Three New Lung Tumor Subtypes Identified In DNA Profiling Study

A new study has identified three subtypes of non-small-cell lung cancer tumors, a finding that may provide valuable clinical information about patient survival in early- or late-stage disease, how likely the cancer is to spread and whether the tumor will prove resistant to chemotherapy.

A report of the study, led by researchers at the University of North Carolina at Chapel Hill’s Lineberger Comprehensive Cancer Center, appears in the November issue of the Journal of Clinical Oncology.

Currently, lung cancer treatment decisions are based largely on the location and size of the tumor and if it has spread, or metastasized. And, lung tumor cells are diagnosed by their appearance under a microscope. About 20 percent of these tumors are classified as small-cell carcinomas; the rest fall into a catch-all diagnosis, non-small-cell carcinoma (NSCLC), for which therapies often lead to unpredictable results.

“We are frequently surprised with the range of responses that our patients’ non-small-cell carcinomas have. Some are very responsive to treatment, some metastasize early, and we have no way of sorting this out up front,” said study lead author Dr. David Neil Hayes, assistant professor of medicine in the division of hematology/oncology in UNC’s School of Medicine.

To that end, Hayes and his colleagues used a relatively new technology, DNA microarray analysis, which allows researchers to identify a tumor’s genetic pattern.

“We found that among patients who have tumors that look similar under a microscope there are dramatically different gene expression patterns,” Hayes said. “But what’s more interesting is that we see evidence that these genetic patterns are associated with significant differences in tumor behavior, which could not be anticipated by any conventional testing method.”

The tumor subtypes, named bronchioid, squamoid and magnoid, according to their genetic pattern, also correlated with clinically relevant events, such as stage-specific survival and metastatic pattern.

For example, bronchioid tumors were associated with the likelihood of improved survival in early-stage disease, while squamoid tumors were associated with better survival in advanced disease.

And although some early-stage bronchioid tumors appear less likely to spread to the brain, they also may be the same tumors that are least likely to respond to chemotherapy because they express many genes associated with resistance to common chemotherapy agents.

“While this is still very preliminary, we hope to take these gene expression patterns and attempt to define a very simple, reproducible system that will allow us to unravel the complex patterns of how the tumors progress and how they respond to therapy,” Hayes said.

“If we can pigeonhole these tumors right from the start, then we can become much more rational in our decision making for treatment and our ability to tell patients what to anticipate in terms of their risk, likelihood of recurrence and response to therapy,” Hayes said. “That’s the goal.”

The new study evaluated lung cancer DNA microarray data sets from the University of Michigan, Stanford University and the Dana-Farber Cancer Institute in Boston, Mass. A total of 231 microarrays, each with 2,553 genes were analyzed. Hayes and his colleagues noted that the three new subtypes were robust and could be found frequently. All were identified in each of the data sets.

Co-authors on the study were Dr. Mark A. Socinski and Dr. Charles Perou from UNC’s Lineberger Comprehensive Cancer Center; Drs. Mathew Meyerson, Katsuhiko Naoki and Arindam Bhattacharjee from the Dana-Farber Cancer Institute and Harvard Medical School; Dr. Stefano Monti from the Massachusetts Institute of Technology; and Dr. Giovanni Parmigiani from the Johns Hopkins University School of Medicine.

Funding for the research came from the Director’s Challenge Program of the National Cancer Institute, part of the National Institutes of Health.

University of North Carolina at Chapel Hill School of Medicine
101 Manning Dr., 6002 East Wing
Chapel Hill, NC 27514
United States
http://www.med.unc.edu

Bad Cholesterol In Patients With Type II Diabetes Studied In Mayo Clinic Proceedings

Results from a clinical study conducted in 1,229 patients with type II diabetes mellitus and high cholesterol showed that VYTORIN® (ezetimibe/simvastatin) provided superior reduction in LDL “bad” cholesterol compared to Lipitor® (atorvastatin) at the dose comparisons studied, according to data published in the December 2006 issue of Mayo Clinic Proceedings. The primary efficacy endpoint was the percent change from baseline in LDL cholesterol at the end of the six-week treatment period.

VYTORIN, which contains ezetimibe and simvastatin, is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food. VYTORIN is marketed as INEGY in many countries outside the U.S.

