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- 2026-03-16 17:49:26
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- Tecentriq approved as adjuvant treatment for NSCLC
- by Nov 15, 2022 05:38am
- On the 14th, Roche Korea announced that its anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) was approved as adjuvant therapy following resection in patients with early-stage non-small-cell-lung cancer, and became the first immunotherapy to receive approval for the indication. Tecentriq may now be used as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher on tumor cells (TC). With this approval, Tecentriq became the first cancer immunotherapy to be approved as adjuvant therapy in early-stage NSCLC in Korea. The indication extension was approved based on findings from an interim analysis of Phase 3 IMpower010 trial. Tecentriq was found to result in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher Also, the disease-free survival (DFS) benefit derived with adjuvant Tecentriq over BSC was consistently observed across most of the subgroups analyzed on the trial, including histology and disease stage. The overall survival (OS) data remain immature for this population, but a trend toward improved survival with atezolizumab over BSC was observed with a stratified HR of 0.43. The median OS and subgroup analysis results at 46 months showed that Tecentriq reduced the risk of disease recurrence or death 57% compared with best supportive care (BSC) in subject patients. The safety profile of Tecentriq was consistent with what has previously been observed with the Tecentriq monotherapy, and no new safety signals were observed. Grade 3-4 adverse effects (AEs) that were most frequently reported in the Tecentriq arm were increased ALT (2%), pneumonia (1%), and increased AST. Based on the data, the U.S. National Comprehensive Cancer Network (NCCN) guideline recommends Tecentriq as adjuvant therapy (Category 2), and the American Society of Clinical Oncology (ASCO) also recommends Tecentriq as adjuvant therapy in its guideline for adjuvant therapy in early-stage lung cancer patients. Sang-We Kim, Professor of Oncology at Asan Medical Center, said, “Around half of NSCLC patients experience recurrence after surgery, some of which at an untreatable state. With immuno-oncology drugs that had been mainly prescribed in metastatic NSCLC now available for use in the early stages of the disease, NSCLC patients in Korea that have a high rate of PD-L1 expression can have the opportunity to reduce their chance of recurrence after surgery and chemotherapy.”
- Company
- CR of AML new drug candidates is identified in Phase 1/2
- by Kim, Jin-Gu Nov 15, 2022 05:38am
- Hanmi Pharmaceutical announced on the 14th that it has confirmed cases of complete response (CR) in various dose groups as a result of phase 1/2 clinical trials of Tuspetinib (HM43239), which is being developed as an AML treatment. Aptose was recently introduced at the KOL webinar, "As a result of the global phase 1/2 for patients with recurrent or refractory acute myeloid leukemia, we confirmed CR cases in all of the various doses (80 mg, 120 mg, 160 mg) of HM43239." Aptose will present details of the study at the 64th ASH in New Orleans, the U.S., from the 10th to the 13th of next month. HM43239 is an oral MKI administered once a day that targets major kinases acting in myelogenous malignant tumors. It was designated as a fast-track development drug by the FDA in May. In 2018, it was also designated as a rare drug. According to the successful results of this clinical trial, Aptose plans to expand clinical trials with single-administration therapy and combination-administration therapy in the future. In the extended clinical trial of single administration therapy, the efficacy of HM43239 120mg will be confirmed in the AML patient group, including patients with FLT3 mutations who do not respond to existing FLT3 inhibitors. In addition, it plans to conduct a combined clinical trial with HM4323980mg and Venetoclax, an existing AML treatment.
- Company
- Merck KGaA has appointed Christoph Hamann
- by Nov 15, 2022 05:38am
- Christoph Hamann, General ManagerMerck Biopharma Korea announced on the 10th that it has appointed Christoph Hamann as the new general representative of its business unit. Harman served as general manager of Merck Biopharma in Malaysia, Singapore, and Brunei, and as Managing Director in Malaysia. Since joining Merck in 2009, he has built various careers through strategic and commercial work in major markets such as Germany, Switzerland, and the United States. In particular, he showed excellent performance as an infertile franchise leader in Europe and vice president of global business development, playing an important role in business development and management at the global and national levels. Including this inauguration in Korea, it will have business experience in a total of seven countries. General Manager Harman majored in economics at the University of Virginia in the United States, and before joining Merck, he spent nine years in investment banking and consulting. "We expect that Korea Merck Biopharma's leadership in the special care sector will be further strengthened by Christian Hamann, a general manager with about 22 years of experience and expertise in various industries, including pharmaceuticals," said the Merck Biopharma division said.
