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- 2026-05-16 03:08:25
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- Kisqali gets a nod from MFDS joining Ibrance and Verzenio
- by Eo, Yun-Ho Nov 06, 2019 09:00am
- Following the footsteps of Ibrance and Verzenio, a third CDK4/6 inhibitor announced its launch in Korean market. On Oct. 30, Novartis officially released news that Kisqali (ribociclib) has been approved by Ministry of Food and Drug Safety (MFDS) as a treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer. Ongoing competition between Ibrance and Verzenio, currently in insurance reimbursement review process as a combination therapy with Faslodex (fulvestrant), is to intensified even more. Kisqali was approved by the regulator as it demonstrated a meaningful improvement of prolonging progression free survival (PFS) from its clinical trial. Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer and proved the drug’s effect on significantly extending patient’s overall survival (OS). Professor Im Seock-Ah of Hemato Oncology Department at Seoul National University Hospital explained, “MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. This finding reflects how Asian region has a great need for a new treatment on premenopausal women with breast cancer”. In the Phase 3 MONALEESA-3, Kisqali proved to extend OS and demonstrated improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination than using the existing endocrine-based therapy alone. The recommended dose of Kisqali is taking 600mg (three 200mg tablets) orally, once daily for 21 consecutive days followed by seven days off treatment. The treatment could be taken with or without food but at set time of the day. Meanwhile, Ibrance and Verzenio are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC) after Cancer Disease Deliberation Committee of Health Insurance Review and Assessment Service (HIRA) has passed both. Reimbursement review process of the both treatments started from same point of origin, cyclin-dependent kinase (CDK) 4 and 6. But their regulator review approaches are different. In November of 2017, Ibrance has already been listed as a first-line therapy (combination with Letrozole) via refund type risk sharing agreement (RSA). And now it is in process of expanding the reimbursed indication. Verzenio, on the other hand, is applying for reimbursement listing for the first time. The treatment has simultaneously applied for reimbursement not only as a second-line therapy, but also as a first-line therapy in combination with aromatase inhibitor. But under its current circumstances, Verzenio’s only option is RSA. Unfortunately, a follow-on drug is not yet eligible for RSA, so Lilly would likely to push on with the second-line therapy indication without any other drug available. Kisqali would also likely to take the same track.
- Company
- Korean companies competing for GSK’s OTC Drugs
- by Jung, Hye-Jin Nov 06, 2019 09:00am
- A pharmaceutical industry insider reported on Nov. 1 that three Korean pharmaceutical companies are competing against each other to acquire sales rights of ten popular over-the-counter (OTC) drugs manufactured by GlaxoSmithKline (GSK). The multinational drug manufacturer said it would soon decide on a partner company. In 2017, GSK signed a supply contract with Dong-wha Pharm for co-promotion and sales rights on ten OTC drugs including Lamisil, Otrivin, Voltaren, Nicotinell, Theraflu, Sensodyne, Breathe Right, Zantac, Polident and Driclor. The two companies’ contract was supposed to last until 2020, but as GSK and Pfizer Consumer Healthcare merged and established a new joint venture, the old contract is said to be terminated. Dong-wha Pharm recently announced that its OTC supply contract with GSK would be terminated on coming Dec. 31. As a result, GSK has been contacting several Korean pharmaceutical companies for a new partnership. Reportedly, GSK is in talks with three companies, including a well-known pharmaceutical company with strong pharmacy sales power along with a famous OTC drug. The pharmaceutical companies are proposing differentiated service fee rates based on sales performance and return policy to win the hearts of GSK for the sales right deal. As the multinational company’s OTC drugs are making about 60 billion won annually, a Korean company winning the deal would secure a stable cash cow. Sources report GSK is closely reviewing respective companies’ sales network, specifically their pharmacy sales power. Sales for OTC drugs are highly dependent on pharmacy sales power due to its nature. Some had predicted Dong-wha Pharm would terminate the contract by the end of the year and renew the contract from next year. But apparently the company is not included among the three candidate companies. However, some experts evaluate the ten popular OTC drugs would generate notable amount of sales, but it could be an unappealing deal to a distributor because of their low marketing margin. At the moment, Dong-wha Pharm is recalling Zantac with ranitidine and other nine items. A GSK official explained “For a new partner company to initiate distribution from January next year, the contract has to be signed before the end of the year. Insiders say the talks are wrapping up. The decision would be made very soon”.
