{"id":19238,"date":"2011-08-31T09:02:22","date_gmt":"2011-08-31T13:02:22","guid":{"rendered":"http:\/\/asweetlife.org\/?p=19238"},"modified":"2016-01-06T05:11:53","modified_gmt":"2016-01-06T10:11:53","slug":"glucapen-the-way-glucagon-ought-to-be","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=19238","title":{"rendered":"GlucaPen: The Way Glucagon Ought To Be"},"content":{"rendered":"

\"\"<\/a>I have written about the GlucaPen before<\/a>, but recently I had the chance to meet with the company, and to see the device in person. As before, I found the GlucaPen to be an obvious solution to an obvious problem\u2014the kind of solution that makes you think, \u201cWell, why didn\u2019t I think of that?\u201d<\/p>\n

What\u2019s the problem? The beginning of the problem is the fact that diabetics on insulin\u2014both type 1 and type 2\u2014suffer from hypoglycemia, or low blood glucose levels, due to the difficulties of dosing and predicting the body\u2019s response. If blood glucose levels get too low, a diabetic risks loss of mental acuity, loss of coordination, and loss of consciousness.<\/p>\n

Fortunately, there\u2019s a quick, chemical means of increasing blood glucose levels if a diabetic reaches the point of losing self-awareness or becoming unconscious: glucagon. Glucagon is a hormone made by the body that raises blood glucose levels, and a formulation is available from Eli Lilly and Novo Nordisk that can be injected intramuscularly or intravenously.<\/p>\n

Unfortunately\u2014and here\u2019s where the obvious problem comes in\u2014the formulations as manufactured and packaged by Lilly and Novo Nordisk are not user-friendly, to say the least.\u00a0 The current glucagon kits are throwbacks to the Lon Chaney<\/a>\u00a0days of Hollywood, something that would be found in the hands of Dr. Frankenstein or the Wolf Man.<\/p>\n

And by that I mean, the needle is gigantic, and the procedure is cumbersome. Because the glucagon peptide is very unstable in solution, it is stored in its lyophilized form (that is, as a powder), and the user must mix the glucagon into solution at the time of use.<\/p>\n

This mixing process is not that hard in theory, or even in controlled circumstances. However, no one needs glucagon under calm conditions. The person responsible for the mixing and administering is not a professional, or even a diabetic used to daily injections. It\u2019s the diabetic\u2019s poor friend or coworker, freaking out as they try to remember what their now comatose colleague told them about the glucagon. And this person has never given someone an injection in his life, much less with a needle the length of his thumb.<\/p>\n

So if we\u2019re lucky, the friend figures it out, administers the glucagon, and everyone turns out okay. If we\u2019re not, the friend uncaps the needle, stabs himself as his shaking hands try to mix the solution with the powder, and passes out.<\/p>\n

Okay, that\u2019s perhaps a little bit melodramatic, but\u2014come on, we\u2019ve sent men to the moon! There must be a better way.<\/p>\n

\"Glucagon<\/a>
Glucagon Kit<\/figcaption><\/figure>\n

And there is. Enter the GlucaPen. Enject, Inc., a biotech start-up, has developed and prototyped a two-chamber glucagon pen designed to automatically mix the glucagon and liquid, and to inject the solution with a simple press of the pen to the patient\u2019s skin. The needle itself is hidden through the whole process, and remains shielded for easier disposal afterwards. The packaging on the pen displays the three easy steps that are necessary to operate the device.<\/p>\n

The prototypes are there, the company is ready; what\u2019s the hold up?<\/strong><\/p>\n

Well, in the biotech world, it seems there are three recurring answers to the question, \u201cWhy don\u2019t I have one yet?\u201d The first is that there are technical difficulties; that\u2019s not a problem here, as the GlucaPen has been designed and manufacturing procedures are standing in waiting. The parts of pen itself will be manufactured by third-parties, Bachem AG, Vetter Pharma AG and SHL Group.<\/p>\n

The second common reason for delay is that the product is waiting for regulatory approval. The GlucaPen has yet to go through the necessary trials to get the desired 505b2 approval from the FDA, but Enject anticipates that the requisite studies will proceed without any technical difficulties. There are two main points they have to prove for the FDA\u2014the first is that their formulation of glucagon, from the Swiss company Bachem, Inc., is bioequivalent to the formulations still on the market. The difference between the GlucaPen\u2019s glucagon and the glucagon currently in glucagon kits is that the GlucaPen uses what\u2019s called synthetic glucagon, rather than recombinant glucagon. The difference between the two is how they\u2019re made– synthetic glucagon is made using a technique called peptide synthesis, in which the desired protein is made in vitro<\/em> (that is, outside of any living organism) by linking together the desired amino acids. Recombinant glucagon, like recombinant insulin, involves inserting the gene\u2019s DNA into a host bacterium like E. coli and collecting the protein that the bacteria then transcribe.<\/p>\n

