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- Company
- Hanmi and SK win the final round of Xarelto patent dispute
- by Kim, Jin-Gu Dec 28, 2020 06:13am
- South Korean pharmaceutical companies won the patent dispute on Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban). As a result, Hanmi Pharmaceutical and SK Chemicals have overcome the last obstacle to prepare an early launch of rivaroxaban generic in next October. On Dec. 24, the Supreme Court ruled in favor of Hanmi Pharmaceutical and SK Chemicals for the third ruling on the negative confirmation scope in Xarelto’s composition patent. Besides the latest case, Hanmi has also won the patent nullification case as well. The patent dispute started from March 2015, when the two companies filed a negative scope confirmation on Bayer’s original tablet. The two Korean companies won the first ruling, and they earned the preferential sales rights after they received the item approval in 2016. However, Bayer disagreeing with the ruling filed an appeal to the Patent Court. But the second ruling remained unchanged from the first. The multinational company then filed the last appeal. The case initiated from November 2016 at the Supreme Court was concluded four years after, bringing good news to the generic companies. Bayer requested for trials for correction, while arguing the case, to lessen the claim but the company also lost the patent nullification case as well. The final ruling was the last step towards the early generic release for Hanmi and SK. The two companies’ generic may be marketed from October 2021 with preferential sales rights lasting until July 3, 2022. A pharmaceutical market research firm UBIST found Xarelto has generated total 50.8 billion won for the outpatient prescription. As of the third quarter this year, 37.6 billion won worth of the drug was prescribed. Now the industry’s interest is shifting towards Chong Kun Dang, who started taking legal action to evade Xarelto’s substance patent. If Chong Kun Dang succeeds in evading the substance patent to be expired in October 2021, the company would be able to launch its generic even before Hanmi and SK.
- Company
- Multinational companies enjoy winter holidays up to 17 days
- by Eo, Yun-Ho Dec 24, 2020 06:10am
- Current status of winter holidays of 20 multinational companiesThis year, a number of multinational pharmaceutical companies' executives and staff members are entering long-term winter holidays. As a result of Dailypharm's survey of the year-end holidays of 20 major multinational companies on the 23rd, it was confirmed that more than 10 companies designated winter holidays for more than 10 days. In particular, as January 1, 2021 turns to Friday, two days of weekend holidays are added to January 2 and January 3, making the holiday season longer. The company with the longest holidays is GSK. The company will be closed for 17 days from the 18th to the 3rd of January 2021. AstraZeneca's employees are also given 14 days of vacation. The company was originally scheduled to start winter holidays from the 23rd, but with the addition of two days of special holidays from the global CEO, the company will enjoy the holidays from the 21st. In addition, Sanofi will be closed from the 22nd, Novartis, Viatris, Pfizer, and BMS will start on the 23rd, Daiichisankyo, Roche, and Boehringer Ingelheim will begin the holiday from the 24th, and Astellas will begin the holiday from the 25th. As of Christmas, a total of 11 pharmaceutical companies will be closed. The KRPIA and MSD start vacations from the late 28th. Most multinational pharmaceutical companies such as Galderma, Gilead, Lilly, Merck, Bayer, Amgen, Janssen, AbbVie, and Eisai have winter holidays using Voluntarily paid off. These multinational employees enjoy a minimum of 10 days off although voluntarily paid off. Even if it is not a designated holiday, many multinational employees are actually starting a break from this week. An official from a multinational company said, "Including the total holidays, there are many employees who take a break for more than 20 days. I am happy to have time to recharge because the industry as a whole has been busy in the aftermath of COVID-19."
