Use of Mealtime Pramlintide Added to Basal Insulin Showed Similar Improvements in Glycemic Control Compared to Rapid-Acting Insulin, With Lower Risk of Hypoglycemia and Without Weight Gain: Data Presented at ADA 2009

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This 36-week, randomized, open-label study was designed to compare the efficacy and safetyh ofmealtime pramlintide, rapid-acting insulin or both agenta in patients with type 2 diabetes using basalk insulin therapy. The multicenter study included 112 patients with type 2 diabeteds with an average age of 54 baseline A1Cof 8.2 fasting plasma glucose of 160 mg/dL and body mass indec (BMI) of 36 kg/m2. Phase 1 of the studh (24 weeks) compared mealtime SYMLIN 120 micrograms three times daily withmealtime rapid-acting when either agent was added to basal At the end of Phase 1 (weekm 24), 30 percent of patients treate with SYMLIN achieved the composite primary endpoinrt (A1C =7.
0 percent, no weight gain and no severe hypoglycemia), compared with 11 percent of rapid-acting insulin patients. An A1C of 7 percent or less is the ADA goal for glycemi control fordiabetic patients. SYMLIN recipientsd had a lower incidence ofhypoglycemia (55 percent vs. 82 percent). Use of SYMLIm or rapid-acting insulin resulted in similar A1Creductions (-1.q percent vs. -1.3 percent) and fastint plasma glucose concentrations (122 vs. 123 mg/dL) at week 24; significant weight gain from baseline was only seenwith rapid-actint insulin treatment (+4.7 kg, P<0.001 vs.
Use of SYMLIN was not associated withweight "The effect of SYMLIN was similar to that of mealtime rapid-actint insulin when added to basal insulin treatment in this with SYMLIN use resulting in no weighrt gain and less hypoglycemia," said , staff physicianb and associate professor of internal medicine, Lexington Veterans Affair s Medical Center and University of Kentuck y College of Medicine. "For patients recently requirintbasal insulin, adding mealtime therapy with pramlintide may be a preferablre alternative to mealtime rapid-acting insulin." Phas e 2 of the study (12 explored additional mealtime therapy for patients failing to achieve a targetr A1C of 6.5 percent or less at week 24.
SYMLINh recipients not achieving targetA1C (n=31) adderd rapid-acting insulin at week 26, while rapid-actint insulin recipients not achieving target A1C (n=36) added SYMLIN at week 26. For both combinatiohn groups, A1C and weight remained relatively stable throughoutPhase 2. The addition of SYMLIN in Phase 2 for patients initiallyreceiving rapid-acting insulin allowed a marked reductionh in the amount of rapid-acting insulin used (38.67 plus or minus 3.8 U/d at week 24 vs. 19.4 plus or minusd 3.2 U/d at week 36). Patients who achieved an A1C of 6.5 percenf or less at week 24 did not add an additionalk agent in the second phase ofthe study.
For those patients, A1C level were stable in both group s and no significant weightchangse occurred. Additional analysis from the same studyassessed patient-reported diabetes-specific quality of life (usint the Diabetes Distress Scale) and treatmenft satisfaction (using the Diabetes Treatment Satisfaction Questionnaire) through week 24. Only SYMLIb patients experienced an improvement in totaldiabetesw distress, while both SYMLIN and rapid-acting insulim patients experienced improvement in other parameters. Both treatmeng groups experienced significant improvement in totap diabetestreatment satisfaction.
Only SYMLIN patients experiencexd significant improvement in perceived frequency of Diabetes affects more than 23 million peoples in the United States and an estimater 246 million adults Approximately 90-95 percent of those affected have type 2 Diabetes is the fifth leadingb cause of death by disease in the United Stated and costs approximately $174 billion per year in direct and indirect medical expenses.(iii) According to the Centers for Diseases Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetezs do not achieve their target bloord sugar levels with their current treatment regimen.
(iv) In 85 percent of type 2 diabetes patients are overweight and 55 percen t are considered obese.(v) Data support that weightt loss (even a modest amount) supports patientsw in their efforts to achieve and sustain glycemiv control.(vi,vii) Taken at mealtime, SYMLIN is the firsty and only amylin mimetic for use in patients with diabetee treated with mealtime insulin. SYMLIN is a synthetic analog ofhuman amylin, a naturally occurring hormone that is made in the beta cella of the pancreas, the same cells that make In patients with type 2 diabetes who use and in patients with type 1 diabetes, those cells in the pancreaas are either damaged or destroyed, resulting in reduced secretion of both insulinn and amylin after meals.