VYTORIN 10/20 mg demonstrated a 53.6 mean percent reduction from baseline in LDL cholesterol as compared to a 38.3 percent reduction observed with Lipitor 10 mg and a 44.6 percent reduction with Lipitor 20 mg – the recommended usual starting doses of both agents. At the next highest doses, VYTORIN 10/40 mg decreased LDL cholesterol significantly more than Lipitor 40 mg – 57.6 percent compared to 50.9 percent, respectively, (p
“Patients with diabetes and high cholesterol are considered to be in the high risk category for heart disease, according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III),” said Theodore Mazzone, M.D., professor, Departments of Medicine and Pharmacology, chief, Section of Endocrinology, Diabetes and Metabolism, University of Illinois, Chicago. “This study showed that VYTORIN was significantly more effective than Lipitor in reducing LDL “bad” cholesterol when comparing the recommended usual starting doses and the next highest doses.”

In this study, the greater LDL cholesterol reductions with VYTORIN 10/20 mg helped more patients with type 2 diabetes (90.3 percent) achieve the LDL cholesterol treatment goal (
In a pre-specified analysis at the doses studied, significantly more patients treated with VYTORIN achieved LDL cholesterol of less than 70 mg/dL, than patients taking Lipitor. Specifically, 59.7 percent of patients taking VYTORIN 10/20 mg reached this LDL cholesterol level versus 21.5 percent of patients taking Lipitor 10 mg and 35.0 percent of patients taking Lipitor 20 mg (p
Additional results from the study demonstrated that VYTORIN (10/20 and 10/40 mg) increased HDL “good” cholesterol by 8.0 and 6.3 percent, respectively, as compared to the HDL increases of 4.3 (p
Significantly greater reductions in triglycerides (TG) were observed for those patients treated with VYTORIN 10/20 mg (25.7 percent) versus patients taking Lipitor 10 mg (22.7 percent; p
High triglycerides and low HDL cholesterol are both risk factors for cardiovascular disease (CVD). The relationship between treatment-induced changes in triglycerides and HDL cholesterol and reduction of CVD risk has not been established.

About the Study

The clinical study was a randomized double-blind, six-week, parallel-group study of 1,229 patients with type II diabetes and high cholesterol designed to evaluate the lipid modifying efficacy and safety of VYTORIN as compared to Lipitor across the recommended usual starting dose and next highest dose comparisons. Mean baseline LDL cholesterol ranged from 144-147 mg/dL in the treatment arms.

Patients were randomized to receive VYTORIN 10/20 mg, 10/40 mg or Lipitor 10 mg, 20 mg or 40 mg. This study enrolled patients with type II diabetes mellitus including those patients with coronary heart disease or other forms of atherosclerosis. Both VYTORIN and Lipitor were generally well tolerated in this study.

Important information about VYTORIN

VYTORIN contains simvastatin and ezetimibe. VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B1, triglycerides and non-HDL cholesterol and to increase HDL cholesterol in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia.

VYTORIN is also indicated for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

VYTORIN is a prescription medicine and should not be taken by people who are hypersensitive to any of its components. VYTORIN should not be taken by anyone with active liver disease or unexplained persistent elevations of serum transaminases. Women who are of childbearing age (unless highly unlikely to conceive), are nursing or who are pregnant should not take VYTORIN.

VYTORIN is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of simvastatin (VYTORIN 10/10, 10/20, 10/40 or 10/80 mg, respectively).

Selected cautionary information for VYTORIN

Muscle pain, tenderness or weakness in people taking VYTORIN should be reported to a doctor promptly because these could be signs of a serious side effect. VYTORIN should be discontinued if myopathy is diagnosed or suspected. To help avoid serious side effects, patients should talk to their doctor about medicine or food they should avoid while taking VYTORIN. In three placebo-controlled, 12-week trials, the incidence of consecutive elevations (>3 X ULN) in serum transaminases were 1.7 percent overall for patients treated with VYTORIN and 2.6 percent for patients treated with VYTORIN 10/80 mg. In controlled long-term (48-week) extensions, which included both newly-treated and previously-treated patients, the incidence of consecutive elevations (>3 X ULN) in serum transaminases was 1.8 percent overall and 3.6 percent for patients treated with VYTORIN 10/80 mg. These elevations in transaminases were generally asymptomatic, not associated with cholestasis and returned to baseline after discontinuation of therapy or with continued treatment. Doctors should perform blood tests before, and periodically during treatment with VYTORIN when clinically indicated to check for liver problems. People taking VYTORIN 10/80 mg should receive an additional liver function test prior to and three months after titration and periodically during the first year.

