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- 2026-03-18 22:46:44
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- The dismissal of an executive in Lundbeck Korea was unfair
- by An, Kyung-Jin Sep 08, 2020 06:11am
- The National Labor Relations Commission issued an order to reinstate the job, saying that the dismissal of former executives in Lundbeck Korea was unfair. According to related industries on the 7th, the National Labor Relations Commission held an interrogation meeting on July 30 and sided with Mr. A in the case of a ``unfair dismissal request'' filed against the company by former Lundbeck Korea executive A. The National Labor Relations Commission recently issued an award containing the contents. The National Labor Relations Commission acknowledged that the dismissal of Mr. A by Lundbeck Korea was unfairly dismissed, and ordered that Mr. A be reinstated to his original position within 30 days from the date on which he was served, and paid the equivalent of the wages he would have received if he worked normally during the dismissal period. In this regard, Lundbeck Korea held a disciplinary committee on April 13th, and Mr. A notified his dismissal in writing for violating Article 12 of the employment rules. ▲ Article 4 (duty of integrity) ▲ Article 9 (prohibited matters) 5 and 6 ▲ Article 27 (waiting order) Article 82 (Disciplinary) 3, 5, 8, 11, and 12. The company's explanation is that despite the violation of internal guidelines during the selection process of the contractor, and misconduct such as lies and non-cooperation in work, Mr. A did not reflect and his work attitude did not improve. and the dismissal was notified properly. Mr. A received a notification of 'dismissal' from the company on April 16, three days after the disciplinary committee was held, and filed a request for relief from unfair dismissal to the committee on June 2nd. The National Labor Relations Commission said, "The dismissal is an abuse of the disciplinary discretion of the employer due to an excessive amount of dismissal compared to the recognized disciplinary grounds." For example, it is pointed out that the problem of the open tendering process for a contractor is that it is not recognized as a misconduct by Mr. A because the CEO and the head office have the final decision authority and the duty of management and supervision. It was considered that the specific grounds for the claim that Mr. A failed to comply with the work order or disturbed the workplace order were insufficient. Among the multiple disciplinary grounds, it is the position that Mr. A only admits one act of attending the academic conference without approval from the management during the waiting period. According to this decision, Lundbeck Korea must reinstate Mr. A within 30 days of service of the decision and pay the wages for the dismissal period, or request a reconsideration with National Labor Relations Commission within 10 days.
- Company
- The contradiction of generic exclusivity
- by Kim, Jin-Gu Sep 07, 2020 06:13am
- Let's imagine! This is the case when the rule for '1st place' in a marathon is set to be '14 seconds after the first goal scored'. Competition will become meaningless, and only fights will increase. The achievements of legitimate efforts that the first place should receive will be shared by numerous 'joint first prizes'. The controversy over the generic exclusivity system is similar. Due to the regulation that suppresses discrimination, the 'contradiction of common first place' is prevalent. It is often observed that up to 45 items receive the right at the same time, and the product is not released even after receiving the right. As the circumstances look like this, the profits from obtaining generic exclusivity are very small. It is calculated that each item is limited to ₩400 million for 9 months. This is the reason why criticism is constantly raised for promoting free rides over the current system. It is also the reason why the pharmaceutical industry is regretting about the government's revised right. ◆5 years of introduction of the rights, benefits average ₩400 million for 9 months The generic exclusivity system was introduced in earnest in 2015. The purpose of the introduction was to provide benefits for the efforts of active pharmaceutical companies in the development of generics and patent challenges. However, as of five years later, most pharmaceutical companies with the generic exclusivity do not benefit. Dailypharm surveyed the prescriptions of products with generic exclusivity since 2015. The average prescription amount for 9 months during the sales period was only about ₩400 million. According to the MFDS, as of the end of August 2020, 140 generics were launched on the market within the generic exclusivity period. The prescription performance of these items during the period was ₩59.3 billion. It is calculated that the average prescription amount per item (₩59.3 billion ÷ 140 items) is only ₩420 million for 9 months. Although there is a difference in the size of the market and the loyalty of the original for each item, criticism has been raised that it is not effective given the nature of the generic exclusivity. In particular, as the number of pharmaceutical companies that jointly acquire the generic exclusivty, the benefits to each pharmaceutical company decrease. This is why pharmaceutical companies, which have led the patent challenge, are complaining that it is 'free ride'. In the case of generics for Amosartan (Amlodipine+Losartan), 21 companies received the right of the generic exclusivity with 45 items. Of these, only 12 (57%) launched products during the period. 