Saturday, June 27, 2009
Sandoz receives approval for Japanese biosimilar
Sandoz has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.Sandoz CEO Jeff George said, "We are pleased that Sandoz, the pioneer in biosimilars and a company with a global reputation for offering high quality medicines at affordable prices, is paving the way in Japan as well. Together with our parent company Novartis, we are fully committed to broadening access to innovative and affordable biopharmaceuticals over the years and decades to come, both in Japan and worldwide."The Ministry of Health, Labour and Wealth (MHLW) announced the approval on June 22, barely three months after the Japanese authorities published guidelines that paved the way for a national biosimilar regulatory pathway, based on similar scientific principles to the approval pathway already in place in the European Union.The Sandoz product will be marketed in Japan as Somatropin BS S.C. injection 5mg / 10mg [Sandoz]. It is approved for the treatment of growth hormone deficiency in children and growth disturbance associated with Turner's syndrome or chronic renal insufficiency. This is the same range of indications covered by the reference product, Genotropin, as approved in Japan. It is approved on the basis that it offers patients comparable quality, safety and efficacy to the reference product.Sandoz pioneered the field of biosimilars / follow-on biologics with the approval and subsequent launch of Omnitrope in the US and Europe. Omnitrope was the first such product to be made available to patients in both regions and the first ever medicine to be approved in the EU as a biosimilar, the European regulatory term for such products. Sandoz is the only company with three biosimilar medicines marketed in Europe.Biosimilars are an integral part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits. Due to the rising costs of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring and broadening global access to medicines. Sandoz is building a strong global biosimilar pipeline, with numerous projects at all stages of development.
St hammers Sun Pharma as USFDA seizes 33 drugs of arm
MUMBAI: US authorities seized drugs made by Sun Pharmaceuticals’ US subsidiary for violation of manufacturing standards, pushing down share prices
of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom. The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP). “The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue. The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours. However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning. “While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.
of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom. The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP). “The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement. Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue. The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours. However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning. “While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.
US drug officals raid Sun Pharma subsidiary in Michigan
MUMBAI: The US Food and Drug Administration (FDA) on Thursday seized 33 drugs manufactured by a subsidiary of Indian pharma major Sun
Pharmaceuticals at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. As news of the raid broke, the Sun Pharma stock plunged 17.59 percent on the Bombay Stock Exchange Friday to Rs1,070 soon after opening bell. The company's subsidiary Caraco Pharmaceutical Laboratories, in which the Indian company holds about 75 percent, was raided owing to its "continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements," the US authorities said. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, FDA's director of Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public." This is not the first time the company has come under the regulator's scanner. Last October, the FDA had conducted inspection of its facilities and found "significant deviations from Current Good Manufacturing Practice (CGMP) regulations". Caraco's drugs were found to be contaminated, even after the company had conducted an internal investigation to determine the cause and taken corrective measures. Since January, Caraco had initiated voluntary recalls of products to protect the public from potentially defective medications. The recalls followed manufacturing defects, including oversized tablets and possible formulation error. But the FDA found these measures inadequate. "FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of CGMP requirements," an FDA statement read. Sun Pharma is the second Indian company this year to have faced FDA's wrath. In February, the US drug watchdog had taken regulatory action against Ranbaxy's Paonta Sahib facility in Himachal Pradesh on the ground it had falsified test results.
Pharmaceuticals at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. As news of the raid broke, the Sun Pharma stock plunged 17.59 percent on the Bombay Stock Exchange Friday to Rs1,070 soon after opening bell. The company's subsidiary Caraco Pharmaceutical Laboratories, in which the Indian company holds about 75 percent, was raided owing to its "continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements," the US authorities said. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, FDA's director of Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public." This is not the first time the company has come under the regulator's scanner. Last October, the FDA had conducted inspection of its facilities and found "significant deviations from Current Good Manufacturing Practice (CGMP) regulations". Caraco's drugs were found to be contaminated, even after the company had conducted an internal investigation to determine the cause and taken corrective measures. Since January, Caraco had initiated voluntary recalls of products to protect the public from potentially defective medications. The recalls followed manufacturing defects, including oversized tablets and possible formulation error. But the FDA found these measures inadequate. "FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of CGMP requirements," an FDA statement read. Sun Pharma is the second Indian company this year to have faced FDA's wrath. In February, the US drug watchdog had taken regulatory action against Ranbaxy's Paonta Sahib facility in Himachal Pradesh on the ground it had falsified test results.