Due to the unknown effects of increased exposure to ezetimibe (an ingredient in VYTORIN) in patients with moderate or severe hepatic insufficiency, VYTORIN is not recommended in these patients. The safety and effectiveness of VYTORIN with fibrates have not been established; therefore, co-administration with fibrates is not recommended. Caution should be exercised when initiating VYTORIN in patients treated with cyclosporine and in patients with severe renal insufficiency.

VYTORIN has been evaluated for safety in more than 3,800 patients in clinical trials and was generally well tolerated at all doses (10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg). In clinical trials, the most commonly reported side effects, regardless of cause, included headache (6.8 percent), upper respiratory tract infection (3.9 percent), myalgia (3.5 percent), influenza (2.6 percent) and extremity pain (2.3 percent).

About Merck/Schering-Plough Pharmaceuticals

Merck/Schering-Plough Pharmaceuticals is a joint venture between Merck & Co., Inc. and Schering-Plough Corporation formed to develop and market in the United States new prescription medicines in cholesterol management. The collaboration includes worldwide markets (excluding Japan). VYTORIN is marketed as INEGY in many countries outside the U.S.

Merck forward-looking statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Schering-Plough Disclosure Notice

The information in this press release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the product potential for VYTORIN. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company’s second quarter 2006 10-Q.

VYTORIN® is a trademark of MSP Marketing Services (C) LLC. All other brands are trademarks of their respective owners and are not trademarks of MSP Marketing Services (C) LLC.

1 Apo B is the protein compound of lipoproteins, LDL and VLDL, which carry cholesterol in the blood.

Schering-Plough Pharmaceuticals
Schering-Plough Pharmaceuticals

Minister Launches Lung Cancer Awareness Month, UK

To highlight the symptoms of lung cancer health minister Rosie Winterton today launched Lung Cancer Awareness Month at the Royal Mail’s South London Mail Centre, where she heard first hand the experiences of lung cancer patients and met representatives from Royal Mail, the voluntary sector and health professionals.

Rosie Winterton said:

“Lung cancer is the second most common cancer in the UK but people don’t realise that if it is caught early enough it doesn’t have to be a death sentence. This is why Lung Cancer Awareness Month is so important. Working in partnership with the voluntary sector, we must ensure that people are aware of the symptoms and know to seek professional help at the earliest opportunity.”

Nearly 38,000 people are diagnosed with the disease each year, and survival rates are vastly improved if the condition is caught early. Symptoms to look out for include:

• A cough that doesn’t go away after two or three weeks
• Worsening of a long-standing cough or coughing up blood
• Persistent chest infections, breathlessness or tiredness
• Persistent weight loss and chest or shoulder pain
• More split or phlegm, especially with blood in it
• Losing your voice but no sore throat, or
• Swelling in your face or neck.

Speaking on behalf of the coalition of charities coordinating the awareness month, Ernie Roberts, who had lung cancer, said:

“Lung cancer is curable if it is diagnosed early enough. The message for this year’s Lung Cancer Awareness Month is simple: see your doctor straight away if you have any of the symptoms of lung cancer. These symptoms may not be serious, in which case, you’ve got nothing to lose by getting them checked out. If they are serious, you’ve got everything to gain – diagnosis at an early stage could save your life.”

Dr Steve Boorman, Royal Mail’s Director of Corporate and Social Responsibility, said:

“At Royal Mail, we recognise the benefits of a strong and proactive employee health service to raise awareness of health concerns such as lung cancer and offer easy-to-access advice, guidance and support as needed. Keeping our people fit and healthy is of paramount importance to Royal Mail – it’s the right thing to do for our people and benefits our business through improved performance to customers and reduced operating costs due to ill health.”

###

Notes:

Rosie Winterton was speaking at the opening of a special bus which will tour Royal Mail sites and give information to their workforce on a range of health issues, including lung cancer. The Royal Mail and the Roy Castle Lung Cancer Foundation are discussing opportunities to work in partnership on a pilot lung cancer awareness campaign for their employees. The Royal Mail were selected because of the large number of staff they employ, and their interest in supporting their workforce and improving their health

WHAT YOU NEED TO KNOW ABOUT LUNG CANCER

Your lungs are crucial to your health and it is important you look after them:
The lungs take in oxygen which is essential for the body to function.
Your lungs protect your body against infection from the germs you breathe in.

