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- 2025-12-27 15:35:01
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- Kisqali joins reimbursement race as Faslodex combination
- by Eo, Yun-Ho Nov 13, 2019 01:11am
- A third CDK4/6 inhibitor in the Korean market, Kisqali now stands next to the first two drugs, Ibrance and Verzenio, as it applies for National Health Insurance (NHI) reimbursement listing. Novartis Korea recently submitted a reimbursement listing application of Kisqali (ribociclib) after its approval by Ministry of Food and Drug Safety (MFDS) on last Oct. 30. Accordingly, Ibrance and Verzenio are to face another competitor, while they are already fighting over insurance benefit under an indication as a combination therapy with Faslodex (fulvestrant),. Currently both Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC), after Health Insurance Review and Assessment Service’ (HIRA) Severe and Cancer Disease Deliberation Committee has passed them as a combination therapy with Faslodex. And now with Kisqali joining the race, the three pharmaceutical companies are to compete intensely against each other for the first-in class indication as ‘second-line combination therapy with Faslodex’. All three of them are in the same class of cyclin-dependent kinase (CDK) 4 and 6. But reportedly, their reimbursement listing applications vary in strategy. In November 2017, Ibrance has already been listed as a first-line therapy in combination with Letrozole via refund type risk sharing agreement (RSA). And now it is in process of expanding the 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. However, a follow-on drug is not yet eligible for RSA. And because its indication as a combination therapy with faslodex targets wider range of patients with prior experience of treatment regardless of menopause, the drug maker Lilly is highly likely to apply as a second-line treatment before any other product applies for it. But, Kisqali is also likely to apply for the second-line treatment indication as well. Kisqali was approved by the regulator based on a meaningful improvement of prolonging progression free survival (PFS) demonstrated in 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 of significantly extending patient’s overall survival (OS). Compared to the existing endocrine-based single therapy, Kisqali’s result in the Phase 3 MONALEESA-3 extended OS longer and improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with locally advanced or metastatic breast cancer.
- Company
- Takeda provides free supply of MM treatment Ninlaro
- by Eo, Yun-Ho Nov 13, 2019 01:09am
- Takeda Pharmaceutical started providing free supply of oral multiple myeloma treatment, Ninlaro. According to industry insider, Takeda Pharmaceutical has decided to provide free supply the only oral option for multiple myeloma treatment, Ninlaro (ixazomib), last month and recently entered general hospital’s list of drug codes. Currently, the Big Five general hospitals including, Seoul National University Hospital, Severance Hospital, and Samsung Seoul Medical Center, have coded in the treatment for prescription. The decision was made as a temporary arrangement due to the delayed insurance reimbursement listing procedure. The treatment was designated as an orphan drug in May of 2017, and was approved in July same year. But its reimbursement application is pending in the hands of Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) to this date. Ninlaro also expanded its indication as a combination therapy with lenalidomide and dexamethasone for multiple myeloma patients who have not responded to at least one standard therapy. The proteasome inhibitor drug demonstrated its efficacy and safety from Phase III TOURMALINE-MM1 clinical trial in patients with relapsed or refractory multiple myeloma. The study found triplet regimen of ixazomib, lenalidomide, and dexamethasone had significantly improved the length of progression free survival (PFS) to average 20.6 months, longer than 14.7 months of PFS recorded by a combination of placebo, lenalidomide and dexamethasone. Meanwhile, a triple combination therapy with Revlimid is the most recommended multiple myeloma treatment option according to the U.S. National Comprehensive Cancer Network (NCC) guideline and the European Society for Medical Oncology (ESMO). And Revlimid (lenalidomide) is the backbone for all triple combination therapies. Following are some of major triple combination therapy options for second line and later treatments; Amgen’s Kyprolis (carfilzomib) KRd combination (Kyprolis, Revlimid, dexamethasone); BMS’ Empliciti (elotuzumab) ERd combination (Empliciti, Revlimid, dexamethasone); Takeda’s Ninlaro (ixazomib) IRd combination (ixazomib, Revlimid, dexamethasone); and Janssen’s Darzalex (daratumumab) DRd combination (Darzalex, Revlimid, dexamethasone).
