Eli Lilly and Company

Supplier profile

Products

Cancer

• Alimta® (pemetrexed)
• Gemzar® (gemcitabine hydrochloride)

Diabetes

• Actos® (pioglitazone hydrochloride)*
• Byetta® (exenatide) injection**
• Humulin® (human insulin [rDNA origin])
• Humalog® (insulin lispro injection [rDNA origin])
• Humalog® Mix75/25™ (75% Insulin lispro protamine suspension, 25% insulin lispro injection [rDNA origin])
• Humalog® Mix50/50™ (50% Insulin lispro protamine suspension, 50% insulin lispro injection [rDNA origin])
• Humulin® Pen (human insulin [rDNA origin]) & Humalog® Pen (insulin lispro [rDNA origin])

Growth Disorders

• Humatrope® (somatropin rDNA origin for injection, Lilly)v

Osteoporosis

• Evista® (raloxifene hydrochloride)

Sepsis

• Xigris® (drotrecogin alfa [activated])

Neuroscience

• Cymbalta® (duloxetine hydrocholoride)
• Prozac® (fluoxetine hydrochloride)
• Strattera® (atomoxetine hydrochloride)
• Symbyax® (olanzapine and fluoxetine hydrochloride)
• Zyprexa® (olanzapine)

Erectile Dysfunction

• Cialis® (tadalafil)***

Please Note: As of July 6, 2005, Lilly announced that it is discontinuing production of Iletin® II Pork Insulin (Regular and NPH®formulations), and Humulin®U Ultralente® and Humulin®L Lente®(Humulin U and Humulin L)****; insulin products. For more information about these products, please visit www.LillyDiabetes.com.

For full prescribing information for these products, use the respective Web site links listed on this page.

• Actos is a registered trademark of Takeda Chemical Industries, Ltd. and is used under license by Takeda Pharmaceuticals America, Inc.<
• Byetta is a registered trademark of Amylin Pharmaceuticals, Inc.
• Cialis is a registered trademark of Lilly ICOS LLC.
• Lente and Ultralente are registered trademarks of Novo Nordisk Pharmaceuticals.
• ReoPro is a registered trademark of Centocor Inc.

Pipeline - Late Stage

Select Late-Stage Pipeline Developments

Exenatide once-weekly - Lilly and its partners, Amylin Pharmaceuticals, Inc. and Alkermes, Inc., recently completed a promising 30-week comparator study of once-weekly exenatide injection and twice-daily Byetta injection in patients with type 2 diabetes. The companies anticipate regulatory submission to the FDA before the end of the first half of 2009.

Olanzapine long-acting injection - In the second quarter of 2007, Lilly submitted new drug applications to the U.S. Food and Drug Administration and the European Medicines Agency (EMEA) for approval of olanzapine long-acting injection.

AIR(R) Inhaled Insulin - Lilly and its partner, Alkermes, Inc., remain committed to their inhaled insulin program. A two-year safety trial and other studies are ongoing for both the inhaled insulin formulation and device. Lilly and Alkermes currently expect regulatory submission to the FDA in 2009.

Arzoxifene - A Phase III osteoporosis prevention trial that enrolled over 300 patients was recently completed. An additional five-year Phase III study, fully enrolled with more than 9,300 patients, examines arzoxifene's potential in vertebral fractures and breast cancer risk reduction. Lilly expects regulatory submission to the FDA in 2009.

Enzastaurin - A Phase III trial is under way for the use of enzastaurin in the treatment of non-Hodgkin's lymphoma, with regulatory submission expected in late 2010 on in early 2011.

Pipeline - Mid Stage

Select Early-to Mid-Stage Pipeline Developments

Diabetes Care - Lilly's diabetes care pipeline reflects the company's longstanding commitment to this core therapeutic area. Two recent business development transactions strengthened Lilly's position. The company recently announced an alliance with MacroGenics to develop and commercialize the humanized anti-CD3 monoclonal antibody teplizumab for type 1 diabetes. Teplizumab is currently being studied in a combined Phase II/III trial. Earlier this year, Lilly acquired the exclusive rights to OSI's Glucokinase Activator (GKA) program, including the lead compound LY2599506. This compound, currently in Phase I, represents a novel approach in addressing type 2 diabetes.

