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Post by Deleted on Sept 15, 2014 7:54:46 GMT -5
Future of diabetes treatments: Florins vs Insulin. This is the mention of Afrezza. It's nice to have friends:
<< I have written much on MannKind Corp.'s (NASDAQ:MNKD) inhalable insulin product Afrezza and only mention here that potential safety concerns - lung cancer risk - have prompted the FDA to order post-marketing studies. There are issues related to the drug/device's marketability, most importantly whether general practitioners not entirely skilled in diabetes care can determine proper dosage levels for inhalable insulin to treat patients effectively. Endocrinologists, better trained, are expensive, but can our overburdened health care system support the ongoing use of specialist to prescribe Afrezza? >>
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Post by liane on Sept 15, 2014 8:27:51 GMT -5
avogadro,
Can you post a link please?
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Post by mannmade on Sept 15, 2014 8:31:41 GMT -5
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Post by liane on Sept 15, 2014 8:55:14 GMT -5
You would think they could at least spell the drug in the title correctly - lol
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Post by kc on Sept 15, 2014 9:34:28 GMT -5
Now who would want to take this drug with the following warnings: Flozins are not nice drugs. Side effects include dehydration, potential kidney or liver disease, and a host of genitourinary complications like vaginal discharge and yeast infection of the penis. Farxiga, a product of Bristol-Meyers Squibb and AstraZeneca PLC (NYSE:AZN) with approval earlier this year for Type 2 diabetes, went through 16 clinical trials with 9,400 subjects and tended to induce bladder cancer. Like Jardiance, the most common side effect was infections of the genitals. The FDA has ordered a whopping six post-approval studies for Farxiga and I'm waiting for the class action lawsuits to start. Future of diabetes treatments: Florins vs Insulin. This is the mention of Afrezza. It's nice to have friends: << I have written much on MannKind Corp.'s (NASDAQ:MNKD) inhalable insulin product Afrezza and only mention here that potential safety concerns - lung cancer risk - have prompted the FDA to order post-marketing studies. There are issues related to the drug/device's marketability, most importantly whether general practitioners not entirely skilled in diabetes care can determine proper dosage levels for inhalable insulin to treat patients effectively. Endocrinologists, better trained, are expensive, but can our overburdened health care system support the ongoing use of specialist to prescribe Afrezza? >>
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Post by kc on Sept 15, 2014 9:35:53 GMT -5
From the SA article on Florins:Now who would want to take this drug with the following warnings: Flozins are not nice drugs. Side effects include dehydration, potential kidney or liver disease, and a host of genitourinary complications like vaginal discharge and yeast infection of the penis. Farxiga, a product of Bristol-Meyers Squibb and AstraZeneca PLC (NYSE:AZN) with approval earlier this year for Type 2 diabetes, went through 16 clinical trials with 9,400 subjects and tended to induce bladder cancer. Like Jardiance, the most common side effect was infections of the genitals. The FDA has ordered a whopping six post-approval studies for Farxiga and I'm waiting for the class action lawsuits to start. Also mentions J&J's Invokana: Johnson & Johnson (NYSE:JNJ) released its own flozin, Invokana that carries the typical list of side effects (excessive thirst, potential harm to organs involved in urination), but with an added distress: large, hive-like swellings on sex organs, plus nightmares and depression, leaving me to wonder which comes first. My contact at Novo Nordisk A/S (NYSE:NVO) feels Jardiance does not offer much over Invokana but may initially give Johnson & Johnson and other oral treatments a run for their money. My question is 'what is Big Pharma doing to diabetics?'
Seems to me that Afrezza's Blackbox warning is nothing compared to the contridictions of taking Florins or Invokana. Future of diabetes treatments: Florins vs Insulin. This is the mention of Afrezza. It's nice to have friends: << I have written much on MannKind Corp.'s (NASDAQ:MNKD) inhalable insulin product Afrezza and only mention here that potential safety concerns - lung cancer risk - have prompted the FDA to order post-marketing studies. There are issues related to the drug/device's marketability, most importantly whether general practitioners not entirely skilled in diabetes care can determine proper dosage levels for inhalable insulin to treat patients effectively. Endocrinologists, better trained, are expensive, but can our overburdened health care system support the ongoing use of specialist to prescribe Afrezza? >>
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Post by mannmade on Sept 15, 2014 9:59:31 GMT -5
Agree with above... Wonder if Sharon realizes how much she is actually helping us (Mannkind)...
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Post by kc on Sept 15, 2014 10:09:51 GMT -5
This is a link from an article in August about Lantus and their patent expiration date battle www.pmlive.com/pharma_news/tentative_us_approval_for_lillyboehringers_lantus_copy_593419Seems that the FDA has given Sanofi automatic stay of 30 months grace on the patent expiration. That is perhaps a great thing for us getting a ramp up for Afrezza by SNY. According to a statement released by the companies, the US regulator is satisfied that the insulin – known as Basaglar – is suitable for use in the treatment of people with diabetes, but cannot grant final approval as Sanofi has filed a lawsuit against Boehringer and Lilly claiming patent infringement.
