Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection (NYSE:LLY)
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`7/27/15, 3:58 PM
`
`Amylin and Lilly Announce FDA Approval of BYETTA(TM)
`(Exenatide) Injection
`
`Apr 29, 2005 /PRNewswire via COMTEX/ --
`
` --A New First-in-Class Treatment for Patients with Type 2 Diabetes--
`
`SAN DIEGO, Calif. and INDIANAPOLIS, Ind., April 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), and Eli
`Lilly and Company (NYSE: LLY) announce that the U.S. Food and Drug Administration (FDA) has approved BYETTA(TM) (exenatide)
`injection as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control
`on metformin and/or a sulfonylurea, two common oral diabetes medications. BYETTA (pronounced bye-A-tuh), the trade name for
`exenatide, is the first in a new class of medicines known as incretin mimetics. BYETTA will be available to pharmacies by June 1, 2005.
`BYETTA improves blood sugar control by lowering both postmeal and fasting glucose levels leading to better long-term control as
`measured by hemoglobin A1C. BYETTA does this through several actions, including the stimulation of insulin secretion only when blood
`sugar is high and by restoring the first- phase insulin response, an activity of the insulin-producing cells in the pancreas that is lost in
`patients who have type 2 diabetes. Most patients in the long-term BYETTA clinical studies also experienced reductions in weight.
`"The availability of a treatment that lowers blood sugar and has the potential to help restore the response of the body's insulin-
`producing cells is an exciting advance for patients with type 2 diabetes," said Dr. David Kendall, Medical Director at International
`Diabetes Center in Minneapolis, Minnesota, and an investigator for the BYETTA clinical studies. "BYETTA is a truly unique tool for the
`management of type 2 diabetes and is an appropriate option to consider when patients cannot control their blood sugar using one or
`more oral medications."
`"Successfully managing diabetes is a daily struggle for millions of Americans," said Ginger L. Graham, President and Chief Executive
`Officer, Amylin Pharmaceuticals, Inc. "Often, current treatments do not provide adequate blood sugar control leaving patients and
`caregivers frustrated. BYETTA, a first-in-class medicine, is a new therapy for those who are not able to effectively control their blood
`sugar with their current oral medications."
`"BYETTA offers an exciting new option for people with type 2 diabetes and marks an important milestone for Amylin and Lilly's
`successful collaboration," said Sidney Taurel, Chairman and Chief Executive Officer, Eli Lilly and Company. "With BYETTA's
`demonstrated effects on blood sugar and its safety profile, physicians and patients now have a new approach to fight the growing
`diabetes epidemic."
`In addition to approving BYETTA for use as an adjunct to existing oral medicines, the FDA also stated that BYETTA is approvable as a
`stand-alone therapy (monotherapy) for patients with type 2 diabetes. Any additional data submitted to support a monotherapy indication
`is expected to receive a six- month review.
`BYETTA is formulated for self-administration as a fixed dose, subcutaneous injection given prior to the morning and evening meals.
`BYETTA will be made available in both a 5-microgram per dose and a 10-microgram per dose prefilled pen-injector device.
`Safety and Tolerability Information
`In the three 30-week controlled trials, adverse events associated with BYETTA were generally mild to moderate in intensity. The most
`frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy in most patients who initially
`experienced nausea, the frequency and severity decreased over time.
`Patients receiving BYETTA in combination with a sulfonylurea have an increased risk of hypoglycemia; to reduce this risk, reduction in
`the dose of the sulfonylurea should be considered. In the 30-week controlled clinical trials, hypoglycemia appeared to be dependent on
`the doses of both BYETTA and a sulfonylurea. Most episodes of hypoglycemia were mild to moderate in intensity and all were resolved
`with oral administration of carbohydrate. No increased risk of hypoglycemia was observed in the 30-week controlled studies with
`BYETTA when used in combination with metformin compared to placebo.
`Patients should also be advised that treatment with BYETTA may result in a reduction in appetite, food intake, and/or body weight and
`that there is no need to modify the dosing regimen due to such effects.
`BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, nor is BYETTA a substitute for
`insulin in insulin-requiring patients. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal
`impairment, or in patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral
`medications that require rapid gastrointestinal absorption.
`For full Prescribing Information, visit www.BYETTA.com .
