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- No more patent-evading IMD, needs new strategies
- by Kim, Jin-Gu Dec 23, 2019 06:29am
- Technically, the days of Korean pharmaceutical companies evading drug patent infringement by modifying the original’s salt base are over. The Supreme Court’s ruling on the solifenacin (trade name: Vesicare) case in the beginning of the year first showed the signs of ending drug patent infringement with incrementally modified drug (IMD). And it was reaffirmed on Dec. 20 with the Patent Court’s ruling for varenicline (trade name: Champix). As for Korean companies, the time has come to seek for other strategy to challenge patent. Experts say it would be more difficult than the old IMD strategy, but it is not say there isn’t any other way to challenge patent. The other feasible strategy is to file an invalidation trial for each item to challenge the accusation of patent infringement. Popular IMD strategy has become a thing of the past Pharmaceutical industry and legal experts say the Champix ruling was actually “expected”. The majority of the experts predicted the solifenacin case would set a new precedent. Only a handful of experts claimed the Supreme Court left a room for interpretation on the patent’s ‘practical equivalence’ and ‘technical obviousness of Person Having Ordinary Skill in the Art (PHOSITA)’. Ultimately, judges made same decisions on following Januvia, Pradaxa, and Champix cases and reaffirmed the Supreme Court’s decision. In August and September, the Patent Court ruled favorably for the original patentee of Pradaxa and Januvia, respectively, against IMDs. Even in last year, IMD with switch in saline base has been the most common strategy for Korean companies to evade patent infringement and launch their generic early. Hanmi Pharmaceutical’s Amodipin is a typical case. By incrementally modifying Pfizer’s Norvasc in 2004, Hanmi Pharmaceutical has been generating tens of billions of won annually after commercializing the antihypertensive amlodipine generic. The first alert went off when the original manufacturer, Astellas Pharma had requested litigation for cancellation of a trial decision on solifenacin IMD to the Patent Court in 2016. Korean companies switched out succinate of the original solifenacin drug with fumarate. The Patent Court recognized two combinations as different substances, and decided that solifenacin fumarate does not infringe the extended patent period. However, the Supreme Court said the otherwise. Following the court’s ruling, lower courts made a series of similar decisions and put the IMD strategy on shaky ground. Pipeline strategy to change inevitably, then how about the originals? Experts predict about 150 IMDs challenging respective patents would end up with similar ruling as the precedents. Accordingly, Korean companies now have no choice but to shift pipeline strategy. The time has come to let go of IMD, the relatively convenient option of evading patent infringement. Considering medium-sized pharmaceutical companies challenged patents with IMDs, the intangible loss for giving up on IMD is expected to be significant. Moreover, the original’s companies could start a domino of litigations. Based on the precedents, the original companies are highly likely to file damage suit against IMDs for infringing their patents. Since the overruling the previous solifenacin decision, Pfizer has requested for an injunction to ban sales of incrementally modified solifenacin, and the court has accepted the request. Other original companies have not been reported to have requested the injunction. The industry is keenly paying an attention on whether or not Pfizer would file the damage suit. The legal experts see that the case would probably be favorable to Pfizer quoting the Supreme and Patent Courts’ decisions and Seoul Central District Court’s injunction. Seeking for other options to challenge drug patent The industry-changing court ruling aside, it’s not to say Korean companies’ patent challenge is absolutely impossible from now on. The patent system can be bypassed. The Patent Court’s ruling on Betmiga (mirabegron) made a day before Champix case is a good example. At the Patent Court on Dec. 18, 11 Korean companies, including Hanmi Pharmaceutical, Chong Kun Dang Pharmaceutical, JW Pharmaceutical, Ildong Pharmaceutical, Intro Biopharma, Alvogen Korea, Kyung Dong Pharm, Shinil Pharmaceutical, Han Wha Pharma and Shin Poong Pharmaceutical won the patent dispute against original company Astellas Pharma. Meanwhile, Korean pharmaceutical companies are apparently trying new patent challenge strategies. The existing IMD strategy was based on defensive confirmation trial for scope of a patent, which means it was challenging a small part of a whole patent. Incremental modification of saline base was meant to challenge a part of extended period of drug patent. On the other hand, the Korean companies filed an invalidation trial instead to challenge the patent. If they win, the trial would nullify not partial, but the whole patent. However, the trial is not to challenge drug patent, but to challenge novel use patent. In other cases, some have challenged the extended period of drug patent with invalidation trial. Hanmi Pharmaceutical and Ahn-gook Pharmaceutical won the invalidation trial against Novartis’ DPP-4 class diabetic treatment Galvus in last February. The two companies have successfully revoked validity of the extend patent on Galvus. A legal expert commented, “More than the Champix’ case, Betmiga’s trial attracted more attention as it was unpredictable. Invalidation trial is surely complicated, but it is not impossible”. “Defensively confirming the scope of a patent is now useless only for IMD, but other option could be used to challenge drug patents”, the legal expert added.