12 pharmaceutical companies only produced a total of ₩1,160 million during the period (May 9, 2015 to April 1, 2016). This is less than ₩100 million per pharmaceutical company. If the rights were monopolized by one pharmaceutical company rather than 21 pharmaceutical companies, it is expected that the results would not have reached ₩100 million. The rest of the products are similar. In the case of generics for Layla, out of the 14 companies that received the right, only 10 launched the product within the period, and they only recorded an average of ₩430 million during this period. 13 companies for generics for Viread received the right, but only 11 companies released the product within the period. The company that launched the product produced an average of ₩370 million per company. Nine companies challenged generics for Feburic, but only 8 released products, and they only achieved an average of ₩79 million won per company. On the other hand, items with fewer competitors tended to have more profits from generic companies. Hanmi alone challenged the patent for Patanol eye drop (Olopatadine)' and received the right of the generic exclusivity as a generic called Olotadine. During the period, Hanmi recorded ₩1.35 billion in prescriptions. Dong-A ST challenged the patent for Dilatrend (Carvedilol) and received the right as a generic called Vasotrol. During the period, Dong-A ST produced a prescription record of ₩990 million. ◆Generic for Amosartan, In addition, the mess of the generic exclusivity is observed in many products. As of the end of August 2020, there are 387 items that have acquired the right of copyright. Excluding items with different capacity in the same lineup, it is calculated that 244 products have received the right. There are 42 original drug patents that these 244 products have overcome. It means that one original product has an average of 5.8 generics and received the right. This trend is observed to be more frequent in larger items. In the case of Amosartan, 21 pharmaceutical companies received the right for 45 items. It means that only 21 people are tied for first place. Other products are also very similar. Most recently, on the 25th of last month, 13 pharmaceutical companies received rights with 21 items on Forxiga (Dapagliflozin). In 2016, Januvia (Sitagliptin) acquired 22 items from 10 companies, and Janumet (Sitagliptin + Metformin) acquired 33 items of 11 companies. 14 companies and 10 companies, respectively, succeeded in acquiring the right for natural drugs, Stillen 2X and Layla. ◆Even after winning the right, half of them were not released within the period. Why? Although many pharmaceutical companies flocked to acquire the right of the generic exclusivity, it is also confirmed that not many pharmaceutical companies actually launched the product. As of the end of August of this year, there are a total of 255 items that have reached the right sales period or are currently in use, of which only 140 items have actually released products to the market within the right sales period. Only 5 out of 10 products (54.9%) that received the right copyright have put products on the market. There are many reasons for not releasing a product even after obtaining the right through patent disputes. The reason is that it won the right, but failed to prove bioequivalence for the release of generics, felt a burden as the patent dispute with the original company passed to the second or third trial, or judged that it was not marketable. However, it is easy to obtain the right of the generic exclusivity as the number of requests for trial increases. ◆Initial request for trial '14 days' It was introduced in 2015. With the conclusion of the Korea-US FTA, the licensed patent linkage system was introduced in 2012, and the system that grants monopoly rights to patent challenge generics through step-by-step enforcement procedures was also revealed. All three requirements must be met in order to obtain the right of copyright. First, it is necessary to first request a trial (confirmation of invalid or passive scope of rights) for the original patent. Second, it must win the patent trial raised in this way. Third, it is necessary to first apply for approval for generics. Acquiring the right seems tricky because all three conditions must be completed, but it is not. This is because the clues are attached to the first requirement, the request for an initial trial. Under the current law, it stipulates that 'company that makes a claim within 14 days after the initial request for a judgment is also recognized'. This regulation causes the contradiction of the joint first place. After winning the referee, the day after the end of the PMS (reexamination), a bunch of applications for permission continued. It was common for dozens of companies to be bound by consignment and got the right at the same time. The first request for judgment became a ticket for the sale of generics. It is not known exactly why the '14 days' rule in question was included when making the law. Some say that this is because the time it took to be published in the patent gazette after a request for a trial was filed for about 14 days. However, it is said that Korea is the only case in the world that regulates 14 days. A patent expert in the pharmaceutical industry said, "The generic exclusivity in Korea has been reduced to a system that has little practical benefit. Due to the scattered initial request for trial, only pharmaceutical companies that challenged patents have been changed to a structure that is relatively damaged."
- Company
- Court to rule against companies on eye drop pricing?