You can make a difference to your lung health:
By keeping physically active, you help keep your lungs healthy.
It is never too late to quit smoking. No matter at what age you stop, you can make a real difference to your health.
If you don’t smoke, don’t start.

Common symptoms of lung cancer include:
A cough that doesn’t go away after two to three weeks
Worsening of a long-standing cough
Persistent chest infections
Coughing blood
Unexplained persistent breathlessness
Unexplained persistent tiredness or lack of energy
Unexplained persistent weight loss
Persistent chest and / or shoulder pain
More spit or phlegm, especially with blood in it
Losing your voice but no sore throat
Swelling in your face or neck.

There are many other causes of these symptoms, so just because you have some of them it does not mean you have lung cancer. However, these symptoms might mean something is wrong with your body. You should seek medical advice if you are concerned.

There are many places you can get help:
Check symptoms with a doctor, nurse, pharmacist or NHS Direct and mention your specific concerns. If you are concerned, request a chest x-ray from your doctor which can identify problems with your lungs.
If you want further advice, then you can contact a charity support line.

Lung Cancer Awareness Month is supported by: Roy Castle Lung Cancer Foundation; Macmillan Cancer Support; Cancer Research UK; Cancer Backup; British Lung Foundation; Men’s Health Forum; Royal Pharmaceutical Society of Great Britain; National Electronic Library for Health; NICE; Department of Health; AS Biss.

For further information please go to:
UK Department of Health

Soy Sauce Bacteria Effective Against Allergies

Tokyo, (JCN) – Kikkoman Corporation has discovered that lactic acid bacteria derived from soy sauce and other fermented foods are effective against allergies.

Specifically, the company has elucidated that tetragenococcus halophilus Th221, a kind of plant-derived lactic acid bacteria found in soy sauce, can induce the generation of interleukin 12 (IL-12), a substance that helps alleviate allergic symptoms.

In recent joint research with the Tokyo University of Agriculture, Kikkoman also discovered that several other plant-derived lactic acid bacteria from fermented foods, such as Leuconostoc mesenteroides, are able to induce the generation of IL-12.

Furthermore, in experiments on mice, they confirmed that these bacteria help alleviate allergic symptoms. In particular, their administration reduces serum IgE levels, an indicator of allergy.

Details of the research will be presented at the Annual Meeting of the Japan Society for Bioscience, Biotechnology, and Agrochemistry 2006, to be held in Kyoto from March 25.

By Aki Tsukioka, JCN Staff Writer

Copyright © 2006 JCN. All rights reserved. A division of Japan Corporate News Network KK.

Eurand’s AdvaTab Cetirizine Successfully Meets Major Development Milestone

Eurand, a specialty pharmaceutical company, today reported the achievement of a major milestone in the development program for its AdvaTab(R) formulation of cetirizine, a leading prescription antihistamine sold in the United States and other markets as Zyrtec(R). AdvaTab Cetirizine is a taste-masked, stabilized formulation that utilizes Eurand’s proprietary Microcaps tastemasking and AdvaTab orally disintegrating tablet (ODT) technologies. The AdvaTab technology produces tablets that disintegrate rapidly in the mouth and can be taken with or without water.

In a pharmacokinetic study, Eurand’s AdvaTab Cetirizine was determined to be bioequivalent to immediate release cetirizine tablets, and to have superior organoleptic properties in terms of taste and texture.

Eurand expects to complete the development program by end of 2006 and will pursue regulatory submissions for the product thereafter.

“We are pleased to have reached this development milestone, which further validates Eurand’s AdvaTab technology,” commented Gearoid Faherty, Eurand’s CEO. “AdvaTab Cetirizine is an important additional dosing option for patients that may benefit from the convenience offered by AdvaTab. Our combined ODT and tastemasking technology platforms provide us and our partners with significant product development opportunities and we look forward to the commercialization of this product and others in our product pipeline.”

