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- 2026-03-19 12:07:18
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- 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.
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- ‘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.
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- Chong Kun Dang in talks over approved Xofluza
- by Kim, Jin-Gu Dec 18, 2019 06:25am
- Xofluza (baloxavir), a follow-on drug for influenza patient treating Tamiflu (oseltamivir), has been recently approved the Korean health regulator, and is now in talks with Chong Kun Dang Pharmaceutical about the marketing deal in Korea. Korean Ministry of Food and Drug Safety (MFDS) has granted an approval on commercialization of Roche Korea’s Xofluza in 20 mg and 40 mg dose last month. The Korean industry predicts Chong Kun Dang would highly likely to grab the marketing rights of the flu treatment in Korea. According to a pharmaceutical industry insider on Dec. 16, Roche Korea and Chong Kun Dang are currently in negotiation over commercialization in Korea. Chong Kun Dang signed an exclusive distribution and sales deal on Tamiflu with Roche in 2012. The contract has been maintained to this day. With the long plausible relationship with the Korean company, the multinational company is positively having talks over Xofluza. The two companies had an official statement issued saying “Xofluza’s commercialization deal in Korea is ongoing at the moment. Nothing has been decided, yet”. When they agree on the final terms, the treatment is expected to be launched early next year at earliest, considering preparation time between the approval and actual launch date. Also taking in account of the insurance reimbursement review period, the treatment would join the competition in around next influenza season, either from winter of 2020 or spring of 2021. Xofluza, after its launch, would have to compete against GC Pharma’s Peramiflu, Hanmi Pharmceutical’s Hanmi Flu and other generics. In particular, Xofluza would compete against Peramiflu for the single-dose prescription. The two have contrasting advantages and disadvantages. Both of them are prescribed for a one-dose administration, but Xofluza is orally taken and Peramiflu is administered intravenously. However, Peramiflu has its indication approved for pediatric patients. Xofluza is currently only approved for adult and teenagers older than 12. Administration convenience and pricing are make-or-break factors the competition against generics like Hanmi Flu. Tamiflu and other generics are inconvenient for the patients as they have to be taken orally for five days. Meanwhile, Tamiflu generics in convenient suspension form are also their strength. Moreover, they have the upper hand with an indication for pediatric patients like Peramiflu.
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- Oraxol by Hanmi apply US license
- by An, Kyung-Jin Dec 18, 2019 06:24am
- The commercialization of the anti-cancer drug 'Oraxol', a technology exported by Hanmi, is imminent. Hanmi's US partner Athenex unveiled its Phase III clinical results for patients with metastatic breast cancer and announced its intention to approve the FDA in early next year. Some assessments suggest that some indicators, such as gastrointestinal adverse events, do not meet expectations. ◆Athenex, confirmation of anticancer effect of Phase III clinical trial for oral Paclitaxel Athenex unveiled the results of its Phase III clinical study at the San Antonio Breast Cancer Symposium (SABCS 2019) held in Texas, USA on 13th (local time). This study compares the efficacy and safety of randomly assigned metastatic breast cancer patients enrolled in 45 Latin American clinical trials into Oraxol group or Paclitaxel IV group. Oral test drug 205 mg / m² three times a week, and the control group received 175 mg / m² of Paclitaxel intravenous injection every three weeks, and then confirmed the tumor response through imaging tests. The conference announcement was similar to the topline results that Athenex released in August. According to the Intention to Analyze (ITT), which included those who discontinued or changed the treatment during the clinical trial, the objective response rate (ORR) of the Oraxol group was 35.8% (95 of 265) better tumor suppression effect (P = 0.001) than 23.4% (32 of 137) of the IV group. The median response time was higher in the Oraxol group (27.9 months) than in the Paclitaxel intravenous group (16.9 months), overall survival (median) was also significantly different (P = 0.035) at 27.9 months and 16.9 months respectively. However, the progression-free survival period (median value) was 9.3 months in the group taking Oraxol, which did not show a statistically significant difference from the IV group (8.3 months) (P = 0.077). Oraxol, Phase III Clinical Results (Source: Athenex) 'Oraxol' is a synthetic drug that Hanmi exported to Athenex in the US in 2011. Hanmi Pharmaceutical turned its Paclitaxel injection into oral by applying its own developed ORASCOVERY platform technology. By blocking the membrane transport protein P-glycoprotein (P-gp) that interferes with the oral absorption of anticancer drugs, it is a mechanism to improve the absorption rate has been pointed out as a disadvantage of oral drugs. The Paclitaxel