- by Chon, Seung-Hyun Sep 07, 2020 06:12am
- The end in two years of legal dispute over the eye drop pricing reduction seems to be approaching. The Supreme Court has ultimately ruled against pharmaceutical companies on one of the two pricing reduction litigation cases. And as the government has won both the first and second trials over the other case, it would be unlikely for the pharmaceutical company to win the last appeal. ◆MOHW authorizes pricing reduction on eye drops twice, the Supreme Court’s final decision made on one The pharmaceutical industry sources reported on Sept. 6, South Korea’s Ministry of Health and Welfare (MOHW) has announced the execution suspension on the pricing reduction in 33 eye drops would be lifted. The ministry’s announcement followed the Supreme Court’s decision. On Sept. 3, the Supreme Court dismissed the appeal made by pharmaceutical companies regarding the government’s attempt to bring down the pricing on eye drop products. The Court stated, “The appellant’s claim for the appeal is clearly unjustifiable, therefore, all appeals would be dismissed.” In December 2018, MOHW has decided to lower the pricing on 33 eye drop products. As the affected pharmaceutical companies filed litigation against the decision, they also requested the suspension of execution on the ministry’s action. As the court accepted the request, the pricing reduction was withheld, but the pricing was brought down, nonetheless, with the Supreme Court’s final decision. The legal dispute between the government and pharmaceutical companies over the pricing reduction in eye drops lasting over two years is getting closer to the end. Two separate litigations were conducted, both aiming to revoke the pricing reduction in eye drop products. On Aug. 27, 2018, the Ministry revised its list of reimbursed drugs and upper limit pricing to bring down the pricing of 307 eye drop items by up to 55 percent. The key change was to apply the same pricing standard on single-use eye drops with same concentration of pharmaceutical substance (dose per mL), regardless of the overall amount of the solution. Regarding the ministry’s decision, 20 pharmaceutical companies claimed the pricing reduction on 299 items is unfair, and filed litigation to the Seoul Administrative Court to nullify the government order. Kukje Pharma, Daewoo Pharm, Daewoong Bio, DHP Korea, BINEX, Samchundang Pharm, Sinsin Pharm, CMG Pharma, Youngil Pharm, Inist Bio Pharmaceutical, Ildong Pharmaceutical, Chong Kun Dang, Taejoon Pharmaceutical, Korea Global Pharm, Hanlim Pharm, Hanmi Pharmaceutical, Humedix, Huons and Huons Medicare were part of the litigation. The Seoul Administrative Court ruled in favor of the government in July last year. The group of pharmaceutical companies filed for an appeal, and the Seoul High Court came to the same decision in last July. As the companies have pushed case on, the Supreme Court is currently reviewing the case. Updates on eye drop pricing reduction litigations The latest decision by the Supreme Court was related to another case. Four months after MOHW’s decision to reduce the eye drop pricing, the ministry has again unveiled a partially revised list of reimbursed drugs and upper limit pricing that lowered pricing on 33 eye drop items by eight companies on Dec. 21, 2018. The pricing reduction was ordered on eye drop items listed after the first pricing reduction order, and the ministry meant to apply the same standard. The litigation was filed by Daewoo Pharm, Sinsin Pharm, Youngil Pharm, Reyon Pharmaceutical, Ildong Pharmaceutical, Hanlim Pharm, Huons and Huons Medicare. The eight companies filed the litigation to revoke the ministry’s order to lower the pricing. In November last year, the Seoul Administrative Court has ruled in favor of the government body, and the court reaffirmed its earlier denial of the litigation during the second trial held in last May. Although the order was given later than the first one, the case was processed faster and reached the Supreme Court’s decision earlier. Accordingly, the 20 pharmaceutical companies await the Supreme Court’s ruling on the first pricing reduction order. Nevertheless, as the courts have ruled against the companies in two prior trials, the Supreme Court would be unlikely to rule otherwise. The pharmaceutical companies argued the pricing reduction is an unfair order as the ministry has abused the discretionary power, violated the principle of trust protection, and taken illegitimate proceedings, but the courts denied the claim. And the Supreme Court has discontinued the trial and dismissed the case. The discontinuance of the trial refers to the Supreme Court dismissing the case without a trial, when the court sees no difference in viewing the prior rulings. The Supreme Court basically made a final decision without even holding the trial. ◆Confusion in drug pricing as the court dismissed and reaccepted the request to suspend the pricing reduction Confusion in the pricing in the affected eye drops was caused as the court once dismissed and accepted the request to suspend the execution of pricing reduction order again. While the pharmaceutical companies filed two litigation cases to revoke the pricing reduction orders, they also requested the court to order suspension of execution. And only one request to withhold the pricing reduction order was accepted. Prior to the first trial with 20 pharmaceutical companies, the companies submitted an application to request the Seoul Administrative Court to suspend MOHW’s pricing reduction on eye drop until 30 days after the court’s decision. Eventually, the pricings were lowered, as of Sept. 22, 2018, when the Seoul Administrative Court dismissed the request. But the companies, again, requested the suspension to the Seoul High Court, which accepted the request and recovered the eye drop products’ original pricing, as of Nov. 30, 2018. Every time the litigation cases proceeded to the higher court, the companies requested for the court to suspend the execution, and the rest of the requests were all accepted. Currently, the ministry’s order to lower pricing on 20 companies’ 287 items, related to the first litigation, is withheld. Although the number of items started from 299, the number has gone down due to some companies withdrawing the litigation or reimbursement. The Supreme Court would soon make the decision on the rest of 287 items.