Study Design

The study was designed to evaluate the pharmacokinetic profile and organoleptic (sensory) properties of AdvaTab Cetirizine (10mg) compared with those of Zyrtec (10mg) immediate release tablets and Zyrtec (10mg) chewable tablets under fed conditions. The study was conducted using 16 healthy volunteers. In a 4-way crossover study design, plasma profiles of cetirizine were determined for each volunteer following administration of a Zyrtec chewable tablet without water, a Zyrtec immediate release tablet with water and an AdvaTab Cetirizine tablet taken both with and without water. Plasma levels of cetirizine were measured over a 24 hour period. In addition, the organoleptic properties of the AdvaTab product were assessed in the trial. AdvaTab Cetirizine was determined to be bioequivalent to both immediate release and chewable immediate release tablets in all conditions tested.

Eurand expects to enter into agreements with strategic partners for the marketing and distribution of the product in the U.S., Europe and other countries throughout the world. Subject to regulatory approvals, Eurand anticipates that it will manufacture and supply its partners’ commercial requirements for the product.

Cetirizine

Cetirizine is approved for the relief of indoor and outdoor allergy symptoms. Pfizer promotes the immediate release products in the United States as Zyrtec tablets and Zyrtec Chewable tablets. The product is promoted in Europe by UCB. Sales of Zyrtec in the United States were approximately $1.36 billion in 2005(1).

AdvaTab

AdvaTab can provide physicians and patients with additional dosing options for patients that can benefit from convenience in dosing such as those that have difficulties in swallowing or patients who may not have ready access to water. AdvaTab can be a suitable dosage form for pediatric patients. Studies estimate that approximately 40% of the American population has experienced problems swallowing tablets.

The AdvaTab technology produces tablets that disintegrate rapidly in the mouth and can be taken with and without water. AdvaTab tablets are comprised of drug particles that may be tastemasked using Eurand’s Microcaps technology and that are designed for either immediate or controlled drug release. The tablets can be packaged in either bottle or blister packs.

Eurand

Eurand is a privately held specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. The Company specializes in four areas: bioavailability enhancement of poorly soluble drugs, customized release, taste masking/fast-dissolving formulations, and drug targeting. Eurand has had three products approved by the FDA since 2000 and is currently developing a pipeline of products based on its proprietary drug delivery technologies. The company also works with many of the world’s leading pharmaceutical and biotechnology companies to develop enhanced forms of their existing products and development compounds.

Eurand is a global company with more than 500 employees and annual revenue of more than $100 million. Eurand is based in Milan, Italy, with research, development and manufacturing facilities throughout the world, including sites in Milan, Italy; Vandalia, Ohio (US) and Paris, France. Eurand has partnered with Warburg Pincus, one of the world’s leading private equity firms. For more information, visit Eurand’s website at http://www.eurand.com.

Eurand
http://www.eurand.com

FDA Approves BYETTA® (exenatide) Injection For Expanded Combination Use

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved BYETTA® (exenatide) injection as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione (TZD). Healthcare professionals will be educated on this additional use for BYETTA in the coming weeks.

In a clinical trial designed to evaluate BYETTA for use in combination with a TZD, 62 percent of patients who added BYETTA to their existing medicines achieved an A1C (a measure of blood glucose levels over time) of 7 percent or less, compared to 16 percent of the patients on placebo. People taking BYETTA also lost an average of 3.3 pounds over 16 weeks, compared to an average weight reduction of 0.4 pounds in the other group. The most common adverse event associated with BYETTA was nausea (40 percent)(1)(2).

“Due to the progressive nature of type 2 diabetes, previous approaches to management frequently failed to achieve target levels of A1C, or resulted in subsequent failure over one to three years,” said Dr. Robert Ratner, Vice President for Scientific Affairs at the MedStar Research Institute in Washington, DC. “The combination of exenatide with metformin, sulfonylureas, or TZDs not only expands our options to achieve optimal glycemic control, but does so with accompanying weight loss.”

BYETTA improves blood sugar control by lowering both post-meal and fasting (early morning) glucose levels resulting in better long-term control as measured by A1C. BYETTA controls blood sugar through several physiologic actions, including the stimulation of insulin secretion only when blood sugar is high. BYETTA restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying, and decreases food intake. The majority of patients in long-term BYETTA clinical studies also experienced weight loss.

“Almost half a million people with type 2 diabetes have used BYETTA to help reduce their blood sugar,” said Ginger L. Graham, Chief Executive Officer, Amylin Pharmaceuticals. “Now, even more people — those who use another common category of oral medicines, TZDs — have a new treatment option and have the opportunity to benefit from the unique clinical benefits of BYETTA.”

