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Sanofi Inhaled Insulin

Sanofi To Cease Marketing Of Mannkinds Inhaled Insulin, Afrezza

Sanofi To Cease Marketing Of Mannkinds Inhaled Insulin, Afrezza

Sanofi To Cease Marketing Of MannKinds Inhaled Insulin, Afrezza Sanofi announced they will discontinue marketing MannKinds inhaled insulin drug, Afrezza, starting in April. The company says the decision was made based on the lackluster number of prescriptions for Afrezza, despite launching a targeted Surprise, its insulin campaign in 2015, along with additional investments in marketing. According to data from Kantar Media, Sanofi made approximately $2 million on sales of Afrezza in the third quarter of 2015, despite spending $3.75 million on advertising for the drug. Since its launch in February of 2015, Afrezza has brought in $5.4 million in total sales. The decision to terminate is due to a number of factors, including the continued low level of prescriptions for Afrezza in the marketplace despite Sanofis substantial efforts, said a spokesperson from Sanofi. The announcement that the licensing agreement for Afrezza between MannKind and Sanofi had been terminated, was made on Tuesday. This is not the end of the line for Afrezza, said Matthew Pfeffer, CEO of MannKind. Pfeffer expressed interest in finding a new licensing or marketing partner for the inhaled insulin, and stressed the need to educate both patients and physicians regarding the value proposition presented by Afrezza. Mannkind had high hopes that Afrezza would become a major non-traditional insulin drug, and the first of its kind on the market. The drug was approved by the US Food and Drug Administration (FDA) in June of 2014, and the company partnered with Sanofi in August of that year in order to commercialize the product. Afrezza is currently the only FDA-approved inhaled insulin drug, and has been marketed towards diabetic patients who dislike using injectable insulin. Afrezza has suffered from the same Continue reading >>

Inhaled Insulin: Controlling A1c Without A Needle

Inhaled Insulin: Controlling A1c Without A Needle

Inhaled Insulin: Controlling A1C Without a Needle Fayetteville Veterans Affairs Medical Center US Pharm. 2015;40(10)(Diabetes suppl):3-7. ABSTRACT: Afrezza is a rapid-acting inhaled insulin that has been FDA-approved as an option for insulin therapy in adults with type 1 or type 2 diabetes. Currently, it is the only inhaled insulin on the market, as an earlier product was discontinued. Spirometry testing is required prior to the initiation of therapy due to the risk of acute bronchospasm. The most common adverse effects with Afrezza include hypoglycemia, cough, throat pain or irritation, and headache. Inhaled insulin may be an option for a certain niche of patients. Pharmacists are able to provide education on dose conversion and proper inhaler usage. Diabetes affects approximately 29.1 million Americans and is considered the seventh leading cause of death in the United States.1 Research and development have led to the expansion of available treatment options for patients with diabetes mellitus. These options include oral medications, injectables, and insulin in addition to lifestyle modifications. A study in adults diagnosed with diabetes showed that 2.9 million (14%) were treated with insulin alone, while 3.1 million (14.7%) were treated with both insulin and oral medications.2 Insulin is vital to regulate blood glucose. Since its discovery in 1923, the types of insulin developed have included bovine, porcine, human, and analogue preparations.3 There have been many changes to the mode of delivery of insulin, including needle and syringe, pen injection, continuous SC insulin infusion (insulin pumps), and now inhaled insulin. Additionally, there is ongoing research to develop a smart insulin patch.4 The ideal insulin formulation is one that closely mimics human physiol Continue reading >>