- Company
- OTC pain reliever market grows surges, Tylenol up by 30%
- by Kim, Jin-Gu Sep 07, 2020 06:12am
- The OTC pain reliever market was yet again dominated by Tylenol and Geworin in the first half of this year. Compared to the first half of last year, specifically, Tylenol’s sales have surged 30 percent. Geworin, EZN6 and Tak-sen followed the market leader on the leader board and generated the highest six-month sales on the record. ◆Tylenol makes KRW 18.6 billion, Geworin KRW 9.7 billion—the highest half-a-year sales yet Product image of Tylenol According to the pharmaceutical market research firm IQVIA on Sept. 2, Janssen’s Tylenol line-ups have generated overall 18.6 billion won from last January through June. It was the highest sales marked by an OTC pain reliever brand launched in South Korea. Compared to last year’s first half at 14.3 billion won, the sales soared by 30 percent. It was the biggest sales made in half a year. Among the three Tylenol line-ups (Tylenol tablet, Tyleno 8-hour ER tablet, Women’s Tylenol tablet), Tylenol tablet and Tylenol 8-hour ER tablet led the exceptional sales growth. Compared to same time last year, the two products grew by 29 percent and 38 percent, repsectively. The market experts evaluate the surge in Tylenol sales were indirectly driven by the COVID-19 epidemic. In last March, the World Health Organization (WHO) advised to use acetaminophen (Tylenol), instead of nonsteroidal inflammatory drug (NSAID) ibupropen, in a suspected case of COVID-19. Although WHO’s recommendation was revoked within two days as the initial statement lacked sufficient evidence, the number of consumers buying acetaminophen kept growing. In fact, pharmacies in Korea often experienced Tylenol shortage during the first half of the year. Samjin Pharm’s Geworin came in second with sales of 9.7 billion won accumulated in the six months. Compared to 8.9 billion won made in last year same time, the figure grew by 7 percent. Geworin also marked its highest half-a-year sales. Geworin also shares the same substance acetaminophen with Tylenol. Nevertheless, Samjin Pharm’s newly launched ‘Geworin soft capsule’ did not perform as much as the company hoped for. The new form of Geworin made a little more than 200 million won in the six months. In last February, the Korean company released Geworin soft capsule, which was the first line-up expansion in the Geworin brand after 41 years. As well as changing the form into a soft capsule, the new Geworin product switched the major substance from the original acetaminophen into ibuprofen. 2020 H1 sales in top OTC pain relievers (Unit: KRW 100 million) Source: IQVIA ◆Sharp increase in EZN6 and Tak-sen, closely tailgating the market leaders The third place was taken by Daewoong Pharmaceuticals EZN6. The five line-ups under the same brand has generated overall 3.5 billion won, making 20 percent jump from 2.9 billion won made in last year same time. EZN6 has been making a steep growth recently. Five years ago in 2015, the brand has made 1.5 billion won and barely took a place in the top 10 OTC pain reliever market. But in 2017, the brand’s sales soared to 2.5 billion won and proudly took a place on the fifth. And in the first half of this year, EZN6 brand has generated sales up to 3.5 billion won. The brand’s outstanding growth has put itself on the third place, surpassing Hanmi Pharmaceutical’s Maxibupen and Chong Kun Dang’s Penzal on the leader board. GC Pharma’s Tak-sen came in fourth with sales reaching 2.8 billion won in the first half of the year. Compared to last year same time, the sales have grown by 6 percent from 2.6 billion won. Tak-sen has also experienced a rapid surge in the sales growth. Compared to five years ago (1.7 billion won) and three years ago (2.2 billion won), this year’s sales marked 59 percent and 25 percent growth, respectively. On the top 10 OTC pain reliever market, the brand’s ranking has leapt from eighth to fourth. Recent sales growth in top OTC pain relievers (Unit: KRW 100 million) Source: IQVIA ◆The rest of the market followed by Penzal, Maxibupen, Carol, Anyfen, Brufen, Champ and Advil The rest of the OTC pain reliever market’s ranking was followed by Chong Kun Dang’s Penzal (2.3 billion won), Hanmi Pharmaceutical’s Maxibupen (2.1 billion won), Ildong Pharmaceutical’s Carol (1.9 billion won), Ahn-gook Pharmaceutical’s Anyfen (1.8 billion won), Samil Pharm’s Brufen (1.4 billion won), Dong-A Pharmaceutical’s Champ (1.4 billion won), Pfizer’s Advil (900 million won), Kyung Dong Pharm’s GNAL-N (500 million won) and Dong Wha Pharm’s Trisfen (200 million won). In particular, Maxibupen (38 percent), Anyfen (23 percent), Penzal (28 percent) and Brufen (25 percent) experienced a steep fall in the sales from last year same time. The pharmaceutical industry views the COVID-19 has significantly affected the OTC pain reliever market in the first six months of the year. As less number of patients visited hospitals and pharmacies amid COVID-19, more consumers tried to stock up first-aid kits including OTC pain relievers. The general OTC pain reliever market sales have grown about 5 percent compared to last year same time.