injection, which is the most commonly used for breast cancer treatment, is changed to oral drug, thereby increasing convenience and increasing marketability. It is also meaningful that Hanmi’s ORASCOVERY platform technology has entered commercialization on track. ◆Investment industry, "Effective goal met, but adverse reaction is key" However, the investment industry is disappointing with the results of the Phase III clinical trials. Although the primary efficacy endpoints were met, the safety profile was ambiguous. Shortly after the conference, Athenex shares fell 17 percent. According to the report, the incidence of alopecia and severe neuropathy adverse events was 17% in the Oraxol group, which was lower than 57% in the intravenous group. Severe neuropathy symptoms were also improved in the Oraxol group at 1% and 8%. Toxicity profile was similar. On the other hand, neutropenia, infection, and gastrointestinal adverse events were higher in the Oraxol group. Athenex Based on this three-phase clinical data, Athenex expresses its intention to commercialize the Oraxol in earnest, and the marketability of the Oraxol is expected to be tested. Atenex executives said during the third quarter of last month's results that they are preparing a pre-meeting to submit a new drug application (NDA) for the US Food and Drug Administration (FDA) in the first quarter of next year. He also said he is also considering expanding the range of Oraxol’s use to other carcinomas, including advanced gastric cancer, using anti-PD-1 antibodies such as Keytruda. In addition to Paclitaxel, the company aims to develop oral formulations of various anticancer drugs such as Irinotecan and Eribulin using ORASCOVERY Platform technology. Athenex executives held the conference call related to the announcement of SABCS 2019. He stressed “Oraxol has achieved meaningful results in phase III clinical trials, and this is the first case of Paclitaxel that has been converted to oral to demonstrate anti-cancer effects, and Oraxol is expected to be an important treatment option for breast cancer patients”.
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- Korean companies now having long year-end holiday
- by Lee, Seok-Jun Dec 17, 2019 12:33pm
- The Korean pharmaceutical industry is starting to adopt the long year-end holiday season to wrap up the year around Christmas and to start fresh from the New Year. Boryung Pharmaceutical and other Korean companies are having a long holiday for the first time this year. Multinational pharmaceutical companies are starting their long holiday season soon like they have been for years. Apparently, AbbVie is to have is the longest 18-day holiday season. Daily Pharm surveyed year-end holiday schedules of 40 pharmaceutical companies in Korea, including top 20 Korean companies, 18 global companies, and two pharmaceutical industry organizations—Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) and Korean Research-based Pharmaceutical Industry Association (KRPIA). Nine out of 20 companies are leaving for the holiday from Dec. 26 to 31. Including public holiday on the Christmas day and the New Year’s day, they are closed for total eight days. The list of companies include GC Pharma, Hanmi Pharmaceutical, Dong-A ST, JW Pharmaceutical, Ildong Pharmaceutical, Boryung Pharmaceutical, Huons, Dongwha Pharmaceutical, and Samjin Pharm. Boryung Pharmaceutical is having their first long-term year-end leave. Five companies including Kwangdong Pharmaceutical, Daewoong Pharmaceutical, Jeil Pharm, Celltrion and Handok’s year-end schedule is to use employee’s individual annual leave. The companies are highly recommending the employees to use the rest of their annual leave. Yuhan is the first to close the office from Dec. 16 to 20. Including the weekends, the companies are on holiday for nine days. But it opens again from Dec. 23 to prep for the next year’s start. Chong Kun Dang Pharmaceutical and Daewon Pharmaceutical have set Dec. 30 and 31 as designated annual leave day. Whereas Ilyang Pharmaceutical and Dongkook Pharmaceutical have designated Dec. 23 and 24 as annual leave day. They took an advantage of weekends and holidays to take a longer holiday. An industry insider commented, “A long year-end holiday season has been a typical system only for multinational companies even until recently, but nowadays Korean companies have implemented the similar system to have refreshing holiday season. Most of them use employee’s annual leave days, but employees can fully enjoy a long holiday with an official corporate holiday season”. Multinational pharmaceutical companies’ long year-end holiday season is not so different from previous years. Among the surveyed multinational companies, AbbVie is having the longest year-end closing. The 18-day leave is to stretch from Dec. 19 to Jan. 5 next year. AbbVie has decided to grant special vacation day on Dec. 30 and 31, and use employee’s annual leaves on other days. The office usually closes on Jan. 2 as it is AbbVie’s foundation day. Pfizer is to close the office from Dec. 17 to the end-of-the-year. Including the New Year’s day, they will be closed for 16 days. AstraZeneca, Boehringer Ingel Heim, Roche, Takeda, Daiichi Sankyo, Sanofi and Amgen are closing around Christmas. Other companies are to use employee’s annual leave for the year-end holiday season.