Inhaled Insulin Flops Again

Inhaled Insulin Flops Again

Managing diabetes doesnt mean you need to sacrifice enjoying foods you crave. Diabetes Self-Management offers over 900 diabetes friendly recipes to choose from including desserts, low-carb pasta dishes, savory main meals, grilled options and more. Afrezza, the inhaled insulin that was approved by the U.S. Food and Drug Administration (FDA) in 2014 after years of anticipation , was abandoned last month by the drug company marketing it Sanofi after a measly $5 million in sales during the first nine months of 2015. To put that number in perspective, this is a product that cost $1.8 billion to develop, and that Sanofi paid $925 million for the right to market. Now, Sanofi is seeking to back out of that marketing deal (an option that was surely part of the original agreement). The company that developed and owns Afrezza, MannKind Corp., has announced that it will seek a new marketing partner. But it remains doubtful that any other company will find a reason to believe it can market the drug better than Sanofi did. So why did Afrezza fail so miserably? And what does this say about the future if there is one of inhaled insulin? A recent article at MedPage Today sought the opinion of several experts on why Afrezza wasnt a success. These experts included doctors at various hospitals and medical schools, only one of whom has actually prescribed Afrezza. While that doctor noted that Afrezza was a major improvement over its predecessor, Exubera, most of the others saw no need to prescribe inhaled insulin to their patients. One doctor surveyed in the article, based in Denmark, noted that none of his patients seem to mind administering insulin by injection, and that the long-term safety of inhaled insulin has not been established (some data suggest that Exubera may have slightly rai Continue reading >>

Breathe Deeply: Sanofi Will No Longer Market Afrezza Inhaled Insulin

Breathe Deeply: Sanofi Will No Longer Market Afrezza Inhaled Insulin

Breathe deeply: Sanofi will no longer market Afrezza inhaled insulin Sanofi will no longer market MannKind's Abrezza. After months of disappointing sales, Sanofi has finally ended its bid to market MannKinds Afrezza inhaled insulin product, which was one of the more controversial and closely watched product launches in the pharmaceutical industry over the last few years. In a memo to employees, the drug maker said it plans to transfer rights to the product back to MannKind in April. Drug maker challenges tribal courts right to hear lawsuit Despite substantial efforts leading to high levels of brand awareness with key healthcare professionals, Afrezza has continued to demonstrate low [prescribing] volume and revenue performance in the marketplace, wrote Jez Moulding, who runs the Sanofi business in the US, and Andrew Purcell, who oversees the companys US diabetes business. (The memo can be seen at the bottom of this post). As for MannKind, the company initally issued a terse statement to say it is reviewing options for the product, but later maintained a new marketing partner will be sought. Afrezza, you may recall, was single-mindedly championed by Al Mann, a wealthy entrepreneur who reportedly invested a considerable portion of his personal fortune in MannKind to bring the product to market. Despite various setbacks with regulators, he stubbornly touted Afrezza as a winning alternative to Exubera, a failed Pfizer product that spectacularly flopped before being withdrawn in 2007. Nonetheless, for years, there was skepticism about the extent to which doctors and patients would embrace the product. And they never did. Afrezza sales totaled a meager $5 million or so through the first nine months of 2015. Among the naysayers, by the way, was Martin Shkreli, who urged the F Continue reading >>

Inhalable Insulin

Inhalable Insulin

Inhalable insulin is a powdered form of insulin, delivered with a nebulizer into the lungs where it is absorbed, generally more rapidly than subcutaneous insulin.[1] Exubera, developed by Inhale Therapeutics (later named Nektar Therapeutics), became the first inhaled insulin product to be marketed in 2006 by Pfizer,[2] but poor sales led Pfizer to withdraw it in 2007.[3] Afrezza, a monomeric inhaled insulin developed by Mannkind, was approved by the FDA in 2014.[4] History[edit] Insulin was introduced by Banting and Best from the University of Toronto in 1921 as an injectable agent. German researchers first introduced the idea of inhalable insulin in 1924.[5] Years of failure followed until scientists realized they might be able to use new technologies to turn insulin into a concentrated powder with particles sized for inhalation. In the 1980s Nektar Therapeutics developed technology to make insulin into small particles that they licensed to Pfizer; Alkermes developed a delivery device that they licensed to Eli Lilly and Company.[5] Once concrete methods were developed, human tests began in the late 1990s.[5] In January 2006, the U.S. Food and Drug Administration (FDA) approved the use of Exubera, a form of inhalable insulin developed by Pfizer;[2] it was approved in the UK in August 2006 but reimbursed by the National Health Service only for people who had problems with needles.[6] A 2007 systematic review concluded that the inhaled hexameric insulin (Exubera) "appears to be as effective, but no better than injected short-acting insulin. The additional cost is so much more that it is unlikely to be cost-effective."[7] In 2007, Pfizer announced that it would no longer manufacture or market Exubera. According to Chairman and CEO Jeffrey Kindler this was because Exubera " Continue reading >>