- Company
- Hanmi·Chong Kun Dang, leading the erectile dysfunction tx
- by Chon, Seung-Hyun Sep 04, 2020 06:53am
- The growth of the domestic erectile dysfunction treatment market has slowed. In the aftermath of COVID-19, the market size has decreased from last year for the first or second consecutive quarter. Generics by Hanmi and Chong Kun Dang are leading the market. According to IQVIA, a drug research institute on the 3rd, the market for erectile dysfunction treatment in the first half of last year was ₩54.5 billion, a 2.6% decrease from the same period last year. In the first quarter, it fell 4.8% from the previous year, and in the second quarter, it decreased by 0.4%. Compared to the first quarter, it showed a slight recovery in the second quarter, but the market's growth has declined. Quarterly erectile dysfunction tx market size (Unit: ₩million, Source: IQVIA) The market for erectile dysfunction treatments continued to expand in size. In the first half of 2017, it increased by 7.2% from the same period last year, and in the first half of 2018 and 2019, the growth rate was 2.3% and 7.4%, respectively. This year, there is a possibility that the spread of COVID-19 led to the sluggishness of erectile dysfunction drugs. It is evaluated that the growth trend has declined due to the prolonged COVID-19, as patients' visits to hospitals were reduced and sales marketing activities were also restricted. The industry diagnoses that the erectile dysfunction treatment market is vulnerable to external factors such as the epidemic of infectious diseases because the severity is lower than that of chronic diseases such as high blood pressure and diabetes, and the nature of essential materials is weak. There is still low recognition that erectile dysfunction is a disease that needs to be treated urgently, which means that changes in the external environment can affect the market growth. PalPal, Viagra, Gugu, Sendom from top left In general, sales growth of major erectile dysfunction drugs also slowed down. However, generics by domestic companies such as Hanmi and Chong Kun Dang are still taking the lead in the market. Hanmi's PalPal, a leading product for erectile dysfunction treatment, recorded sales of ₩5.2 billion in the first half of the year, down 4.9% from the same period last year, but the sales are still huge. PalPal is a generic product containing Sildenafil, which Hanmi released shortly after the expiration of Viagra's patent in 2012. Since beating Viagra in 2013 and Cialis in 2015,It is keeping its unrivaled lead. PalPal has more than doubled sales of the original product Viagra. Considering that PalPal is less than half the price of Viagra, it is possible to calculate that the actual sales volume is more than four times. Among the generic products, Hanmi's Gugu increased by 12.5% from the previous year with sales of ₩2 billion in the first half. In the first quarter, it recorded a growth rate of 6.8%, and in the second quarter, sales increased by 18.0% from the previous year. Considering that major erectile dysfunction treatment products recorded a combined sluggishness, the growth is remarkable. Gugu beat Cialis in the second quarter of last year, and in the second quarter of this year, and pursued Viagra by ₩100 million. Quarterly sales trend of major erectile dysfunction drugs (Unit: ₩million, Source: IQVIA) Hanmi took up 26.3% of the total erectile dysfunction treatment market as of 2Q with only two products due to the promotion of PalPal and Gugu. On the other hand, sales of Viagra and Cialis are sluggish. Viagra's sales in the first half of the year were ₩2.1 billion, down 12.1% from last year. Cialis recorded only ₩1.6 billion, down 5.6% from the first half of last year.