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- Champix, conclusion of patent disputes imminent
- by Kim, Jin-Gu Dec 17, 2019 06:34am
- A patent dispute over the Champix(Vareniclin) marks the end. The Patent Court has announced that it will issue a judgment on a patent dispute related to the Champix on the 20th , 4 days later. The result of the Champix patent dispute attracted interest in that it could see the future of domestic salt-modifying drugs after the so-called ‘Solifenacin decision’ earlier this year The legal disputes between the two sides were so intense that the court would postpone the sentence four times. The ruling, originally scheduled for February, was postponed for four months, from May to August to October to December. The jurisdiction of the judiciary is also a matter of how deep. The ruling of the patent court is expected to be applied as a definitive ruling. This is because the Supreme Court's appeal is unlikely, as the expiration date of the material patent is almost imminent. ◆Patent Judge sided with generic company, Pfizer appeals In September 2016, more than 20 domestic companies, including Hanmi Pharmaceuticals, filed a patent dispute with Pfizer. Domestic companies tried to speed up the launch of generics with the strategy of “avoiding patents with salt changes.” It is a strategy that avoids the extended duration of material patents by developing salt-changing generics and raising passive judgments on the scope of rights. The Patent Judge, the first case of a patent dispute, raised the hands of domestic companies. Based on this, domestic companies have launched salt-modifying drugs since last November. Pfizer dissatisfied with the decision of the Judge. The company filed a lawsuit with the Patent Court asking to cancel the decision. The ruling on the lawsuit is sentenced on the 20th. ◆Interpretation over Supreme Court's decision to Solifenacin. During the second trial over Champix, a ruling was imposed elsewhere that would have a modest impact on the case. It was a Solifenacin decision issued by the Supreme Court in January this year. The Supreme Court sided with the original company, Astellas, in a salt-altering patent dispute between the original company and the generic company over Solifenacin, an overactive bladder treatment. The key point of the ruling was that ‘the salt-modified product and the original product had substantially the same active ingredients, therapeutic effects, and uses, and those skilled in the art could easily change the salt’. Interpretations were mixed with this ruling. Pfizer and other originals interpreted the Supreme Court as setting a case for the salt change, which has been the main patent evasion strategy of domestic companies. Of course, the case is expected to affect the results of the Champions suit. On the other hand, some domestic companies draw a line that the case of Solifenacin salt-modifying drug and the Champix salt-modifying drug, which were previously lost, is quite different. They explain that the 'substantial identity' that has been crucial in the Solifenacin decision is a separate part of the decision. They also argues that there is a difference in the ease of realization of technology by trade technicians. ◆If a domestic company loses, 'Change salt patent avoidance' strategy useless The patent court's decision will act as a measure of whether to avoid the patent of salt-modified products in the future. If the patent court raises Pfizer's hand in accordance with the Supreme Court case, domestic companies will not be able to use the patent evasion strategy by changing the salt. On the other hand, if the patent court raises the hands of domestic companies separately from the Soliphenacin case, the avoidance of salt-changing patents by domestic companies is likely to continue strategic vitality. A legal personnel said, “At present, the patent court is expected to apply Solvenasin's judgment as a precedent and side with Pfizer, however, as domestic companies insist, there is some possibility of judging the Solifenacin case and the Champix case separately. Either way, it will have a big impact on our strategy for avoiding salt modifications in the future”. ◆Material patent expires after 7 months, Less possibility of 3 trial appeals On the other hand, even if the patent court raises Pfizer's hand, there is a possibility that domestic companies are unlikely to lead the case to the Supreme Court. This is because the champix material patent expiration is shortly until July 19 next year. Given the time it takes to appeal after the Supreme Court appeals, it is likely that the avoidance of the extended patent duration, which was the original purpose of the patent dispute, has already been achieved. In addition, as domestic sales of Champix have been plunging recently, domestic companies' economic incentives have weakened significantly. According to drug research firm IQVIA, Champix's 3Q revenue was ₩5.7 billion, down 46% from ₩10.6 billion a year earlier. It is a quarter compared to the peak season, ₩21.4 billion in the first quarter 2017. An official in the pharmaceutical industry said, "With a huge drop in sales of successful successes, we know that many pharmaceutical companies have decided to stop the release of Champix salt-modifying drugs regardless of the Soliphenacin case." Champix
