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- 2026-05-18 20:59:53
- Policy
- GSK & SK Bio also stopped supplying TD vaccines
- by Lee, Tak-Sun Jul 21, 2021 05:51am
- Greencross TD Vaccine Prefilled Syringe InjSK Bioscience will also withdraw its products from the TD vaccine market that prevents diphtheria and tetanus in adults. GSK, which had been importing and supplying TD vaccines last year, also stopped supplying them in the Korean market. As a result, GC Pharma, which is manufacturing domestic drugs, is expected to strengthen its position in the TD vaccine market. According to the MFDS on the 16th, SK Bioscience said it will stop importing SK Td Vaccine, which it is supplying, after the 18th of next month. It said, "As the company that was supplying the undiluted solution stopped supplying the finished product, the company also stopped supplying the finished product." Sk Td Vacine is known to have imported the undiluted solution from GSK in Germany and made it into a finished product in Korea. Last year, GSK announced that Novartis will stop supplying TD vaccines in the process of integrating and maintaining production lines for business efficiency after acquiring the vaccine business unit. Therefore, it is observed that this effect may have been caused by the discontinuation of Sk Td Vacine. The adult TD vaccines now available in Korea are GC Pharma's "Greencross TD Vacine Prefilled Syringe Inj" and Accesspharm's "diTeBooster SSI". GC Pharma's position is expected to be strengthened as GSK and SK Bioscience have stopped supplying TD vaccines. GC Pharma succeeded in domesticizing the TD vaccine in 2016 and contributed to reducing its dependence on imports. The product developed by GC Pharma has been commercialized for the first time in six years since 2010 with consulting support from the MFDFS. At the time, the MFDS said that the localization of the TD vaccine is expected to replace the import of 450,000 people every year. In terms of sales by IQVIA last year, Greencross TD Vacine Prefilled Syringe Inj was about ￦1.4 billion in sales. SK Td Vacine's sales were only about ￦900 million. GSK's products were discontinued, reaching only about ￦300 million, and Accesspharm's products also reached ￦300 million. Accesspharm is said to be imported from SSI in Denmark as complete products. The only domestic product is Greencross TD Vacine Prefilled Syringe Inj. An official from the pharmaceutical industry said, "As a result of the localization of TDI vaccines for adults, we can respond to the suspension of supply of imported products." "It seems that there will be little impact on the market because there is domestic product even when SK Bioscience products are not imported."
- Company
- Domestic Rx sales are showing strength in H1
- by An, Kyung-Jin Jul 21, 2021 05:51am
- Lipitor Pfizer's treatment for dyslipidemia ranked first in outpatients in the first half of the year. Drugs developed with domestic technologies such as "Rosuzet" and "Zemimet" led by HK-Inoen's "K-CAB" have increased their market influence despite the chaos of COVID-19 outbreak. The originals of multinational pharmaceutical companies, which once had sales, have stagnated since the expiration of patents. According to UBIST, a pharmaceutical research agency on the 19th, Pfizer's Lipitor topped the list with a cumulative prescription amount of ￦86.5 billion in the first half of this year. Lipitor (Atorvastatin) is a treatment for dyslipidemia, which was introduced to the domestic market in 1999 by Pfizer Korea. Since the expiration of the patent, insurance drug prices have fallen by half and more than 130 generics have been released, but they are still showing strong sales in the prescription drug market. Except for 2017, it has topped the prescription list for the past 10 years. Viatris, which was launched in November last year with the merger of Upjohn and Mylan, which have been in charge of Pfizer's patent-expired drugs, is in charge of sales. However, looking at the quarterly performance, the upward trend has slowed somewhat since COVID-19 outbreak began in earnest. By 2019, the average amount of Lipitor prescription