- Company
- Keytruda coverage expansion plan back to MSD for revision
- by Eo, Yun-Ho Sep 04, 2020 06:53am
- Regarding the Keytruda coverage expansion, the South Korean authority passed the ball back to MSD Korea. The pharmaceutical industry sources reported Health Insurance Review and Assessment Service (HIRA) informed MSD on Sept. 2 about PD-1 inhibitor Keytruda’s (pembrolizumab) financial burden reduction plan the Cancer Deliberation Committee discussed during an on-paper meeting on Aug. 26. The sources confirmed HIRA has requested MSD to revise the financial plan once more. But on a positive side, the health authority expressed their intention to be flexible on the controversial clause of ‘pharmaceutical company covering the administration cost of the first three cycles.’ This could be interpreted as a huge progress. As the MSD’s global headquarters was unconvinced of the clause, the company could have more wiggle room in expanding the coverage. However, the government proposed MSD to resubmit a financial plan ‘equivalent to the initial clause.’ In other words, MSD would have to increase the company’s financial burden more than the initial financial plan and the plan amended three times by the Cancer Deliberation Subcommittee and deferred by the Committee on Aug. 26. If the Cancer Committee refuses the new financial plan, Keytruda’s attempt to expand coverage would be technically over. Regarding the issue, MSD official noted, "To answer the government’s effort to positively review the unprecedentedly revised financial cost reduction plan, the company would discuss means to extend the company’s part in lessening the financial burden further for the last time.” The official added, “Delivering fair treatment opportunity to cancer patients in both South Korea and other countries is the most important part. The company would thoroughly discuss about the plan revision and submit it to the government again for the Cancer Deliberation Committee to reconsider in October.”
- Company
- Celebrex barrier still too high for NSAID Acelex
- by Nho, Byung Chul Sep 04, 2020 06:52am
- The 22nd Korean-made novel drug (Bio-venture No. 1) and a nonsteroidal anti-inflammatory drug (NSAID) for arthritis Acelex (polmacoxib) seems to be stuck in a box pattern, struggling to narrow the sales gap with its biggest competitor Celebrex (celecoxib). IQVIA data found Acelex has generated 598 million won, 4.01 billion won, 4.78 billion won, 4.49 billion won and 5.34 billion won from 2015 through 2019, respectively. Celebrex has also generated 37.1 billion won, 34.4 billion won, 32.6 billion won, 36.4 billion won and 40.1 billion won in year 2015 through 2019, respectively, and its global sales have reached over 850 billion won. Both Acelex and Celebrex are not stepping out of their respective sales brackets ranging from 4 billion won to 5 billion won, and from 35 Billion won to 40 billion won. The two products are sluggish to break through the brackets, having no explosive growth in sight. Celebrex has consolidated the market leadership by selling the product seven times more than Acelex last year. Acelex, developed by Crystal Genomics, has received Ministry of Food and Drug Safety (MFDS) approval in 2015 as a tissue-selective COX-2 inhibitor that selectively impedes COX-2 enzyme inducing inflammation and pain. The drug has conducted clinical trials not only in South Korea, but also in the U.S. and Europe. During its Phase III study, Acelex has confirmed to improve the participating patients’ physical function scores, as part of osteoarthritis indicators, faster than Pfizer’s Celebrex. Released to the market in 2000, Celebrex selectively hinders COX-2 enzyme causing pain and inflammatory. Celebrex has been an inevitable competitor of Acelex with its benefit of alleviating symptoms of osteoarthritis, rheumatoid arthritis and pain, while it lowers risk of digestive system complications that other existing NSAIDs often cause. Acelex has been distributed to major general hospitals and university hospitals in Korea through a partnership deal with Dong-A ST signed in September 2015, and it signed another sales deal with Daewoong Pharmaceutical in March 2018. Dong-A ST is in charge of healthcare institutes with over 300 beds, and other hospitals and clinics are handled by Daewoong Pharmaceutical. The drug is also expanding the sales network through its own subsidiary Crystal Life Sciences. And in late last year, the company launched a tablet form of the brand to expand its line-up. Acelex 2 mg tablet has generated 149.9 million won in last first quarter. After signing a co-marketing deal with Jeil Pharmaceutical in 2015, Pfizer and the Korean company each have been focusing their sales force on Celebrex sales in general hospitals, semi-general hospitals and clinics, assigned according to respective strength. Although Acelex has salespeople 1.6 times more than the competitor, the Korean-made drug could not overcome Celebrex’ consolidated prescriber networks. Dong-As ST and Daewoong Pharmaceutical have reportedly dispatched about 430 (180/ 250) sales people for Acelex, and Pfizer and Jeil Pharmaceutical have about 260 sales people (60/ 200) for Celebrex. Unless Acelex takes assertive and effective sales and marketing strategies now, it would be difficult for the drug to see a quantum jump from this point where the sales have been unchanged for five years. With such underwhelming performance in South Korea, Crystal Genomics have been actively working on exports and license-out deals. Acelex is accounted for approximately 38 percent of the overall sales of Crystal Genomics, which made 14 billion won last year.
