GE and Lilly Announce Research Collaboration to Co-Develop Molecular In Vitro Diagnostics for Cancer Treatments

GE Global Research, the General Electric Company’s (NYSE:GE) centralized research and development organization, and GE Healthcare today announced a three-year collaborative research agreement with Eli Lilly and Company (NYSE:LLY) to discover and develop advanced in vitro diagnostic assays that may predict cancer treatment response to targeted therapies.

In addition to Lilly’s existing chemotherapy agents, Lilly is developing targeted cancer therapeutics, which are now in both early and late stage clinical development. GE is developing advanced multiplexed tissue-based assays and image analysis tools that can measure multiple biological pathways. The goal of this collaboration is to discover key protein and gene signatures that will predict the likelihood that a medication will be effective in treating certain cancers. Once identified the signatures can then be used to pre-select patients who are good candidates for the targeted therapy.

“The co-development of diagnostics and therapeutics is a major strategy of GE Healthcare’s “Early Health” vision, and our collaboration with Lilly and our expansion into in vitro diagnostics is right in line with this strategy,“ said, Dr. Michael Montalto, head of Molecular Imaging and Diagnostics Advanced Technologies for Global Research. “The combination of diagnostics and therapeutics is opening new doors in the fight against cancer and other life-threatening diseases. Through the application of molecular and cell biology to understanding disease, we can provide pharmaceutical companies with more advanced tools to develop more optimal drug therapies for cancer patients.”

“Our collaboration with GE complements Lilly’s research and development strategy of tailored therapeutics, or in other words, finding the right dose of the right medication at the right time for patients. Through our collaboration with GE Healthcare and GE Global Research, we hope to identify biomarkers for two of our targeted cancer therapeutic agents by examining patient tissues in order to determine which patients are most likely to respond to the medications and just as importantly which are not,” said Dr. Richard Gaynor, M.D., vice president, cancer research and global oncology platform for Eli Lilly and Company.

As the world becomes more educated and advanced in molecular medicine, the healthcare industry is experiencing a growing convergence of therapeutics and diagnostics. Through the use of molecular diagnostic tools that can discover key protein or gene signatures, pharmaceutical companies can begin to use that information to determine which patients are most likely to respond to a particular medication based on their particular genetic makeup.

The agreement between GE and Lilly will provide GE with access to clinical tissue samples from unidentified patients enrolled in Lilly’s clinical trials. In turn, Lilly will have access to GE’s advanced technologies in automated tissue-based image analysis and molecular reagents. These tools can be used during drug development to aid Lilly in evaluating the effectiveness of their drug candidates and potentially select patients for future trials.

In addition to helping Lilly identify patients for future trials, the diagnostic tools GE is providing also have the potential to greatly reduce the time and cost of cancer drug development.

The collaboration with Lilly is consistent with GE Healthcare’s Early Health Vision, which is about transforming healthcare delivery from a focus on treating late disease to a focus on adopting an Early Health model of care – where prevention, pre-disease detection, and early diagnosis are the key drivers. GE Healthcare has a strong portfolio of in vivo diagnostic imaging technologies and molecular contrast agents to assist with the detection and diagnosis of cancer, and expanding this strength toward in vitro diagnostics is a natural extension of this strategy.

About GE Global Research

GE Global Research is one of the world's most diversified industrial research organizations, providing innovative technology for all of GE’s businesses. Global Research has been the cornerstone of GE technology for more than 100 years, and is now focused on developing breakthrough innovations in areas such as molecular medicine, alternative energy, nanotechnology, advanced propulsion, and security technologies. GE Global Research is headquartered in Niskayuna, N.Y. and has facilities in Bangalore, India; Shanghai, China; and Munich, Germany. Visit Global Research at www.ge.com/research.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Headquartered in the United Kingdom, GE Healthcare is a US$17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

About Lilly

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.

Eli Lilly and Company to Acquire Privately Held Hypnion

Eli Lilly and Company and Hypnion, Inc. today announced that they have signed a definitive merger agreement whereby Lilly will acquire Hypnion, a privately held neuroscience drug discovery company focused on sleep disorders. The transaction has received the requisite approval of Hypnion stockholders and is expected to close near the end of the first quarter of 2007, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and other customary closing conditions. Financial terms of the deal were not disclosed.

"The acquisition of Hypnion provides Lilly with a broader and more substantive presence in the area of sleep disorder research," said Steven M. Paul, M.D., executive vice president, science and technology for Lilly. "Hypnion has leveraged its expertise in this area to develop both innovative technologies and molecules, including the promising insomnia compound HY10275. We are excited to bring this expertise to Lilly and continue the efforts to discover better treatments for patients struggling with insomnia and other sleep disorders."

Nick Galakatos, Ph.D., chairman of Hypnion, commented, "Having demonstrated the promise of our pipeline of sleep medicines in the clinic and our enabling SCORE technology, we recognized that a partnership with a leading pharmaceutical company was our best strategy for moving forward quickly. Given Lilly's long record of achievement in neuroscience, we are confident that together we can produce safer and more efficacious sleep medications."

In January, Hypnion announced that its compound HY10275 met the primary and secondary endpoints in the company's initial Phase II clinical trial at doses of 1 mg and 3 mg in adults with transient insomnia. HY10275 is a proprietary compound discovered and developed by Hypnion as a dual-acting H1/5HT2a compound using the SCORE-2004(TM) technology.

Lazard Freres served as financial advisors to Hypnion, while Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as their legal advisors. For Lilly, Lehman Brothers served as financial advisors and Dewey Ballantine served as legal advisors on the deal.