per quarter was close to ￦48 billion, but the average of last year was barely over ￦46 billion. This year's performance was ￦43 billion in the first quarter and ￦43.5 billion in the second quarter, which is not up to its peak performance. The cumulative amount of prescriptions for the first half of the year decreased by 8.1% from ￦94.1 billion a year earlier. The prolonged COVID-19 situation is believed to have been affected by the contraction of hospital visits and the overall foreign prescription market. During the same period, Hanmi's Rosuzet ranked second in prescriptions, with outpatient prescriptions rising 13.8% year-on-year to ￦53.4 billion. Rosuzet is a combination drug composed of Ezetimibe and Rosuvastatin. Since its release in late 2015, it has ranked first in the market among the same ingredients. Analysts say that Hanmi's strategy to enter the composite market before its competitors was effective as it secured Ezetimibe license from patent holder MSD. Sales of Rosuzet rose more than 10% year-on-year every month even at a time when face-to-face sales marketing activities were severely restricted due to COVID-19 last year. In the second half of last year, the monthly prescription amount exceeded ￦8 billion, surpassing Gliatamin as the second-largest outpatient prescription. This year, the company set its own record of ￦9.4 billion in monthly prescription amount, narrowing the gap with No. 1 Lipitor. Sales of Daewoong Bio's Gliatamin was ￦46.3 billion in outpatients in the first half of last year, down 3.5% from a year earlier. Gliatamin is generic of the brain functional enhancer Choline alfoscerate. The government has received two sanctions, including a reduction in benefit. However, Gliatamin's influence in the prescription drug market remains robust. The competition item, Chongkundang Gliatirin, increased 0.4% year-on-year to ￦40 billion in outpatient prescriptions over the same period. The amount of outpatients for K-CAB in the first half of the year increased 47.8% year-on-year to ￦45.4 billion. If the current trend continues, it is predicted that the amount of outpatients will easily exceed ￦100 billion by the end of the year. K-CAB (Tegoprazan) is a flagship product of HK Inno.N (formerly CJ Healthcare), which is about to be listed. It is a new type of anti- ulcer drug called "P-CAB," which competitively combines proton pumps and potassium ions located in the final stage of acid secretion in stomach wall cells, thus inhibiting gastric acid secretion. Sales of K-CAB rose to ￦5 billion in the first year of its release, compared to ￦1.7 billion in monthly prescriptions. It secured gastrointestinal reflux disease as its first indication, and added gastrointestinal ulcer treatment in July of the same year. In the first half of this year, when most of the drug performance was sluggish, it rose to fourth place in prescription, threatening third-place Gliatamin. The joint sales strategy with Chong Kun-dang, which has a differentiated mechanism from the existing PPI. The increase in prescriptions for products developed by domestic companies was noticeable. The amount of outpatients for LG Chem's diabetes combination drug Zemimet in the first half of this year was ￦41.1 billion, up 8.4% from the previous year. Zemimet is a second compound that combines Metformin with Zemiglo (Gemigliptin), a new diabetes drug developed by LG Chem. It has been co-selling with Daewoong Pharmaceutical since 2016. Due to changes in the diabetes treatment market, which prefers multi-drug prescriptions, it has surpassed the performance of Zemimet. In the top 10 outpatient Rxs, sales of prescriptions for the past six months have fallen. The amount of outpatient prescription for Sanofi's anti-thrombotic drug Plavix was ￦44.8 billion, down 2.3% from the previous year. Boehringer Ingelheim's hypertension combination drug Twynsta and Gilead Science's hepatitis B treatment Viread fell 8.1% and 6.7% in the first half, respectively. AstraZeneca's treatment for dyslipidemia, Crestor, decreased 9.2% from the previous year to ￦38.8 billion in the first half of the year, ranking among the top 10 outpatients Rx.