- Company
- Galderma Korea appoints Younhee Kim as the new CEO
- by Eo, Yun-Ho Sep 03, 2020 12:55pm
- Galderma Korea has appointed Younhee Kim, former general manager of the Medical Solution Division, as the new CEO. According to related industries, CEO Kim started official business as the official president on the October 1st. Rene Wipperich, former CEO of Galderma's Korean subsidiary for two years from September 2018, has been confirmed to have moved to a Swiss subsidiary. Galderma Korea was transformed into a Korean president system about two years after former CEO Heung Bum Park resigned. CEO Rene Wipperich joined Nestlé, a Galderma holding company in 1999, and served as general manager of commercial operations at Nestlé's headquarters after representing Malaysia and Singapore, as well as representing Indonesia. The new CEO Kim has accumulated her career as a marketing manager in the women's business unit and vaccine business unit after working at MSD Korea. Afterwards, she served as Marketing Head of Merz Korea, experiencing the skin and beauty field, and until recently led the Medical Solution Division at Galderma's Korean subsidiary. Meanwhile, last year, Galderma became independent from its parent company Nestlé Healthcare Division after 28 years of inauguration. The change in ownership was due to the Swedish private equity EQT VIII fund (EQT), Luxinva and PSP Investments, a 100% subsidiary of the Abu Dhabi Investment Authority (ADIA), and a consortium of renowned institutional investors. It was completed under an exclusive negotiation with its former owner Nestlé SA. Since then, Galderma has been providing various medical solutions and solutions for consumer skin health through a total of two business units: the medical solution business unit including the pharmaceutical business unit and the aesthetic business unit, and the consumer care business unit.
- Company
- Sales of immunotherapy for Cancer are ↑18 times in 4 years
- by An, Kyung-Jin Sep 02, 2020 06:19am
- (Clockwise from top left) Yervoy, Opdivo, Keytruda,Imfinzi,& Tecentriq Immunotherapy for Cancer is expanding rapidly in the domestic pharmaceutical market. The domestic immune checkpoint inhibitor market started with Yervoy (Ipilimumab), Keytruda (Pembrolizumab), and Opdivo (Nivolumab), and generics such as Tecentriq (Atezolizumab) and Imfinzi (Durvalumab) were added one after another, sales increased by 18 times over the past four years. MSD's Keytruda, which took the lead in the lung cancer treatments, occupied 60% of the total market, showing its influence, and Roche's Ticentric' & AstraZeneca’s Imfinzi are on the rise. According to IQVIA, a drug market research institute on the 1st, sales of five types of Immunotherapy for Cancer in the first half of this year was a joint venture of ₩126.7 billion. This is a 31.7% increase from ₩96.1 billion in the first half of last year. It increased by 17.5 times from ₩7.2 billion four years ago. Immuno-anticancer agents are monoclonal antibodies that induce T cell activation by blocking inhibitory signals from T cells involved in immune regulation in the body. Unlike chemotherapy or targeted anticancer drugs, they are also called third-generation anticancer drugs in that they treat cancer by activating the body's immune system. There are various types of immune anticancer agents, but immune checkpoint inhibitors that treat cancer by activating immune function by suppressing the immune checkpoint, which is a pathway through which cancer cells evade immune cells, are collectively referred to as immune anticancer drugs. In Korea, BMS and Ono Pharmaceutical's immune anti-cancer drug Yervoy was approved in December 2014 as the primary treatment for melanoma patients who could not operate or have metastasized, Yervoy is the first immune checkpoint inhibitor that acts on the CTLA-4 protein on the surface of immune cells. In 2015, immune checkpoint inhibitors with mechanisms that inhibit PD-1 protein, such as Keytruda of MSD and Opdivo of BMS, were released and the market scale was in earnest. Since then, competition is accelerating with the launch of Roche's Tecentriq in 2017, AstraZeneca's Imfinzi in 2018, and Merck·Pfizer's Bavencio in 2019. Quarterly sales trend of five major immune checkpoint inhibitors (Unit: ₩ million, Source: IQVIA) Currently, Keytruda has taken the lead in the market. The sales of Keytruda in the first half of this year were totaled at ₩72.3 billion. It is 26.4% higher than ₩57.2 billion in the first half of last year, leading overall drug sales. Of the five immune checkpoint inhibitors, the proportion of Keytruda accounted for close to 57.1%. Keytruda inhibits the 'PD-1' protein on the surface of T cells to prevent binding to the PD-L1 receptor and acts as a mechanism to activate T cells. Following the first indication, melanoma, it has shown excellent efficacy in over 30 carcinomas