Cardiovascular - Development is ongoing for the company's oral Factor Xa inhibitor for thrombotic disorders, with Phase 3 trials in VTE prophylaxis expected to begin in 2009. Two other indications for Factor Xa are also being pursued.

Oncology - Phase II trials are ongoing for ASAP, an oncology molecule being studied for non-small-cell lung cancer and melanoma, with new Phase II studies now initiated for ovarian cancer and soft-tissue sarcoma. Phase II trials are set to begin for survivin ASO, an antisense molecule targeted at solid tumors that Lilly is developing with its partner, ISIS Pharmaceuticals; a second antisense molecule targeted at solid tumors, eIF-4E ASO, is also set to begin Phase II studies in 2008. The company's early-stage oncology pipeline includes an additional five agents that progressed into Phase I clinical testing in 2007.

Neuroscience - In the area of Alzheimer's disease, Lilly continues to successfully develop two different but complementary Phase II molecules, a gamma-secretase inhibitor and an A-beta antibody. In 2008, another promising neuroscience molecule, NERI, is set to begin Phase III testing for depression and Phase II testing for ADHD. Phase II testing continues for the mGlu2/3 receptor agonist for schizophrenia, while LY2624803, the lead insomnia molecule obtained in the Hypnion acquisition, is slated to begin additional Phase II trials in 2008. GRC 6211, part of a portfolio of TRPV1 antagonists acquired from Glenmark Pharmaceuticals, is currently in early Phase II development for various pain conditions, including osteoarthritic pain. The early-stage neuroscience pipeline also includes molecules targeted for Parkinson's disease, alcoholism, migraine and chronic pain.

Anti-inflammatory - Lilly's mid-stage pipeline includes two promising molecules targeting rheumatoid arthritis currently in Phase II.

Personalized Medicine Speech

The rise of personalized medicine is one of the most important developments in health care today … and you’ve brought together the right mix of sponsors and experts from academic medicine, business, and patient care settings.

Of course I’m pleased that you saw fit to include someone from a major pharmaceutical company as well. Personalized medicine will change health care almost across the board … but nowhere, I would argue, are the cross-currents of change more powerful – or the stakes higher – than in the development, manufacture, and sale of prescription medicines. In my industry, we would be powerless to resist personalized medicine – not to say foolish.

For that reason, we at Lilly remain mystified by the skepticism that persists around the questions: “Are the drug companies really on board with personalized medicine? And will their business models accommodate products more finely targeted to patient groups within a disease category?”

I can only speak for Eli Lilly and Company but my answers to those questions are, “Yes, we’re not only on board but also trying to serve as a kind of conductor, helping to coax others on board. And, yes, our business model will accommodate personalized medicine. It may in fact depend on it.”

I’d like to use my time here today to elaborate on those contentions.

Let me start by challenging the widespread notion that personalized medicine is entirely, or even primarily, about unlocking the secrets of the human genome. Genomic medicine certainly serves to extend and hopefully to accelerate our goals but the promise of personalized medicine is actually much broader and much more deeply rooted.

Contrary to popular perceptions, the pharmaceutical industry has rarely pursued “one-size-fits-all” strategies in our promotional efforts. Segmentation of disease categories and patient groups has long been the norm. Today, however, what’s fundamentally different is the availability of tools, technologies, and new knowledge to inform such segmentation and to render it more relevant and meaningful.

The concept of the “biomarker” is a good example. Biomarkers – as telltale indicators of biological activity that help to guide treatment decisions – are nothing new. Longstanding measures such as HbA1c levels to determine appropriate diabetes regimens … or cholesterol levels to assess the possible benefit of statins – each of these are biomarkers.

Today, biomarkers are more pervasive and sophisticated than ever before, and they are coming into play at much earlier stages of drug development.

Presentations & Webcasts