- Company
- “Need to set up cold chain for COVID-19 vaccine ASAP”
- by Dec 24, 2020 06:09am
- Professor Lee Jae Hyun “Pfizer and Moderna both use mRNA type of COVID-19 vaccines and it is a highly unstable substance that requires exceptional level of cold chain management. Especially, the response plan on how to react on an emergency, for instance malfunctioning storage tool or power outage, is the most important part.” A Sungkyunkwan University College of Pharmacy professor, Dr. Lee Jae Hyun said as above on Dec. 21 at the Korea Pharmaceutical Distribution Association (KPDA) ‘Pharmaceutical Distribution Development Forum 2020’ that opened a discussion on the current pharmaceutical cold chain in South Korea and related solutions. As the number of biological drugs like vaccine is climbing, the drug distribution industry has to inevitably take account of cold chain. More specifically, Pfizer and Moderna have developed COVID-19 vaccine based on the novel technology using mRNA, which demands highly intricate control of the environment. However, only a handful of companies in the South Korean drug distribution industry has a cold chain for general biological medicine, not even suitable for the mRNA vaccine. Also at the forum, the chairman of KPDA Cho Sun-hye said, “Because the core of our industry is pharmaceutical distribution, we must achieve the hegemony in cold chain. And this forum was organized to swiftly and preemptively establish infrastructure for the cold chain market, and to prepare ourselves for the changes.” A cold chain is an environment with overall temperature control used to store and distribute biological drugs at its optimal state. The most integral part of cold chain is maintaining the optimal temperature for the entire process of distribution. Professor Lee Jae Hyun introduced a vaccine cold chain guideline and explained of the vaccine storing and distribution the industry is paying a close attention to these days. The professor elaborated, “The primary factor is to set a system that defines how to handle storing and shipping when using cold chain, what type of transportation cradle would be prepared and how to get to the destination. And also a validation system is needed to confirm the preparation of the system.” Dr. Lee stressed the cold chain has to be ready to handle emergency situation like malfunctioning and power outage. Moreover, a supply manager and quality control manager should be appointed to document the vaccine management criteria according the Good Distribution Practice (GDP). A wholesale manager can personally check the vaccine shipment, but a separate vaccine management staff should be designated with a proper training to react appropriately and timely to an emergency situation. A general prerequisite of a vaccine cold chain storage is a space that can maintain an adequate temperature and level of humidity. Refrigerated storage or a deep freezer has to use a biologic-specific fridge with an automatic thermostat. The professor highlighted, “Vaccine’s stock can vary depending on the season, but a distributor should have a sufficient space to manage all stock and more for the needed equipments.” The storage equipment has to be strictly maintained regularly, and it has to be kept clean all the time to ensure there is no dust on the heat conducting coil or motor. The storage equipment has to be validated for its adequate temperature via temperature mapping, which confirms well distributed target temperature in all spaces by using the temperature sensor and finding the maximum and minimum value. Professor Lee said, “Although an expert specialist can be hired to maintain the storage, especially for temperature and humidity, environmental hygiene and protection against pests and weather, the wholesale distributor would be held responsible so the company should visit and check the site regularly.” As soon as vaccines arrive, they would be moved to the storage immediately. And the staff in charge would have to record the arrival date and time, the name of acceptor and maintenance staff, the state of the vaccine with the corresponding solvent at the time of arrival, the name of vaccine accepting company, type and volume of the vaccines, and manufacturing serial number and expiration date. Professor Lee added, “For the thermostat in the vaccine cold chain, I recommend using a thermostat with tuning certification. And in case of temperature fluctuation issue caused by aged equipment, the temperature record should be archived for over two years at least.”