such as lung cancer, head and neck cancer, gastric cancer, and cervical cancer, showing overwhelming results worldwide. Last year, it surpassed ₩10 trillion in global sales, ranking second in sales following Humira (Adalimumab), and It is observed that it will rise to the top in global sales by 2026. In Korea, because of its high price, the quarterly sales of Keytruda remained around ₩3 billion, but the application of health insurance benefits for secondary treatments for non-small cell lung cancer in August 2017 acted as a catalyst for sales growth. Keytruda sales exceeded ₩10 billion in the first quarter of 2018, and quarterly sales of ₩30 billion have been recorded since the second quarter of last year. In the first quarter of this year, it lowered Lipitor (Atorvastatin) and rose to the top in domestic pharmaceutical sales, and continued to lead for two consecutive quarters. If the reimbursement is expanded, the sales volume is expected to increase even more. However, there is a difference between the sales aggregate of Keytruda and the sales that the company actually secures according to the risk-sharing contract (RSA) of the refund type·expenditure cap signed with the government at the time of listing. Opdivo, which was once pointed as the biggest rival of Keytruda, widened the gap with sales of ₩30.6 billion in the first half of this year. Opdivo lost its leadership to Keytruda after clinical failure related to primary lung cancer treatment in 2017. In Korea, after setting a new record for quarterly sales of ₩17.2 billion in the fourth quarter of 2018, the trend continues to decline. As of the first half of this year, the share of the five immune checkpoint inhibitors accounted for 24.2% of sales. Opdivo is evaluated as having missed the market leadership because it failed to preoccupy it as a primary treatment indication for non-squamous non-small cell lung cancer showing positive PD-L1 findings. Non-small cell lung cancer accounts for about 80% of all lung cancers. About 25-30% of them are classified as squamous non-small cell lung cancer. Market share of 5 immune checkpoint inhibitors in the first half of 2020 (Unit: %, Source: IQVIA) Except for Keytruda and Opdivo, the influence of other items in the immune checkpoint inhibitor market is still insignificant. In the first half of this year, Yervoy's sales were ₩700 million, similar to the same period last year. Yervoy was first released in Korea, but it has not exceeded ₩2 billion in annual sales. Although it is trying to rebound in sales by adding indications for combination with other treatments such as Opdivo, its application range is limited compared to other PD-1 and PD-L1 inhibitors. The quarterly sales of Roche's Tecentriq and AstraZeneca's Imfinzi are rapidly increasing since their domestic release. Tecentriq recorded ₩15 billion in sales in the first half of last year, more than four times higher than ₩3.7 billion in the first half of last year, making it the third largest of the five immune checkpoint inhibitors. The market share rose to 11.8%. Imfinzi, which started generating sales in the first half of last year, recorded sales of ₩8.1 billion in the first half of this year. Five kinds of immune checkpoint inhibitors are trying to expand their indications based on continuous clinical research. Bavencio recently concluded a drug price negotiation with the NHIS, and the application of insurance benefits is imminent. For the time being, the domestic immune checkpoint inhibitor market is expected to continue high growth.
- Company
- AZ Korea Director Chon as a new Country President Indonesia
- by Eo, Yun-Ho Sep 02, 2020 06:18am
- Chon Sewhan, a director at AstraZeneca Korea, has been promoted as a Country President at PT. AstraZeneca Indonesia The industry sources reported the current Cardiovascular, Renal and Metabolic Diseases (CVRM) Business Unit Director, Chon Sewhan, has been appointed as a Country President Indonesia as of Sept. 1. Started off his career as an accountant, Director Chon was an acting-Country President Korea, until the current Country President Kim “Juno” Sangpyo was appointed after former Country President Liz Chatwin has been transferred back to the Australian and New Zealand office in September 2017. After graduating from Korea University, he earned his MBA from University of Pennsylvania the Wharton School and worked at a global accounting consulting group, PWC. He stepped into the pharmaceutical industry as a financial manager at Abbott Korea, and gained his experience in finance, R&D and business development from Novartis Headquarters, the U.S. branch and AstraZeneca Korea. In 2018, Chon was appointed as CVRM Business Unit Director at AstraZeneca Korea. The global company has yet to decide his successor. And due to COVID-19, the new Country President Indonesia would be remotely working from South Korea for a while.
