GERD), It has 4 indications in total. Although reimbursement is not applied to all four indications yet, K-Cab has shown clear growth every year after preoccupying Korea’s P-CAB market. According to the pharmaceutical market data research firm UBIST, since recording 29.8 billion won in sales in 2019, K-Cab’s sales have more than doubled last year to record 72.6 billion won. Also, just in the first quarter of 2021, it already recorded sales of 22.5 billion won. Simple calculations show that if K-Cab’s sales continue at a similar level, the company may surpass 100 billion won in sales this year. However, the industry's prevailing view is that it will take more time to see a shift in the overall market, given that the sales of PPIs are still record around 200 billion won. This is why some predict that if Daewoong Pharmaceutical’s Fexuprazan is approved and released in Korea in the current environment, the rivalry between the two products may actually expand the P-CAB market. An official from A Pharmaceuticals said, “It seems that HK Inno.N’s also knows that the overall share of the pie, the market share of P-CABs in general needs to be expanded to shift the market trend from PPIs to P-CABs. Just like how the PPI market grew due to the introduction of many products in its class, Daewoong Pharmaceutical’s entry into the P-CAB market with its strong sales power will certainly make some waves in the current market situation.” In other words, the rivalry between HK Inno.N and Daewoong’s products may bring synergy in their market. Another product receiving attention in this context is Takeda Pharmaceuticals Korea’s Vocinty. Vocinty, known as the originator of this class of next-gen GERD treatment, was approved in March 2019, but no clear news on its release has been shared yet. An official from Takeda Pharmaceuticals Korea said, “We are working to provide innovative medicines to patients according to our decision-making priorities. However, we cannot disclose specifics on whether or not and when certain products will be released." However, with K-Cab looking to sell over 100 billion won this year and Daewoong Pharmaceutical’s entry imminent in Korea, the industry expects that Takeda may not be able to postpone the launch of Vocinty any longer. However, one obstacle for Vocinty, which is sold under the name Takecab in Japan, is its price. In Japan, the 10mg Vocinty tab. is sold at 130.3 yen (1,339 Korean won) and the 20mg Vocinty tab. is sold at 195.5 yen (2,005 Korean won). This is more expensive than the 50mg K-Cab tab that is currently sold at 1,300 won in Korea. On this, an official from B Pharmaceuticals said, “Many considerations need to be made for a product’s release including the adjustment of its price. However, the company may be able to contemplate much longer, considering the increased P-CAB market in Korea. In addition to Vocinty, which verified its competitivity in Japan, the introduction of Daewoong’s Fexuprazan in the market may trigger a three-way race in the P-CAB market."
- Company
- Trials to suspend refund negotiations for CA drugs fail
- by Chon, Seung-Hyun May 11, 2021 06:00am
- Once again, the pharmaceutical companies have failed to suspend the execution of negotiations for the retrieval of insurance that has been paid for 'choline alfoscerate.' Both of the trials that were filed by two groups of pharmaceutical companies against the health authorities in Korea were dismissed by the court. According to industry officials, the Seoul High Court 1-1 ruled to dismiss the appeal by 28 companies including Chong Kun Dang filed to suspend the execution of negotiations on the retrieval of insurance. After the Seoul Administrative Court rejected the claim for the suspension of execution on January 29th, Chong Kun Dang and the other companies immediately appealed, but to no avail. The court of the second trial also dismissed the case. The law firm Kim & Shin is in charge of the lawsuit. At the end of last year, the Ministry of Food and Drug Safety (MFDS) ordered the National Health Insurance Service (NHIS) to make refunding deals for 230 choline alfoscerate products. The deal, which contains the condition 'If the trial fails, the whole amount of insurance paid for choline alfoscerate drugs that are prescribed from the date the clinical