- Company
- Domestic companies won the first trial of 12 patents
- by Kim, Jin-Gu Dec 23, 2020 06:09am
- This year, domestic pharmaceutical companies have challenged 12 new patents. In 4 out of 12 patent disputes, generic companies have won all of them, and the remaining 8 cases have yet to be tried. According to the pharmaceutical industry on the 21st, a total of 12 patent disputes pending from January this year to this day. Daewoong and Chong Kun Dang were the most active companies to attack original patents. Each requested 4 patent trials. Subsequently, it was found that Dongkoo Bio&Pharma, Dong-A ST, Mothers Pharm, CTC Bio, Aju, Chodang, Cosmax pharma, Penmix, and Huons requested two patent trials. In addition, JW-Pharma, Kwang Dong, Daehan, Dongkwang, Myungin, Boryung, Arlico, Wooridul, Ildong, Choa, Taejoon, Theragenetex, Hana, Kolmar Korea, Hyundai, Whanin, and Huvist filed a patent trial one by one. 10 of 12 patents were owned by Global Pharmaceuticals. The remaining two were one patent for Chong Kun Dang's GERD treatment Eso Duo. Chong Kun Dang is a challenger in four other patent disputes and is defending two Eso Duo patent disputes. A total of 4 cases were concluded of the 12 patent trials filed this year. Generic companies won all four patent disputes (first trial). In February of this year, the first patent dispute began this year when JW Life Sciences requested a trial to confirm the scope of passive rights to Pfizer's Precedex (Dexmedetomidine) formulation patent. Daehan joined, too. The KIPO took the side of JW Life Sciences in the first trial. Currently, Pfizer has filed a suit to cancel the trial in the Patent Court of Korea in objection. Subsequently, on the 20th of the same month, CTC Bio filed a trial to confirm the scope of passive rights to the patent for the formulation of Chong Kun Dang's GERD treatment,Eso Duo. Aju and Chodang joined. The three companies also challenged another formulation patent for Eso Duo in September. However, Daewon and Sinil, which had challenged Eso Duo’s patent with them, voluntarily withdrew the judgment. On the 28th of the same month, Myungin challenged Eisai's Crystalline Form Patent for'Fycompa film coated tab', a treatment for epilepsy. A trial was filed with Whanin to confirm the scope of rights, and at the first trial, generic companies won. In March, Theragenetex filed an invalidation trial for a patent for the use of Handok's osteoporosis treatment Bonviva. The treatment is sold by Handok in Korea, but the patent right is in Roche. Following Theragenetex, Choa, Wooridul, Arlico, Kolmar Korea, Huvist, Ildong, Hana, Hyundai, Dongkwang joined. In the same month, Daewoong challenged two patents for the formulation of Belkyra, an injection drug for improving allergan's jaw fat. When Allergan splits the existing formulation patents and registers two new patents for patent defense, it also filed a negative trial for confirmation of the scope of rights. The dispute ended with the victory of Daewoong and Penmix. On July 22, Taejun filed a trial to confirm the scope of passive rights to a patent for the formulation of Novartis' glaucoma treatment Simbrinza (Brimonidine tartrate/Brinzolamide). The first trial is still in progress. On the 31st of the same month, Boryung filed a trial for a passive confirmation of the scope of rights against Celgene's Pomalyst. Kwang Dong joined, and the results of the first trial have not yet come out. On September 29, Daewoong challenged the formulation and use patents of Amgen's psoriasis treatment Otezla (Apremilast) at the same time. A trial for invalidation was requested for the use patent, and a trial to confirm the passive scope of rights was requested for the formulation patent. When Daewoong challenged patent of Otezla, Dong-A ST, Chong Kun Dang, Dongkoo Bio&Pharma, Mothers, Huons, and Cosmax pharma joined. The first trial is still in progress. For the last time this year, Chong Kun Dang filed a judgment for passively confirming the scope of rights to material patent of Bayer's NOAC (new oral anticoagulant) Xarelto. In the case of Xarelto, SK Chemicals and Hanmi overcame the formulation patent and received generic for exclusivity. If Chong Kun Dang succeeds in material patent, it can release generics before SK Chemicals and Hanmi.
- Company
- “30-year presence of antihypertensive Novarsc to continue"
- by Eo, Yun-Ho Dec 22, 2020 06:13am