Sanofi Ends Marketing Deal With Developer Of Inhaled Insulin - The Boston Globe

Sanofi Ends Marketing Deal With Developer Of Inhaled Insulin - The Boston Globe

An inhaled insulin championed by a billionaire medical entrepreneur appears headed for market failure after being abandoned by the company with the rights to market it. MannKind, the developer of the insulin, announced Tuesday that Sanofi, the big French drug company with the marketing rights, was terminating the agreement between the two companies. The move by Sanofi is not a surprise since the inhaled insulin, called Afrezza, has had dismal sales since being approved by the Food and Drug Administration in June 2014. Sanofi reported sales of only 5 million euros, or a little more than $5 million, in the first nine months of 2015. Still, MannKind's shares plummeted in trading Tuesday. The company is expected to face significant money problems without Sanofi's support. MannKind was started by Alfred E. Mann, who made a fortune founding aerospace and medical device companies, including the insulin pump manufacturer MiniMed, which was sold to Medtronic for about $3 billion. But Mann, now 90, spent much of his accumulated wealth backing MannKind as it suffered many setbacks before finally winning FDA approval of Afrezza. Mann and other supporters of Afrezza said the product would provide millions of diabetics with a new option that might be more attractive to them than injecting themselves with insulin up to several times a day. But Pfizer had already suffered a costly failure in trying to market an inhaled insulin called Exubera. MannKind had hoped to succeed where Pfizer failed because its inhaler was much smaller and more discreet the size of a referee's whistle, while Pfizer's was the size of a tennis ball can. MannKind had also said its insulin had some desirable medical characteristics, other than being inhalable, although there was debate on that. But Afrezza still Continue reading >>

Sanofi And Mannkind Announce Afrezza, The Only Inhaled Insulin, Now Available In The U.s. - Feb 3, 2015

Sanofi And Mannkind Announce Afrezza, The Only Inhaled Insulin, Now Available In The U.s. - Feb 3, 2015

Sanofi and MannKind Announce Afrezza, the Only Inhaled Insulin, Now Available in the U.S. PARIS and VALENCIA, Calif., Feb. 3, 2015 / PRNewswire / -- Sanofi and MannKind Corporation announced today that Afrezza (insulin human) Inhalation Powder, the only inhaled insulin, is now available by prescription in U.S. retail pharmacies nationwide. Afrezza is approved by the U.S. Food and Drug Administration to control high blood sugar in adults with type 1 and type 2 diabetes. Experience the interactive Multimedia News Release here: "Many people living with diabetes are not able to control their blood sugar on their current medications and may benefit from using insulin. Now they have another option to administer insulin that is not an injection," said Dr. Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine in St. Louis and Afrezza clinical trial investigator. "This delivery option may help change the dialogue between health care professionals and people living with diabetes about initiating or intensifying insulin therapy." Afrezza is a drug-device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal. Afrezza can help control high blood sugar as part of a diabetes management plan that may include diet, exercise and other diabetes medications. Afrezza should not be used in patients with chronic lung disease such as asthma or COPD. Afrezza cannot be used to treat diabetic ketoacidosis. Afrezza is not recommended in patients who smoke or who have recently stopped smoking. "Afrezza is an important addition to Sanofi's growing diabe Continue reading >>