trial protocol is submitted to its the product's deletion from the benefits list shall be paid back in full by the company,' meant the deal was a 'negotiation for the retrieval of insurance.' In other words, the ministry intends to make a contract with the pharmaceutical companies so that when the clinical re-evaluation for choline alfoscerate that is being conducted on order by MFDS fails, the companies would have to pay back all of the insurance received for every prescribed choline alfoscerate drug from the date the clinical trial protocol was submitted to the date their license is revoked. Pharmaceutical companies have unanimously filed an administrative suit and complaint to suspend the execution of the order to pay back the insurance for choline alfoscerate drugs. The companies divided into two groups for the lawsuit. Lee&Ko is in charge of the suit for the 28 companies including Daewoong Bio, and Kim & Shin is in charge of the suit for the 28 companies including Chong Kun Dang. Daewoong Bio and the other companies have filed for the suspension of execution on December 30th of last year, but the first and second trials were both dismissed. The second trial was turned down on February 4th, a month after the case was filed, and the case is currently pending in the Supreme Court. Chong Kun Dang. and the other companies filed their complaint to suspend execution on January 8th of this year and received the dismissal ruling on January 29th. Chong Kun Dang and the companies appealed, but the case was again dismissed in the second trial recently. The administrative suit on choline alfoscerate has not been ruled yet. The Daewoong Bio's group and the Chong Kun Dang's group have both filed suits to the Seoul Administrative Court to cancel the negotiation order and notification, against the MFDS and NHIS separately. The cases of the two groups are to be merged for review, and the first proceedings are scheduled in July. Recently, NHIS failed to reach an agreement with pharmaceutical companies regarding the reimbursement of their choline alfoscerate products. NHIS and the companies were unable to reach an agreement after extending the negotiation period two times. As a result, the MFDS will have to delete the products from the benefits list or order renegotiations.
- Company
- The cobas SARS-CoV-2 & Influenza A/B Test was approved
- by May 10, 2021 05:56am
- Roche Diagnostics Korea announced on the 6th that it has obtained permission from the MFDS to "cobas SARS-CoV-2 & Fluenza A/B," which can diagnose COVID-19 and flu at the same time. The cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider. It is based on automated molecular diagnostic equipment 'covas 6800' and 'covas 8800', and can proceed from nucleic acid extraction to gene amplification, test, result analysis, and report through one-stop automation method. The cobas 6800 provides 384 tests per eight hours and the cobas 8800 provides 960 tests. The intervention of personnel to replace reagents and consumables reduced the cobas 6800 to once every eight hours and the cobas 8800 to once every four hours, respectively, improving the convenience of the medical staff's COVID-19 test. This automated test prevents errors caused by manual work through an all-in-one solution that is inspected in a single equipment from extracting nucleic acids to producing test results, and also reduces the risk of contamination caused by external substances. The cobas SARS-CoV-2 & Influenza A/B confirmed over 97% sensitivity and specificity through clinical studies. For COVID-19, the sensitivity associated with the false (fake-positive) risk was 100.00%, and the specificity associated with the false (fake-positive) risk was 99.82%. For influenza A, sensitivity and specificity were 97.14% and 99.04% respectively, and for influenza B, sensitivity and specificity were 100.00%. The cobas SARS-CoV-2 & Influenza A/B was approved for EMA by the FDA in September 2020 and obtained European Medical Device Certification (CE) in the same month. Johnny Tse Roche, CEO of Diagnostics Korea, said, "We expect high-capacity fully automatic cobas SARS-CoV-2 & Fluenza A/B not only improves the speed and convenience of testing, but also helps prevent the spread of infections and provide appropriate treatment for patients."