Tuesday, June 23, 2009
Dr Reddy's launches Bispec in India
Dr Reddy's Laboratories, the second largest Indian pharma giant, has commenced marketing of Bispec (Solifencin succinate) in India for the treatment of over active bladder (OAB). Bispec is the best-in-class for OAB and has lesser incidence of dry mount and constipation. The product is available in tablet form and in dosages of 5 mg and 10 mg.People suffering from OAB have a warning time of about 12 seconds. Solifencin succinate helps to increase the warning time to about 32 seconds. The market size for product used in the treatment of OAB is about Rs 19.4 crore and it growing at a rate of 7 per cent per annum. Solifencin acts by competitively inhibiting Acetyl choline from binding to cholinergic receptors present in bladder. This reduces bladder contractions and improves warning time in over active bladder patients. DRL has other leading brand TORQ in this segment.
Aurobindo gets nod for 5 new registrations from MCC - South Africa
Aurobindo Pharma Ltd, Hyderabad based generic pharmaceutical and API company, has received Medicines Control Council (MCC) South Africa's approval to manufacture and market five products in South Africa.According to a company press release, the MCC has approved two ARV category drugs of Auro-Abacavir 300mg tablets (Abacavir), Auro-Abacavir 20mg/ml (Abacavir) oral solution and three anti-infective category drugs of Auroprozil 250mg & 500mg (Cefprozil) tablets, Auro-Cefotaxime 250mg, 500mg, 1000mg & 2000mg (Cefotaxime) injection and Auro-Cefalexin 250mg & 750mg (Cefalexin) tablets. Aurobindo now has a total of 36 registrations approved by the MCC, the release said.
German, UK-based biotech cos eye India for outsourcing
BANGALORE: As part of the cost-cutting measures to combat global recession, German and UK-based biotech companies plan to outsource more work,
transfer technology and tap India’s burgeoning biotechnology market.
“We will see more collaborations in industrial enzyme technology, bio-food technology, renewable energies and regenerative medicine. Several companies plan to bring in over $100 million investments to India this year and set up production facilities here,” said Martin Pohle, consultant Bio Mitteldeutschland Gmbh, which works towards strengthening the BT industry in Anhalt, Central Germany. The Indian bio-tech industry is poised to grow by 18% in FY09 to Rs 12,137 crore from Rs 10,274 crore in FY08, said CMD of Biocon Kiran Mazumdar Shaw. This year, more partnerships are likely to be struck between Western and Indian companies, she said. Germany’s Biobase Gmbh, which provides biological databanks, will be bringing more work to India and expand its infrastructure. “We have more than 50% cost advantage in India, and now only 10-15% of our work is done in Germany, 85% of the work is done in India,” said Biobase CEO, Michael Tysiak. Companies like UK-based Oxygen Healthcare (O2H) are setting up new labs in Ahmedabad SEZ. It will source molecules from India because of the cost advantage here and market them in Japan, US and Europe. These molecules will be used for drug discovery procedures for diseases such as cancer. “The Indian base makes us competitive. We are able to deliver the same kind of quality as in the UK and US, where you pay three times more compared to India,” said Ekta Ahuja, manager business development, O2H. Britian’s Institute of Pharmaceutical Innovations (IPI) is looking at a JV with Indian companies and will transfer technology through its two spin-outs — Crystec Pharma and Lena Naoceutics. “With Crystec, we have a plant in China and now we want to set up a plant in India. We will collaborate with Indian partners through Lenananoceutics. A total investment of £20 million is required for these ventures,” said Anant Paradkar, professor at IPI.
transfer technology and tap India’s burgeoning biotechnology market.