- Company
- Ulcerative colitis added to Stelara's domestic indications
- by Eo, Yun-Ho Dec 23, 2019 06:29am
- Janssen's interleukin-12/23 (IL-12/23) inhibitor 'Stelara' can be prescribed for ulcerative colitis. According to the industry, the KFDS recently approved Janssen's Stelara (Ustekinumab) as a treatment for moderate to severe adult active ulcerative colitis. As a result, Stelara has acquired four indications in Korea, including ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease. The expansion of Stelara's ulcerative colitis indications was based on the UNIFI program, Phase III. The program consisted of one maintenance therapy with subcutaneous injection every 8 weeks for 44 weeks after one initial induction study with a single intravenous injection of Stelara. The study found that 19% of Stellar dose groups reached clinical remission in 8 weeks and 58% of patients responded. In maintenance studies, 44% showed improved tissue endoscopic mucosal membranes after one year. Meanwhile, starting with Stelara in the interleukin therapeutic market, four items are approved including ▲IL-17's Cosentynx (Secukinumab) by Novartis, ▲Lilly's Taltz (Ixekizumab), ▲IL-23 Inhibitor, Tremfya (Guselkumab). In addition, Boehringer Ingelheim is conducting a global phase III study comparing the IL-23 inhibitor 'BI655066' with Stelara, and Brodalumab, developed by AstraZeneca, has also been shown to be effective in direct comparison with Stelara and has been approved in Europe.
- Company
- Drug trade volume to hit all-time high over USD 10 bln
- by Kim, Jin-Gu Dec 22, 2019 09:51pm
- Korea’s accumulated trade volume is expected to surpass USD 10 billion for the first time. The biggest impact is from a significant surge of pharmaceutical export volume. This year’s overall pharmaceutical export volume is projected to go over 3.6 billion dollars. The number almost doubled, compared to four years ago in 2015. According to statistic data from Korea Customs Service, the accumulated pharmaceutical trade volume, as of November, reached 9.34 billion dollars (approximately 10.91 trillion won). If the trend continues, the pharmaceutical trade volume from this year alone is expected to surpass the 10 billion-dollar mark for the first time. Pharmaceutical import and export volume by year. 2019 includes projected December figure based on performance as of November. (Source: Korea Customs Service) In recent years, the trade volume grew constantly reaching 6.27 billion dollars, 7.44 billion dollars, 7.94 billion dollars, and 9.37 billion dollars in years from 2015 to 2018, respectively. The pharmaceutical export volume had the biggest surge. As of November, the pharmaceutical export volume reached 3.34 billion dollars (approximately 3.91 trillion won). Outperforming last year’s export volume at 3.27 billion dollars, this year’s volume is expected to easily make over 3.6 billion dollars by the end of the year, hitting the highest point in the history. The all-time high export volume was possible this year due to strong performance from Celltrion and Samsung Biologics’ biosimilars and Daewoong Pharmaceutical’s Nabota export. Moreover, the government building stronger ties with Southeast Asian countries have helped the increase in export to their markets. On the other hand, pharmaceutical import volume has reached 5.99 billion dollars as of November (approximately 7.32 trillion won). The trade surplus, balancing export and import volumes, is to get better by a bit. Last year’s pharmaceutical trade made a deficit of 2.83 billion dollars. This year’s deficit is expected to be around the similar level of 2.8 billion dollars. Pharmaceutical import and export volume from January to November, 2019. (Source: Korea Customs Service) Apparently, Korea’s overall trade volume has surpassed one trillion dollars this year. The trade volumes in last three years have exceeded one trillion-dollar mark since 2017. China, the U.S., Germany, Japan, the Netherlands, France, the U.K. Hong Kong and Italy as well as Korea are the only ten countries around the world to have overall trade volume over one trillion dollars.