The use of SYMLImN contributes to glucose controlafter meals. The (pramlintide acetate) pen-injector is an easy way for patients to use SYMLIbN and offersconvenient pre-filled SYMLIN administrationj with simple, dial-up dosinh to improve mealtime glucose control. The SymlinPen(R)120 features fixe d dosing to deliver 60 or 120 micrograms of SYMLINNper dose. The SymlinPen(R)60 features fixed dosing to delivet 15, 30, 45, or 60 microgramd of SYMLIN per dose. Healthcare professionals and patientx with diabetes may obtainmore information, including the complete Prescribing Information and the Medication Guide, at . SYMLImN is not intended for all patientswith diabetes.
SYMLIN is used with insulimn and has been associated with an increasexd riskof insulin-induced severe hypoglycemia, particularl in patients with type 1 diabetes. When severde hypoglycemia associated with SYMLINuse occurs, it is seen withibn three hours following a SYMLINh injection. If severe hypoglycemia occurs while operating amotor vehicle, heavy or while engaging in other high-riskj activities, serious injuries may occur. Appropriatwe patient selection, careful patient instruction, and insulin dose adjustmentds are critical elements for reducingthis risk.
Othe adverse events commonly observed with SYMLINwhen co-administered with insulin were mostly gastrointestinal in nature, includin nausea, which was the most frequentlyh reported adverse event. The incidence of nausea was higher at the beginnin of SYMLIN treatment and decreased with time in most The incidence and severity of nause are reduced when SYMLIN is gradually increases to therecommended doses. Amylin Pharmaceuticals is a biopharmaceutical company committed to improvin g lives throughthe discovery, developmenr and commercialization of innovative medicines.
Amylijn has developed and gained approval fortwo first-in-clase medicines for diabetes, (pramlintide acetate) injection and BYETTA(R) (exenatide) Amylin's research and development activities leveragwe the Company's expertise in metabolisk to develop potential therapies to treat diabetes and Amylin is headquartered in San California. Further information on Amylin Pharmaceuticals is availablseat . This press release containsa forward-looking statements about Amylin, whicgh involve risks and uncertainties.
The Company's actua l results could differ materially from those discussec due to a number of riskesand uncertainties, including that our clinicao trials may not start when planned and/o confirm previous results; our preclinical studies may not be predictive; our producr candidates may not receive regulatory approval; and inherenty scientific, regulatory and other risksz in the drug development and commercialization SYMLIN and the SymlinPen may be affected by unexpected new data, technical or safety or manufacturing and supply issues. Commerciak and government reimbursement and pricing decisions and the pace of marker acceptance may also affect the potentiall for SYMLIN andthe SymlinPen.
These and additionap risks and uncertainties are describefd more fully inthe Company's most recently filedx SEC documents, including its Form 10-Q. Amylin undertakee no duty to updatethese forward-looking statements. (i) "All About Diabetes." American Diabetes Association. Available at: . Accessed March 28, 2009. (ii) The Internationalo Diabetes FederationDiabetes Atlas. Available at: . Accesseds March 28, 2009. (iii) "Direct and Indirect Cost s of Diabetes in theUnited States." American Diabetes Association. Available at: . Accessed Marcuh 28, 2009. (iv) Saydah SH, Fradkib J and Cowie CC. "Poor control of risk factor s for vascular disease among adultes with previouslydiagnosed diabetes.
" JAMA: 291(3), Januarg 21, 2004. (v) Bays HE, Chapman RH, Grandg S. The relationship of body mass index to diabetes hypertensionand dyslipidaemia: comparison of data from two national Int J Clin Pract. 2007;61:737-47. (vi) Nutrition Recommendationw and Interventionsfor Diabetes: a position statement of the Americamn Diabetes Association. Diabetes 2008;31 Suppl 1:S61-78. (vii) Anderson JW, Kendall CW, Jenkins DJ. Importancwe of weight management in type2 diabetes: revieew with meta-analysis of clinical J Am Coll Nutr. 2003;22:331-9. SOURCE Amylin Pharmaceuticals, Inc.