{"id":428938,"date":"2010-03-15T08:19:13","date_gmt":"2010-03-15T12:19:13","guid":{"rendered":"http:\/\/www.xconomy.com\/?p=68498"},"modified":"2010-03-15T08:19:13","modified_gmt":"2010-03-15T12:19:13","slug":"amylin-alkermes-diabetes-drug-delayed-by-fda","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/428938","title":{"rendered":"Amylin, Alkermes Diabetes Drug Delayed by FDA"},"content":{"rendered":"\n
Biotech<\/a>, diabetes<\/a>, Drugs<\/a><\/div>\n

\t\t\"amyalks\"<\/a>
\n\t\tLuke Timmerman wrote:<\/strong><\/p>\n

[Updated: 8:38 am Eastern, 3\/15\/10<\/em>] Amylin Pharmaceuticals and its partners Eli Lilly and Alkermes are going to have to wait a while to celebrate. The FDA has delayed an application from San Diego-based Amylin (NASDAQ: AMLN<\/a>) and Indianapolis-based Eli Lilly to start marketing their new diabetes drug, the first once-weekly shot, as a more convenient alternative to control blood sugar.<\/p>\n

The silver lining is that the drug, exenatide once-weekly, doesn’t need to pass any new animal tests or clinical trials before it can be cleared for sale in the U.S., the companies said today in a statement. The FDA’s “complete response letter” raises issues around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy (REMS) program and “clarification of existing manufacturing processes,” the companies said. The FDA raised some issues at a December inspection of Amylin’s Ohio manufacturing plant, although those have been addressed, the companies said.<\/p>\n

The drug application is being closely watched<\/a> because it takes the active ingredient in Amylin’s best-selling drug and combines it with a biodegradable polymer technology from Waltham, MA-based Alkermes (NASDAQ: ALKS<\/a>) that makes it last longer in the blood. That polymer is the difference between an existing drug that must be injected twice a day and the newer form, which only requires one shot a week. The product will be marketed under the name Bydureon, the companies said.<\/p>\n

[Updated company comment, 8:38 am Eastern<\/em>.] The companies have already begun working on their response to the FDA letter, and expect to submit answers within a few weeks, Amylin CEO Dan Bradbury said in a conference call this morning. “We have a clear path forward,” Bradbury said.<\/p>\n

Amylin has the most at stake in the FDA’s decision to approve exenatide once-weekly, since it only has two other approved products, and the new drug is poised to drive its earnings for years to come. Alkermes stands to collect a 7.5 percent royalty on worldwide sales of the drug, without having to pick up any expenses for marketing or manufacturing. The drug is likely to generate peak worldwide sales of about $2 billion in 2017, according to JP Morgan analyst Cory Kasimov. An estimated 25 million people in the U.S. suffer from the chronic disease.<\/p>\n

Investors appeared relieved that the FDA’s issues can be resolved relatively quickly. Shares of Amylin climbed about 5 percent in pre-market trading to $21.25 at 8:08 am Eastern time after the announcement.<\/p>\n

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Biotech, diabetes, Drugs Luke Timmerman wrote: [Updated: 8:38 am Eastern, 3\/15\/10] Amylin Pharmaceuticals and its partners Eli Lilly and Alkermes are going to have to wait a while to celebrate. The FDA has delayed an application from San Diego-based Amylin (NASDAQ: AMLN) and Indianapolis-based Eli Lilly to start marketing their new diabetes drug, the first […]<\/p>\n","protected":false},"author":1192,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-428938","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/428938","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/1192"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=428938"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/428938\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=428938"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=428938"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=428938"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}