- Company
- Is MFDS going to suspend sales on nizatidine with no NDMA?
- by Chon, Seung-Hyun Nov 06, 2019 08:59am
- Pharmaceutical industry is walking on thin ice as the government initiated impurity investigation on stomach ulcer medicine. Now that the U.S. detected impurity in nizatidine, following a case in Japan, probability of finding impurity in nizatidine has gotten higher in Korea. The industry is on high alert against the government’s possible order to suspend sales of nizatidine drug without detecting any impurity, which was the case with ranitidine. According to an industry insider, Ministry of Food and Drug Safety (MFDS) ordered pharmaceutical companies to submit complete nizatidine product manufacturing record and to test active pharmaceutical ingredient (API) chemically similar to the ingredient. MFDS ordered companies to submit API usage record and other archived evidences to confirm manufacturing record until Nov. 4. The ministry seems to be investigating uses of all complete product with both Korean-made and imported nizatidine Nizatidine is an H2-receptor antagonist similar to ranitidine suspended of sales from last September. After deciding to suspend sales of all ranitidine drugs, MFDS also set a plan to investigate similar APIs, starting with nizatidine first. Ministry’s nizatidine usage record investigation resembles that of ranitidine’s. On last Sept. 20, MFDS directed pharmaceutical companies to investigate ranitidine API usage record, and six days after on Sept. 26, the ministry announced sales suspension on all ranitidine items. The industry presumes MFDS is about to announce nizatidine investigation result based on the precedent case. And now, the industry is nervously waiting for the ministry’s decision on nizatidine items. .Possibility of finding N-Nitrosodimethylamine (NDMA) has been raised at home and aboard, already .A private U.S.-based research institute, Valisure unveiled their testing report on nizatidine last September and stated they have detected NDMA .Previously, Valisure proposed regulators to recall ranitidine as it detected excessive level of NDMA in the API .Their latest report state researchers found one-seventieth of NDMA in ranitidine was detected in nizatidine .Japanese Ministry of Health, Labour and Welfare announced Japan-based Ohara Pharmaceutical tested their nizatidine product and detected NDMA exceeding the accepted level .The ministry reported the company decided to voluntarily recall their products due to the issue .On Nov .4, the U.S .Food and Drug Administration (FDA) released a statement about their investigation on NDMA found in ranitidine, and stated four nizatidine items from two companies had NDMA .However, the said nizatidine drugs had NDMA within the accepted level and were not included in the voluntary recall subject group .Some of pharmaceutical companies in Korea are promoting that their nizatidine drugs are NDMA free .However, some have raised concern about possibility of detecting NDMA in nizatidine ingredient used in Korea .At the moment, total nine API manufacturing plants have been registered to produce nizatidine .Korean Medical Association (KMA) has already advised doctors to refrain from prescribing nizatidine .In last month, KMA official said “The recent ranitidine incident has created a social turmoil, so the organization advised members to refrain from prescribing nizatidine containing drugs until MFSD announces final investigation result and its further action” .Pharmaceutical companies are keeping a close eye on MFDS’ further action for when finding minuscule amount of NDMA in nizatidine .The companies are afraid of the ministry ordering sales suspension on all nizatidine drugs for questionable cases of NDMA not detected from most of the complete product, and a single manufacturing unit containing minuscule amount of NDMA exceeding acceptable level .As for ranitidine drugs, all seven manufacturing plants had NDMA surpassing acceptable level in the API, but each item manufactured in a same plant had different levels of NDMA .For instance, some ranitidine drugs manufactured from one plant were found with unacceptable level of impurity and others were not .Result of NDMA investigation on collected ranitidine API (Source: MFDS)At the time, MFDS official stated “After collecting issue API and investigating them, each registered items from one manufacturing plant had different levels of NDMA and similar cases have also been found in other countries” .After making the statement, the ministry ordered sales suspension on all ranitidine drugs, judging that ranitidine itself is too unstable to be consumed .A pharmaceutical research institute, UBIST reported last year’s volume of nizatidine drug prescription for outpatient reached 25.9 billion won .Although it would be about one tenth of the ranitidine market, some pharmaceutical companies are faced with serious damage from sales suspension on popular nizatidine products .Pharmaceutical companies continue to urge the Korean regulators to suspend sales limited to items exceeding acceptable NDMA level like the case in the U.S .Some of the industry is also questioning credibility of the NDMA testing methodology as same API has been detected with different levels of NDMA .A pharmaceutical industry insider stressed, “MFDS has decided to suspend sales on valsartan and ranitidine drugs, regardless of each sample showing different level of the carcinogen .The regulators should use more precise investigative methodology and limit penalty to items with exceeding level of NDMA only” .