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- Venture capital investment on bio sector breaks record again
- by Kim, Jin-Gu Dec 16, 2019 10:55pm
- The new investment volume in pharmaceutical and bio industry is expected to mark the highest figure in the history, despite multiple risks occurred in the year. Following last year’s record-breaking volume, this year’s investment volume is to break the last year’s record. Korean Venture Capital Association (KVCA) recently published a Venture Capital Market Brief, as of October 2019. The report found the accumulated new investment volume all across industries reached 3.52 trillion won until the October. Apparently, pharmaceutical, bio and medical sector marked the highest ratio of the entire volume. The sector received investment of 984.1 billion won as of October, taking up about 27.9 percent of the total accumulated investment volume. Last year alone, the sector’s investment volume surpassed 841.7 billion won. Following after the top invested sector, the ICT service sector was invested with 782.5 billion won (22.2 percent) showing a gap of 200 billion won with the top sector. Based on the trend, the pharmaceutical, bio and medical sector’s new investment volume in the year is expected to exceed one trillion won for the first time in the history. After placing itself on the top spot last year, the pharmaceutical, bio and medical sector’s new investment volume has been widening the gap between the second place. The sector actually outperformed itself despite a series of fallouts in the year, like revoked approval on Kolon Life Science’ Invossa-K, and failed Phase 3 trials by SillaJen, Helixmith and HLB. KVCA reported 17 out of 21 special technology listing cases were from the pharmaceutical, bio and medical sector. 11 companies from the sector either have already been listed or are to be listed until the end of the year. The association official explained the background of skewed new investment volume and said “Ever since the special technology listing system was implemented from 2005, the pharmaceutical, bio and medical industry’s share of the overall special technology listing has been the biggest at 78.6 percent”.
- Company
- Huons, challenges localization of Hyaluronidase
- by Lee, Seok-Jun Dec 16, 2019 10:55pm
- Huons Group will challenge the global hyaluronidase market worth ₩3 trillion. HuonsLab, a bio research and development company specializing in Huons Group, announced on 16th that it has signed a commissioned research agreement contract with Panzen, a cell line development company, to develop ‘human gene recombinant hyaluronidase’ cell line development and production process development. Panzen, founded in 1999 is engaged in research and development of biopharmaceutical products at home and abroad, including recombinant cell lines and process development. This year, Korea's own biosimilar anemia treatment (EPO) 'Panpotin' was approved in Korea. Hyaluronidase is a recombinant enzyme protein that breaks down hyaluronic acid and is used as a drug diffusion agent. Hyaluronidase has been recently developed to increase the use of Hyaluronic acid fillers for cosmetic purposes, and to increase drug delivery ability in accordance with the trend of developing antibody treatment or protein drugs subcutaneously rather than intravenously. According to GosReports, the global market for hyaluronidase is estimated to be ₩2.70 trillion by 2020. Huon's Lab challenges the localization of human genetic recombinant hyaluronidase. Huon’s Lab plans to establish a development system from the development of human gene recombinant hyaluronidase cell line with Panzen, which has the know-how and technology for the development of recombinant protein-producing cell line and process development. “We are expanding our bio business at the group level to lead the global healthcare market” said Wan-seop Kim, Huon's CEO. "Recombinant human hyaluronidase is an important technology that can be used in various therapeutics. If successful, it can be competitive in the global biologics technology market.".