Practically speaking, there should be very little difference between the two chemicals, and in fact the synthetic formulation of glucagon is used in humans in Japan, but Enject must prove this to the FDA. The first step is to make sure the glucagon is safe; Enject anticipates that the FDA will require only a small animal toxicology study. The second step is to make sure the synthetic glucagon behaves equivalently to the recombinant form in human subjects. For this, Enject plans a clinical trial with 32 non-diabetic adult volunteers. After fasting overnight, the patients will be randomized to receive injections of the Bachem glucagon and Novo Nordisk\u2019s version in turn, a week apart. If the effect of the synthetic glucagon is statistically similar to that of the recombinant glucagon, this should be sufficient to establish bioequivalence.<\/p>\n

The second sticking point for the FDA will be CMC\u2014chemistry, manufacturing, and controls. Are the manufacturing processes consistent and error-free? Does each batch of pens come out the same? Here, too, Enject is confident that they will pass with flying colors, and is ready to begin setting up production of there first batch of pens that will serve as the test batch for the FDA.<\/p>\n

That, then, brings us to the third reason a product gets held up\u2014cold, hard cash. Enject is ready to take on the FDA, and thinks that regulatory approval is forthcoming; the problem is that the clinical trials and manufacturing approval will take an estimated fifteen million dollars to complete, according to Enject. That sum would get Enject to the point of having 120,000 \u2013 180,000 pens ready for distribution, but raising that sum is no easy task.<\/p>\n

Thus far, Enject has raised about four million dollars (a pittance, in the biotech world) from angel investors and private parties, but for the additional 15 million, they will need more substantial funding. They are in ongoing discussions with potential investors and interested parties in the pharmaceutical industry. According the company, the challenges they have to routinely overcome include the misconception \u00a0that the current glucagon kits are sufficient, and there is no substantial market opportunity for GlucaPen.<\/p>\n

Enject, of course, believes there is a market, and is going a long way to demonstrate that, \u00a0commissioning a survey-based study distributed via the internet \u00a0to characterize the impacts of severe hypoglycemia according to both patients and caregivers (mostly parents). The study, with survey questions designed in collaboration with Dr. William Polonsky, a well-known figure in the field of diabetes psychology, incorporates the opinions of 655 respondents, 420 of which were diabetic patients.<\/p>\n

Notably, the vast majority– 96% of caregivers and 99% of patients– of both patients and caregivers had seen at least one severe hypoglycemic event since diagnosis. Further, a third of caregivers had actually administered a glucagon injection. Many patients and caregivers agreed\u201486% and 93%, respectively\u2014that glucagon kits were lifesavers.<\/p>\n

However, despite the reported use-cases and respect for the glucagon kits, 45% of patients felt that the current kits were \u201ctoo complicated for my family or friends to use.\u201d And, though that\u2019s less than half of patients, I can\u2019t help but wonder\u2014if 45% of patients have no able responder nearby, the likelihood of a severe hypoglycemic event turning fatal or permanently damaging is greatly increased.<\/p>\n

So where does the GlucaPen fit in to that likelihood? Based on pictures and a video demonstration, 93% of caregivers and 77% of patients thought the GlucaPen was an improvement over the current kits, and 98% of caregivers and 90% of patients expressed interest in obtaining at least one pen when they are available.<\/p>\n

These figures, though, hide the ebullience and excitement that is visible in patient and caregiver commentary. One caregiver said, \u201cI love it! I have always thought that our current kit would be difficult to deal with in a high stress situation. I would immediately buy one of your new Glucagon pens! Long overdue!\u201d Another, capturing well the anxiety about anxiety that colors my consideration of glucagon, noted, \u201cAbsolutely brilliant! Would be much easier for another person to use and I could stop worrying so much!\u201d<\/p>\n

The implication, then, is that there is a market for glucagon pens, beyond even the very basic concern that many caregivers, school personnel, and emergency responders feel inadequately prepared to save lives with the current product. The trick for Enject, then, will be convincing investors and strategic partners that this is the case, and then moving the pen through the pipeline into pharmacies.<\/p>\n

Will they be able to do it? It looks like the product is ready, the market is ready, and even the regulatory landscape is ready. All that\u2019s left, then, is some business magic\u2014 which is to say, some combination of luck, the right handshakes, and favorable financial conditions to bring the GlucaPen to us.<\/p>\n

\n","protected":false},"excerpt":{"rendered":"