- Company
- The trend to advertise vaccines is diversity and young men
- by May 07, 2021 06:02am
- GSK Rotarix model Jo Jeong-seok, MSD Gardasil9 model Jeong Gyeong-ho, Yoo Byeong-jae, Jo Se-ho, and Pfizer Pharmaceutical PREVENAR13 model Choi Gwi-hwaVaccine advertisements by pharmaceutical companies are diversifying. Instead of the flu vaccine, it has diversified into vaccines for rota virus, pneumococcus, cervical cancer, and whooping cough. This is to raise awareness of vaccinations for vaccines that have not been well-known until now as interest in preventing infectious diseases has increased due to COVID-19. The main model was a young male entertainer. According to the pharmaceutical industry on the 7th, MSD Korea is the most active. MSD selected singers Mommy Son, comedian Jo Se-ho and Yoo Byung-jae as models for the advertisement of the HPV virus (cervical cancer) vaccine Gardasil9 only last year. Also recently, actor Jung Kyung-ho was selected as the new Gardasil 9 model. The reason MSD has introduced a variety of male models is to emphasize the importance of vaccination against the HPV virus in men. Until now, the HPV virus vaccine was widely known as a cervical cancer vaccine, so there was a strong recognition that it was only suitable for young women. However, although this virus is rare, it can also cause anal cancer and genital warts in men. As a result, MSD, which focused on women's marketing with comedian Park Na-rae as a model, began to use a large number of young male models to improve awareness. Mami Son's rap and Jo Seho and Yoo Byungjae's parody competition aroused the interest of young men. In April, it emphasized a clean concept with actor Jung Kyung-ho as a model. GSK also introduced actor Jo Jung-seok, who is considered the best advertising star since August of last year, as a model of the rotavirus vaccine Rotarix. His credible image and comfortable voice are favored by young people, regardless of gender. In particular, Rotavirus vaccine is suitable for newborns, and at the time of selection, Jo Jung-seok also became a parent with the child. This is Rotarix first public TV commercial. GSK said, "To inform the necessity of vaccination against Rotavirus that does not apply to NIP, and to raise brand awareness, we will conduct a public advertisement with Jo Jung-seok." GSK also launched a public TV commercial for the whooping cough vaccine Boostrix this year. Since the main target of Boostrix is adults over 50, we decided to be the main model as actor Seong Dong-il. GSK emphasized the importance of vaccination by arousing the attention of silver generations to whooping cough with Boostrix advertisements. GSK introduced various versions of Boostrix advertisements, and raised consensus with the camping entertainment program" the Wheeled House Camping Edition' starring Sung Dong-il. Pfizer Pharmaceuticals selected actor Choi Gwi-hwa as a new model for the pneumococcal vaccine PREVENAR13 in November of last year. As interest in pneumococcal vaccine increased amid the COVID-19 crisis, a public TV advertisement was held in two years. Choi Ki-hwa, with his wife, child, and grandparents going to receive PREVENAR13, appealed to the point that it is a vaccine that is suitable for the whole family. The number of vaccine advertisements, which had not been in public marketing until now, has increased, but the widely-known flu vaccine advertisement has somewhat slowed down. In 2019, GSK, GC Pharma, and SK Bioscience showed active public advertisements, led by actors Cha In-pyo and Yoon Se-ah, but last year the frequency of advertisements decreased significantly. Sanofi Pasteur was the only one to run an advertisement with singer Song Ga-in as a model for Vaxigrip. It is analyzed that this was affected by the widening of NIP targets due to COVID-19.
- Company
- Cherry Huang to succeed Jenny Zheng as head of Janssen Korea
- by Eo, Yun-Ho May 07, 2021 06:01am
- Janssen will continue to have a foreign leader head its Korean subsidiary. According to industry sources, Janssen Korea has appointed Cherry Huang as the next CEO of Janssen Korea to take Jenny Zhuang’s place after Zhuang’s term ends in April. Cherry Huang, who is currently the CFO of Janssen Asia Pacific, will be leading Janssen Korea from June this year. Hwang had served over 20 years in Johnson & Johnson since 1997 and has held various finance roles within the company. She had built her career in finance in various regions including in the Southeast Asian cluster, China, and Singapore. With Jenny Zhuang’s transfer, the board of directors (BOD) of the Korean Research-based Pharmaceutical Industry Association has also undergone some change. Following the resignation of Jenny Zhuang as director, KRPIA appointed Hye-young Lee, CEO of Viatris Korea as its new board director. Zheng has served as the Area Managing Director of Janssen Korea/Taiwan/Hong Kong since 2018. She holds a Bachelor of Engineering, Naval Architecture degree from Shanghai Jiao Tong University, and completed her Master of Business Administration (MBA) with Honors from the University of Chicago Booth School of Business.