“There are two core defects to type 2 diabetes, beta cell failure and insulin resistance,” said Vince Mihalik, Global Brand Development Leader for Diabetes and Endocrine, Lilly. “The ability of BYETTA to improve beta cell responsiveness and lower weight complements the TZD effect on insulin resistance very nicely.”

About BYETTA

BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the intestine, liver, pancreas and brain(3). BYETTA is 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 a thiazolidinedione. For full prescribing information, visit http://www.BYETTA.com.

About Diabetes

Diabetes affects more than 20 million in the United States and an estimated 194 million adults worldwide(4)(5). Approximately 90-95 percent of those affected have type 2 diabetes. People who have type 2 diabetes either do not produce enough insulin and/or the cells in the body do not respond normally to insulin. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses(6). Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.

According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve target A1C levels (the target is less than 7.0%, according to American Diabetes Association guidelines) with their current treatment regimen(7).

Important Safety Information for BYETTA® (exenatide) injection

BYETTA improves blood sugar control in patients with type 2 diabetes who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with problems digesting food or those who have severe disease of the stomach or kidney. Before using BYETTA, patients should tell their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding. BYETTA has not been studied in children.

Sulfonylureas, commonly used products among patients with type 2 diabetes, can cause hypoglycemia (low blood sugar). Therefore, when BYETTA is used with a medicine that contains a sulfonylurea, there is an increased risk of this possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients. BYETTA may reduce appetite, the amount of food eaten, and body weight, however no changes in dose are needed for these side effects. These are not all the side effects with BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For complete safety profile and other important prescribing considerations, visit http://www.BYETTA.com.

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin’s research and development activities leverage the company’s expertise in metabolism to develop potential therapies to treat diabetes, obesity and cardiovascular disease. Amylin is located in San Diego, California with over 1,500 employees nationwide. Further information on Amylin Pharmaceuticals is available at http://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 http://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 http://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 additional indications for BYETTA may not be received and/or that BYETTA may be affected by unexpected new data or technical issues. The potential for BYETTA may also be affected by competition, 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’s and Lilly’s most recently filed SEC documents such as their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty to update these forward-looking statements.

P-LLY

(1) Bernard Zinman, Byron Hoogwerf, Santiago Duran Garcia, Denai Milton, Joseph Giaconia, Dennis Kim, Michael Trautmann, Robert Brodows. “Safety and Efficacy of Exenatide in Patients with Type 2 Diabetes Mellitus Using Thiazolidenediones with or without Metformin.” Abstract presented at ADA 2006.

(2) Amylin Pharmaceuticals and Eli Lilly and Company press release. “BYETTA® Shown to Reduce Blood Glucose Levels When Added to Patients Using a TZD.” (3) 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 & Metabolism. 2003; 88(7):3082-3089.

(4) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed April 12, 2005.

(5) “All About Diabetes.” American Diabetes Association. Available at http://www.diabetes.org/about-diabetes.jsp. Accessed November 9, 2006.

(6) “Direct and Indirect Costs of Diabetes in the United States.” American Diabetes Association. Available at http://www.diabetes.org/diabetesstatistics/cost-of-diabetes-in-us.jsp. Accessed November 9, 2006.

(7) 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.

Eli Lilly and Company
http://www.lilly.com

Cancer Research UK Launches Monthly Podcast

Cancer Research UK, the world’s leading independent organisation dedicated to cancer research, is adding its voice to the digital airwaves by launching a brand new podcast this week.

The charity will produce a magazine-style programme every month, showcasing every aspect of Cancer Research UK’s work – from world-class scientific research to health awareness campaigns; from fundraising efforts to survivors’ stories and much, much more.

Each show is around fifteen minutes long and designed to appeal to all ages. The podcast is fronted by Dr Kat Arney, who has helped present the BBC’s Naked Scientists radio show for the past three years.

Dr Arney said: “There are so many great things that Cancer Research UK wants to shout about, and podcasting is a great way to communicate with our supporters and the public. I hope that people will tune in every month to catch up on the latest news and stories.The first show kicks off with a roundup from the recent National Cancer Research Institute conference, catching up with the latest news in cancer research from around the world. We’ll also be finding out how our supporters have been celebrating Breast Cancer Awareness Month – from celebrity guests to making a splash in the Serpentine. And there’s a chance to win a limited edition pink rubber duck, signed by our celebrity guest.”