- Company
- Doctors choose PPI to replace ranitidine alternative
- by Nho, Byung Chul Nov 12, 2019 06:26am
- Apparently, healthcare providers are in favor of proton pump inhibitor (PPI), as an alternative to ranitidine after confirmed contamination of carcinogen N-nitrosodimenthylamine (NDMA) in some of ranitidine products. Doctor Ville, an online community exclusive to healthcare providers, recently conducted a survey on 1,664 doctors about alternatives to ranitidine. The survey studied which medicine would healthcare providers prescribe in place of ranitidine, due to the sales suspension on ranitidine products. 1,664 doctor members of the online community, who prescribes ranitidine, participated in the latest survey. 33.4 percent, 20.7 percent, 4.4 percent, 3.6 percent, and 3.6 percent of survey participants were from internal medicine, family medicine, neurology, surgical, and dermatology departments, respectively. Apparently, the overall 796 doctors are prescribing ranitidine for about ten patients a day. The study found the most number of doctors (48.7 percent) are considering on prescribing PPI instead of ranitidine, and other options like H2RA (35 percent) and mucosal protective agent (15.1 percent) followed. On a questionnaire confirming doctor’s preference order of single agent treatment alternative to ranitidine, 82.9 percent of survey participants ‘agreed’ with the order of ‘PPI, H2RA and mucosal protective agent’ as preferred options in the order. Among the group of doctors who chose PPI for an alternative option, 70.6 percent of them particularly picked esomeprazole as their primary option in mind. Lansoprazole (11.6 percent), rabeprazole (9.8 percent) and pantoprazole (8 percent) followed the list of preferred options of PPI. 43.2 percent of the group of doctors who chose H2RA answered they are contemplating on famotidine, and others chose lafutidine (29 percent), cimetidine (14.9 percent) and nizatidine (12.9 percent), in the order of preference. The survey also reported doctors’ preference order of mucosal protective drug was rebamipide (64.5 percent), artemisia asiatica medicine (27.1 percent), sucralfate (4.4 percent) and bismuth (4.0 percent). As for ranitidine combination therapy, 40.6 percent of doctors answered ‘combination of esomeprazole and Mosapride’, and other combinations of ‘esoeprazole and rebamipide (27.2 percent)’, ‘famotidine and rebamipide (18.5 percent)’ and ‘famotidine and Mosapride (13.6 percent)’ followed the list. 86.4 percent of the survey participants said they ‘agree’ on top three preferred prescription option of alternative ranitidine combination therapy to be ‘PPI and mucosal protective agent,’ ‘PPI and PKT’ and ‘H2RA and mucosal protective agent’, in the respective order. On the other hand, 58.2 percent of doctors said the most crucial factors affecting ranitidine-alternative option are ‘acid blocking and mucosal protective effects,’ and other 18.2 percent of doctors said ‘safety’.
- Company
- Mavyret’s 8-week indication approved in Korea
- by Eo, Yun-Ho Nov 11, 2019 10:40pm
- A hepatitis C treatment Mavyret is to soon be available as an eight-week treatment in Korea, after its approval in the U.S. After receiving an approval from the U.S. Food and Drug Administration (FDA) first, AbbVie received an approval from Korean Ministry of Food and Drug Safety (MFDS) last month for another indication as an eight-week once-daily treatment for chronic hepatitis C virus (HCV) patients across all genotypes (GT 1 to 6) with compensated cirrhotic, who has never been treated before. However, the drug is planning to follow a separate approval procedure for genotype 3 HCV. Moreover, Mavyret now can be prescribed to treat pediatric patients over age of 12 with HCV. The drug has been approved in the U.S. as an eight-week pan-genotypic treatment for treatment-naïve patients without cirrhosis in August, 2017. The indication expansion got a nod from the regulators based on evidence resulted in the Phase 3b EXPEDITION-8 study, a single-arm, open-label clinical trial evaluating the safety and efficacy of Mavyret in treatment-naïve adult patients with all six genotypes of chronic HCV and compensated cirrhosis. In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatments (SVR12). The EXPEDITION-8 study had one reported case, out of 336 patients treated, for relapse, and found none of them discontinued treatment due to adverse reaction. The indication expansion on adolescent patient from age 12 to 18 was based on results from Part 1 of DORA study, a single-arm, open-label clinical trial assessing the safety and efficacy of Mavyret in pediatric patients treated for eight or 16 weeks. The study demonstrated 100 percent SVR12 in the adolescent patient group, proving the efficacy of the treatment successfully. Professor Kim Ji Hoon of Korea University Guro Hospital stated, “With the launch of Mavyret last year, eight-week treatment for HCV of all genotypes is now a prevalent option for the disease. But now with the new approval shortening the treatment duration from 12 weeks to eight weeks, patients