- Dr. Kim Cheol-ho Norvasc (amlodipine) is not the world’s first calcium channel blocker (CCB). However, it is undisputedly the most famous CCB. Launched in 1990s, Norvasc was not the first-in-class but it instigated a notable change in the market with the first once-daily administration. Some say the drug marked the early beginning of the current day convenient administration marketing. A star of hypertension drug market Novarsc is now celebrating its 30 year anniversary of marketing approval in South Korea. Surely it is an old drug, but it still has its high reputation firmly built around ceaseless evolution. In 2017, Norvasc T was released to the market for the patients, who need amlodipine and telmisartan simultaneously. The company also introduced an improved bottle packaging to enhance the convenience of patients and healthcare providers storing and managing Norvasc T and to absorb the moisture of telmisartan. And besides the existing line of 5 mg and 10 mg tablets, the brand also launched 2.5 mg tablet for children from age six to 17, which was the first among all CCB original drugs for hypertension. From then on, Novarsc has been offering necessary dosage options to effectively bring down blood pressure in patients ranging from six years of age to elderly. Daily Pharm interviewed Dr. Kim Cheol-ho, a professor at Seoul National University Bundang Hospital Department of Internal Medicine to hear more about the value of Novarsc. -This year marks the 30th year for Novarsc. What was your first impression on the drug? And how was the hypertension treatment scene back then? Around 1989, I discovered Norvasc from an international journal. Back then the drug had not been introduced to South Korea, yet. During that time, only diuretics, beta-blockers and first and second generation CCBs with short duration of action were available. As amlodipine, or Norvac, was introduced, the South Korean market welcomed a once-daily calcium blocker. -How did it improve the treatment scene particularly, other than administration convenience or adherence? The drug’s coercion effect was groundbreaking. First, we used nifedipine three times a day, and then Perdipine twice a day. But when we switched to once-daily Novarsc, we found the blood pressure went down significantly. It was a shocking experience. -Since the release of Novarsc, how did the trend in hypertension treatment or cardiovascular disease prevention shift? Simply put, the paradigm had changed. Although previously we had diuretics, beta-blockers and first generation angiotensin-converting enzyme (ACE) inhibitors, their antihypertensive effects were not strong enough. But with Novarsc’s remarkable coercion effect, more patients were able to reach the target blood pressure level. Especially from 2000, when the Separation of Prescription and Dispensing (SPD) System was implemented, patients had to get prescription for drugs and the hypertension control in South Korea has gotten much better. From early 2000 to mid-2000s, the hypertension control rate in South Korea was increased from approximately 10 percent to 40 percent. CCB was an integral factor to the improvement, and Novarsc’s part in CCB was huge. -What is the latest topics addressed about hypertension control? There are two major questions—‘is the blood pressure the lower the better?’ and ‘is the treatment the earlier the better? We have not found a clear answer to the question of ‘is the blood pressure the lower the better?’ It is an issue of how much antihypertensive effect is good.’ And it relates to a definition of how high is high. Although we do not have accurate data to support how early the hypertension treatment should start, I personally advise discovering the hypertension patient in their 30s to 40s is better. Recent studies claim high blood pressure is related to a cause of dementia, so treating it from early on would help patients maintain their cognitive function as well. -Would you say the significant influence of Novarsc in hypertension management would be maintained in the future? For a long time, its presence would continue to be noticeable. It is true that the drug has contributed immensely in protecting the Korean people from cardiovascular diseases for three decades. In last decade, the improvement rate in hypertensive control in South Korea has been growing sluggishly. Almost to the point there is no growth. Both the people and the healthcare providers should pay more attention, and the government and relevant organizations should also raise awareness of the condition.
- Company
- Boryung's FAH is expected to be released soon
- by Kim, Jin-Gu Dec 22, 2020 06:10am
- (From left) Dukarb, Tuvero, and Kanarb Boryung's hypertension combination drug is expected to be released in the second half of next year. If FAH is released next year as planned by Boryung, it will be the 7th 'Kanarb Family'. Interest is focused on whether to continue the Ducaro and Archave successes as the 5th and 6th Kanarb family this year. According to the pharmaceutical industry on the 21st, phase III clinical trial of Boryeong's three-drug hypertension drug based on Kanarb is in the final stage. Product release is possible as early as the second half of next year. Boryung is developing under the name 'FAH', a combination of Fimasartan, Amlodipine, and a diuretic (HCTZ) for high blood pressure. Boryung has conducted Phase III clinical trial on 250 hypertensive patients at 32 domestic hospitals since May 2019. Boryung released its own Fimasartan-based