- Company
- Collapse of Cialis, 6th place in 4 years
- by An, Kyung-Jin Dec 16, 2019 06:21am
- (Clockwise from top left) Photographs of Cendom, Viagra, Palpal, Cialis The market position of Cialis, which squeezed the market for erectile dysfunction with Viagra, was greatly reduced. In the aftermath of the generic drug market by domestic pharmaceutical companies, sales shrank to one-third of patent expiration. The share rank has changed from 1st to 6th place four years ago. Generic products such as 'Palpal' and 'Cendom' continued to strengthen in the entire erectile dysfunction treatment market. According to IQVIA data on the 11th, the market for erectile dysfunction drugs in the third quarter was ￦28.3 billion, an increase of 8.3% compared to the previous year. This is an increase of 13.8% from ￦25.3 billion in the third quarter 2015. Quarterly market size is steadily rising as generic products launched by domestic pharmaceutical companies are growing. Quarterly Sales of Major Erectile Dysfunction Therapeutics (Unit: KRW million, Source: IQVIA) In terms of sales of erectile dysfunction treatment, Hanmi Pharmaceutical's 'Palpal' has firmly maintained its leading position for four years since 2016. Palpal is a generic product of Viagra (Sildenafil) released in 2012. Palpal sold ￦5.7 billion in the third quarter, accounting for 20.1% of the market for erectile dysfunction. The company's sales grew 10.6% YoY to ￦5.2 billion, maintaining a more than double gap with its second-place Cendom. Palpal, which made an entry mark in the erectile dysfunction treatment market immediately after its patent expiration, exceeded sales of Viagra, the same ingredient as its original product, within a year after its release. In the fourth quarter of 2015, even the original Cialis, which was Tadalafil-based, beat the original erectile dysfunction treatment throne. Since then, it has not missed a market leader. Strong accent for generics were even more pronounced in the Tadalafil market. Chong Kun Dang's 'Cendom' remained second in sales, selling ￦2.5 billion in the third quarter. The company's market share increased to 8.8%, recording a 6.3% year-on-year growth. Cendom is a generic product that was released after the Cialis (Tadalafil) patent expired in September 2015. Since its launch, its market share has gradually increased, surpassing the original Cialis in the fourth quarter of 2017. In the fourth quarter of last year, the company is chasing Palpal by exceeding Viagra sales. Gugu by Hanmi, Another generic product of Tadalafil, ranked fourth overall in the third quarter, selling ￦1.8 billion, a 6.3% increase from the previous year. Original pharmaceuticals from multinational pharmaceuticals showed a sharp decline. Cialis sales in Lilly Korea fell 13.6% YoY to ￦1.5 billion. Compared to ￦5.1 billion in the third quarter of 2015, two-thirds of sales evaporated. At the same time as Cialis expired, it gave Palpal by Hanmi Pharmaceuticals a leading position in sales of erectile dysfunction drugs in Korea. Since then, The sales have been sequentially overtaken by Pfizer Viagra and Chong Kun Dang Cendom. Lilly signed a contract with Handok, a former sales partner, last year Lilly took complete charge of Cialis' domestic distribution, marketing and sales activities. However, there was no sales rebound effect. Cialis was pushed down to the same ingredient generic product, Gugu, in the second quarter of this year, and was lower than SK Chemical's 'MvixS' (Mirodenafil). After four years of patent expiry, the sales ranking has fallen by five steps. The gap with Dong-A 'Zydena (Udenafil), which ranked seventh in the third quarters, is only ￦10 million. Pfizer's Viagra sales are unlikely to recover. Viagra's third quarter sales came in at ￦2.4 billion, similar to the same period last year. The domestic market for erectile dysfunction drugs is estimated at 8.4%. It was once called the pronoun for erectile dysfunction, but its current sales are less than half of its Palpal. Comparison of 2018-2019 3Q revenue of major erectile dysfunction treatments (Unit:￦1million, %, Source: IQVIA)
- Company
- Industry feels growing pressure on metformin risk
- by Chon, Seung-Hyun Dec 16, 2019 06:21am
- Ministry of Food and Drug Safety (MFDS) The pharmaceutical industry’s concern over metformin impurity contamination is growing. The industry’s eyes are focused on the government’s action following its ongoing metformin usage status review. Some of pharmaceutical companies are promptly equipping themselves with impurity analyzer a self-testing. ◆MFDS initiates metformin usage status review, the industry fears of follow-up action An industry source reported on Dec. 15 that Korea’s Ministry of Food and Drug Safety (MFDS) has ordered pharmaceutical companies to assess manufacturing record of pharmaceutical product containing ‘metformin hydrochloride’ and investigate used active pharmaceutical ingredient. MFDS asked companies to report total number of drug items consisting of metformin substance, names and number of manufactured items, and names and number of non-manufactured items until Dec. 17. Molecular structure of metformin Pharmaceutical