with all genotypes of HCV, except for genotype 3, who has no experience of treatment can have a shorter treatment of eight weeks, regardless of cirrhosis.” Meanwhile, drug committees of all five major general hospitals in Korea, including Seoul National University Hospital, Severance Hospital, Samsung Seoul Hospital, Asan Seoul Medical Center and Seoul St. Mary’s Hospital, passed Mavyret for prescription. Similar to hepatitis B and alcohol, hepatitis C virus is a main cause of liver cancer. About 70 to 80 percent of HCV cases progress to chronic hepatitis, and 30 to 40 percent of such case get worsen to cirrhosis and liver cancer. Up to three or four years ago, only option for HCV treatment was combination therapy of injection and oral antiviral. For the long treatment duration of six to 12 months, patients had to endure many adverse events, and even so, the treatment success rate was just around 50 percent. The treatment success rate reached 90 percent and treatment duration was shortened to 12-to-24 weeks after orally taken direct-acting antiviral (DAA) was launched in the market.
- Company
- Generic to pay for original’s lowered pricing loss?
- by Kim, Jin-Gu Nov 08, 2019 08:55am
- To this date, a boundary of patent infringement damage against generic was up to ‘sales profit of generic’. But now a lawsuit claims the damages should include ‘loss made from original’s price reduction’ due to generics’ launch. Related court case is currently waiting for the Supreme Court’s final decision. Lilly Korea and two Korean companies, Hanmi Pharmaceutical (“Hanmi”) and Myung In Pharm (“Myung In”), are tangled in a decade-long fierce dispute over patent covering Xyprexa (olazapine). Initially, Xyprexa’s patent was supposed to expire on Apr. 24 of 2011, but Hanmi and Myung In challenged the patent. Both ‘Intellectual Property Trial and Appeal Board’ and Patent Court ruled in favor of the Korean companies stating that the original’s patented invention lacks creativity. Based on the ruling, Hanmi and Myung In launched their generics in early 2011, a few months earlier than the challenged patent’s expiration date. At the same time, Xyprexa’s price was lowered by the government. Patent case gets a twist, litigation for damages immediately followed But, things got complicated as the Supreme Court overruled the previous decision stating the patent is still valid. The patentee, Eli Lilly, filed litigation for damages against the two Korean companies’ patent infringement. As a result, Hanmi and Myung In paid Lilly all sales profit made from the generic as damages. Typically, a patent infringement case concludes there. But Lilly did not stop and filed another case claiming the two companies should also pay for Lilly’s loss caused by the original’s price reduction. Lilly insisted Hanmi and Myung In’s early generic release had the original’s price to drop and hence, the loss from the price reduction should be compensated. Contrasting second trial, Supreme Court to make final decision in December at earliest The court gave a nod to some of Lilly’s claim at the first trial against each of the two Korean companies. But the second trial was ruled quite the opposite. The Seoul High Court dismissed Lilly’s claim on the case against Hanmi. Infringement of patent was recognized, but the court rejected damage claim on loss by drug price reduction. On the other hand, the Patent Court agreed with Lilly’s case against Myung In. The decision ordered Myung In to pay damages even for Lilly Korea’s loss generated by the original’s price drop. The court stated “The generic’s drug price listing application has directly affected government’s decision. And it brought Xyprexa’s price down to 80% of the original price”. The two contrasting decisions have been sent to the Supreme Court. Experts predict the court would make a decision by the end of the year. “The Supreme Court is reviewing legal principle and the issue comprehensively. The court decision would be out before next year,” a legal expert commented. More burden on early generic release if Lilly wins Actually, the damage amount alone for the two Korean companies was not that much. For instance, Myung In was ordered to pay damage of KRW 98.07 million from the first and second trials. The total sales were low to begin with, as the launch was only a few months ahead of the patent expiration. However, pharmaceutical industry’s patent experts view the decision on the litigation would significantly affect the industry. The court ruling in favor of Lilly would heavily influence early release of generics in the future. If patent infringement damages are to consist of generic sales profit and loss by the original’s price reduction, the damage amount could sum up astronomically and detrimentally depending on the generics’ release date. The Supreme Court’s final decision is soon to be made. As a matter of fact, Korean judiciary has never made a precedent ordering a generic manufacturer to pay for the original’s loss by price reduction. Now the public waits to see whether or not an exceptional decision would be made.