hypertension drug Kanarb in 2010, and has added five combinations so far. Boryung It started with Lacor (Fimasartan potassium/HCTZ) in 2013, Dukarb (Fimasartan potassium/Amlodipine) and Tuvero (Fimasartan + Rosuvastatin) in 2016. In February of this year, Dukaro (Amlodipine Besylate/ Fimasartan Potassium Trihydrate Granule/ Rosuvastatin Calcium (Micronized)) was released, and in September, Akarb (Atorvastatin Calcium Trihydrate/ Fimasartan Potassium Trihydrate Granule) was released, expanding the Kanarb family lineup. The Kanarb family is promising to exceed ₩100 billion in outpatient prescriptions this year. According to the drug market research institute UBIST, the Kanarb family recorded a prescription record of ₩94.3 billion until November. This is because, while the prescription amount of the single drug Kanarb has slowed, the prescription amount of the combination drugs, led by Dukarb, has increased significantly. Dukaro and Akarb, launched this year, are considered successful. Dukaro produced ₩5.4 billion by November, and Akarb produced ₩700 million in two months of launch. If the 7th Kanarb family is released next year, attention is focused on whether it will continue to succeed. The key is the competition drugs. The market for a combination drug for hypertension with ARB + CCB + diuretics is already dominating the market. Daiichisankyo's Sevikar HCT (Amlodipine/Olmesartan medoxomil/HCTZ), Hanmi's Amosartan plus (Amlodipine/Losartan potassium/Chlorthalidone), Ildong's Twotops Plus (Telmisartan/Amlodipine/HCTZ), Yuhan's True Set (Amlodilate/Chlorthalidone) /Telmisartan) is in competition. Until the third quarter of this year, Sevikar HCT had sales of ₩24.6 billion, Amosartan plus ₩17.4 billion, True Set ₩7.4 billion, and Twotops Plus ₩4.7 billion 20 items have been released as generics for Sevikar HCT due to the expiration of the patent. An official from the pharmaceutical industry said, "Kanarb's material patent will expire in February 2023. Boryung will try to launch as much variety of Kanarb-based combination drugs as possible before the patent expires." He said, "How much synergy between Boryung and its existing products in the competitive high blood pressure triple-drug market will determine the performance of the 7th Kanarb family."
- Company
- First line therapy for NSNLC, starts of combination therapy
- by Eo, Yun-Ho Dec 22, 2020 06:09am
- Various combinations have been approved for NSNLC (non-small cell lung cancer), the most competitive field for new anticancer drugs. Competition is expected to intensify in the future as numerous studies are underway based on immuno-cancer drugs and targeted anti-cancer drugs. Lilly threw the hat into the ring in Korea. The company is in the process of expanding insurance benefits for primary prescriptions of NSCLC of VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib). Cyramza's combination therapy was approved in Korea in July. The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far. The possibility of Cyramza+Tarceva combination therapy was confirmed through a phase III RELAY. The Cyramza+Tarceva combined group reduced the risk of death by 40% compared to the Tarceva alone group, and the combined group showed a difference of more than 7 months from the control group at 19.4 months. Overall survival (OS) has not yet been derived. The median follow-up was 20.7 months, and the objective response rate was 76.3% in the Cyramza combination group and 74.7% in the Erlotinib alone group, but the median response duration was 18.0 months and 11.1 months. It is also encouraging that about 70% of the patients who participated in the RELAY study included East Asians. The immune anticancer drug Opdivo((Nivolumab), which has suffered from wage issues in Korea, is also starting a new challenge. Ono and BMS added a first-line indication for non-small cell lung cancer in combination with PD-1 inhibitor Opdivo and CTLA4 inhibitor Yervoy (Ipilimumab) on the 16th. The effectiveness of Opdivo-Yervoy combination therapy in the first line of NSNLC was confirmed through a Phase 3 CheckMate-9LA study. CheckMate 9LA (NCT03215706) is a phase III randomized study evaluating NIVO + IPI + 2 cycles chemo vs chemo in 1L stage IV/recurrent NSCLC A statistically significant improvement in OS was observed with NIVO + NSCLC-optimized IPI + a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC. No new safety signals were reported. In addition, the results of extended follow-up for 12.7 months showed that the median OS of the two cycles of Opdivo+Yervoy chemotherapy was 15.6 months, which was consistently improved compared to 10.9 months of chemotherapy. Meanwhile, Opdivo+Yervoy combination therapy was approved as an indication for renal cell carcinoma in Korea, and it is in the process of registration after passing the Cancer Disease Review Committee in June. Cyramza was listed as a refund-type risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018.