- Company
- Astrazeneca-SK supplying Diabetics worth $100 million/year
- by Eo, Yun-Ho Dec 22, 2019 09:51pm
- President Dong-hyun Jang (left) & President Leif Johansson (right) AstraZeneca and SK announced that the drug was manufactured and produced under the partnership signed by the two companies in January 2018 and is being supplied to 3 million people with diabetes in 98 countries. The agreement contributed to SK's successful entry into the global biopharmaceutical manufacturing and production business and the growth of AstraZeneca, with a value of approximately $ 100 million annually. At the headquarters of SK Group, Leif Johansson, Chairman of AstraZeneca and Dong-hyun Jang, SK CEO exchanged commemorative plaques to celebrate the achievement of important milestones through the cooperation of the two companies. The event was attended by Swedish Foreign Minister Anna Hallberg, Minister of Trade, Industry and Energy, Jung-yeol Yoo, Director of Health and Welfare , In-taek Im, government officials, and officials from both companies. In accordance with the agreement between the two companies, SK Biotech, a wholly owned subsidiary of SK, manufactures and produces APIs (Active Pharmaceutical Ingredients) for diabetes treatments such as AstraZeneca's blockbusters, Forxiga (Dapagliflozin) and Onglyza (Saxagliptin). Raw materials manufactured and produced in Korea will be converted into pharmaceuticals at the SK Biotech Ireland plant in Swords, Ireland, which SK Group acquired in 2018. AstraZeneca is responsible for producing and supplying treatments to patients around the world using this materials. Leif Johansson, Chairman of AstraZeneca said, “SK Biotech is an important strategic partner of AstraZeneca and is a good example of Korea's high value and quality level in the manufacture of pharmaceutical products, Since 2018, the two companies have collaborated to deliver medicines that change the lives of patients and contribute to the patient and the society as well as to business growth”. Dong-Hyun Jang, president of SK, said, “We have been cooperating for common social values since 2018 through partnership with AstraZeneca to provide innovative medicines to patients. SK Pharmteco (SK CMO Integrated Subsidiary) will continue to solidify our partnerships by expanding the production of raw materials for a wider range of diseases”. On the other hand, AstraZeneca signed a memorandum of understanding (MOU) with the KOTRA, the KHIDI, the KoreaBIO and the KPBMA in the Korea-Sweden Business Summit held in Seoul on the 18th and announced that the company would strengthen cooperation to accelerate innovation in the Korean biohealth industry.
- Company
- SK Holdings reaffirms partnership with AstraZeneca
- by Lee, Seok-Jun Dec 20, 2019 06:36am
- On Dec. 19, SK Holdings CEO Jang Dong-hyun met with Chairman Leif Johansson of AstraZeneca at the SK Group Headquarters, Seoul. At the meeting, SK Biotek and AstraZeneca announced they have been supplying diabetes treatment to about hundred countries since their partnership deal signed in January 2018. The two companies stated their partnership is valued at approximately USD 100 million. After the acquisition of Bristol-Myers Squibb’s (BMS) manufacturing facility in Ireland, SK Biotek also gained a partnership with a global pharmaceutical giant, AstraZeneca. The Korean company took over the manufacturing facility and specialized human resources, as well as the supply contract with AstraZeneca. The industry evaluates the acquisition was a successful M&A that took in account of earning the extra global partnership. Reportedly, AstraZeneca last year generated 22 billion dollars (about 26 trillion). SK Holdings CEO Jang Dong-hyun (left) and AstraZeneca Chairman Leif Johansson met and briefed about performance so far at a partnership signing meeting on Dec. 19 More than half of BMS manufacturing contract in Ireland was signed by AstraZeneca SK Biotek and AstraZeneca’s relationship goes all the way back to June of 2017. SK Biotek, wholly-owned subsidiary of SK Holdings, made a decision on the acquisition of BMS manufacturing facility in Ireland (currently owned by SK Biotek Ireland). BMS’s facility in Ireland used to manufacture active pharmaceutical ingredients for anticancer, anti-diabetic and cardiovascular disease treatments. Among array of contracts, approximately 50 percent of them were signed by AstraZeneca. Accordingly, when BMS sold its manufacturing facility in Ireland, SK Biotek also took over the contracts by AstraZeneca along with the facilities and human resources. After making the final decision on the acquisition, SK Biotek immediately scheduled a meeting with the headquarters of AstraZeneca in July that year. Apparently, they talked about maintaining the contract for the future. SK Biotek not only took over BMS’ manufacturing facility, but also expanded global partnership roster. Now the company works with Pfizer and Novartis, as well as AstraZeneca. The Thursday’s meeting reaffirmed the ties between SK Biotek and AstraZeneca is still strong. A stock trading firm insider noted, “It was only natural for SK Biotek, with the complete acquisition of BMS’ manufacturing facility in Ireland, to start