- Company
- “Evenity is effective in patients at very-high-risk of OP"
- by May 07, 2021 06:01am
- The strategic paradigm for osteoporosis treatment has shifted. Compared to the past where not many patients were treated for osteoporosis and those who were treated used bone resorption inhibitors like bisphosphonate, a more aggressive treatment paradigm has landed in the field of osteoporosis treatment. The development of new drugs had triggered such changes in the treatment trend. Unlike bone resorption inhibitors, the only option patients used to have as a bone-forming agent was teriparatide; however, the introduction of Amgen’s ‘Evenity (romosozumab)’ brought all the difference. Evenity is the first and only bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. With the introduction of this promising new drug, the American Association of Clinical Endocrinology∙American College of Endocrinology (AACE∙ACE) newly defined a Very-high-risk group for osteoporosis fractures by revising the 2020 guidelines for the diagnosis and treatment of postmenopausal osteoporosis, to recommend aggressive drug treatment from early on. Dailypharm met with Dr. Felicia Cosman, professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons, to hear about the latest advances and trends in the treatment of osteoporosis. Professor Felicia Cosman. Dr. Cosman is explaining the latest advances in the treatment of osteoproosis in a virtual webinar held on the 4th. (Pic. From the virtual interview) -- Last year, the international guideline newly defined the 'very-high-risk group for osteoporosis fracture' and presented different treatment strategies according to the patient’s level of risk. Could you tell us the background and specifics of the revised guideline? =Academic societies in Korea and abroad have newly defined patients with high risk of fractures as a ‘very-high-risk group for osteoporosis fracture’ and recommends bone-forming agents to be more effective in increasing bone strength. These group of patient can be considered ‘at emergency of osteoporosis’ and are at high risk of experiencing fractures in the near future. The international osteoporosis foundation defined the very-high-risk group for osteoporosis fracture as ‘patients with a 10% or higher probability of experiencing fractures within 2 years.’ Also, according to a retrospective cohort study by Professor Balasubramanian that researched 377,561 women that are 65 years or older who recently experienced fractures, the cumulative risk of subsequent fractures in these women were 10% and 18% in 1 and 2 years, respectively. One notable fact is that the risk and area of subsequent fractures varied according to the initial fracture site. Patients with initial vertebral fracture had the highest risk of refractures at 14%, and those with initial ankle fracture had the lowest risk at 5%. However, as the 2-year risk of refracture in patients with ankle fractures was also 10%, these patients were also categorized as a very-high-risk group. Multiple fracture patients are also classified as a very-high-risk group, regardless of their recent fracture events. This very-high-risk group should use bone-forming agents from early on for rapid bone formation. In the past, bone resorption inhibitors were considered as the first treatment option for these patients; however, the paradigm has shifted to using bone-forming agents from early on. -The new guidelines recommended 4 kinds of treatment strategies for the very-high-risk group. Evenity, which shows a dual effect to increase bone formation and inhibit bone resorption, was also first recommended in the revised guidelines. What is your opinion on this, and how should we devise treatment strategies using the recommended therapies? =As I mentioned before, the paradigm has changed to acknowledge that starting treatment with bone-forming agents like Evenity, followed by bone resorption inhibitors may be more effective for bone formation. This is why Evenity was also included as an option in the new guideline. There aren’t many head-to-head studies on Evenity and teriparatide; however, there is one that was published on NEJM in 2014. The Phase II trial that studied women aged 55 to 85 with low bone mineral density showed that Evenity had improved the BMD in hip, femoral neck and spine more than teriparatide. Evenity also had a higher effect in increasing bone density compared to teriparatide in the hip and spinal area a follow-up