- Company
- Adding AUS as a drug price reference country raise concerns
- by Nho, Byung Chul Nov 14, 2022 06:07am
- The health authorities are known to be considering including Canada and Australia as reference countries for drug pricing reevaluations. Currently, the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service refer to drug prices of G7 countries - US, UK, Germany, Switzerland, Italy, France, and Japan – for evaluations and assessments. Adding the two countries, which are considered to be those with the lowest drug price, is expected to raise some issues. From what has been known so far, the government is planning to include Canada and Australia as reference countries and use the drug prices of the counties as standard, but if their use extends to the pricing of new drugs introduced from abroad and new drugs developed in Korea, this may deprive patients of their right to treatment and drive local pharmaceutical companies into a crisis. In Korea, the price of generic drugs is set at 53.55% of the original version. This is slightly higher than that in other countries, ranking 4th among OECD member countries. However, this relatively higher price is only applied to some original and generic drugs and is interpreted to be a strange phenomenon arising from Korea’s odd brand name-based prescription structure rather than ingredient name. According to a booklet issued by Canada’s new drug pricing review committee that was disclosed at the recent NA Audit, the reimbursement listed price of drugs such as Plavitor, Viread, and Simvastatin is 3 to 14 times higher in Korea compared to those in the US. However, rashly concluding that the generic drug price in Korea is higher than those of reference countries without considering how the higher insurance price set for new drugs from multinational pharmaceutical companies during initial listing affected the generic price, may likely cause distortion of the drug price system. As such, applying such an invasive drug price reduction policy of adding Canada and Australia as reference countries following the unilateral drug price reduction that was applied in 2012 and the satisfaction of ‘self-bioequivalence and DMF registration’ requirement, may severely harm and distort the development of the pharmaceutical and bio industry that is regarded as the new growth engine of the future. According to one research institute, some of the generics sold in Australia are sold at a price 1/5th of that in Korea, therefore, the possibility that adding Australia as a reference country may cause a collapse in Korea’s drug pricing system cannot be ruled out. More importantly, Canada and Australia, the countries that the health authorities are considering adding as drug price reference countries are not even new drug developers. Based on US FDA data, 66 new drugs were developed in the US, 25 in Europe, 6 in Japan, and 2 in China over the past 5 years. Just like Korea, Canada and Australia have been unable to overcome the FDA’s high barrier and receive new drug approvals in the US. An industry official emphasized, “As we have learned overcoming the swine flu and COVID-19, establishing and fostering pharmaceutical and bio sovereignty is essential and must be pursued in the long-term. Therefore, applying the short-sighted measure of reducing generic drug price just to save KRW 1.5 trillion in the short term is not the answer.” Currently, the external size of Korea’s pharmaceutical and bio industry is about KRW 27 trillion, and the proportion of original and generic drugs is about 6:4. However, in the case of original prescription drugs, it is not an exaggeration to say that multinational pharmaceutical companies dominate the market as it accounts for over 90% of the original drugs marketed in Korea. Another industry official said, “With the absence of a preferential pricing policy for domestic new drugs, cutting generic drug prices can only be interpreted as a short-sighted policy on the government's part that will only hand over Korea’s pharmaceutical and bio sovereignty to foreign companies." Meanwhile, health authorities and the pharmaceutical industry have not reached a conclusion and is still discussing adding Canada and Australia to the reference countries, but have made a consensus in calculating the average monthly exchange rate using the average exchange rate of 1 to 36 month prior to the pricing negotiations.