“We will see more collaborations in industrial enzyme technology, bio-food technology, renewable energies and regenerative medicine. Several companies plan to bring in over $100 million investments to India this year and set up production facilities here,” said Martin Pohle, consultant Bio Mitteldeutschland Gmbh, which works towards strengthening the BT industry in Anhalt, Central Germany. The Indian bio-tech industry is poised to grow by 18% in FY09 to Rs 12,137 crore from Rs 10,274 crore in FY08, said CMD of Biocon Kiran Mazumdar Shaw. This year, more partnerships are likely to be struck between Western and Indian companies, she said. Germany’s Biobase Gmbh, which provides biological databanks, will be bringing more work to India and expand its infrastructure. “We have more than 50% cost advantage in India, and now only 10-15% of our work is done in Germany, 85% of the work is done in India,” said Biobase CEO, Michael Tysiak. Companies like UK-based Oxygen Healthcare (O2H) are setting up new labs in Ahmedabad SEZ. It will source molecules from India because of the cost advantage here and market them in Japan, US and Europe. These molecules will be used for drug discovery procedures for diseases such as cancer. “The Indian base makes us competitive. We are able to deliver the same kind of quality as in the UK and US, where you pay three times more compared to India,” said Ekta Ahuja, manager business development, O2H. Britian’s Institute of Pharmaceutical Innovations (IPI) is looking at a JV with Indian companies and will transfer technology through its two spin-outs — Crystec Pharma and Lena Naoceutics. “With Crystec, we have a plant in China and now we want to set up a plant in India. We will collaborate with Indian partners through Lenananoceutics. A total investment of £20 million is required for these ventures,” said Anant Paradkar, professor at IPI.
Pfizer charges Sun with another patent violation
MUMBAI: A legal battle between US pharma giant Pfizer and Indian company Sun Pharmaceutical has escalated, with the world’s largest maker of
medicines alleging in court filings that in addition to the original patent that it claims Sun violated, it infringed another patent when it sought approval for its generic version of Lyrica, a blockbuster drug used to treat seizures. In a case filed in the US District Court for the District of Delaware on May 3, 2009, Pfizer had alleged that Sun infringed on a patent that Pfizer and Northwestern University held. Last week, the company charged Sun with violating another patent for Lyrica. Incidentally, Pfizer will lose patent protection for this drug only in 2018. Lyrica (pregabalin) is used for treating pain caused by neurological diseases such as postherpetic neuralgia as well as seizures. Lyrica currently ranks third in the anti-seizure market, and is estimated to have global sales of approximately $1.2 billion. The drug’s sales jumped 45% in 2008 to $675 million, offsetting Pfizer’s losses from its blockbuster drug Lipitor. Lyrica may become Pfizer’s leading product by 2012. The pharma giant, in its filing, said it had received a letter from Sun Pharma informing that Sun’s abbreviated new drug application (ANDA) contained a claim that the “175 patent was invalid, unenforceable, and not infringed by Sun’s proposed product”. Pfizer is seeking an injunction that would bar Sun from marketing and manufacturing generic versions of Lyrica (pregabalin) prior to patent expiration as well as monetary relief, if Sun were to sell its generic product, and fees and costs.” When contacted, a Sun Pharma spokesperson said: “We don’t comment on our product pipeline or the associated litigation.” Indian pharma majors Lupin and Wockhardt have also been taken to court by Pfizer for infringement of other patents related to the same drug. Teva, Sandoz, Actavis, Cobalt Laboratories, Alphapharm are some of the other generic companies that Pfizer is in litigation with over Lyrica.