The current glucagon kits are not user-friendly, to say the least…<\/p>\n","protected":false},"author":16,"featured_media":19387,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1443,1547],"tags":[899],"yoast_head":"\nGlucaPen: The Way Glucagon Ought To Be<\/title>\n<meta name=\"description\" content=\"Diabetics on insulin\u2014 type 1 and type 2\u2014suffer from hypoglycemia. Glucagon is a quick, chemical means of increasing blood glucose levels...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/asweetlife.org\/?p=19238\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Karmel Allison\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=19238\",\"url\":\"https:\/\/asweetlife.org\/?p=19238\",\"name\":\"GlucaPen: The Way Glucagon Ought To Be\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=19238#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=19238#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/08\/Glucapen-home1.jpg\",\"datePublished\":\"2011-08-31T13:02:22+00:00\",\"dateModified\":\"2016-01-06T10:11:53+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/f5fcddf5f602b824791c194a1ab8d4d3\"},\"description\":\"Diabetics on insulin\u2014 type 1 and type 2\u2014suffer from hypoglycemia. Glucagon is a quick, chemical means of increasing blood glucose levels...\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=19238#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=19238\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=19238#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/08\/Glucapen-home1.jpg\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/08\/Glucapen-home1.jpg\",\"width\":600,\"height\":304},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/asweetlife.org\/?p=19238#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/asweetlife.org\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"GlucaPen: The Way Glucagon Ought To Be\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/asweetlife.org\/#website\",\"url\":\"https:\/\/asweetlife.org\/\",\"name\":\"ASweetLife\",\"description\":\"The Diabetes Magazine\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/asweetlife.org\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/f5fcddf5f602b824791c194a1ab8d4d3\",\"name\":\"Karmel Allison\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/64faa2c004e005a70478b823e766a419?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/64faa2c004e005a70478b823e766a419?s=96&d=mm&r=g\",\"caption\":\"Karmel Allison\"},\"description\":\"Karmel was born in Southern California, diagnosed with Type 1 Diabetes at the age of nine, and educated at UC Berkeley. Karmel now lives in San Diego with her husband, where she is loving the sunshine, working in computational biology at the University of California, San Diego, and learning to use the active voice when talking about her diabetes.\",\"url\":\"https:\/\/asweetlife.org\/?author=16\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"GlucaPen: The Way Glucagon Ought To Be","description":"Diabetics on insulin\u2014 type 1 and type 2\u2014suffer from hypoglycemia. Glucagon is a quick, chemical means of increasing blood glucose levels...","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/asweetlife.org\/?p=19238","twitter_misc":{"Written by":"Karmel Allison","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/asweetlife.org\/?p=19238","url":"https:\/\/asweetlife.org\/?p=19238","name":"GlucaPen: The Way Glucagon Ought To Be","isPartOf":{"@id":"https:\/\/asweetlife.org\/#website"},"primaryImageOfPage":{"@id":"https:\/\/asweetlife.org\/?p=19238#primaryimage"},"image":{"@id":"https:\/\/asweetlife.org\/?p=19238#primaryimage"},"thumbnailUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/08\/Glucapen-home1.jpg","datePublished":"2011-08-31T13:02:22+00:00","dateModified":"2016-01-06T10:11:53+00:00","author":{"@id":"https:\/\/asweetlife.org\/#\/schema\/person\/f5fcddf5f602b824791c194a1ab8d4d3"},"description":"Diabetics on insulin\u2014 type 1 and type 2\u2014suffer from hypoglycemia. Glucagon is a quick, chemical means of increasing blood glucose levels...","breadcrumb":{"@id":"https:\/\/asweetlife.org\/?p=19238#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/asweetlife.org\/?p=19238"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/?p=19238#primaryimage","url":"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/08\/Glucapen-home1.jpg","contentUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2011\/08\/Glucapen-home1.jpg","width":600,"height":304},{"@type":"BreadcrumbList","@id":"https:\/\/asweetlife.org\/?p=19238#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/asweetlife.org\/"},{"@type":"ListItem","position":2,"name":"GlucaPen: The Way Glucagon Ought To Be"}]},{"@type":"WebSite","@id":"https:\/\/asweetlife.org\/#website","url":"https:\/\/asweetlife.org\/","name":"ASweetLife","description":"The Diabetes Magazine","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/asweetlife.org\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/f5fcddf5f602b824791c194a1ab8d4d3","name":"Karmel Allison","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/64faa2c004e005a70478b823e766a419?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/64faa2c004e005a70478b823e766a419?s=96&d=mm&r=g","caption":"Karmel Allison"},"description":"Karmel was born in Southern California, diagnosed with Type 1 Diabetes at the age of nine, and educated at UC Berkeley. Karmel now lives in San Diego with her husband, where she is loving the sunshine, working in computational biology at the University of California, San Diego, and learning to use the active voice when talking about her diabetes.","url":"https:\/\/asweetlife.org\/?author=16"}]}},"_links":{"self":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/19238"}],"collection":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=19238"}],"version-history":[{"count":0,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/19238\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/media\/19387"}],"wp:attachment":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=19238"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19238"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19238"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}