a business with the facility’s existing clients. The terms of SK Biotek-BMS deal stated details of transferring facility, human resources and some of synthetic ingredient manufacturing contracts”. “However, it was not so clear whether or not SK Biotek would be able to maintain the existing partnership. The new partnership signing could have been held for SK Biotek to secure global partnership with AstraZeneca, on top of the manufacturing contract in Ireland”. SK Group’s focus on pharmaceutical sector is led by a SK Holdings and SK Discovery expanding business in two different sub-sectors. SK Holdings own SK Biopharmaceuticals (drug discovery) and SK Pharmteco (CMO). SK Chemicals (pharmaceutical business), SK Plasma (blood products), and SK Bioscience (vaccine) are formed under SK Discovery. SK Holdings, following its acquisition of SK Biotek Ireland and AMPC Fine Chemicals, established SK Pharmteco as the U.S.-based holding company. SK Holdings and SK Discovery are thriving in their respective field of business while not sharing shares between them.
- Company
- Companies done submitting metformin record, what now?
- by Chon, Seung-Hyun Dec 20, 2019 06:32am
- Ministry of Food and Drug Safety (MFDS) Pharmaceutical companies in Korea have completed submitting usage record of metformin medicine to the government body. The industry seems to be patiently waiting for the government’s follow-up action on finding impurity in metformin-containing drugs. According to pharmaceutical industry insiders on Dec. 18, pharmaceutical companies have completed submission of metformin medicine manufacturing status report as requested by Ministry of Food and Drug Safety (MFDS). They compiled data from respective manufacturing plant and sent in the material until Dec. 17. On Dec. 13, MFDS has asked the companies to hand in manufacturing record of drug items containing ‘metformin hydrochloride’ and detailed research result of using the active ingredient by Dec. 17. MFDS requested information on the total number of pharmaceutical products containing metformin, name and number of items with manufacturing record, and name and number of items without manufacturing record. The information should cover all items distributed considering use-by date of complete products. For example, when an items’ use-by date is three years, then the item’s entire manufacturing record after December 2016 should have been submitted. The ministry has also called for a full report on active ingredients used in the metformin products. It is collecting detailed information on DMF registration number and manufacturing plant of a complete product containing the ingredient under each serial number. MFDS preemptively taking a detailed look into the records of active ingredient usage, in case impurity is found. When a specific active pharmaceutical ingredient and complete product is discovered with an issue, the ministry plans to take a prompt and accurate action based on the collected information. Molecular structure of metformin Impurity risk in metformin first started from Singapore. On Dec. 4, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin containing drugs they investigated. The result confirmed contamination of N-Nitrosodimethylamine (NDMA) has surpassed daily acceptable level. The pharmaceutical industry is anxious that the Korean regulator is “considering on taking follow-up actions like sales ban when the active ingredient is found contaminated”. In fact, before the government body took an action on ranitidine and nizatidine cases, the ministry had reviewed detailed information on complete product and the active ingredients. The ministry held back on the action for ranitidine and nizatidine medicine, until the thorough review on complete products and the ingredients was completed. The ministry may decide to ban sales on metformin medicine, if it confirms the same active ingredient recalled in Singapore has been imported to Korea. In the case of valsartan, MFDS had immediately ordered a sales ban on drugs with the substance when Europe decided to recall the products. Metformin-containing complete products recalled in Singapore have not been imported to Korea, yet. But whether or not the recalled active ingredient has been imported yet has not been confirmed. Reportedly, the Singaporean health regulator decided to recall the products based not on testing result of active pharmaceutical ingredient, but on complete products. However, it is highly unlikely that the Korean regulator would take an action in just a few days as it has not collected samples of metformin ingredients and complete products for testing. Both for ranitidine and nizatidine medicine, the regulator announced the follow-up measure after collecting samples of ingredients and complete products from different manufacturing dates, along with a thorough review on usage record. Ironically, the ministry has not presented an official procedure of NDMA testing for metformin, yet. MFDS is currently working on NDMA testing for metformin, which is scheduled to be completed by the end of the year. When the official testing procedure is set, the ministry is to collect the active ingredient and complete products for testing.