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`https://investor.lilly.com/releasedetail.cfm?ReleaseID=161886
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`Page 1 of 3
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`SANOFI-AVENTIS Exhibit 1026 - Page 1
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`IPR for Patent No. 8,951,962
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`

`
`Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection (NYSE:LLY)
`
`7/27/15, 3:58 PM
`
`About BYETTA
`BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same
`effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple
`effects on the stomach, liver, pancreas and brain that work in concert to regulate blood sugar.(1) BYETTA was approved by the FDA for
`use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed
`oral medications metformin, a sulfonylurea or both. For full Prescribing Information, visit www.BYETTA.com .
`About Incretin Mimetics
`Incretin mimetics is a new class of therapeutics for use in the fight against type 2 diabetes. An incretin mimetic works to mimic the
`antidiabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the
`body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon
`following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. BYETTA is the first
`FDA-approved agent of this new class of medications.
`About Diabetes
`Diabetes affects an estimated 194 million adults worldwide(2) and more than 18 million in the United States.(3) Approximately 90 to 95
`percent of those affected have type 2 diabetes, a condition where the body does not produce enough insulin and/or the cells in the body
`do not respond normally to insulin.(3) Diabetes is the fifth leading cause of death by disease in the United States(4) and costs
`approximately $132 billion per year in direct and indirect medical expenses. Type 2 diabetes usually occurs in adults over the age of 40,
`but is increasingly common in younger people.(3)
`According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60
`percent of diabetes patients do not achieve target hemoglobin A1C levels (less than 7 percent according to American Diabetes
`Association guidelines(5)) with their current treatment regimen.(6)
`Amylin to Webcast Investor Conference Call
`Amylin Pharmaceuticals will webcast a conference call to discuss the BYETTA approval and commercialization plans on Friday, April
`29, 2005 at 12:00 p.m. ET (9:00 a.m. PT). Ginger L. Graham, President and Chief Executive Officer of Amylin Pharmaceuticals, will
`lead the call.
`The call will be webcast live through Amylin's corporate website, and a recording will be made available following the close of the call.
`To access the webcast, please log on to www.amylin.com approximately fifteen minutes prior to the call to register, download and install
`any necessary audio software. A recording will be available by phone for 24 hours beginning approximately one hour after the close of
`the call and can be accessed at 888-286-8010 (domestic) or 617-801-6888 (international), conference ID number 65243380.
`About Amylin and Lilly
`Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and
`commercialization of innovative medicines. Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in
`metabolism is available at www.amylin.com .
`Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live
`longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals
`improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For
`more information about Lilly's current diabetes products visit www.lillydiabetes.com .
`Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical
`products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific
`organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the
`world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com .
`This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those
`discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA may not prove to
`be an important new therapeutic option, additional indications for BYETTA may not be received, BYETTA may not be commercially
`available when planned and/or may be affected by unexpected new data or technical issues. The potential for BYETTA may also be
`affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance and any issues related to
`manufacturing and supply. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed
`SEC documents such as their Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking
`statements.
`REFERENCES
`(1) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-
`4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of Clinical Endocrinology &
`
`https://investor.lilly.com/releasedetail.cfm?ReleaseID=161886
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`Page 2 of 3
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`SANOFI-AVENTIS Exhibit 1026 - Page 2
`
`IPR for Patent No. 8,951,962
`
`

`
`Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection (NYSE:LLY)
`
`7/27/15, 3:58 PM
`
`Metabolism. 2003; 88(7):3082- 3089.
`(2) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-
`2FD3-87B73F80BC22682A. Accessed April 12, 2005.
`(3) Centers for Disease Control and Prevention, National Diabetes Fact Sheet. Available at:
`http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf.
`(4) Kochanek KD, Murphy SL, Anderson RN, Scott C. Deaths: Final data for 2002. National vital statistics reports; vol 53 no 5.
`Hyattsville, Maryland: National Center for Health Statistics. 2004.
`(5) American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2005;28:S4-36S.
`(6) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2
`diabetes. Diabetes Care. 1999;22:403-408.
`P-LLY
`(Logo: http://www.newscom.com/cgi-bin/prnh/20050427/LILLYAMYLINLOGO )
`SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
`
`Jamaison Schuler of Lilly, +1-317-655-2111; or Eric Shearin of Amylin,
`+1-858-552-2200, ext. 7177
`
`http://www.prnewswire.com
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`Copyright (C) 2005 PR Newswire. All rights reserved.
`News Provided by COMTEX
`
`https://investor.lilly.com/releasedetail.cfm?ReleaseID=161886
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`Page 3 of 3
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`SANOFI-AVENTIS Exhibit 1026 - Page 3
`
`IPR for Patent No. 8,951,962