study, In practice, the approach needs to be set differently for each patient. For example, a patient in his/her 60s who had experienced spinal fracture may have a low BMD in his/her spine, but a normal BMD in the hip area. If the patient has no other risk factors, he/she may choose to use teriparatide. -As the lead author of the Phase III FRAME (FRActure study in postmenopausal woMen with ostEoporosis) trial, you found that Evenity-Prolia was more effective in reducing the risk of fracture than placebo-Prolia. =The FRAME study compared patients treated with Evenity and placebo for 1 year, both followed by Prolia for 1 year to assess the risk of fractures. Study results showed that at month 12, Evenity reduced the risk of new vertebral and all clinical fracture risk by 73% and 38%, respectively, compared to placebo. Also, patients treated with Evenity saw a mean percent increase in BMD over placebo of 13.3% at the lumbar spine, 6.8% at the total hip, and 5.2% at the femoral neck. This is a superior increase in BMD compared to both mono and dual therapies. Based on such results, the researchers were able to reconfirm that Evenity is the top priority treatment option for patients at very high risk of fractures as it quickly reduces the risk of fractures while increasing bone formation. In particular, Evenity is more suitable for patients with a low BMD in the hip and nonvertebral areas, as well as the vertebrae area. -Despite Evenity’s potency, why do patients need to switch to Prolia after 1 year? Could patients who saw much benefit from Evenity extend their treatment period? =The treatment period reflects the results of the Phase II trial on Evenity. In the Phase II trial, Evenity showed a very high bone-forming effect for 1 year. After that, its effect was comparable to those of bone resorption inhibitors. While no additional benefits were seen in the second year of Evenity treatment, such as an increase in bone mass, patients who switched to Prolia after 1-year of Evenity treatment saw the better effect. Based on such findings, the 1-year treatment period was deemed reasonable considering the administration cycle and number. -- What are your thoughts on the risk of adverse cardiovascular events that were added to the indications in Europe, U.S., and Korea? =The only clinical study on Evenity that presented adverse cardiovascular events was the Phase III ARCH trial that compared Evenity with alendronate. In the study, a higher rate of major adverse cardiac events (MACE), which is defined as the composite of cardiovascular deaths, myocardial infarction, or stroke, was reported at week 12 in patients treated with Evenity (2.0%, 41/2,040 participants) compared to those treated with alendronate (1.1 %, 22 /2,014 participants). However, when including heart failure events, there was no significant difference in MACE between the two groups. In conclusion, the risk and benefits that each patient may see from using Evenity need to be analyzed and compared. Of course, the decision must comply with the recommendations set in the approval process. In the U.S., use of Evenity is restricted for patients that are at very high risk of experiencing cardiovascular events. This includes patients who have experienced strokes or myocardial infarction within 1 year. -In Korea, the reimbursement standards directly affect treatment strategy. In consideration of the reimbursement standards currently set for Evenity in Korea, what areas do you think require further discussion? = When I saw Korea’s reimbursement criteria for Evenity, I wondered whether its application after 2 or more fractures was appropriate. As I have mentioned before, there is ample evidence to support the validity of prescribing Evenity even after just a single fracture. Also, the criteria that first requires the use of bisphosphonates is quite similar to the pre-revised international guideline. The problem is that prescribing bone-forming agents after the use of bisphosphonates doesn’t provide as good an effect in reducing fractures. Korea also needs to consider the paradigm shift in osteoporosis treatment that has already begun. In the past, the global consensus was to first use bisphosphonate; however, this has completely changed now. With the introduction of Evenity, it has been recognized that the right time to use bone-forming agents for optimal effect is in the early stages when patients are identified to be at very-high-risk of fractures.