- Company
- Patent ruling changes NOAC market…Eliquis surpasses Xarelto
- by Kim, Jin-Gu Jul 20, 2021 05:47am
- The Supreme Court’s ruling shook up the new oral anticoagulant (NOAC) market in the second quarter of this year. With Daiichi Sankyo’s ' Lixiana (Edoxaban) still in the lead, 'Eliquis(apixaban),’ which had experienced a decline in sales after its generics were released, made a successful rebound. On the other hand, Eliquis’s generics that had once rapidly expanded its share in the market virtually disappeared. The Supreme Court’s ruling in April had directly affected the disappearance of generics. The other two NOAC products - ‘'Xarelto (rivaroxaban)’ and ‘Pradaxa (dabigatran)’ - however, saw a continued decline in its prescription performance. ◆Original drug maker’s sales 7%↑ vs. generic companies 40%↓ after Supreme Court ruling According to the market research institution UBIST on the 20th, the overall size of the NOAC prescription market in Q2 this year amounted to 46.7 billion won. This was a 2% YoY decrease from Q2 of the previous year. The 4 original NOAC products saw mixed results in prescription performance. Prescription for Daiichi Sankyo’s Lixiana and BMS’s Eliquis had increased, whereas the same for Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa fell. Lixiana still kept a solid lead in Q2 this year. It sold 17.2 billion won in prescription sales ins Q2 this year, an 8% YoY increase from Q2 of the previous year. Prescription sales of Eliquis also increased by 7%, from 12.1 billion won to 13 billion won in the same period. Eliquis’ sales had fallen continuously since its release until Q1 this year and then made an upward turn for the first time in Q2 this year. In this process, the NOAC market’s rank also changed. Until Q1 of this year, Xarelto was second place in the NOAC market, but Eliquis outsold Xarelto and took second place in Q2. The Supreme Court’s ruling in April is predicted to have been the direct cause of the change in sales. In April, the Supreme Court overturned the first and second trial judgments in the dispute over Eliquis’s substance patent and ruled in favor of BMS. The ruling had alternate effects on Eliquis’s original drug maker and its generics. Immediately after the ruling, Eliquis’s sales turned upward. On the other hand, sales of Eliquis’s generics were nearing '0'. Companies that used to sell Eliquis generics, including Chong Kun Dang, Yuyu Pharma, Samjin Pharm, Hanmi Pharmaceutical, Aju Pharm, and Yoo Young Pharm rushed to discontinue sales of their products in response to BMS’s forewarning of filing a claim for damages. The cumulative sales of the generics had increased continuously from 0.3 billion won in Q3 2019, 0.6 billion won in Q4 2019, 1.2 billion won in Q1 2020, 1.7 billion won in Q2 2020, 2.2 billion won in Q3 2020, 2.6 billion won in Q4 2020, and 3 billion won in Q1 2021. However, after the supreme court’s ruling, its sales fell sharply to 1 billion won in Q2 this year. The 1 billion won sold in the second quarter is believed to be prescriptions on previously released quantities to distributors. ◆Xarelto·Pradaxa↓…Will the decline continue due to the release of generics? The other two NOAC products – Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa – continued to see a decline in their prescription performance. Xarelto's sales fell by 9% from 12.5 billion won in Q2 last year to 11.4 billion won in Q2 this year. In the same period, Pradaxa’s sales fell 15%, from 1.7 billion won to 1 billion won. In addition, generics of Xarelto and Pradaxa are expected to be released in the second half of this year, reinforcing the prospect that their prescription performance will continue to decline. Exclusive marketing approval for Pradaxa’s generics was approved on the 18th. Under the approval, Intro Biopharma, Aju Pharm, Jin Yang Pharmaceutical, and Huons may now release Pradaxa’s generics until April next year. For Xarelto, Hanmi Pharmaceutical and SK Chemicals succeeded in overcoming the original’s patent. The companies may release the 2.5mg formulation of Xarelto’s generics from October 4th this year.
- Policy
- CSO expenditure report Act, effective immediately
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The government promulgated the revised Pharmacist Act today (20th), which includes restrictions on co-living and clinical 1+3 of generic and new drugs and mandatory preparation of CSO expenditure reports. In accordance with the revised Pharmaceutical Law, restrictions on 1+3 generic and improvement new drugs and regulations requiring CSOs to be included in the scope of pharmaceutical suppliers and to prepare expenditure reports will be enforced immediately after promulgation. Dailypharm summarized the details and timing of implementation of the revised Pharmacist Act. ◆Limitation of 1+3 on generic and improvement new drugs ◆ The regulation shall be implemented immediately after the announcement to specify data to be submitted when marketing of generic and improvement new drugs. New generics and improvements to obtain marketing permits after today will be subject to restrictions on clinical data. However, the 1+3 regulation was not applied to medicines (IND), which are already undergoing clinical trials. At this time, pharmaceutical companies approved for the clinical trial plan must submit and report to the Minister of Food and Drug Safety within one month from the enforcement date of the revised Pharmaceutical Law, along with evidence that they have decided to jointly develop medicine. In addition, the government decided not to apply 1+3 regulations to the clinical trial data before the enforcement of the revised Pharmaceutical Law. It does not apply regulation retrospectively.