Cancer Research UK’s chief executive, Professor Alex Markham, said: “A fundamental part of Cancer Research UK’s vision and purpose is to help people understand cancer and the progress being made to beat the disease. We are embracing new media such as podcasting because we’ll be able to increase the number of people we can speak to, informing them about our progress towards beating the many different types of cancer, offering advice on how to reduce the risk of getting the disease, and also how they can support our life-saving scientific research.”

Download the Cancer Research UK podcast, listen online or subscribe to our RSS feed by clicking here.

Together with its partners and supporters, Cancer Research UK’s vision is to beat cancer.

— Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.
— Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.
— Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.
— Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

http://www.cancerresearchuk.org

TV Viewing And Physical Inactivity Independently Associated With Metabolic Risk In Children

Watching TV and level of activity in children appear to be associated independently of each other with risk factors that may influence the chance that children have of developing metabolic diseases (e.g., diabetes) and cardiovascular diseases in later life.

An ongoing study, the European Youth Heart Study is examining the nature, strength, and interactions between personal, environmental, and lifestyle influences on later risk of these diseases. As part of this study, European researchers questioned 1,921 children from three regions in Portugal, Estonia and Denmark on the hours of TV viewed and measured their activity over a 4 day period. They also measured six metabolic-risk factors (body fatness, blood pressure, fasting triglycerides, inverted high-density lipoprotein (HDL) cholesterol, glucose, and insulin levels and calculated a metabolic risk score for each child based on these risk factors.

The researchers showed that there was a positive association between TV viewing and adiposity (fatness), but not with the overall risk score. However, the physical activity of the children was independently and inversely associated with systolic and diastolic blood pressure, fasting glucose, insulin, triglycerides and with the overall risk score, independently of obesity and other factors.

TV viewing has previously been linked to metabolic-risk factors in youth. However, it had been unclear whether this association was independent of physical activity and obesity. This study showed that TV viewing and physical activity should be considered as separate entities as they are differently associated with adiposity and metabolic risk. The authors conclude that “preventive action against metabolic risk in children may need to target TV viewing and physical activity separately.” These results will be presented during the International Diabetes Federation 19th International meeting in Cape Town on Thursday the 7th December.

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world’s scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org

Accuray Introduces First And Only Radiosurgery Products Designed For The Non-Invasive Treatment Of Lung Tumors

Accuray Incorporated, the global leader in the field of robotic radiosurgery, today introduced three new products designed to improve the way lung cancer is treated. These products — Xsight(TM) Lung Tracking System, Xchange(TM) Robotic Collimator Changer and 4D Treatment Optimization and Planning System — combine with the Accuray CyberKnife(R) Robotic Radiosurgery System to offer a non-invasive, fiducial-free lung cancer treatment option that eliminates the risk of complications common with the implantation of markers or fiducials. Moreover, the products can shorten treatment times through treatment planning optimization and reduced treatment delivery interruptions.

These products will be on display in Booth 219 at the American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting at the Pennsylvania Convention Center in Philadelphia, November 5-9.

“Lung cancer radiosurgery using the CyberKnife System is growing, with more than a 130 percent increase in the number of patients treated in the last year alone. The Xsight Lung Tracking System offers a significant technological breakthrough which further enhances the CyberKnife System’s position to become the standard of care for lung radiosurgery,” said Euan S. Thomson, Ph.D., president and chief executive officer of Accuray. “With the first and only non-invasive radiosurgical means to precisely target and treat tumors, Accuray is breaking down barriers for patients who may not otherwise be able to receive treatment.”

The Xsight Lung Tracking System uses sophisticated image processing and registration techniques to directly lock onto and track the tumor throughout the treatment. It works seamlessly with Accuray’s Synchrony(R) Respiratory Tracking System to track, detect and correct for tumor and patient movement, allowing patients to breathe normally without the need for gating or breath holding techniques. Xsight Lung’s radiosurgery accuracy may eliminate the need for the invasive placement or tracking of radiographic markers or fiducials reducing the risk inherent to traditional treatment methods.

