Amylin Pharmaceuticals

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Amylin Pharmaceuticals, Inc. develops medicines to treat diabetes, obesity, and cardiovascular disease. The company's two lead drugs are SYMLIN and exenatide, both developed to treat diabetes. SYMLIN and exenatide are in late-stage development, nearing full approval for commercialization. Amylin also has several other drugs in earlier stages of the development and approval process, including pharmaceuticals known as AC2592, AC137, and AC162352. Most of Amylin's financial support comes from a collaboration agreement with Eli Lilly & Co. to develop and market exenatide. In 2001, SYMLIN was scheduled for review by the FDA's Endocrinologic and Metabolic Drugs and Advisory Committee (EMDAC). The drug's existence was at stake. SYMLIN, slated to be the first drug to work with insulin to lower levels of blood glucose without having the side effect of weight gain, needed to gain EMDAC's approval if it had any chance of passing through final regulatory review and entering the market. The FDA not only typically heeded the rulings of EMDAC, but also was more conservative than its panel, often ruling against a drug EMDAC had approved. As the July 2001 review with EMDAC neared, Cook and other executives went to great lengths to ensure SYMLIN earned EMDAC's approval. The company rehearsed its presentation of SYMLIN, creating a simulated setting that followed the exact configuration of the tables and chairs in EMDAC's presentation room in Washington, D.C. The company invited diabetes specialists from throughout the country to ask Amylin's staff the same type of questions the panel's specialists were expected to ask. "We trained our people to use slides and how to present," Cook said in an April 7, 2003 interview with San Diego Business Journal. "We wanted them to be totally comfortable with the physical surroundings of the event so that when they went in front of the panel they wouldn't have stage fright." Amylin staged a final rehearsal in Washington, D.C., before appearing before EMDAC. Amylin's team of SYMLIN presenters made their case before EMDAC in July and waited for the nine-member panel's findings. EMDAC voted 8-1 that SYMLIN's trials proved efficacy, but the panel ruled 8-1 against using the drug for Type I diabetes and 6-3 against using it for Type II diabetes. EMDAC also voted 8-1 that SYMLIN appeared not to be safe. The panel's findings portended disaster, suggesting that nearly 15 years of work had been in vain. "The jury is still out," Cook told reporters after the panel's votes were revealed, as quoted in the April 7, 2003 issue of San Diego Business Journal, but few observers shared his muted optimism. Amylin appeared on the verge of collapse. The deathblow of a drug developer had been delivered, but in October 2001, three months after EMDAC's ruling, a stunning announcement offered a lifeline. In a decision the April 7, 2003 issue of San Diego Business Journal described as "baffling," the FDA voted against the recommendations of EMDAC and issued an "approvable letter" for SYMLIN. Although the FDA said it wanted to see more data before approving SYMLIN for market, the unusual reversal renewed hope that the drug, which one analyst claimed could generate $260 million in worldwide revenue annually, would give Amylin its first marketable product. Source: International Directory of Company Histories , Vol.67. St. James Press, 2005.