companies have to provide all information of items even covering ones in distribution at the moment, 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 be looked into. The ministry is also calling for a full report on active ingredients used in the metformin products. It means the ministry means to collect detailed information on DMF registration number and manufacturing plant of a complete product containing the ingredient under each serial number. The procedure resembles the ranitidine and nizatidine cases. When they find an issue in specific active ingredient and complete drug, the ministry can take a fast and accurate action based on the information submitted by companies. The pharmaceutical industry predicts the government direction is a part of the ministry’s preparation process, in case impurity is discovered in metformin medicine. 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. MFDS had immediately ordered a sales ban on drugs with valsartan when Europe decided to recall the products, but it held back on the action for ranitidine and nizatidine until the thorough review on complete products and the ingredients was completed. The risk of metformin impurity broke out 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. Since then, the U.S., Europe and Japan initiated impurity testing on metformin drugs. All three regions are recommending companies to conduct self-testing on NDMA levels in their metformin drugs. ◆Companies initiating impurity self-tests and purchasing analyzer Companies in Korea are also encouraged to run self-tests on their metformin-containing items. So far the ministry has not officially instructed companies to test impurity in metformin ingredients. In fact, the ministry has not even ordered them to test NDMA level in complete product or announced a plan to collect all items for further investigation. MFDS’ lack of instruction could be because of the U.S. and Europe have not ordered for a recall on products with alarming impurity level, and also because the problematic metformin ingredient and complete product with the ingredient have not even been imported to Korea. Moreover, there has not been an official procedure of NDMA testing presented by the ministry. The complete products with contaminated metformin recalled in Singapore have not been imported to Korea, yet. However, it has not been confirmed yet if the active ingredient used in the recalled product has been used in Korea. Apparently, the Singaporean regulator has decided to recall the products after testing complete products, not the active ingredient. The pharmaceutical companies in Korea have no other choice, but to test their metformin products according to the active pharmaceutical ingredient impurity risk management measure the ministry has unveiled recently. While announcing the investigation result of nizatidine contamination last month, MFDS ordered companies to conduct a self-test on all of their synthetic active ingredients for impurity like NDMA. Accordingly, synthetic ingredient manufacturer and importer, as well as complete product companies, have to evaluate contamination risk in drugs either during manufacturing or storing processes. Pharmaceutical impurity risk management initiative unveiled by MFDS last month Moreover, pharmaceutical companies have to immediately report any discovery of impurity to MFDS after conducting self-evaluation on suspected items with risk of NDMA-like impurity contamination. Basically, metformin became the first substance to be ‘suspected for contamination risk’ since the ministry’s impurity risk management initiative. The industry seems to be in process of attempting self-analyze NDMA level in metformin medicine. However, the testing process has not been so simple without an official testing procedure and lack of laboratories with proper analysis equipment. Currently, only nizatidine-containing products verified with approved level of NDMA can be distributed, but the testing laboratories are unable deliver testing results in requested time as they are backed-up with all companies with nizatidine products. MFDS has ordered pharmaceutical companies to supply nizatidine-containing item with passing level of cancer-causing NDMA contamination (less than 0.32ppm), verified by testing done for each item serial number. The test can be done by Korean Good Manufacturing Practice (GMP) certified manufacturer, MFDS designated quality test institute, city and provincial-managed environment research lab and Korean Pharmaceutical Traders Association. MFDS ordered pharmaceutical companies to test NDMA level in nizatidine medicine before supplying Some of pharmaceutical companies are even considering on purchasing testing equipment to run it by themselves. But an analyzer costing up to 300 million to 500 million won, beside the six-figure annual maintenance, cost is definitely putting a strain on the company. A pharmaceutical company insider commented, “The company is taking account of equipping impurity risk examination system as its own quality management program. We are also discussing possibility of sharing an ownership and purchase cost of the analyzer”.