- Company
- CKD to outrun SK and Hanmi with Xarelto patent challenge
- by Kim, Jin-Gu Dec 22, 2020 06:09am
- 자렐토 제품사진 Chong Kun Dang is now the sole contender to challenge Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban) substance patent. As it overcame Xarelto’s formulation patent, Chong Kun Dang plans to enter the follow-on drug market faster than SK Chemicals and Hanmi Pharmaceutical, who won the preferential sales rights. According to a pharmaceutical industry source on Dec. 18, the South Korean company has requested the Patent Court to provide a negative scope confirmation on Xarelto’s substance patent. So far, Chong Kun Dang is the only one filed the suit. Xarelto own three patents; a formulation patent expiring in 2024, an indication patent expiring I 2022, and a substance patent expiring in 2021. A number of Korean companies have successfully evaded the formulation patent. Bayer registered the indication patent, after the court ruled favorable for the Korean companies on evading the formulation patent. In 2015, SK Chemicals and Hanmi Pharmaceutical jointly filed for the negative scope confirmation on Xarelto’s formulation patent and won the first and second cases. Since then, Hanlim Pharm, GC Pharma, Samjin Pharm and Yungjin Pharm were also able to evade the patent. Currently, Bayer’s appeal case is pending in the Supreme Court. SK Chemicals and Hanmi Pharmaceutical that evaded the formulation patent, were the first ones to receive the preferential sales rights. The two companies can sell the generic drugs exclusively for nine months from Oct. 3 next year, when the substance patent is expired. And now, Chong Kun Dang is intercepting by challenging the substance patent. If the company succeeds and overcomes the substance patent, Chong Kun Dang would be able to launch its product faster than SK Chemicals and Hanmi Pharmaceutical with the preferential sales rights. However, the feasibility of the substance patent would be the deciding factor. Unlike the formulation and indication patents, the substance patent challenge tends to be even more difficult. In 2015, Daewoong Pharmaceutical filed a substance patent challenge on Xarelto to nullify the patent, the court has dismissed the case and there has never been another substance patent challenge. At the moment, Chong Kun Dang has a generic named ‘Riroxia’ approved to market. Both the tablet and capsule forms have been approved. Capsule form option is only offered by Chong Kun Dang. Even if Chong Kun Dang fails to challenge the substance patent but succeeds in evading formulation and indication patents, Riroxia in a capsule form can be sold regardless of the preferential sales right. However, the company has not tapped on either formulation or indication patents, yet. A pharmaceutical market research firm UBIST found Xarelto has raised 50.8 billion won last year for outpatient prescription. Up until the last third quarter, the prescription volume of the drug reached 37.6 billion won.
- Company
- Another effect of Botox, possible to treat hair loss
- by Dec 21, 2020 06:19am
- Following cosmetic surgery, botulinum toxin formulations are expanding their scope to treat hair loss. It is noteworthy as researches confirming the potential as a treatment for hair loss in Korea are ongoing. Byeong-cheol Park, Professor of Dermatology, Dankook UniversityDankook University dermatology professor Park Byeong-cheol confirmed the effect of botulinum toxin on hair loss improvement in the Sponsor- Investigator Trials conducted by Daewoong Pharmaceutical's Nabota. In 22 subjects, Nabota was treated for 6 months and the reaction was confirmed. As a result, the number of hairs increased statistically significantly at week 24. The study results were published in the December issue of the SCI-level journal Journal of the American Academy of Dermatology (JAAD). This study is a kind of exploratory study, and there is a limitation that there is no control group and the number of subjects is small. However, Professor Park Byung-cheol said, "It is meaningful that we have confirmed the mechanism of hair loss treatment of botulinum toxin through a cell experiment, and that the researcher's clinical trial has confirmed its potential. We can proceed to the later phase II clinical trial and the phase III study according to the results. It was an opportunity to lay the groundwork for that,” he revealed the significance of the study. Dailypharm conducted an interview with Professor Park to find out the potential of botulinum toxin preparations to treat hair loss. ▶What are the limits in the treatment of androgenetic hair loss? -The oral drugs Finasteride (Propecia), Dutasteride (Avodart) and minoxidil are the treatments for androgenic hair loss that have been approved by the US Food and Drug Administration (FDA) so far. These are the most important treatments and the basis of hair loss treatment. However, in some patients, the effectiveness of these treatments may be insufficient, and it is true that each drug has side effects. In addition, Finasteride and Dutasteride have limitations that women of childbearing potential cannot take. ▶A study on hair loss treatment was conducted with botulinum toxin. Please explain the research