(Article 31 (10 through 15) The provisions that prohibit reauthorization and reporting of items less than five years after the date of cancellation of item permits or reports of changes by false or illegal means, and medicines less than three years after the cancellation. (Article 31(16)) ◆Compulsory preparation and submission of CSO expenditure reports ◆ The provisions to include pharmaceutical companies and CSOs entrusted with drug sales promotion tasks to prevent MDs and pharmacists from providing economic benefits such as of January 21 next year. The CSO's regulation requiring preparation and submission of medical and pharmacist expenditure reports and requiring related books and evidence data to be kept for five years will also take effect on January 21st next year. In addition, regulations that allow the Minister of Health and Welfare to conduct a survey on the expenditure reports of pharmaceutical suppliers and announce the results and entrust the work to related institutions or organizations will take effect six months after the promulgation (January 21 next year. The regulation on the disclosure of CSO expenditure reports to the public by an ordinance of the MOHW shall take effect two years after the promulgation, that is, July 21, 2023.(Article 47, Article 47-2, Article 69-4, and Article 95) ◆Designation of Drug Day as National Anniversary =A provision that designates November 18 every year as Drug Day and allows local governments to conduct events, education, and promotional projects or support related group activities shall be implemented immediately. November 18 is expected to be the first day of Drug Day as a national holiday event.(Article 2) ◆Punishment of Rx drug buyers = Regulations that prohibit and punish steroid injections, ephedrine injections, and specialist drugs to consumers who cannot sell drugs such as medicine and pharmacists will also be enforced six months after the date of promulgation. That is, it will take effect on January 21 next year. If the regulation is enforced, consumers who illegally purchase Rx drugs will be fined up to 1 million won, and those who report illegal buyers will be able to pay rewards set by Presidential Decree.(Article 47-4 and 90 and Article 98 (1) 7-3) ◆Expanding the size of the Central Pharmaceutical Review Committee=The provision to increase the number of the Central Pharmaceutical Review Committee, an advisory body of the MOHW and the MFDS, from one to two. ◆Legalization of phase 3 conditional permission system = The provision to upgrade phase 3 conditional quick marketing permission to the Pharmacist Act, which is operated by the notice, shall take effect six months after its promulgation (January 21 next year). It allows the head of the MFDS to quickly approve medicines for serious or rare diseases prescribed by the Act on the Management of Serious or Rare Diseases after a central medical review, and clarified procedures and submissions. Pharmaceutical companies with conditional authorized medicines must check the implementation of the conditions and report them to the head of the MFDS, and the head of the MFDS is allowed to order the implementation of the conditions. If pharmaceutical company that receives conditional permission for facilities and items by fraud or fraudulent means fails to report or fulfills an order to fulfill the conditions, the conditional permission can be revoked. The Pharmaceutical Affairs Act has also raised the provisions related to pharmaceuticals that can be reviewed preferentially for other licensed medicines.(Articles 35 and 35-2 through 6)
- Policy
- Kymriah reimbursement was not discussed at CDRC meeting
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The Korea Leukemia Patients Organization (KLPO) The Korea Leukemia Patients Organization (KLPO) expressed its regrets to the government and Novartis Korea for excluding the first CAR-T treatment Kymriah from the agenda for deliberation at the Review Committee for Cancer Diseases meeting that was held on the 14th. On the 19th, KLPO said, “A disconcerting situation occurred. Kymriah was not even able to enter the first gateway for NHI listing and be put on the agenda for deliberation for the Review Committee for Cancer Diseases meeting. We will fight with the government and Novartis for the reimbursement of Kymriah.” The patient group demanded an explanation from the company and authorities on why Kymriah was not put up as an agenda for deliberation. 4 months had passed since its approval in March but no discussion on its reimbursement has started despite its use of the “approval-benefit appraisal linkage system.” The CAR-T therapy Kymriah is a one-shot personalized gene therapy. 8 out of 10 end-stage acute lymphoblastic leukemia patients and 4 out of 10 end-stage acute lymphoblastic lymphoma patients were found to survive in the long-term with Kymriah. The patient group insisted that the reimbursement discussions need to start as soon as possible as around 200 patients with relapsed or refractory end-stage acute lymphoblastic leukemia or lymphoma die within 3-6 months, KLPO said, “With the issue of reimbursement delays arising due to cost-sharing in ultra-high-priced drugs, we expected the committee to request the company to come up with a reasonable cost-sharing plan. The Ministry of Health and Welfare and Health Insurance Review and Assessment Service needs to explain why Kymriah, a drug in issue for its ultra-high-price rather than its treatment efficacy, was not put on the agenda for deliberation.” “The 6th Review Committee for Cancer Diseases meeting will be held on September 1st. Even if Kymriah is deliberated then, the drug will be listed 2 months later than if it was discussed at the last meeting. The treatment process for life-threatening diseases and the administrative process regarding their financial issues should be considered separately.” “We understand that Kymriah’s NHI listing may become the model for listing ultra-high-priced drugs in Korea and that the government needs to take a careful approach in its reimbursement. However, making excuses that they need the time to review the matter with no preparation in advance for the well-expected ultra-high-priced drug listing issue is negligence on the government’s part.” And as around 30 countries including the U.S. have been using Kymriah, and its treatment is already insured in Japan, KLPO stressed that Kymriah reimbursement should be discussed promptly. Lastly, KLPO added, “In addition to the government, the company also needs to prepare a reasonable cost-sharing plan. We are prepared to fight to our death with the government and Novartis Korea for the prompt benefit listing of Kymriah.”