- Company
- Biosimilar Ultomiris to follow Soliris next year at earliest
- by Kim, Jin-Gu Nov 04, 2019 03:12pm
- Sources predict Ultomiris would enter the Korean market and a competition against a blockbuster antibody, Soliris, next year. According to pharmaceutical industry on Oct. 30, the drug manufacturer of Ultomiris, Alexion is preparing for a launch in Korea at the end of next year. The follow-on antibody drug already has been approved by FDA in the U.S. and by EMA in Europe last December and July, respectively. Like the case with Soliris, Handok is highly likely to manage Ultomiris’ approval and healthcare reimbursement application in Korea, but sales and marketing company has not been decided, yet. Currently, Handok is in charge of Soliris’ sales and marketing in Korea. Both Alexion and Handok are hesitant to give a clear plan, as they are still working on Ultomiris’ approval in Korea first. An official from Handok said, “Handok would be handling Ultomiris’ application for approval and healthcare reimbursement listing. At this point, it is still too early in the process for both companies to discuss about approval application schedule in Korea” and “sales and marketing contract would be dealt with after they are handled”. Alexion insider hinted, “Specific schedule has not been set, yet, but we are aiming to get approval from Korea at the end of next year”. Now the title has been taken away, but Soliris used be called the ‘most expensive drug in the world’. In 2010, it costed 500 million won for a year-long treatment of Soliris. Worldwide sales marked USD 3.14 billion (about 3.59 trillion won). The patient size may be small but because of its extremely expensive price, the sales volume is still massive. However, Soliris is soon to face biosimilar competitors as its patent expiration date is approaching. In the U.S., Amgen has reportedly filed a suit invalidating patent for Soliris as a preparation for an early release of its biosimilars product. If Amgen wins the case, the original patent expiration in 2027 would be moved up as early as 2021. In Korea, Samsung Bioepis and Abxis are currently developing biosimilars. Prospective competitors expect their products to excel in the market considering the original cost 500 million won a year. Alexion’s Ultomiris launch prep is also closely related to the original patent case. The blockbuster original and the biosimilars have overlapping indication of ▲paroxymal nocturnal hemoglobinuria (PNH) and ▲atypical hemolytic uremic syndrome (aHUS). Also the market could favor Ultomiris over Soliris as number of annual injection is about a quarter of Soliris’. The original is supposed to be shot once every other week, whereas Ultomiris is shot once every