background, design, and results. -Botulinum toxin is used not only to improve wrinkles but also to prevent and treat scars, and one of the main mechanisms at this time is to inhibit TGF-β. TGF-β is also known to inhibit hair growth and progression from hair to telogen hair. I thought there would be something in common, so I started my research. This study was a pilot study, comparing before and after treatment in 22 subjects without a control group. Except that there was no control group, the reaction was confirmed after treatment for at least 6 months following the general guidelines for confirming the improvement in the efficacy of hair loss suggested by the Ministry of Food and Drug Safety. Effectiveness evaluation statistically verified the change in the number of hairs per unit area at 12 and 24 weeks compared to the baseline at week 0 and the degree of improvement by clinical pictures. Side effects were confirmed through vital signs at each visit, medical examination, and blood tests at weeks 0 and 24. The treatment method was to inject botulinum toxin (Nabota) into the hair follicle of the subject every 4 weeks with 30 units of botulinum toxin (Nabota) for a total of 24 weeks for a total of 24 weeks. At week 24 of treatment, the number of hairs increased significantly (p=0.012). No serious drug-related adverse events were reported. Daewoong ▶How was the satisfaction the patient felt after treatment? -In addition to the researcher's objective evaluation, the subject's subjective satisfaction was evaluated through a questionnaire. △ Overall scalp shape improvement, △ improvement of hair density in the area of hair loss, △ improvement of the degree of hair loss, △ improvement of hair growth rate, △ improvement of hair thickness. ▶What mechanism of botulinum toxin preparations has the effect of treating hair loss? -It is assumed that botulinum toxin inhibits the secretion of TGF-β1 from hair follicle cells, which inhibits the progression and growth of hair at rest. The increase in TGF-β1 secretion by'dihydrotestosterone (DHT)' is known to be one of the major causes of androgenic hair loss. In this study, an increase in TGF-β1 was also observed by DHT, and it was confirmed by cell experiments that the expression was decreased when treated with botulinum toxin. ▶Looking at the results of this study, there was a significant improvement at week 24, but not at week 12 (p=0.803). In other words, it means that the change was insignificant until 3 months of the procedure. What do you think is the reason? -I think the cycle of hair or the cumulative concentration of the drug may have had an effect. Normally, the hair growth period is 4-6 years, and the period of regression is 3 weeks, and the period of rest is about 3 months. Considering this, it can be interpreted that it may not be effective at the third month. Or it is thought that a period of cumulative concentration may have been necessary for the drug to exert its effect. Accordingly, a follow-up study currently underway is confirming the treatment response by increasing the concentration slightly. ▶This study was only for men. Could female hair loss patients benefit from hair loss treatment with botulinum toxin? -In fact, there are few treatments for female type hair loss, so many people are also interested in this. Although clinical studies have not been conducted yet, the results cannot be predicted, but since TGF-β1 inhibits general hair growth, it is expected that botulinum toxin that blocks this will be effective in female-type hair loss. Currently, botulinum toxin is also injected into female hair loss patients with consent at the clinic site for therapeutic purposes. ▶Isn't there a tolerance problem even in hair loss treatment of botulinum toxin? -Botulinum toxin has been used for a long time as a treatment for wrinkle improvement, and since it is a topical injection treatment, it has been used without significant side effects. Since hair loss treatment is also a local treatment, it has the advantage that it can be treated while minimizing systemic side effects. In particular, in existing wrinkles, injections are made into muscles with abundant blood supply, but in hair loss, because dermal hair follicle injections are performed, systemic absorption through blood vessels is expected to be less, so there is a high possibility that no noticeable systemic side effects were observed. Since this study was only conducted for 6 months, long-term observation is necessary. Problems have also been raised about the formation of neutralizing antibodies and resistance to botulinum toxin injections, but this is known to occur mainly in patients who frequently receive high-dose intramuscular injections. Hair loss treatment is expected to have less resistance, but this part will be confirmed through follow-up studies. ▶Aren't patients reluctant to get an injection into the scalp? -Because getting an injection into the scalp itself causes pain, there is a factor to be reluctant. However, since there is a motive for the treatment of hair loss, they are injected once a month, and various tips are used to minimize pain during injection, so most patients at the actual clinic say that they have pain, but it is