- Company
- Anti-ulcer market fluctuates from impurity risk aftermath
- by Chon, Seung-Hyun Dec 19, 2019 06:41am
- Apparently, the anti-ulcer treatment market is still shaken with the impurity contamination risk. The market volume of nizatidine drugs, with a recent discovery of impurity exceeding an acceptable level, subsided within a month. A several cases of impurity found in products brought down the H2 receptor antagonist prescription volume, but rather pushed up the proton-pump inhibitors (PPI) prescription volume. Among PPI class drugs, esomeprazole has been the strongest in the market. On Dec. 18, pharmaceutical industry research firm UBIST reported the outpatient prescription volume of H2 receptor antagonist last month marked 9.3 billion won with a 5.6-percent decrease from the month before. Immediately after the sales ban on ranitidine, the prescription volume of the medicine has plunged to 40 percent level and the descending trend line continued to last month. Monthly trend of outpatient prescription volume of H2 receptor antagonist-containing drugs (unit: KRW 1 million) Source: UBIST Monthly trend of outpatient prescription volume of H2 receptor antagonist-containing drugs, except ranitidine drugs (unit: KRW 1 million) Source: UBIST Ruling out ranitidine, the H2 receptor antagonist market showed inconsistent prescription volume. The H2 receptor antagonist prescription volume, except ranitidine, skyrocketed from 6.4 billion won in September to 9.8 billion won in October by 53.5 percent. As most of ranitidine prescriptions were switched to other H2 receptor antagonist substance, the general market volume also expanded. But the H2 receptor antagonist prescription volume went down only in a month. Specifically, the nizatidine drugs took a noticeable fall. Monthly trend of outpatient prescription volume of major H2 receptor antagonist substance (unit: KRW 1 million) Source: UBIST In last month, nizatidine drug prescription volume fell by 30.5 percent from the previous month and generated 2.3 billion won. When ranitidine drugs were banned, nizatidine drugs’ perception soared by 42.5 percent from September to October. But merely in a month, the volume went back down to the September volume. The fall was affected by the discovery of impurity in some of the items. On Nov. 22, Ministry of Food and Drug Safety (MFDS) found unacceptable level of cancer-causing N-nitrosodimethylamine (NDMA) in nizatidine-containing drugs, and banned sales on 13 items. Unlike ranitidine, only some of nizatidine drugs were banned. Doctors could choose other nizatidine-containing items other than the banned ones, but they started prescribing other options due to unsettling risk of the substance. Benefitting from the sales ban on ranitidine and nizatidine drugs, famotidine and lafutidine drug prescription volumes reached their highest peak. Famotidine prescription volume doubled in October from the previous month, and was increased by 10.6 percent from October to November as well. Whereas lafutidine prescription volume reached 2.6 billion won, increased by 13.3 percent from the previous month and reached its peak. Cimetidine’s prescription volume was at 1.1 billion won last month and took a slight fall. Insufficient supply of active ingredient depleted stock and was excluded the drugs from the impurity risk benefit. Drugs in PPI class maintained a positive trend line last month as well. Last month, PPI-class treatments had outpatient prescription volume of 42.2 billion won with an increase of 1.0 percent from the previous year and recorded the highest volume of the year. In September, the volume reached 37.3 billion won and had a 17.7-percent surge in a month. Monthly trend of outpatient prescription volume of PPI-containing drugs (unit: KRW 1 million) Source: UBIST Meanwhile, esomeprazole-containing drugs had the steepest growth. Last year, the drug’s outpatient prescription volume grew by 5.0 percent in a month and reached 17.7 billion won. After making an increase of 21.3 percent from September to October, the drug’s prescription volume was expanded even more. Esomeprazole prescription volume last month soared by 27.4 percent from September. As of November, esomeprazole dominated 40.0 percent of the PPI medicine market. It could be interpreted that the doctors have switched from ranitidine and nizatidine to esomeprazole as they prefer the medicine the most within the PPI class. Rabeprazole’s prescription volume in last month went up by 1.2 percent from the month before, but lansoprazole, pantoprazole, ilaprazole and omeprazole’s prescription volume in November were dropped by a little than in October. But in general, the said PPI-class medicines had more than a ten-percent surge from September, benefitting from the impurity contamination risk. Monthly trend of outpatient prescription volume of major PPI substances (unit: KRW 1 million) Source: UBIST