medicines alleging in court filings that in addition to the original patent that it claims Sun violated, it infringed another patent when it sought approval for its generic version of Lyrica, a blockbuster drug used to treat seizures. In a case filed in the US District Court for the District of Delaware on May 3, 2009, Pfizer had alleged that Sun infringed on a patent that Pfizer and Northwestern University held. Last week, the company charged Sun with violating another patent for Lyrica. Incidentally, Pfizer will lose patent protection for this drug only in 2018. Lyrica (pregabalin) is used for treating pain caused by neurological diseases such as postherpetic neuralgia as well as seizures. Lyrica currently ranks third in the anti-seizure market, and is estimated to have global sales of approximately $1.2 billion. The drug’s sales jumped 45% in 2008 to $675 million, offsetting Pfizer’s losses from its blockbuster drug Lipitor. Lyrica may become Pfizer’s leading product by 2012. The pharma giant, in its filing, said it had received a letter from Sun Pharma informing that Sun’s abbreviated new drug application (ANDA) contained a claim that the “175 patent was invalid, unenforceable, and not infringed by Sun’s proposed product”. Pfizer is seeking an injunction that would bar Sun from marketing and manufacturing generic versions of Lyrica (pregabalin) prior to patent expiration as well as monetary relief, if Sun were to sell its generic product, and fees and costs.” When contacted, a Sun Pharma spokesperson said: “We don’t comment on our product pipeline or the associated litigation.” Indian pharma majors Lupin and Wockhardt have also been taken to court by Pfizer for infringement of other patents related to the same drug. Teva, Sandoz, Actavis, Cobalt Laboratories, Alphapharm are some of the other generic companies that Pfizer is in litigation with over Lyrica.
Retail sale of swine flu drug under lens
NEW DELHI: The Drug Controller General of India (DCGI) may soon crack the whip on those selling oseltamivir, the medicine to treat swine flu, in
retail stores. In a move to step up vigil on the retail sale of the drug at high prices, the DCGI has asked all state drug inspectors to keep a check on the movement, manufacture and sale of the medicine in their jurisdictions, a health ministry official, who asked not to be named, said. The present warning from the health ministry reiterating that the drug should not be sold in the open market and in private hospitals by pharmacies comes at a time when companies are urging the government to allow retail sale of the drug.Drug makers manufacturing or importing oseltamivir are allowed to either sell it to government hospitals or directly to the government through a tender. The government is worried about a possible illegal stocking of the drug and panic consumption that could result in the virus developing a resistance to the medicine. “There may be people willing to take advantage of swine flu and make money out of it. This product is meant for government supply only and it is not permitted to be sold through retail chemists and druggists in India. Indiscriminate use of this drug by the public could result in the virus developing resistance to this,” the official said. Companies, such as Cipla, Ranbaxy and Hetero, have developed generic version of the drug. The DCGI’s move was prompted by reports that the only drug, oseltamivir, to treat swine flu is available at various pharmaceutical retail outlet at a very high price. The World Health Organisation (WHO) has reported 35,928 laboratory confirmed cases of H1N1 influenza, from 76 countries till Monday. According to the health ministry, so far samples of 329 persons have been tested in India, of which 35 have been tested positive for novel influenza A H1N1.
retail stores. In a move to step up vigil on the retail sale of the drug at high prices, the DCGI has asked all state drug inspectors to keep a check on the movement, manufacture and sale of the medicine in their jurisdictions, a health ministry official, who asked not to be named, said. The present warning from the health ministry reiterating that the drug should not be sold in the open market and in private hospitals by pharmacies comes at a time when companies are urging the government to allow retail sale of the drug.Drug makers manufacturing or importing oseltamivir are allowed to either sell it to government hospitals or directly to the government through a tender. The government is worried about a possible illegal stocking of the drug and panic consumption that could result in the virus developing a resistance to the medicine. “There may be people willing to take advantage of swine flu and make money out of it. This product is meant for government supply only and it is not permitted to be sold through retail chemists and druggists in India. Indiscriminate use of this drug by the public could result in the virus developing resistance to this,” the official said. Companies, such as Cipla, Ranbaxy and Hetero, have developed generic version of the drug. The DCGI’s move was prompted by reports that the only drug, oseltamivir, to treat swine flu is available at various pharmaceutical retail outlet at a very high price. The World Health Organisation (WHO) has reported 35,928 laboratory confirmed cases of H1N1 influenza, from 76 countries till Monday. According to the health ministry, so far samples of 329 persons have been tested in India, of which 35 have been tested positive for novel influenza A H1N1.