acceptable. ▶Wouldn't the temporary effect of botulinum toxin formulations be a disadvantage? What new treatment benefits do you think can offer more than existing hair loss treatments? -Androgenic hair loss is basically a progressive disease caused by genetic factors, so if you stop taking any medication, hair loss may progress again, and this is the same with botulinum toxin treatment. However, in this study, there are cases in which it was unofficially confirmed that hair loss does not progress for about 3 months after the last treatment. Factors that cause hair loss can vary, and the effects on hair loss treatment are also diverse. Accordingly, botulinum toxin can be used in a variety of ways, including the purpose of increasing the effect in patients with insignificant effect on the existing treatment, the purpose of maximizing the effect in patients with good effect in the past, and alternative purposes in patients with no effect on treatment. .In particular, it is expected that it can be used in patients who are unable to take existing drugs .▶Please tell us about the significance and limitations of this study and the follow-up studies This study is meaningful in that it has confirmed its possibility as an exploratory study as the first step to find out whether botulinum toxin can be used as a hair loss treatment .In particular, the mechanism was also confirmed through cell experiments .Since it is a small-scale study without a control group, it can be recognized as a universal treatment only when the later phase 2 and final phase 3 clinical trials are completed, but it is meaningful in that the basis for these studies has been prepared .As a follow-up study, a study is underway to find the optimal concentration and usage to maximize the therapeutic effect .In the future, we plan to study the therapeutic effect in gynecomastia, the presence or absence of neutralizing antibodies that may occur during treatment, and further analysis of the therapeutic mechanism at the cellular and hair follicle organ levels.
- Company
- US ITC bans Nabota from importing for 21 months
- by An, Kyung-Jin Dec 21, 2020 06:19am
- The US International Trade Commission (ITC) issued an order to ban imports from the US for 21 months on Jubo (Nabota), a botulinum toxin product developed by Daewoong. According to industry sources on the 17th, the US ITC issued a final ruling on the 16th (local time) in a lawsuit between Medy Tox and Daewoong infringement of trade secrets of botulinum strains. However, the period for the US import ban was drastically reduced from 10 years to 21 months. As a result of the preliminary judgment, they accepted the allegations of stealing Medy Tox strain and manufacturing technology, but decided that the strain was not a trade secret and therefore did not fall under the ITC's regulatory matters. Medy Tox and Daewoong have been struggling for a long time over the source of the botulinum strain. In 2019, Medy Tox and Allergan filed a lawsuit against Daewoong and Evolus to the US ITC, and in July this year, the ITC administrative judge ruled that Daewoong's Nabota was banned from US imports for 10 years. Since then, Daewoong has filed for an objection, and ITC accepted it and proceeded with a re-examination. The final judgment was also postponed three times from November 6 to November 19 and again to December 17. The ITC is a federally independent, quasi-judicial body directly under the President of the United States with extensive investigative power on trade issues. After the ITC makes a final decision that a violation of Article 337 exists, it will be passed on to the President and approved by the President. The President of the United States has the right to veto a decision within 60 days of the date of delivery by the ITC. If the President exercises his veto power, the ITC's final decision and action shall take effect on the date the President's veto is notified. In the US, it is believed that Allergan won the ruling. Bloomberg reported on the ITC ruling, "AbbVie has blocked Botox rivals from importing to the United States. As the ITC decided to ban US imports for 21 months on Jubo, which Evolus sells, it will be able to maintain a monopoly." AbbVie owns the license and sales rights of Botox through the acquisition of Allergan. Immediately after the final ITC decision was delivered, Evolus shares, which are listed on the NASDAQ, fell 3.9% from the previous trading day. Evolus, as a partner of Daewoong, is in charge of selling Jubo in the US. However, with this ruling, the dispute between the two companies over the source of the botulinum strain is not expected to end immediately. Daewoong said that the decision made by the ITC Committee regarding the final decision of the ITC was based on Allergan's domestic industrial protectionism to protect the monopoly market, and therefore Daewoong will appeal. An official of Daewoong said, "It is clear that Daewoong developed Nabota without infringement of trade secrets. We will fight to the end by mobilizing all legal procedures in the ongoing dispute to uncover the truth." Nabota's US sales portion of annual sales is currently less than 2%, so the impact on corporate management is expected to be insignificant.”