- Company
- Heart failure drug Entresto makes KRW 10 bil in Q3
- by Kim, Jin-Gu Nov 14, 2022 06:07am
- Pic of Entresto Novartis’ chronic heart failure treatment ‘Entresto’ is growing rapidly. Its quarterly sales first exceeded KRW 10 billion in 5 years since its release in Q3 this year. The analysis is that its rapid growth was due to its de facto domination of the market. However, with the nearing entry of ▲SGLT-2 class diabetes treatments, ▲new chronic heart failure treatments, ▲Entresto generics, various prospects are being raised on whether Entresto will be able to maintain its growth rate. ◆Quarterly prescriptions of Entresto exceed KRW 10 billion…2.6 time growth in 3 years According to the market research institution UBIST on the 12th, Entresto’s Q3 prescriptions amounted to KRW 10.5 billion. This is a 21% increase from KRW 8.6 billion in Q3 last year and a 2.6-time increase from the same period 3 years ago in Q3 2019. Entresto is a drug used to reduce the risk of death and hospitalization in patients with left ventricular (LV) dysfunction. As a combination of neprilysin inhibitor sacubitril and an angiotensin receptor blocker (ARB) valsartan, it has a double mechanism of action. where sacubitril works on the neurohormonal system and reinforces the heart protection effect and valsartan blocks the angiotensin II receptor. Novartis received approval for the drug in Q2 2016 and released the drug with reimbursement in Q4 2017. Until now, no suitable treatment existed for chronic heart failure before Entresto. ACE or ARB inhibitors were mainly prescribed with not much effect. Quarterly prescriptions of Entresto (Unit: KRW 100 million, Data: UBIST) Entresto’s sales rose rapidly based on its sole lead in the field of chronic heart failure. After recording KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then to KRW 32.3 billion in 2021. Its cumulative sales recorded KRW 29.2 billion in Q3 this year. At this pace, its sales are expected to reach nearly KRW 40 billion by the end of the year. ◆SGLT-2 inhibitors, new treatments, and generics knock to enter the heart failure treatment market However, varying prospects are being made on how long this growth will last. The biggest variable is that the SGLT-2 class antidiabetics were approved for the heart failure indication. The Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of chronic heart failure. The SGLT-2 inhibitors specified in the guidelines are limited to 'Jardiance (empagliflozin)' and ‘Forxiga (dapagliflozin).’ If reimbursement is also extended to chronic heart failure after the amendment of the guidelines, the market is expected to grow further. Pic of Forxiga(left), Jardiance (right) SGLT-2 inhibitors have a larger scope of indication than Entresto. Entresto can be used in patients with heart failure with reduced ejection fraction, heart failure with mildly reduced EF, and heart failure with preserved ejection fraction. On the other hand, Entresto cannot be used for HFpEF. Therefore, if Jardiance and Forxiga are reimbursed, they will compete with Entresto in the heart failure market. On the other hand, there is also a prospect on the possibility of combined prescription using SGLT-2 inhibitors and Enhertu based on study results that showed improved prognosis with combined use. In that case, sales of Entresto and Jardiance/Forxiga will all rise in synergy. Pic of VerquvoAnother variable is the introduction of new chronic heart failure treatments with a new mechanism of action. Currently, Bayer has announced the release of ‘Verquvo (vericiguat).’ Bayer received approval for Verquvo in Korea in December last year and submitted an application for reimbursement in August this year. Verquvo is a drug with a new mechanism of action. Entresto blocks the harmful effects from the natural neurohormonal system activated by myocardial and vascular dysfunction. Verquvo improves myocardial and vascular function by stimulating the synthesis of intracellular cyclic guanosine monophosphate (cGMP) that regulates vascular tone, cardiac contractility, and cardiac remodeling. Also, the possible entry of Entresto’s generics can also act as a big variable in Entresto’s sales growth. 13 Korean pharmaceutical companies have won the first trial against Novartis on Entresto’s patent and were qualified to release Entresto generics. If the companies succeed in releasing Entresto generics, their price will automatically be discounted by 30%. One year after its release, the price will be further reduced to 53.55% from the existing price.