- Policy
- Pfizer vaccine available in Korea for ages 12 or older
- by Lee, Tak-Sun Jul 20, 2021 05:46am
- Pfizer's COVID-19 vaccine has become available in Korea for people over 12 years of age. The MFDS announced on the 16th that it has approved the change of Comirnaty, which can be used to prevent COVID-19 among people aged 12 and older. The dosage and indications of the vaccine can be diluted once with 0.3ml and inoculated additionally after three weeks, just like the existing 16 years old or older. Pfizer vaccines have also been approved in the United States (May 10, Europe (June 2), Canada (May 5) and Japan (May 31). The MFDS determined that the overall safety was similar to that of those aged 16 or older and was in good condition. In the age of 12–15 years of age, the cases of adverse effects following the inoculation of Comirnaty were similar to those aged 16 and older, with no significant adverse effects. Common adverse effects were injection pain, fatigue, headache, muscle pain, chills, joint pain, and fever, most of the symptoms were mild to moderate and disappeared within days of vaccination. The effectiveness of the 12- to 15-year-olds was sufficient after evaluating the effects of COVID-19 prevention and immune responses. As a result of evaluating the preventive effect of 1,983 people (1,005 vaccine groups and 978 placebo groups) who were not infected with COVID-19 until the 7th after the 2nd vaccination, 0 people in the vaccine group and 16 people in the placebo group showed 100% prevention effect. The virus neutralization test was evaluated on 360 people (12–15 years of age 190, 16–25 years of age 170) who were confirmed not to have been infected with COVID-19 until one month after the second inoculation, and the virus neutralization test met the criteria for ages 16–25 years of age. When comparing immune responses at one month after two inoculations, it met 1.5 times the noninferiority standard. Pfizer vaccines have become available in Korea for people aged 12 and older, but the KDCA has not yet included the age group in the list. Attention is focusing on whether it will be included in the vaccination list after discussions.
- Company
- The Effects and Challenges of Vitrakvi
- by Jul 20, 2021 05:46am
- Bayer's "Vitrakvi" has been able to treat cancer patients who are positive for NTRK gene fusion, regardless of cancer type. The NTRK gene plays an essential role in the physiology, development and function of the nervous system through the TRK protein, which causes problems when unrelated genes are combined. This phenomenon, called NTRK gene fusion, produces a fusion TRK protein that transmits abnormal signals. Eventually, the downstream pathway becomes hyperactive, causing problems in cell growth and survival, leading to cancer. All cancers can be caused by NTRK gene fusion, but they vary in frequency from cancer to cancer. There are very few cases of NTRK gene fusion in commonly known small cell lung cancer (SCLC) or direct colorectal cancer. On the other hand, NTRK gene fusion is frequently found mainly in rare cancers such as secretive salivary gland cancer, secretive breast cancer, and infant-type fibrous sarcoma. So far, there have been no treatments targeting NTRK gene fusion. In May last year, Bayer's "Vitrakvi (Larotectinib)" was approved, paving the way for treatment of patients positive for NTRK gene fusion in Korea. Vitrakvi is a targeted anti-cancer drug developed exclusively for NTRK gene fusion. It is also an anti-cancer drug that can be used in patients who are positive for NTRK gene fusion. In Korea, less than 50 cancer patients are known to show NTRK fusion-positive casers every year. Vitrakvi demonstrated superior effectiveness in NTRK gene fusion positive patients. Clinical results for 159 patients published in the international journal Lancet last year showed an objective response rate (ORR) of 79%, and a median response period of 35.2 months (mDoR). It has shown therapeutic effects for about three years. There were also 24 cases (16 per cent). At the time of