eight weeks. Summing up a year worth of injections, Soliris and Ultomiris are shot 26 times and six to seven time a year (52 weeks), respectively. Accordingly, the drug expense for Ultomiris would be significantly lower. A global pharmaceutical industry analytic firm, EvaluatePharma has once evaluated Ultomiris’ market value at 10.9 billion dollars (about 12.26 trillion won). The figure is over a triple of Soliris’ global sales volume of 3.14 billion dollars.
- Company
- 3분기만에 1천억 '거뜬'...잘 나가는 K-신약 캐시카우
- by Chon, Seung-Hyun
- [데일리팜=천승현 기자] 국내 개발 의약품이 외래 처방시장 상위권에서 맹활약을 이어갔다. 한미약품의 복합신약 로수젯과 HK이노엔의 케이캡이 3분기만에 처방액 1000억원을 훌쩍 넘어섰다. 대웅바이오의 뇌기능개선제 글리아타민도 선전했다.19일 의약품 조사기관 유비스트에 따르면 비아트리스의 고지혈증치료제 리피토가 올해 3분기 누계 가장 많은 1468억원의 외래 처방금액을 기록했다. 작년 같은 기간보다 2.6% 감소했지만 선두 자리를 견고하게 지켰다. 리피토는 지난 1999년 국내 발매됐다. 국내 출시된 지 20년이 넘었고 100여개 제네릭과 다양한 조합의 복합제가 집중적으로리피토를 견제하고 있지만 여전히 처방 의약품 시장에서 강력한 영향력을 나타냈다. 특허만료 이후 제네릭의 집중 견제에도 처방 의약품 시장에서 강력한 영향력을 과시했다. 다만 최근 성장세는 주춤한 모습이다. 리피토는 지난 2018년부터 지난해까지 5년 연속 외래 처방금액 선두를 기록했다. 국내기업 한미약품과 HK이노엔이 자체 개발한 로수젯과 케이캡이 3분기만에 1000억원 이상을 올리며 선두권에서 고공행진을 이어갔다.로수젯은 지난 9월까지 누적 처방액이 전년보다 19.5% 증가한 1309억원을 기록하며 전체 2위에 이름을 올렸다. 2015년 말 출시된 로수젯은 로수바스타틴과 에제티미브 2개 성분으로 구성된 고지혈증 복합제다.로수젯은 시장 선점 효과와 스타틴·에제티미브 복합제 인기몰이로 가파른 성장세를 거듭하고 있다. 스타틴·에제티미브 복합제는 저밀도 지단백 콜레스테롤(LDL-C)을 낮추는 데 탁월한 효과를 보이는 데다 2개의 약을 따로 복용하는 것보다 약값 부담이 크지 않다는 이유로 선호도가 높아지는 추세다.로수젯은 지난 2020년 처음으로 처방액 1000억원을 넘어섰고 4년 연속 1000억원 돌파를 가볍게 확정지었다.로수젯의 분기별 처방액을 보면 2018년 3분기 처방액 112억원에서 올해 3분기 455억원으로 5년 새 4배 가량 뛰었다. 로수젯은 발매 이후 매 분기 신기록을 경신하며 꾸준한 상승세를 지속했다. 지난 2019년 3분기 처방액 200억원 넘어섰고 2021년 3분기와 지난해 4분기에 각각 300억원과 400억원을 돌파했다. 로수젯의 3분기 처방액 455억원은 선두 리피토와의 격차가 27억원에 불과했다. 케이캡은 3분기 누계 처방실적이 1141억원으로 전년보다 18.7% 성장했다. 케이캡의 지난 3분기 처방액은 400억원으로 전년동기대비 20.6% 뛰었다. 2020년 3분기 213억원에서 3년동안 88.1% 상승하며 성장세가 꺾이지 않고 있다. 지난 2018년 국내개발 신약 30호로 허가받은 케이캡은 '칼륨 경쟁적 위산분비억제제(P-CAB)’ 계열의 항궤양제다. 위벽 세포에서 산분비 최종 단계에 위치하는 양성자펌프와 칼륨이온을 경쟁적으로 결합시켜 위산 분비를 저해하는 작용기전을 나타낸다.케이캡은 기존 프로톤펌프억제제(PPI) 계열 제품보다 약효가 빠르게 나타나고, 식사 전후 상관 없이 복용이 가능한 점 등 장점을 앞세워 높은 성장세를 지속하고 있다. 케이캡은 출시 3년째인 2021년 처방액 1000억원을 돌파했고 지난해까지 2년 연속 1000억원을 넘어섰다. 올해는 일찌감치 처방액 '1000억원 클럽'에 이름을 올렸다.케이캡은 미란성과 비미란성 위식도역류질환에 이어 위궤양, 소화성 궤양·만성 위축성 위염 환자에서 헬리코박터파일로리 제균을 위한 항생제 병용요법, 미란성 위식도역류질환 치료 후 유지요법 등 5개 적응증을 순차적으로 확보했다. 당초 위식도역류질환에 이어 위궤양에 건강보험 급여가 적용됐고 최근 나머지 적응증도 모두 건강보험이 적용되면서 성장세가 더욱 높아진 것으로 분석된다.국내 개발 의약품 중 대웅바이오의 뇌기능개선제 글리아타민이 지난달까지 전년동기보다 23.5% 증가한 1150억원의 처방액을 올리며 전체 3위에 이름을 올렸다. 글리아타민은 효능 논란에 이은 급여축소, 환수협상 명령 등 고비를 겪고 있는데도 처방 시장에서는 오히려 영향력을 확대했다. 콜린알포세레이트 성분의 종근당글리아틴도 3월 누계 처방액이 전년보다 12.2% 증가한 827원으로 고공행진을 이어갔다.한국오가논의 고지혈증복합제 아토젯은 3분기 누계 처방액이 749억원으로 11.9% 증가하며 상위권에 포진했다. 아토젯은 아토르바스타틴과 에제티미브를 결합한 복합제다. 2021년부터 국내기업 100여곳이 아토르바스타틴·에제티미브 시장에 동시다발로 진입했지만 아토젯 시장은 더욱 견고한 상승세를 나타냈다. 아토젯은 종근당이 판매하고 있다.