- Company
- Carcinogen impact halves Zantac global sales
- by An, Kyung-Jin Nov 07, 2019 08:55am
- Suspected sales damage due to impurity found ranitidine came true for global pharmaceutical company Sanofi-Aventis’ Zantac. On Oct. 31, Sanofi reported global net sales of the company’s third-quarter 2019 rose by 1.1 percent over a year to EUR 9.5 billion (about 12.4 trillion won). Mainly driven by new atopic dermatitis treatment Dupixent, Sanofy Genzyme’s sales were up by 19.5 percent than last year same quarter, but Consumer Healthcare (CHC) sales contrasted drastically as it only grew about 0.4 percent. The company reported CHC global sales in the third quarter marked 1,136 million euro (about 147 billion won). Zantac is an original ranitidine medicine developed by GSK and is sold by Sanofi in the U.S. Canada and some other countries. Sanofi used to make Zantac sales of about 130 million euro sales annually. In each quarter the OTC drug used to make over 30 million euro, but this third quarter it only made about 14 million euro (about 18.1 billion won) with 58 percent drop from a year ago. The figure reflects Sanofi’s decision to voluntarily recall the products in the U.S. and Canada from last month. Sanofi Consumer Healthcare and Zantac’s global sales trend (Unit: € 1 million) Source: Sanofi On October 18, Sanofi officially made a statement about voluntary recall on Zantac OTC in the U.S. and Canada. The decision was made 37 days after the U.S. Food and Drug Administration (FDA) disclosed possibility of ranitidine medicine contaminated with N-nitrosodimethylamine (NDMA) carcinogen. Reportedly, Sanofi’s decision was mainly affected by ‘inconsistencies’ in preliminary test results of the API used in the U.S. and Canada products. However, the recall is limited to the two countries only as the API supplier varies in different regions. At the moment, recall on ranitidine medicine prescribed to Zollinger-Ellison syndrome patients in Columbia, Honduras, Guatemala, Ecuador and other Latin American countries is ongoing. Sanofi Chief Executive Officer, Paul Hudson, joining the conference call commented “As FDA raised concern over the safety of ranitidine medicine, Sanofi has decided to conduct precautionary voluntary recall on Zantac in the U.S. and Canada. Despite the negative issue in last quarter, CHC has maintained relatively stable sales”.
- Company
- Scouting fresh face for CEO at merged BMS and Celgene
- by Eo, Yun-Ho Nov 07, 2019 08:54am
- Merged Korean branch of Korea Bristol-Myers Squibb (BMS) and Celgene has now high probability of bringing in a new chief executive officer from outside of the company. According to pharmaceutical industry, BMS and Celgene headquarters have agreed on scouting a CEO openly for the merged Korean office scheduled to open before next year. Reportedly, many of current and former pharmaceutical company CEOs in Korea have applied for the job, including the current 47-year-old Celgene Korea CEO Ham Taejin. The company associates views that the headquarters’ decision to make it a public recruitment could mean they are contemplating on hiring personnel currently unassociated with the company. Including the headquarter office, BMS and Celgene are in process of appointing CEOs for major regional offshoots. And merged regional corporations with new CEO are undergoing overall reorganizations. The Korean branch has appointed a new head for Regulatory Affair department, and other departments including Market Access, Government Affair and Public Relation are also expect some changes. More than anything, the company insiders confirmed the two companies have reached a fair agreement to reorganize the corporation regardless of who is acquiring whom. In last January, BMS announced acquisition of Celgene with a value of about USD 74 billion (about 86.4 trillion won). BMS was said to acquire Celgene in cash and stock equity, and pending merger is still ongoing after closing the agreement. Sources confirm, BMS and Celgene have mutually agreed to hire a new CEO for the merged corporation. Besides the CEO scouting, the two companies are working on reorganization of the merged company.
- Company
- 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” .