Afrezza Inhaled Insulin: Sanofi Terminates Partnership With Mannkind

Afrezza Inhaled Insulin: Sanofi Terminates Partnership With Mannkind

Afrezza Inhaled Insulin: Sanofi Terminates Partnership with MannKind Afrezza, the second attempt to commercialize an inhaled insulin, is now on life support. Today, Sanofi-Aventis announced that it was terminating its distribution agreement with its maker, MannKind . Contractually, Sanofi couldnt terminate their relationship with MannKind and their inhaled insulin, Afrezza, until January 1, 2016, but the departure was not a surprise. MannKind has even signaled that they might be looking to sell the drug, explains TheWall Street Journal. The rapid-acting inhaled insulin comesin the form of a powder, for use by patients with both type 1 and type 2 diabetes.The actual inhaler device isjust a few inches long and less than an inch wide, making it very portable and discrete. Many people with diabetes have been excited about the promise of inhaled insulin: fewer shots, faster onset and a reduced risk of hypoglycemia. The reportedreduced risk of hypoglycemia was notapproved by the FDA for use in marketing. But in a competitive environment with so many alternatives, is inhaled insulin different enough to justify the high cost? This announcement suggests not. Judy Hoskins, who has lived with type 1 diabetes for 58 years, appreciated more stable blood sugars with Afrezza. Hoskins explains, My control was good on it as it eliminates peaks and valleys and sort of levels out your graph line. But I havent had an A1c that wasnt between 5.5and6.0 since I went on the pump 14 yeas ago, so I cant say it made my A1c better. But Hoskins did share a few challenges with using Afrezza, The big problems for me are: I worry about long term lung problems as those really havent been tested out yet, and its in the highest tier of my insurance copay so I have a really high monthly copay for it. I tr Continue reading >>

The Return Of Inhaled Insulin

The Return Of Inhaled Insulin

Darrell Hulisz, RPh, PhamD Associate Professor, CWRU, School of Medicine Doctor of Pharmacy Candidate, ONU College of Pharmacy Inhaled insulin first made an appearance on the US market in 2011. The design of the metered dose device was cumbersome and lacked portability, was withdrawn by the manufacturer, Pfizer, with about a year. Recently, Sanofi began marketing a new inhaled insulin known as Afrezza®. The product has received FDA approval in both type 1 and type 2 diabetes. Afrezza® is a human insulin product that is rapidly absorbed upon inhalation. Patients place a pre-filled cartridge containing either 4, 8, or 12 units of insulin into an inhaler. Patients exhale fully, then inhale sharply and hold their breath for as long as comfortable to get the medication absorbed. This creates a rapid absorption and a decreased duration of insulin action that more closely resembles endogenous prandial insulin release. The pharmacokinetic profile more closely resembles ultra-short acting insulin, such as insulin lispro or aspart. In clinical trials for Type 1 diabetes, Afrezza® was found to be non-inferior to insulin when comparing patients' mean drop in HgbA1C. However, one trial found that patients taking injectable insulin were more likely to achieve a HgbA1C below 7% at the end of the 24 week trial period. In Type 2 diabetes, Afrezza® was studied to determine its viability as an add-on therapy in addition to oral diabetes medications. The clinical trial examined Afrezza® in combination with oral medication compared to oral medication alone. The group taking Afrezza® had greater diabetes control at the end of the trial period. While this is not a surprising finding, it does confirm its potential use as an add-on therapy for uncontrolled Type 2 diabetics. The side effec Continue reading >>

Inhalable Insulin: A Losing Battle?

Inhalable Insulin: A Losing Battle?

Diabetes is on the rise. In the UK, the number of sufferers is now estimated at over four million, and the figure is expected to surpass five million by 2025. Across the Atlantic, more than 29 million people have diabetes – a staggering 9.3% of the American population. A further 86 million have prediabetes, placing them at heightened risk of becoming ill. For many sufferers, especially those with type 1 diabetes, regular insulin injections are a lifeline. On top of lifestyle measures and other medications, they may need to use their syringe or autoinjector as many as four times a day. Injections, however, are far from the most comfortable or convenient route of administration. For a number of years, the pharmaceutical community has been on a quest for alternatives, with many pondering whether insulin could be inhaled instead. History repeats In 2006, the world’s first inhalable insulin, Pfizer’s Exubera, was released to great fanfare. Forecast to draw in $2bn a year in sales, the drug was expected to revolutionise the diabetes treatment landscape. Unfortunately, in the face of mounting safety concerns, Exubera was pulled. As the hype died down, a number of similar products in development were quietly shelved. It wasn’t until February 2015, with the release of Sanofi’s Afrezza, that the potential seemed to rise again. Developed by MannKind, this drug-device combination product comprises a dry formulation of insulin delivered through a small portable inhaler, and was also valued at around $2bn (around a tenth of the total global insulin market). It was intended to meet "a recognised need for an insulin that doesn’t require an injection". So when, in January 2016, Sanofi announced it would pull the plug on Afrezza, history appeared to repeat itself in the most Continue reading >>