- Company
- Punishment for rebate MD is on the rise
- by Jung, Hye-Jin Dec 19, 2019 06:35am
- A series of tougher penalties rulings against the medical personnel's illegal rebates have been issued. Once caught, the ruling to collect the full rebate collection has become the trend. Analysts say that the justice department increase the level of rebate punishment. Dailypharm's analysis of the major rulings on drug rebates on the 17th showed that in four recent cases, medical personnels were charged with the amount of rebates they received from pharmaceutical companies in addition to imprisonment or fines. Dr. A, who runs a hospital in Paju, Gyeonggi-do, was charged with receiving ₩15 million for prescribing medicines from a pharmaceutical company and was sentenced to a fine of ₩3 million by the Suwon District Court in September. The court ordered Dr. A to collect ₩100 million in addition to the fine. In October, similar rulings were followed in Suwon and Daegu. The Suwon District Court Seongnam branch decided on a year of imprisonment and a ₩150 million penalty for Dr. B, who operates an ophthalmologist in Ulsan. The additional ₩150 million is the rebate that Mr. B received twice from a pharmaceutical company. The Daegu District Court sentenced doctor C, who received a rebate, to pay a fine of ₩2 million and a penalty of ₩2.65 million. The penalty is also equal to the amount of rebate that Mr. C received from the related pharmaceuticals. Unlike other doctors, Dr. B was sentenced to one year in jail because he demanded more rebates from pharmaceutical companies on the condition that he would increase the size of the existing hospital and increase the volume of drug transactions. The court found that Mr. B was aggressively trying to get a rebate, and gave him to a severe sentence. In November, the Suwon District Court decided to pay a fine of ₩4 million by applying to Dr. D for violating medical law. Dr. D was not accompanied by a punishment, but the ruling said that “It is necessary, but it is clear that it did not collect from an abbreviated order, so the addition of collections in addition to previously sentenced sentences is not permitted in the interpretation of section 457, paragraph 2 of the Criminal Procedure Act”. the court revealed the reason for not being sentenced. In addition, the Seoul Central District Court ruling, which was made earlier, also shows a trend of strengthening the penalty. In June, the court sentenced Doctor E, who violated the Medical Law, two years probation for one year in prison and two years probation for eight months in jail for a representative of a wholesaler who violated pharmaceutical laws that provided rebates. Four of the five rebate-like judgments were received 100% collection. The other one, which did not order the collection, also revealed a valid basis for which the criminal law does not allow for collection. Article 88 (2) of the current Medical Law allows the collection of medical personnels who have received illegal rebates. Such trends in local jurisdictions show recent trends in penalties for drug rebates. Previously, even if rebates were caught, fines, probation, and imprisonment were mostly imposed, but as the recent rulings show, the government is collecting 100% of the rebates illegally received by medical personnel. The lawyer Jong-sik Woo of the law firm Gyuwon also made the same opinion that “Is it because of the light punishment that the judges are not eradicating the rebate?” Attorney Woo said, “A recent analysis shows that there is a clear trend to strengthen the penalty, recently the ruling on illegal rebates shows that the frequency of collecting 100% of the money received is almost the same”. “The legal basis for the surcharge was from the stage of a dual punishment system. The law was not changed, but the court is raising the surcharge level recently”. “It is analyzed that the Tribunal is moving towards the strengthening of collections to eradicate drug rebates.” he added.