- Company
- Why SK and GC's deal for Xarelto exclusivity right misfired
- by Kim, Jin-Gu May 06, 2021 06:07am
- SK Chemicals's discussions with GC Pharma on handing over the exclusivity rights of Xarelto (rivaroxaban) had broken down in the end. The reason is known to be that the scope of the patent avoided by SK Chemicals does not match the composition of the generic developed by GC Pharma. According to industry sources on the 5th, the sale of the exclusivity rights of Xarelto between SK Chemicals and GC Pharma ended in misfire. The two companies had been discussing selling the exclusivity rights of Xarelto. GC Pharma's intent to enter the generics market 9 months earlier than other companies seemed to be in line with SK Chemicals's intent to sell its exclusivity rights. However, the discussion ended in a misfire. Officials from both companies stated, “It is true that there had been discussions, but the deal was broken off.” The industry points to the scope of a patent avoidance that SK Chemicals owns as the cause of the breakdown. SK Chemicals, along with Hanmi Pharmaceutical, succeeded in avoiding the composition patent for Xarelto 2.5mg. After winning the first trial in November 2015, the companies obtained the exclusivity right through the first Marketing Authorization Application (MAA) in July of the following year. However, the scope of the exclusivity right the two companies have obtained was limited to the 2.5mg dosage. The component patent of the remaining doses of Xarelto, 10mg, 15mg, and 20mg, had not been registered by Bayer in the first place. When filing for patent avoidance of Xarelto's composition patent, the argument of SK Chemicals and Hanmi Pharmaceutical was that its "manufacturing process was different from the original.” The original tablet is manufactured through a wet granulation process after suspending rivaroxaban in a hydrophilic binder. On the other hand, the generics developed by SK Chemicals and Hanmi Pharmaceutical are made by first spray drying the lactose hydrate and hypromellose+solvent solution into fine powder instead of granules, then adding excipients for tablet manufacturing, followed by compression and tableting. The Intellectual Property Trial and Appeal Board (IPTAB) and the court acknowledged the significant difference in manufacturing and ultimately ruled that SK and Hanmi's generic does not violate the original’s scope of patent. However, the problem was that this manufacturing method was different from the method used in the generic that was self-developed by GC Pharma. As GC Pharma's generic was manufactured in a different way than the one that was acknowledged as 'different from the original drug' by IPTAB, GC Pharma would not be able to exercise the exclusivity rights even if they purchased it. So, GC Pharma either had to develop a new generic with the method through which SK Chemicals avoided the original patent or give up the deal. GC Pharma's decision was to give up the deal. “The two companies started negotiations without specific knowledge of the scope of the exclusivity right, so the deal eventually ended up nowhere,” explained a pharmaceutical industry official. On whether to proceed with the sale of exclusivity rights of Xarelto with other companies, an official from SK Chemicals said, “We haven’t yet made other deals after discussions with GC Pharma had broken down.” According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year. This was a 1% decrease from the 50.8 billion won in 2019. In the first quarter of this year, 11.9 billion won worth was sold. In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana and is followed by Eliquis and Pradaxa.
- Company
- Moderna’s next steps in Korea…vaccine production scenarios
- by Kim, Jin-Gu May 06, 2021 06:07am
- The establishment of Moderna’s Korean subsidiary has begun. Moderna's business team from its U.S. headquarters had visited a factory of a domestic pharmaceutical company. The company's actions are adding strength to the speculation that domestic production of Moderna's vaccines is imminent. The factory that the business team had visited the previous month is expected to act as an outpost for Moderna’s vaccine production. On this, various scenarios on whether Moderna will directly take charge of vaccine production in Korea or will contract a domestic company to produce the vaccine are being raised in the industry. ◆'Establishment of ‘Moderna Korea’ … why enter Korea? According to industry sources on the 3rd, Moderna had posted an announcement on its website to hire a GM (General Manager) for Korea. Industry officials interpret this as the company's first step into establishing subsidiaries in Korea, Japan, and Australia as stated by the compnay on the 15th last month. The most likely purpose for entering Korea is to produce COVID-19 vaccines. Moderna