Fda Approves Inhaled Insulin For Diabetes

Fda Approves Inhaled Insulin For Diabetes

FDA approves inhaled insulin for diabetes Product is first inhaled drug designed for treatment of type 1 and type 2 diabetes. Patients with diabetes now have a new option for insulin delivery. The FDA recently approved inhaled human insulin powder (Exubera, Pfizer and Sanofi-Aventis) as a new insulin delivery option for adult patients with type 1 diabetes or type 2 diabetes. This is the first approval for an inhaled insulin delivery system. Until now, patients with diabetes who need insulin to manage their disease had only one way to treat their condition, Steven Galson, MD, MPH, director of the FDAs Center for Drug Evaluation and Research, said in a press release. It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars. Inhaled human insulin powder, shown above, appeared to be an effective alternative treatment. Inhaled human insulin powder was recommended for approval in September after the FDAs Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed data from clinical trials of the drug. Clinical trials demonstrated that patients using inhaled human insulin powder were often able to reach peak insulin concentration quicker than patients taking some regular insulins. Peak insulin levels were achieved at an average of 49 minutes with inhaled human insulin powder; peak levels were achieved at an average of 105 minutes with regular insulin. The studies also demonstrated that the decrease in HbA1c levels seen in patients treated with inhaled human insulin powder was similar to the decrease seen in patients treated with subcutaneous insulin. During one 24-week study, 23% of patients treated with inhaled human insulin powder and 22% of patients treated with subcutaneous insulin group achie Continue reading >>

Dance Biopharm: Sanofis Afrezza Handling Stunted Inhaled Insulin R&d

Dance Biopharm: Sanofis Afrezza Handling Stunted Inhaled Insulin R&d

Related tags: Inhaled insulin , Inhalable insulin , Mannkind corporation Despite Sanofis conflicted management and subsequent abandonment of Afrezza, the market opportunity for inhaled insulin is still huge, according to Dance Biopharm's CEO. This week , Sanofi abandoned its commercialisation deal for the inhaled insulin product Afrezza, leaving developer MannKind Corporation looking for a new distribution and licensing partner. The news is the latest blow to the inhaled insulin sector which was left unsettled following the failure of Exubera in 2007 . A lack of acceptance by patients and physicians led Pfizer to pull its product a year after launch and at a cost of $2.8bn, and within a matter of months fellow Big Pharma firms Eli Lilly and Novo Nordisk abandoned their own development projects. Despite this background, Dance Biopharms CEO John Patton said there is still a market for inhaled insulin, though Sanofis actions have marred his own companys efforts in developing Dance-501, a pocket-sized inhaler device and insulin container designed to deliver prandial insulin. The less-than-optimal performance of Sanofi with Afrezza has had an impact on our development, because investors have become more sceptical about inhaled insulin, so raising money has been difficult and that has slowed our development effort. he told in-Pharmatechnologist.com. This particular news is not helping! He continued, blaming both Exubera and Afrezzas problems primarily on a lack of persistence and commitment by their marketers. Exubera never had a chance, and Afrezza may have been priced too high and was targeted to a very small percentage of the insulin users. Sanofi is looking to reinvigorate growth in its diabetes franchise through its marketed products Lantus and Toujeo, and Patton said t Continue reading >>