- Company
- The market is recovering for the first time in two years
- by Kim, Jin-Gu Nov 14, 2022 06:07am
- The size of outpatient prescriptions of Montelukast for asthma and allergic rhinitis has increased by 21% in a year. The market, which had been stagnant for the past two years due to the COVID-19 incident and side effect issues, seems to be recovering from its previous year's prescription performance this year. It was found that the impurity negative factor that occurred at the beginning of the year also did not have a significant impact on the market recovery. According to UBIST, a pharmaceutical market research institute on the 9th, the outpatient RX in the Montelukast asthma treatment market in the third quarter of this year was 80.5 billion won. It increased by 18% compared to 68 billion won in the same period last year. Compared to the cumulative prescription amount (75.3 billion won) in the third quarter of 2020, two years ago, it increased by 7%. Montelukast is a common drug for allergic rhinitis and asthma. The original is Singulair by Oganon, Korea. MSD Korea received domestic approval in 2000. More than 100 domestic pharmaceutical companies are selling generics with the same ingredients. The market for this ingredient treatment has grown steadily until 2019. However, due to the COVID-19 crisis in 2020, visits to hospitals for children and adolescents who are mainly prescribed this drug have decreased significantly. At the same time, the U.S. Food and Drug Administration (FDA) attached a black box warning, adding to the issue of side effects. The market suffered a slump for more than two years until the end of last year. The market size, which expanded to 123.9 billion won in 2019, shrunk to 101.8 billion won in 2020 and 96.3 billion won in 2021. It seems to be rebounding this year. It recovered to 92% of the cumulative prescription amount (88 billion won) in the third quarter of 2019 before the COVID-19 incident and side effect issues occurred. If the current trend continues, it is expected to expand to more than 110 billion won by the end of the year. ◆ Most of the major products have increased prescription amount Analysts say that the risk of impurities that occurred earlier this year did not lead to a decrease in prescription performance. In January of this year, the Ministry of Food and Drug Safety decided to introduce pharmaceutical companies Impurities tests have been ordered for montelukast ingredients and finished drugs. It was a precautionary measure according to safety information that NDPA was detected in Montelukast-based raw material drugs. Pharmaceutical companies submitted the results of the impurity test to the Ministry of Food and Drug Safety in April. However, it is reported that NDPA impurities were not detected in domestic products, including the original Singulair. In the case of Montelukas preparation, unlike Valsartan and Ranitidine, large-scale sales prohibition or recovery did not proceed. In fact, most of the major products' prescription performance increased compared to the same period last year-on-year. Hanmi Pharmaceutical's Monterizine recorded a cumulative prescription performance of 8.3 billion won in the third quarter of this year. It increased by 25% compared to 6.7 billion won in the same period last year. Compared to the cumulative 5.7 billion won in the third quarter of 2019, before the outbreak of COVID-19, it increased by 1.5 times. This year, for the first time, the annual prescription amount is expected to surpass 10 billion won. Montezal, another montelukas formulation of Hanmi Pharmaceutical, also saw its cumulative prescription increase by 20% from 3.3 billion won to 3.9 billion won in the third quarter. Monterizine is a combination that combines Montelukas with Levocetirizine, a third-generation antihistamine. During the same period, HK inno. N Lukio increased by 5% from 6.4 billion won to 6.7 billion won. Boryung Asluka rose 199% from 1.3 billion won to 4 billion won, Hutex Pharmaceutical's Singuldown rose 15% from 2.7 billion won to 3.2 billion won, Singulmon rose 7% from 2.6 billion won to 2.8 billion won, and Daewoong Bio's Dawoong Montelukast rose 85% from 1 billion won to 1.9 billion won. The original product, Singulair, saw its cumulative prescription amount fall 4% from 24.5 billion won last year to 23.4 billion won this year. Singulair is being sold by Oganon Korea. Oganon Korea was spun off from MSD Korea early last year. During the spin-off process, Singulair's copyright was transferred to Organon Korea.