has been producing 500 million doses of its vaccine annually at its U.S. and European plants. However, the whole amount of the vaccines produced by the two plants are being supplied locally. The production amount of the two plants is said to be tight and is just enough to meet the local demand. Therefore, vaccines for other regions must be produced in other factories. This is also true for the 20 million doses that the company agreed to supply to Korea. Moreover, in the case of the United States, the Defense Production Act fully controls the export of raw materials and equipment used in the production of COVID-19 vaccines, which gives strength to the theory that Moderna will produce vaccines in Korea. Moderna had posted a job announcement on its website to hire a GM for Korea. ◆Why Moderna’s business team visited A Pharmaceutical’s plant In mid-April, a business team from Moderna headquarters visited a plant of a domestic pharmaceutical company, A Pharmaceuticals. "I know that Moderna 's HQ visited and inspected A Pharmaceutical's plant and manufacturing facilities around 2 weeks ago,” said an industry official. However, whether the company has visited plants of other pharmaceutical companies remains unknown. Some are interpreting the visit as Moderna's move to secure a base for the domestic production of its vaccine. However, whether Moderna will be directly producing the vaccine, or will consign its production to a domestic company has not been decided yet. ◆Direct manufacturing or CMO… three possible scenarios The industry has been pushing three scenarios based on the two facts mentioned above. The first scenario is where Moderna takes over the A company’s plant to directly produce its vaccine. mRNA vaccines are largely manufactured in three steps. raw material manufacturing → lipid nanoparticle coating → finished product manufacturing. The key technology in the production of mRNA vaccines lies in the lipid nanoparticle coating process. When injected, mRNA quickly degrades in the body, therefore, the technology that surrounds it with lipid nanoparticles to keep it intact for a long period of time is important. Moderna has been known to pay extreme attention to the security of this technology. It has been using the direct production method to prevent technology leakage in the U.S. and Europe. On the surface, the company has signed a CMO deal with Lonza, a Swiss-based global CMO company, but then directly invested 70 million francs (about 86 billion won) and 40 million francs (about 49 billion won), in the U.S. and Swiss factory respectively. The industry views it as no different from direct production. In the same way, Moderna may start direct production of its vaccine by acquiring a share of a plant in Korea. The second scenario is that Moderna will make a CMO deal with a domestic company to produce the vaccine. Usually, global pharmaceutical companies do not use their own factories when establishing Korean subsidiaries. Most of the companies receive ‘import permits’ rather than ‘ manufacturing permits’ upon their establishment. Rather, in recent years, the trend has been for the subsidiaries to withdraw the already-established factories. Most recently, Janssen, as well as Bayer, Novartis, Abbott, Pfizer, Boehringer Ingelheim, Roche, and MSD previously had also withdrawn operation of their plants. This is why some believe that Moderna, like other companies, will not set up a factory in Korea. For Moderna, which owns only one type of vaccine, the factory is likely to remain a nuisance after COVID-19 ends. Accordingly, some speculate that the vaccine will be developed under a CMO deal with a domestic company. However, whether Moderna will make a technology transfer deal or participate in production by acquiring some of the domestic company’s shares is unknown. The third scenario is that Moderna will dualize the manufacturing process. Moderna will take charge of the core process, and then consign a domestic company for the last step, the fill&finish process. GC Pharma is a prominent candidate for Moderna's filling and packaging process. GC Pharma has already been selected as a CMO for COVID-19 vaccines by CEPI (Coalition for Epidemic Preparedness Innovations), a global private organization, in October last year. GC Pharma's manufacturing will take place in its Ochang plant, and the company plans to fill and finish more than 500 million doses. In addition, GC Pharma already has ties with Moderna. It has already signed a contract for the domestic approval and distribution of the Moderna vaccine. In this scenario, after the raw material is manufactured by Moderna and A Pharmaceutical company, filling, finishing and domestic distribution of the finished product would likely be handled by GC Pharma based on the relationship already established between the two companies.
