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BostonMatty
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35+ years as a private investor, college finance/economics adjunct lecturer, corporate project engineer and business development strategist, individual and small business tax preparation. Corporate experience in communications and energy BS Mechanical Engineering - Carnegie Mellon University MBA... More
  • Management Makes A Difference: A Case Study 0 comments
    Jul 7, 2013 12:26 PM

    Amylin Pharmaceuticals developed a drug named Byetta (exenatide), a Type 2 diabetes drug, which was an analog based upon gila monster saliva. Gila monsters eat only twice a year so their digestive systems work extremely slowly. Amylin bought the rights to the analog but needed clinical trials funding from a partner to proceed. They received that assistance from E. I. Lilly for 50% of the earnings in the US and worldwide rights to market the drug outside the United States. Exenatide, a twice a day injectable from a pen which automatically dispenses the right dosage with a simple twist of the cartridge, was approved by the FDA in April, 2005. It was confirmed as a second-line therapy, only after first line treatments, such as metformin, had failed.

    Amylin was the first to market this GLP-1 (glucagon-like peptide-1 receptor agonists 1) drug, despite Lilly's interference (they have a large insulin franchise and were developing their own GLP-1) and the typical slow approval process by the FDA during the Bush Administration. Yet Amylin lost its lead when it failed to have enough pens available early, let LLY assist in the sales in the US while trying to develop its own sales organization and was slow to get to the internists who handle most of the diabetic patients (versus endocrinologists).

    Amylin also faced a pancreatitis scare campaign initiated by Lehman's research team at that time, now Barclay's. Amylin's management had the data to rebuke the scare but took several years, including new studies, to get it to the FDA, meanwhile losing market share and potential new customers.

    Merck's Januvia, a pill, came to market and, because of a very large needle-phobic patient population, stole quite a bit of the non insulin market.

    The turbulent Amylin-Lilly partnership came to an end when Lilly struck a deal to market Boehringer Ingelheim's DPP-4 inhibitor (en.wikipedia.org/wiki/Dipeptidyl_peptida...), violating the Byetta marketing agreement and precipitating an Amylin law suit. The suit was settled and Amylin regained all the rights to Byetta.

    Now there are multiple GLP-1 and DPP-4 inhibitor competitors and only recently did the approval of a once a week version of Byetta, Bydureon, induce Bristol Myers to purchase Amylin at a fraction of what it could have commanded with even good management execution. Carl Icahn got involved a few years prior to the buyout and that alway spells problems for management.

    I used Byetta for 5 years; it had minor side effects, nausea in getting started which faded after a few weeks. It kept my A1c in check until recently when I have been able to control it with diet and exercise and no longer use any type 2 drug. Insulin can kill and it adds weight, not a good side effect for a diabetic. Byetta reduces weight and can never induce hypoglycemia by itself.

    This was a transformational drug, yet never realized its potential as the blockbuster it should have. That was due to losing its "first to market advantage" and drug efficacy superiority to ineffective management, who let a devious partner in, failed multiple times at the FDA (not receiving first line approval and not overcoming a black box requirement for pancreatitis) , and missed a potentially great launch with insufficient sales, marketing and product.

    Great science can be nullified by inept management. Fair to good science (Januvia) can become blockbusters+++ with superior management strategy, execution and promotion..

    1 - GLP-1 is an essential incretin hormone.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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