announcement, the median value of the overall survival period (mOS) was 44.4 months and the median value of the progressive survival period (mPFS) was 28.3 months. Vitrakvi has been effective not only in adults but also in pediatric patients. Twenty-four patients under the age of one were also included in the clinical trial, which showed equal efficacy without difference from adults. Vitrakvi is therefore licensed for use regardless of adults or children. Oh Do-yeon, a professor of oncology at Seoul National University Hospital, said, "As a result of prescribing Vitrakvi in a 6-year-old pediatric patient with thyroid cancer, the cancer mass spread to the lungs was so good that video findings showed few feared side effects." The professor said, "I've been taking medicine for four years, and it's been working well so far." The challenge for Vitrakvi is data. For now, medical staff are not aware of NTRK fusion-positive casers. It is also unknown whether there will be a consistent effect on each type of cancer. Professor Oh Do-yeon also said, "If you look at each type of cancer, the number of patients is very small, so it is difficult to determine whether 80% of ORR can be maintained for each type of cancer." The professor explained, "If there are more parameters over time, the answer will come out." Professor Oh said, "There is a lot of controversy over when to treat Vitrakvi among the standard treatments established for each cancer species." If NTRK fusion-positive casers are found, they will use Vitrakvi before other treatments, but different medical staff members have different ideas. "If data accumulates more and medical staff's perception of NTRK gene fusion improves, we expect to use Vitrakvi in the early stages." Another stumbling block for Vitrakvi is whether to register pay.Vitrakvi passed the first stage of the HIRA's Cancer Drugs Benefit Appraisal Committee in May with the same NTRK targeted drug Roche's Rozlytrek. Bayer is pushing for a quick listing as a pharmacoeconomic study and PE study exemption track. Attention is focusing on Vitrakvi's move as there have been no cases of anti-cancer drugs being registered as salaries regardless of cancer.
- Company
- ‘Tagrisso’ tenaciously attempts reimb. for 1st line NSCLC
- by Eo, Yun-Ho Jul 19, 2021 10:34am
- AstraZeneca Korea is attempting to receive insurance benefits for ‘Tagrisso’ once again after modifying its reimbursement standards. Industry officials said that AstraZeneca Korea had recently reapplied for expansion of insurance benefit for its 3rd generation EGFR TKI Tagrisso (osimertinib) to first-line treatment in non-small cell lung cancer (NSCLC). The key strategy for the approval of insurance benefits this round is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to provide the benefit to those who have a high treatment need rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would also naturally allow for a broader discussion on its fiscal impact. Thus, whether the agenda will be put up for deliberation at the Health Insurance Review and Assessment service’s Review Committee for Cancer Disease meeting planned in September is gaining attention. If reviewed, this will be the fourth time the agenda is discussed by the Review Committee for Cancer Disease As the committee passed MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ for the first-line treatment of lung cancer at the meeting in July after 4 years of deliberation, attention is focused on the committee’s decision for Tagrisso as well. Tagrisso, which added its indication for first-line treatment of lung cancer in Korea in December 2018, aimed to expand its reimbursement to the indication in 2019. However, after deliberation by the Review Committee for Cancer Disease in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in first-line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) that there was an issue with the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the first-line reimbursement of Tagrisso.”
- Company
- Prolonged Galvus patent dispute… results to come next year?