- Company
- The popular Daewoong's Nabota
- by Nov 14, 2022 06:06am
- EvolusDaewoong Pharmaceutical's botulinum toxin drug Nabota exceeded $100 million in cumulative sales in North America this year. This is an increase of 61% compared to the previous year. According to the earnings report of Daewoong Pharmaceutical partner Evolus on the 9th (local time), Jeuveau, which is sold by the company, recorded cumulative sales of $13.6 million (14.3 billion won) in the third quarter of this year, up 61.1% from a year earlier. Jeuveau is the North American product name of Nabota, a botulinum toxin formulation exported by Daewoong Pharmaceutical. Sales in the third quarter were $33.21 million (45.6 billion won), the lowest this year, but increased by 24.5% compared to the same period last year. Evolus is a global copyright partner of Nabota developed by Daewoong Pharmaceutical. Since the approval of the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. Early last year, the ITC dispute with Allergan and Medytox was terminated to resolve the negative factors. Nabota has recorded more than $30 million in sales for the fourth consecutive quarter as active marketing for Nabota and demand that had slowed down due to COVID-19 have increased. In the second quarter of last year, it broke its biggest quarterly sales of $37.16 million (51 billion won). Evolus predicted that growth momentum will continue in the fourth quarter with the recently launched large-scale campaign "Switch Your Tox." The campaign added 650 new customer accounts in the third quarter, securing more than 8,800 customers so far. The rate of reordering remains above 70%. The number of consumers who wrote the Evolus Reward loyalty program reached nearly 450,000. "The large-scale campaign has kept demand for Nabota strong," said David Moatazedi, CEO of Evolus. "Evolus will be able to reach the top of this year's revenue guidance range of 143 million to 150 million dollars, which is about 50% annual growth." This is about three times the expected growth rate of the toxin market, he said. Evolus also started selling Nabota in the UK in October. Nabota, which was officially released under the name Nuceiva, delivered its first order last month. Evolus will also launch Nabota in other countries in Europe next year.
- Company
- Daewoong obtained an item license for Fexuclu
- by Nov 11, 2022 05:52am
- FexuclueDaewoong Pharmaceutical announced on the 10th that Fexuclu, a new drug for gastroesophageal reflux disease, obtained an item license from the Philippines FDA on the 3rd. The approval was made about eight months after submitting an application for item permission (NDA) at the end of February. It takes about three years to obtain an item license in the Philippines, and Daewoong Pharmaceutical explained that it has greatly shortened the period based on its know-how. Daewoong Pharmaceutical will invite KOLs, including the chairman of the Philippine Gastroenterological Society, to hold a Fexuclu symposium on the 24th and share directions and opinions on entering the Philippine market. Starting from the Philippines, the company will accelerate its overseas expansion of Fexuclu. It plans to submit NDA to 10 countries around the world by the end of this year. So far, a total of eight countries have applied for item permits, including the Philippines, Brazil, Indonesia, Thailand, Mexico, Chile, Ecuador, and Peru. Fexuclu is a new drug for gastroesophageal reflux disease in the P-CAB series officially launched in Korea by Daewoong in July. By improving the shortcomings of existing PPI preparations, it is characterized by fast and stable suppression of gastric acid secretion by combining with a proton pump without the need for activation by gastric acid. There are a total of two indications of Fexuclu: ▲ treatment of erosive gastroesophageal reflux disease (40 mg) ▲ improvement of gastric mucosal lesions of acute gastritis, and chronic gastritis (10 mg). In particular, Fexuclu is the only P-CAB drug in Korea for gastritis indication, and the 2022 European Gastroenterology Association recently published the results of Fexuclu's gastritis adaptation study. Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "It is very encouraging that Fexuclu received approval for the first time overseas by drastically shortening the license period in the Philippines, one of Daewoong Pharmaceutical's branch offices, and this is a proven case of Daewoong Pharmaceutical's global business capabilities."