- Company
- Eli Lilly applies for reimbursement of Emgality in Korea
- by Eo, Yun-Ho May 04, 2021 05:55am
- The new migraine treatment ‘Emgality’ is seeking reimbursement benefits in Korea. According to industry officials, Eli Lilly Korea has recently submitted a reimbursement application for its calcitonin gene-related peptide (CGRP)-targeted migraine prevention therapy ‘Emgality (galcanezumab).’ Emgality, the first CGRP-targeted migraine prevention treatment to be introduced in Korea, selectively binds to CGRP, a substance known to be a key cause of migraine, and blocks its binding to the receptor. The drug was designated as an orphan drug in April of last year and approved in September of the same year. Recently, Emgality was additionally approved by the FDA as a treatment for episodic cluster headaches. Emgality had received much attention as a promising drug in the field of migraine along with ‘botulinum toxin.’ However, as a non-reimbursed drug, the demand for better access to the drug has been rising. If approved, the reimbursement is expected to have a significant impact on the migraine market. Emgality had passed the drug committee (DC) in major general hospitals in Korea including the Seoul National University Hospital and Severance Hospital. Lilly Korea and SK Chemicals have been co-promoting Emgality in Korea. With ‘Ajovy (fremanezumab),’ another CGRP-targeted therapy, soon to enter the Korean market, attention is on how the migraine treatment market will be reorganized in the future. The approval was based on results of the EVOLVE-1 and EVOLVE-2 trials which involved 1,773 patients with episodic migraines for 6 months, and the REGAIN trial which involved 1,113 patients with chronic migraines (at least 15 headaches a month for at least three months) for 3 months. Results of the two trials on episodic migraine patients comparing the MHDs per month over a 6-month period showed that compared to baseline (Emgality group 9.2 and placebo group was 9.1), Emgality demonstrated efficacy over placebo in treating migraines. In particular, in the EVOLVE-2 trial that involved Korean patients, the mean MHDs per month was reduced by 2 more days during the 6-month period in the Emgality group (226 patients) compared to the placebo group (450 patients) (Emgality 4.3 days vs. placebo 2.3 days). Also, 59% of patients treated with Emgality (compared to 36% in the placebo group) saw a 50% reduction in MHDs over the 6-month period. 34% (18% for the placebo group) saw a 75% or more reduction, and 12% (6% for the placebo group) saw a 100% reduction in MHDs. “Emgality showed a migraine prevention effect from the first week. Episodic migraines patients who experienced migraines 4 to 14 days a month have experienced a reduction by half compared to before treatment, and 1 in 7 patients showed a 100% response rate,” said Professor Min-kyung Joo of the Severance Hospital. “The drug may bring a big difference to patients who have been struggling to maintain their daily and social life due to migraines.”
- Company
- Hanmi launched a new challenge for patent of Entresto
- by Kim, Jin-Gu May 03, 2021 05:54am
- EntrestoHanmi took a new challenge in patenting the heart failure treatment Entresto (Sacubitril/Valsartan). It was already challenging other patents and requested an invalidation trial for a more difficult patent. If Hanmi succeeds in overcoming its patent on its own, it is expected that it will be able to release generics earlier than other companies. According to the pharmaceutical industry on the 3rd, Hanmi filed a trial against Novartis on the last day of last month for invalidation of composition and use patent of Entresto. This patent is known to be the most difficult to overcome among the four patents listed as Entresto. Patents registered as Entresto are ▲use/composition patent expiring in July 2027 ▲crystalline patent expiring in September 2027 ▲composition patent expiring in November 2028 ▲composition patent expiring in January 2029. The use/composition patent that expire first are in fact playing the role of product patent. Entresto is a heart failure treatment with the addition of Valsartan, an ARB-series hypertension treatment, and Sacubitril, an NEP inhibitor series, another treatment for hypertension. With the expiration of each patent, Novartis conducted a clinical trial by combining the two active ingredients, and was licensed as a treatment for heart failure. The reason that Hanmi newly challenged the most difficult patents to overcome is to preoccupy the generic market. Earlier, 20 companies, including Elyson, have requested a trial to confirm the scope of passive rights for a crystalline patent that expires in September 2027. This included Hanmi. If they overcome the patent, it was possible to release generics after July 2027. If Hanmi additionally overcomes the patent, it will receive generic for exclusivity, and will be exclusive for 9 months regardless of the success of challenges such as Elyson. The key is whether other companies will join the challenge. if an invalidation trial is filed within 14 days like Hanmi, a generic for exclusicity can be jointly secured after the successful challenge. Elyson's Rx performance has been increasing rapidly since its launch in Korea in October 2017. According to UBIST, Elyson has grown more than three times in two years to ₩20.3 billion last year after it produced ₩6.3 billion in 2018, the first year of its release. In the first quarter of this year, prescriptions amounted to ₩5.8 billion, the highest quarterly prescription amount ever.