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- The patent dispute surrounding Novartis’ anti-diabetic DPP-4 inhibitor ‘Galvus (vildagliptin)’ may be prolonged and not be concluded within this year. With the substance patent of the said product to expire in March of next year, the benefits of early release will disappear for generic companies if the ruling comes after then. However, generic companies plan to continue the legal dispute to the end in consideration of the impact this case will have on future pharmaceutical patent strategies set by the industry in general. ◆4 years of legal dispute over invalidation of the extended period for a substance patent deepens Supreme Court’s concerns Pic of Galvus1According to the pharmaceutical industry, the legal dispute between the original drugmaker Novartis and generic companies centered around Ahn-Gook Pharmaceutical is ongoing for 4 years now. The case is currently pending in the Supreme Court. In November last year, Novartis filed an appeal to the Supreme Court despite the partial win it received in the second trial. The period for the dismissal of appeal to the Supreme Court had passed, and the Supreme Court will now officially review the legal dispute. However, negative prospects on whether the Supreme Court will make a final decision soon are being raised, as the court will have to carefully examine this new type of legal dispute that had not existed in the past. A legal official said, “Many legal suits to invalidate the extended period of substance patents for pharmaceuticals had been filed; however, the claims had never been recognized in the first or second trial. The Galvus case was the first ruling by the court that accepted the invalidation claim to shorten the extended term of a patent.” “Due to these issues that require careful consideration, the Supreme Court seems to be seriously contemplating on the case. Even the parties in dispute will not be able to predict the date of the Supreme Court's ruling, and there is a possibility that a final decision will not be reached within this year," he added. ◆Despite substance patent expiry in March 2022, generic companies are 'in for the whole fight' The key is whether the Supreme Court will make its ruling before March 4th of next year. March 4th is the date when the substance patent for Galvus expires. If the court’s ruling comes after May 4th, the generic companies will not be able to reap the benefits of overcoming Galvus’s patent or from the early release of its generic. According to UBIST, Galvus and Galvusmet sold 8.1 billion and 36.4 billion won in outpatient prescriptions last year. If the ruling comes after March, the generic companies will lose the opportunity to acquire the right to exclusive marketing approval of their generic in the prescription market that amounts to 40 billion won per year. Despite the risks, the generic companies plan to fight the full battle, as the results of this legal dispute may set a new milestone for generic companies in establishing patent strategies for generics in the future. If the generic companies succeed in invalidating even just one day of the extended patent term, this will may start a series of challenges on substance patents of original drugs, an area that had been considered impregnable. ◆187 days vs 55 days vs 0 days… What will the Supreme court’s judgment be? The Supreme Court‘s ruling is expected to be one of the three – recognizing the ‘187 days invalid’ by accepting the ruling of the first trial; recognizing the ’55 days invalid’ by accepting the ruling of the second trial, or accepting Novartis’ claim and not recognizing any part of the term invalid. The conflict began 4 years ago in July 2018 when Ahn-Gook Pharmaceutical requested a trial claiming that part of the term extended for the substance patent of Galvus is invalid. Hanmi Pharmaceutical later joined in the fight. Patent rights are usually protected for 20 years from the filing date. For pharmaceutical products, the time taken for clinical trials and regulatory approval is added to the protection term. Depending on the recognized period, patent protection for a drug can last 21 years or even 22 years. The same applied to Novartis when applying for Galvus’s patent in Korea. The company requested the patent term for Galvus to be extended to make up for the time spent on clinical trials and for the regulatory review by the Ministry of Food and Drugs Safety. The Korean Intellectual Property Office accepted the request and extended the term by 2 years, 2 months, and 23 days (1068 days). Ahn-Gook Pharmaceutical claimed that the 187 days of the extended term for Galvus’s substance patent was invalid. IPTAB accepted Ahn-Gook claim and ruled the 187 days invalid. Novartis appealed, and the case went to the hands of the Patent Court of Korea. Intellectual Property Trial and Appeal Board had overturned the first instance judgment to take Novartis’ side. However, the court ruled that only 55 of the 187 days are invalid. As a result, Ahn-Gook did lose the suit but reaped the rewards. As a result, Novartis once again appealed, and the case is not being reviewed by the Supreme Court.
- Company
- Emtuen became the largest shareholder of SillaJen
- by An, Kyung-Jin Jul 19, 2021 05:56am
- SillaJen said that Emtuen paid ￦60 billion for 18.75 million shares. Emtuen will become SillaJen's new largest shareholder starting with the payment, seeking to normalize its management and strengthen its expertise in bio-industry companies. On the 13th of next month, SillaJen will hold an extraordinary shareholders' meeting at the Korea Broadcasting Center in Yangcheon-gu, Seoul and appoint new board members. According to SillaJen, the new board consists of people who can normalize management and develop bio expertise. GreenFireBio.LLC personnel, a U.S. drug development company with Emtuen as the largest shareholder, are also expected to join the board of directors of SillaJen. "We will do our best to become a pioneer in the bio industry as well as responsible management as the new largest shareholder," an Emtuen official said. "We will make efforts to establish a virtuous cycle model for the bio industry that leads to Emtuen, Sillazen and GFB." "With capital and expertise, Emtuen is truly pleased to be the new largest shareholder," said SillaJen. "We will do our best in research and development as SillaJen is able to make a new leap forward." Emtuen sets the entire new shares to lock-up period for three years to advocate responsible management as the largest shareholder and guarantee minority shareholders rights.