Sun Pharma USFDA nod for anti hypertensive drug
MUMBAI: Sun Pharmaceutical Industries on Friday said it has got the approval for its Abbreviated New Drug Application (ANDA) for the generic version
of Quinapril Hydrochloride tablets used in the treatment of hypertension and congested heart failure. The Quinapril Hydrochloride Tablets are generic version of 'Accupril' tablets from Pfizer's portfolio and are available in four strengths, the company said in a filing to Bombay Stock Exchange. The drug have annual sales of approximately $ 45 million in US, it added.
of Quinapril Hydrochloride tablets used in the treatment of hypertension and congested heart failure. The Quinapril Hydrochloride Tablets are generic version of 'Accupril' tablets from Pfizer's portfolio and are available in four strengths, the company said in a filing to Bombay Stock Exchange. The drug have annual sales of approximately $ 45 million in US, it added.
NEW DELHI: Elder Pharmaceuticals has signed an agreement with US-based MD Anderson Cancer Center to conduct human experiments for its
NEW DELHI: The domestic pharmaceutical industry has demanded exemption in income-tax and fiscal incentives in the forthcoming Budget for promoting
research and development (R&D) in the field of drug discovery in India. "We have sought exemption in income-tax under section 80, for promoting R&D in the pharmaceutical sector," Piramal Healthcare Executive Director Swati Piramal said. She said India is lagging behind countries such as Canada and Israel in R&D, which is very worrisome for the domestic pharma industry. "The provision for the exemption for R&D was there till 2007 and we simply want to revive it," Piramal added. Echoing similar sentiments, Indian Pharmaceutical Alliance Secretary General D G Shah said, "We are not making any special demand from the government but are only seeking that government must recognise the high risk associated with drug discovery and should provide adequate funding for that." The industry has also demanded a decision on the central drug authority bill, which is pending in Parliament for the last five years. Apex body of drug exporters Pharmaexcil, in its representation to the finance ministry and commerce ministry, has demanded a Rs 1,000-crore fund to support small and medium enterprises for Schedule M compliance (minimum standards set by government for producing drugs) and to meet global regulatory standards. Pharmaexcil Chairman Venkat Jasti said that for innovation led growth, the industry needs to build huge infrastructure to develop human resources, have a proper regulatory mechanism and for having a strong Intellectual Property Regime. "Besides, it needs funding for drug discovery activities. Long-term commitment with a special fund needs to be created," he added. However, another major chamber SPIC has demanded that the government should increase the limit of excise exemption for small scale industries to Rs five crore from the current Rs 1.5 crore.
research and development (R&D) in the field of drug discovery in India. "We have sought exemption in income-tax under section 80, for promoting R&D in the pharmaceutical sector," Piramal Healthcare Executive Director Swati Piramal said. She said India is lagging behind countries such as Canada and Israel in R&D, which is very worrisome for the domestic pharma industry. "The provision for the exemption for R&D was there till 2007 and we simply want to revive it," Piramal added. Echoing similar sentiments, Indian Pharmaceutical Alliance Secretary General D G Shah said, "We are not making any special demand from the government but are only seeking that government must recognise the high risk associated with drug discovery and should provide adequate funding for that." The industry has also demanded a decision on the central drug authority bill, which is pending in Parliament for the last five years. Apex body of drug exporters Pharmaexcil, in its representation to the finance ministry and commerce ministry, has demanded a Rs 1,000-crore fund to support small and medium enterprises for Schedule M compliance (minimum standards set by government for producing drugs) and to meet global regulatory standards. Pharmaexcil Chairman Venkat Jasti said that for innovation led growth, the industry needs to build huge infrastructure to develop human resources, have a proper regulatory mechanism and for having a strong Intellectual Property Regime. "Besides, it needs funding for drug discovery activities. Long-term commitment with a special fund needs to be created," he added. However, another major chamber SPIC has demanded that the government should increase the limit of excise exemption for small scale industries to Rs five crore from the current Rs 1.5 crore.
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