Sanofi filed the lawsuit in January this year triggering an automatic 30-month stay of approval by the FDA, meaning Lilly and Boehringer cannot launch their insulin in the US until the middle of 2016 even thought the patent for Lantus is set to expire in 2015.
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Post by ezrasfund on Sept 16, 2014 9:22:44 GMT -5
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Post by seanismorris on Sept 16, 2014 17:08:24 GMT -5
An Exclusive Interview with Al Mann, Founder and CEO, Mannkind Corp. www.diabetesincontrol.com/articles/85-clinical-gems/16894-an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corpAM: As I said, Exubera was very difficult to deliver, very inconvenient, it was quite expensive and its clinical effects were not adequate. Exubera and the other inhaled products in development were not even clinically as good as injected insulin. I'm not surprised that endocrinologists were not enthusiastic about Exubera; also we expected it to fail. We used to joke about it. Yet people do remember the Exubera fiasco, may not understand why it failed and some would likely relate Afrezza to Exubera. We will have to overcome that reference so it is important that we make sure endocrinologists do understand that Exubera's failure was not because it was inhaled but due to its clinical deficiencies and expensive pricing. They must be made to realize that Afrezza is very convenient and that it has kinetics which truly mimic natural pancreatic insulin. It has none of the long persistence leading to the hyperinsulinemia which causes so much of the hypoglycemia in current insulin therapy. Afrezza is so very different from all those early efforts to create an inhaled insulin. We just have to educate people to understand how valuable and important are the kinetics of Afrezza and not just that it is delivered by inhalation. Of course, patients really do appreciate that you don't have to inject it and they enjoy the simplicity and convenience of Afrezza. Patients will surely create substantial demand for Afrezza, but in my view it is the significant clinical value of Afrezza resulting from its kinetics that will assure its success. Plenty of room for making Afrezza even better through optimizing mealtime inhalation. AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed "at the beginning of the meal," but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat. For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat. For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start. Interestingly I believe the size of all those doses should probably be the same for most patients. Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing. SF: Is that instruction not on the label to take it after you start eating? AM: The label says the dose should be taken "at the beginning of the meal." We are planning new trials to provide more data to validate what should be more optimal dosing protocols for most patients. SF: Is Sanofi going to help support you with all these studies? AM: Sanofi will actually do most of them.
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Post by dreamboatcruise on Sept 16, 2014 18:22:51 GMT -5
Everyone should read through this whole article... especially those that blame the company for share price due to not beating the afrezza drum enough. Clearly Al is making the case for Afrezza being a game changer... as he always has. It is also interesting that it answers the "new process question"... it's to get cartridges up to 36 equiv insulin units.
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Post by mannmade on Sept 16, 2014 19:19:16 GMT -5
The Holy Grail... And with the quotes below from Al Mann in today's article we have the Holy Grail for diabetics short of a cure... This is what will likey stop the progression of the disease when the endos figure out they can give more basal to lower FG levels and not risk severe hypos... "Remember the Science..."
AM: I don't know the largest drop, but many Afrezza patients achieved HbA1cs under 7% and quite a large number even under 6.5%. Frankly part of the problem in the trials was that from experience with other insulins the fasting glucose was generally not lowered as it should have been; had that been done the A1c results would have been much better.
AM: Any hypoglycemic incident in a patient using Afrezza would be treated in the same way as he/she would be treated today with any other exogenous insulins. We cannot make any claims about hypoglycemic risk since the label does not enable us to, but the kinetics of Afrezza were included in the package insert and those should suggest that unless the dose is taken on an empty stomach Afrezza should not cause a real hypoglycemic risk. During the prandial period it would be difficult to deliver enough Afrezza to cause a hypoglycemic incident and Afrezza is virtually gone before the digestion is completed. There should be almost no risk of a post prandial hypoglycemic event.
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Post by mannmade on Sept 16, 2014 19:47:09 GMT -5
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Post by brentie on Sept 16, 2014 22:05:36 GMT -5
Afrezza Job Openings Sanofi has added job openings for Afrezza and pre-launch activities are now underway. Afrezza in combination with Toujeo could/should allow Sanofi to protect its #1 ranking for long acting insulin sales and the dynamic duo could produce combined sales that double Lantus all time peak sales. Combined sales from Afrezza/Toujeo could easily exceed $10 billion and Afrezza alone for early Type II could add another $5 billion. www.cafepharma.com/boards/showthread.php?p=5214161
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Post by seanismorris on Sept 16, 2014 23:45:45 GMT -5
Lizard, I agree Al has really stepped up bat for shareholders.
Sanofi is also stepping up big time to make Afrezza a success. I think it was pretty obvious that some key items were left out of the Afrezza Label. Sanofi will be spending big bucks on new trials to get the Label they want (and Afrezza deserves).
Sanofi is doing everything possible to make Afrezza a success. From reading Al's words, I'm thinking the initial Afrezza adoption may be a little slower than we'd like, but once Sanofi completes these targeted trials (optimizing when to take Afrezza -showing better a1c, proving Less Hypos as a Primary Endpoint, and getting the Ultra label) Afrezza's sales are going to explode. And, right in time for the European Afrezza launch.
That 65/35 deal is looking really good.
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