- Company
- SK Biopharm’s Q3 sales rise 270% with rise in Xcopri sales
- by Nov 11, 2022 05:51am
- SK Biopharmaceutical’s sales rose greatly in Q3 with the rising sales of its new anti-epileptic drug ‘Xcopri (cenobamate)’ in the US. On the 10th, SK Biopharmaceutical announced sales of KRW 88.8 billion in Q3 this year, a 270.9% on-year increase. The company also reported an operating loss of KRW 9.2 billion in the same period. Almost half of its sales were driven by Xcopri. Xcopri generated sales of KRW 47.4 billion in the US in Q3 this year. This is over a twofold increase on-year from the KRW 19.9 billion it had generated in Q3 last year. Xcopri’s sales have been driving the performance of the company after getting on track this year. After recording KRW 10 billion in sales in Q1 2021, Xcopri’s sales exceeded KRW 20 billion by Q4 last year. Only a half year later, its sales exceeded KRW 40 billion. Xcopri’s cumulative sales this year reached KRW 119.4 billion. Xcopri’s amount of prescriptions in the US has also been rising continuously. Its prescriptions in Q3 this year rose 12% compared to those in Q2. Xcopri’s monthly prescriptions exceeded 15,000 in August. The company explained that this is a 1.8-time increase compared to the average prescription amount of its competitors at 29 months. SK Biopharmaceutical attributed the rise in US sales to the active online and digital marketing it had relayed in the US. To strengthen its sales capabilities for Xcopri in the US, the company carried out active marketing activities to HCPs and patients. Also, in line with the improvement seen in the face-to-face sales environment, the company reorganized its US local sales and marketing organization and maximized sales efficiency. The company’s analysis is that the activities led to the improvement of relevant indicators, including the total number of calls, rate of face-to-face sales activities, new prescription amount, etc. The company also actively embraced the use of social media and delivered various experiences of patients using Xcopri on the company’s official YouTube channel and sent Direct Messages to patients and their caregivers. Also, the company reserved a large booth at the American Epilepsy Society Annual Meeting that will be held in Q4 to further raise Xcopri’s brand awareness. The company plans to attend various academic conferences and focus on promoting and marketing its drug to epilepsy specialists. Also, a TV commercial for epilepsy patients is planned for the next year. SK Biopharmaceuticals predicted that this year's global sales of Xcopri will exceed its target of KRW 185 billion, with the product’s accelerated entry into new markets in Europe and Latin America. Xcopriis scheduled to be released in Finland, Switzerland, Spain, and France through its European partner Angelini Pharma within the year. The company’s operating loss was reduced by KRW 40.7 billion on-year to record KRW 9.2 billion. However, the cumulative operating loss amounted to KRW 86.5 billion due to its investments in clinical trials for follow-up drugs and promotional activity in the US in the first half of the year.
- Company
- Impinzi's indication is expected to be approved in Korea
- by Eo, Yun-Ho Nov 10, 2022 05:46am
- Impinzi is also expected to have options for treating immuno-cancer drugs in the area of biliary tract cancer. According to related industries, the Ministry of Food and Drug Safety is reviewing the expansion of biliary tract cancer indications of Imfinzi, an immuno-cancer drug before PD-L1 inhibition mechanism. Permission is possible as early as this year. Impinzi is drawing more attention in Korea as researcher-led clinical trials conducted by Oh Do-yeon, a professor of oncology at Seoul National University Hospital, played a leading role in adding indications. Impinzi's specific biliary tract cancer indication was validated through a TOPAZ-1 study with "conventional chemotherapy (Gemcitabine·Cisplatin, GemCis) in the primary treatment of local progressive or metastatic biliary tract cancer" and obtained approval from the U.S. FDA in September. The TOPAZ-1 study is a multinational, randomized, double-blind, and placebo-controlled phase 3 clinical trial in 685 patients with progressive biliary tract cancer that compared and evaluated the combination of Impinzi, which is added to the existing standard treatment "GemCis." It is also worth noting that in the TOPAZ-1 study, patient recruitment was conducted in 17 countries, including the United States, Europe, and South America, and about 55% of the total was registered in Asian countries including Korea, Thailand, Japan, and China. As a result of the study, the Impinzi combined group had a 20% lower risk of death than the placebo combined group. However, the extension of the median value of the total survival period was only 1.3 months compared to the control group. The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%), and zones (40.2%). Potentially serious side effects were 62.7% in the Impinge combined group and 64.9% in the placebo combined group, suggesting that most side effects were due to chemotherapy in both groups. Impinzi's expansion of biliary tract cancer indication was made under Project Orbis, priority screening, and designation of rare drugs. AstraZeneca, a developer, is currently in the process of expanding its indication in many countries, including Korea, Europe, and Japan.