- Company
- New flu season to spark up another round of competition
- by Kim, Jin-Gu Dec 18, 2019 02:25pm
- KCDC public service announcement about preventing influenza by getting flu shot, properly washing hands, covering mouth when coughing and visiting healthcare institute when feeling unwell The flu season in Korea has just arrived for the year. Korea Centers for Disease Control and Prevention (KCDC) issued a flu warning on November 15. The season is to last until May next year. The new flu season is to start up even more fierce competition in the flu treatment market. The market leader, Tamiflu (oseltamivir) sales has been tumbling down since oseltamivir generics were launched. What’s worse, the flu treatment’s adverse reaction risk reported last season had its market position precarious. Now the gap between Tamiflu and the runner-up Hanmi Flu is in arm’s length. Prescription volumes of generics, on the other hand, are neck-and-neck, while the original’s performance is stagnating. Moreover, intravenously administered Permiflu jumped in to the already-heated competition strong with convenience of single-dosage. Now with the new flu season just penning, let us round up the highlights of the flu treatment market. ◆Tamiflu adverse reaction risk from last year, so what’s next this year? Last winter, Tamiflu was struck down with a concerning issue. In December last year, a middle school student fell from an apartment and was found dead in Busan, after taking Tamiflu. The student’s family suspected adverse reaction as she complained of hallucination after taking Tamiflu. And the media highlighted sporadic reporting of suicidal reaction from Tamiflu in Japan. The risk did not subside easily. As a result, the original and oseltamivir generics together generated prescription volume of 24.7 billion won in last flu season from November 2018 to May 2019. Compared to the 2017-2018 season generating 31.1 billion won, the last season’s sales dropped more than 20 percent. Besides, it was a big loss for the drugs considering the flu season struck hard last year. According to Health Insurance Review and Assessment Service (HIRA), 4.74 million patients visited hospitals for flu in the 2018-2019 season. The figure was at four-year high and it was 5.5 times more than 860,000 patients in the 2014-2015 season and 2.1 times more than 2.29 million patients in the 2017-2018 season. Tamiflu and generic prescription volume (source: UBIST) and flu patient size from last five season (source: HIRA) While the overall oseltamivir products had a drop in prescription volume, the original Tamiflu took the biggest blow. Its prescription volume plunged from 12.2 billion won to 7.7 billion won in a year. Hanmi Flu generating the second highest sales narrowed the gap with Tamiflu from 3.8 billion won to 1.7 billion won in the same period. The industry predicts the generic could actually surpass the original this season according to the trend. Top two market leaders Tamiflu and Hanmi Flu’s prescription volume in last five seasons (Unit: KRW 100 million) Source: UBIST ◆Peramiflu almost triples market share As a result of Tamiflu’s adverse reaction risk, GC Pharmaceutical’s Peramiflu (peramivir) took the opportunity. Compared to the previous season, the peramivir medicine’s market share more than doubled last season. The National Assembly Health and Welfare Committee reported 67,518 patients were prescribed with Peramiflu as of December last year. It was 4.4 times more than 15,481 patients in the season before. In the general flu treatment market including Tamiflu, Peramiflu’s share soared from 2.0 percent to 5.4 percent, about 2.7 times the rate. Some hospitals and clinics struggled to get a hold of Peramiflu stock, because a sudden spike in sales exceeded projected demand,. Apparently, pediatric institutes especially had difficulty in acquiring needed supply. Peramiflu also won expanded indication on pediatric patient under the age of two. And some sees that the word of mouth from young patients’ parents, concerned of the recent Tamiflu risk, have affected the shortage. ◆Hanmi Flu gulping up generic market share Since Roche introduced Tamiflu to Korea in 2000, its market share grew significantly in 2009 with the new influenza sweeping the nation. And the treatment dominated the