The Ins And Outs Of Afrezza®, The Only Inhaled Insulin

The Ins And Outs Of Afrezza®, The Only Inhaled Insulin

AFREZZA is a man-made rapid-acting inhaled insulin breathed in through your lungs and is used to control high blood sugar in adults with diabetes. AFREZZA is available by prescription only. AFREZZA is not for use in place of long-acting insulin. AFREZZA must be used with long-acting insulin in people who have type 1 diabetes. AFREZZA is not for use to treat diabetic ketoacidosis. It is not known if AFREZZA is safe and effective for use in people who smoke. AFREZZA is not for use in people who smoke or have recently stopped smoking (less than 6 months). It is not known if AFREZZA is safe and effective in children under 18 years of age. What is the most important information I should know about AFREZZA? AFREZZA can cause serious side effects including: Sudden lung problems (bronchospasms). Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting AFREZZA, your healthcare provider will perform a detailed medical history, physical examination, and will give you a breathing test (called spirometry) to check how your lungs are working. Who should not use AFREZZA? Do not use AFREZZA: During episodes of low blood sugar (hypoglycemia). If you have chronic lung problems such as asthma or COPD. If you are allergic to regular human insulin or any of the ingredients of AFREZZA as this may cause a significant and severe allergic reaction. What should I tell my healthcare provider before using AFREZZA? Before using AFREZZA, tell your healthcare provider about all your medical conditions, including if you: Have lung problems such as asthma or COPD. Have or have had lung cancer. Are using any inhaled medications. Smoke or have recently stopped smoking. Have kidney or liver problems. Are pregnant, plan Continue reading >>

Mannkind Taps Medtech Reps After Sanofi Deal Fails

Mannkind Taps Medtech Reps After Sanofi Deal Fails

Home Mannkind taps medtech reps after Sanofi deal fails Mannkind taps medtech reps after Sanofi deal fails Mannkind chief commercial officer Michael Castagna is trying to resuscitate the inhaled insulin maker after its co-marketing agreement with Sanofi (NYSE: SNY ) was cancelled at the beginning of the year due to disappointing sales. Hes fielding a team of about 70 people to sell the companys Afrezza insulin inhaler, with about coming from the medical device industry. We are looking to build a high energy nimble company that reflects the speed of the medical device industry, articulation of the science from biotech and a relentless focus on helping patients suffering from diabetes, Castagna told Fortune. But at Mannkind, time is running out. The company owes Sanofi $68.8 million and had $27.7 million in cash on hand as of May, down from $59.1 million to start the year. The company also faces some challenges with their product, including the need for spirometry and titration, 2 tasks that make prescribing and administering the combination product less convenient than standard injectable competitors in the fast-acting segment of the market. We know about of our targets already have a spirometry machine in the office. Another have a referral source, and our research indicates a device at a price point of about $400 to $750 is something most physician practices will buy, Castagna said. The company plans to offer Afrezza with a new titration pack of 180 insulin cartridges instead of 90, in order to help patients adjust their dose during the titration period, he said. Another issue facing the recovering Afrezza business is pricing. In spite of a 35% priceincrease in injected meal-time insulin in the last 24 months since Afrezza was reviewed by the FDA Continue reading >>

Updates On Inhaled Insulin: Reaching For The Stars In Post-prandial Glucose Control

Updates On Inhaled Insulin: Reaching For The Stars In Post-prandial Glucose Control

the Endocrine Society Center for Learning Updates on Inhaled Insulin: Reaching for the Stars in Post-Prandial Glucose Control Updates on Inhaled Insulin: Reaching for the Stars in Post-Prandial Glucose Control Hyatt Regency Orlando- Regency Ballroom S This activity is supported by an educational grant from MannKind Corporation CLICK "BEGIN" TO EVALUATE SESSIONS, CLAIM CME, AND PRINT A CERTIFICATE OF ATTENDANCE OR CERTIFICATE OF PARTICIPATION. This continuing medical education activity should be of substantial interest to endocrinologists and endocrine fellows, pediatric endocrinologists and pediatric endocrine fellows, and other healthcare professionalswho treat patients with diabetes. Upon completion of this educational activity, participants will: New safety and efficacy data for ultra-rapid-acting insulin Selection of patients who are appropriate candidates for rapid-acting insulin Patient education points for use of inhaled insulin therapy Effective use of ultra-rapid insulin therapy in clinical practice Level 4 (Learning: Competence (Shows How)) Clinical Associate Professor of Medicine, Division of Endocrinology, Metabolism, and Lipid Research The faculty, committee members, and staff who are in position to control the content of this activity are required to disclose to the Endocrine Society and to learners any relevant financial relationship(s) of the individual or spouse/partner that have occurred within the last 12 months with any commercial interest(s) whose products or services are related to the CME content. Financial relationships are defined by remuneration in any amount from the commercial interest(s) in the form of grants; research support; consulting fees; salary; ownership interest (e.g., stocks, stock options, or ownership interest excluding diversif Continue reading >>

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