About Hypnion, Inc.

Hypnion is a neuroscience drug discovery and development company that is focused on sleep disorders. The company was founded in 2000 by leading scientists in the field of sleep disorder research and has proprietary rights to the sleep-wake drug discovery system, SCORE-2004(TM). The system is predictive of human response and allows high-throughput pre-clinical testing of non-addictive sleep disorder drug candidates. Additional information about Hypnion is available at www.hypnion.com

FDA Approves Eli Lilly and Company Cymbalta

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta® (duloxetine HCl) for the treatment of generalized anxiety disorder (GAD), a condition that affects more than 6.5 million American adults in a given year.(1) Because GAD presents with a variety of symptoms, it can be difficult to diagnose(2) and may have a negative impact on a person's ability to function properly in work, family and social situations.(3)

The safety and efficacy of Cymbalta in the treatment of GAD was established in three randomized, double-blind, placebo-controlled studies in more than 800 non-depressed adults with GAD. In all studies, Cymbalta significantly improved core anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA), compared with placebo. In addition, Cymbalta patients reported greater improvement in functional impairment associated with the illness, including improved ability to perform everyday activities at work, home, and in social situations.

"If left untreated, symptoms of generalized anxiety disorder may worsen, potentially impacting many aspects of a person's life, including their job and social relationships," said Susan Kornstein, M.D., professor of psychiatry at Virginia Commonwealth University. "With this approval, physicians and patients will be happy to know that there is another medication now available to treat this debilitating condition."

Cymbalta, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitor (SNRI),(4) has been studied in more than 25,000 patients worldwide and is already approved for the treatment of major depressive disorder and management of diabetic peripheral neuropathic pain, both in adults.

"More than 4.5 million adults in the United States have been prescribed Cymbalta for major depressive disorder or diabetic peripheral neuropathic pain," said Mike Detke, M.D., Ph.D, Cymbalta medical director for Eli Lilly and Company. "We are excited to offer a new, approved treatment option for generalized anxiety disorder patients and are eager to continue our research with this medication."

In clinical trials, on average, patients treated with Cymbalta for generalized anxiety disorder experienced a 46 percent improvement in anxiety symptoms compared to 32 percent for those who took placebo, as measured by the Hamilton Anxiety Scale. In addition, patients in these studies experienced a 46 percent improvement in function compared to 26 percent for those who took placebo as measured by the Sheehan Disability Scale. The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction. In clinical trials, Cymbalta was studied in a dose range of 60-120 mg per day. While a 120mg/day dose was shown to be effective, there is no evidence that doses greater than 60mg/day confer additional benefit. Cymbalta comes in a capsule, and the target daily dose is 60 mg.

About Generalized Anxiety Disorder

Approximately 6.5 million Americans are diagnosed with generalized anxiety disorder each year.(5) Symptoms persist for at least six months and can include exaggerated worry or chronic anxiety, irritability, poor concentration, sleep disturbance and fatigue.(6,7) Generalized anxiety disorder may be brought on, or worsened by, stressful life events. The illness also tends to be chronic with periods of exacerbation and remission.(8)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of duloxetine is not fully known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Cymbalta is approved in the United States for the treatment of major depressive disorder, the management of diabetic peripheral neuropathic pain and now the treatment of generalized anxiety disorder, all in adults. Cymbalta is not approved for use in pediatric patients.

Important Safety Information

Cymbalta is approved to treat major depressive disorder, diabetic peripheral neuropathic pain and generalized anxiety disorder. In children and teens, antidepressants can increase the risk of suicidal thoughts or actions. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behavior or thoughts of suicide, especially at the beginning of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril® (thioridazine) or have uncontrolled glaucoma. Patients should speak with their doctor about all medicines they are taking, including those for migraine to avoid a potentially life- threatening condition. Patients should tell their doctor about their alcohol consumption, if they have liver disease, and about all of their medical conditions.

Patients taking Cymbalta may experience dizziness or fainting upon standing. The most common side effects of Cymbalta include:

-- For MDD: nausea, dry mouth and constipation -- For DPNP: nausea, sleepiness and dizziness -- For GAD: nausea, fatigue and dry mouth This is not a complete list of side effects.

For full Patient Information, visit www.cymbalta.com. For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com/

About Eli Lilly and Company

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

(1) National Institute of Mental Health (NIMH). "Facts About Generalized Anxiety Disorder." Available at: http://www.nimh.nih.gov/publicat/gadfacts.cfm. Accessed on February 6, 2007. (2) Gliatto, Michael, F. "Generalized Anxiety Disorder." American Family Physicians, Vol. 62/No. 7, October 1, 2000.

(3) Leon, Andrew et al. "Assessing Psychiatric Impairment in Primary Care with the Sheehan Disability Scale." Int'l J. Psychiatry in Medicine. Vol. 27 (2), 1997, pp. 93-105

(4) Bymaster, FP et al. "The Dual Transporter Inhibitor Duloxetine: A Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and Clinical Results in Depression." Current Pharmaceutical Design. 2005; 11: 1475-1493.

(5) Mental Health America. "Generalized Anxiety Disorder." Available at: http://www1.nmha.org/camh/anxiety/gad.cfm. Accessed on January 17, 2007.

(6) National Institute of Mental Health (NIMH). "Anxiety Disorders." Available at: http://www.nimh.nih.gov/publicat/anxiety.cfm#anx7 December 2006.

(7) APA. "Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition." 1994, pp 472-476.

(8) APA. "Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition." 1994, pp 472-476.