market in the 2014-2015 season. In the 2015-2016, Hanmi Pharmaceutical modified the original’s saline substance to avoid patent infringement and launched Hanmi Flu. The incrementally modified drug generated 1.5 billion won from the first season’s prescription and had a perfect soft landing on to the flu treatment market. The prescription sales also hiked exponentially in the 2016-2017 season at 8.3 billion won. From the 2017-2018 season, Tamiflu’s patent was expired and generics flooded out to the market. About 50 pharmaceutical companies entered the oseltamivir generic market. The generics made a huge success from their first year. 31.1 billion won worth of generics were prescribed in their first flu season from 2017 to 2018. Tamiflu and oseltamivir generics’ prescription volume in 2018-2019 season (Source: UBIST) However, their sales plummeted to 24.7 billion won with the Tamiflu risk in the 2018-2019 season. But the upside was that the market share of generics in the overall flu treatment market surged from 60.9 percent to 68.8 percent. The generic’s share is expected to surpass 70 percent this season. Interestingly, the number one generic Hanmi Flu’s prescription volume has dropped from 8.4 billion won in 2017-2018 season with share of 26.9 percent to 6.0 billion won in 2018-2019 season with 24.3 percent market share. The decrease in Hanmi Flu’s market share was actually shared among other generic items including Fluone (Jeil Pharm), Seltaflu (Inist Bio), Tami-infle (Hutecs), Boryung Tami (Boryung Pharmaceutical), Tamipro (Arlico Pharm), Bisel Flu (Wooridul Pharmaceutical), Dongwha Flu N (Dongwha Pharm) and Tamiforce (Ilsung Pharmaceuticals). All of the said generics had growth in sales and market share. Meanwhile, Roche Korea is aiming for a turnaround with a new launch of Xofluza. However, the company would be unlikely to recover the fall this season as the new flu treatment launch would take a place in March next year at earliest.
- Company
- ‘Noltec’, domestic new drug sets a new record
- by Chon, Seung-Hyun Dec 18, 2019 06:25am
- Il Yang's anti-ulcer drug 'Noltec' is breaking a record every day. Continued upward trend after expanding indications, the company benefited from the reflection of impurities from competing drugs. According to UBIST, a drug research agency on the 17th, Noltech's outpatient prescriptions last month increased by 16.7% to ₩2.9 billion. By November, the cumulative prescription amount for this year was ₩28.2 billion, up 20.1% from last year's ₩23.5 billion. Noltec, released as a new domestic drug at the end of 2009, is a proton pump suppression (PPI) drug developed by Il Yang Pharmaceutical. Noltec's recent upswing is fueled by increased indications and the exit of competitive products. Initially, Nortec was licensed to treat only 'gastric ulcer' and 'duodenal ulcer'. But at the beginning of the launch, it did not stand out in the market. The reason for this is that they did not have indications for reflux esophagitis, which account for about 80% of the PPI drug market. Nortec's sales have risen vertically since winning the indication for reflux esophagitis in 2012. In 2014, the prescription amount exceeded ₩10 billion, and since then, H. pylori bactericidal indications have been added, showing rapid growth, and recorded prescription amount of ₩26.2 billion last year. Recently, the suspension of Ranitidine have been worked favorable factor. In September, the government suspended a sale of all anti-ulcer ranitidine products. In fact, it decided to exit the market because of its excess of carcinogen N-nitrosodimethylamine (NDMA). The discontinuation of ranitidine led to a significant increase in the use of H2 receptor antagonists and PPI-based drugs with similar treatment areas, and Noletec benefited. Recently, some of the Nizatidine-based products have been discontinued due to NDMA detection, and PPI-based drugs are becoming more popular. Nortec's prescription exceeded ₩3 billon for the first time in October, just after Ranitidine was discontinued. It increased 23.2% YoY and rose 20.1% MoM. Since the Ranitidine’s suspension of sale, prescriptions for October and November totaled ₩6 billion, up 20.3% YoY. If this is the case, Nortec is likely to surpass ₩30 billion in prescriptions for the first time since its launch.