The Xsight Lung Tracking System is designed to offer a non-invasive, more comfortable alternative for patients while maintaining the precision and accuracy required for radiosurgery treatments. Published data(1) states that there is a risk of pneumothorax when fiducials are used to mark lung tumors. By using non-invasive means to precisely target lung tumors, oncologists will be able to more quickly and effectively treat patients, including ones who are now considered to be medically inoperable.

“Radiosurgery with the CyberKnife System has proven to be quite successful in treating our lung cancer patients,” said John J. Kresl MD, PhD of Arizona Oncology Services at St. Joseph’s Hospital and Barrow Neurological Institute. “Because these new tools from Accuray are non-invasive, we believe they will enhance our ability to treat lung tumors, including those in patients who may not be able to withstand the complications that could result from the implantation of fiducials.”

“A study in the most recent issue of the New England Journal of Medicine showed that regular screenings detected lung cancer in its earliest stages, and was curable when treatment quickly followed,” said Eric P. Lindquist, senior vice president and chief marketing officer. “We believe the Accuray CyberKnife System offers these stage I lung cancer patients an ideal alternative. With over 1000 patients treated on the CyberKnife System to date, we believe that radiosurgery will continue to be a viable treatment option for lung cancer patients.”

Also debuting at ASTRO today are the:

— Xchange Robotic Collimator Changer, which has the automated ability to change secondary collimators during the treatment, eliminating the need to re-enter the treatment room, while also minimizing related treatment delays.

— 4D Treatment Optimization and Planning System, which takes into account not only the movement of the tumor, but also the movement and deformation of tissue. Using this system, clinicians can better deliver the prescribed radiation dose to the targeted area while minimizing the damage to surrounding tissue.

About the CyberKnife(R) Robotic Radiosurgery System

The CyberKnife System is the world’s first and only radiosurgery system that utilizes intelligent robotics to treat tumors anywhere in the body with sub-millimeter accuracy. The CyberKnife System treats patients in single or staged (typically 2-5) sessions by delivering multiple beams of precisely directed radiation that converge upon the tumor while minimizing injury to surrounding healthy tissue. Image guidance and computer controlled robotics combine to continuously track, detect and correct for tumor and patient movement throughout the treatment. Because of this precision and accuracy, no head or body frame is required.

About Accuray

Accuray Incorporated is a global leader in the field of robotic radiosurgery. Its CyberKnife System is the world’s first and only intelligent robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. More than 100 CyberKnife Systems have been purchased by leading medical centers throughout the world and a large body of peer-reviewed papers supports its clinical practice. To date, the CyberKnife System has treated more than 25,000 patients worldwide. For more information, please visit http://www.accuray.com.

(1) Reichner, Cristina A., et al. The Placement of Gold Fiducials for CyberKnife Stereotactic Radiosurgery Using a Modified Transbronchial Needle Aspiration Technique. J Bronchol. 2005;12:193-195.

Accuray Incorporated
http://www.accuray.com/

GA2LEN – Global Allergy And Asthma European Network – Press Conference & Plenary Session – Media Invitation

WHAT?
Press Conference (10:00-11:00), followed by session “Allergy throughout life – GA2LEN in action”(11:00-13:30)

WHEN?
31 March 2006 – Press Conference (10.00-11.00), Session “Allergy throughout life – GA2LEN in action” (11.00-13.30)

WHERE?
Palais am Funkturm, Messedamm 22, 14055 Berlin, Germany

GA2LEN (Global Allergy and Asthma European Network) is a EU-funded network of excellence, bringing together epidemiological and clinical researchers who investigate allergy and asthma across the life stages. Launched as a Network of Excellence of 25 leading European teams as well as the European Academy of Allergology and Clinical Immunology (EAACI) and the European Federation of Allergy and Airways Diseases Patientsґ Associations (EFA) on February 2004, a total budget of EUR 14.4 million for a five-year period has been allocated from the EU’s Sixth Research Framework Programme for GA2LEN activities. The collaboration project reflects recognition of growing concern among European citizens about rising rates of allergy and asthma.

GA2LEN started its work with the clear intention to establish a world-wide competitive network of European centres of excellence in order to enhance the quality and relevance of research in the area of allergy and to address allergy and asthma in their totality. The network focuses its research programme on developing new ways of preventing and managing allergies and asthma. In the long term, GA2LEN aims also to decrease the socioeconomic burden of allergy and asthma in Europe. Allergic diseases are estimated to cost Europe 25 billion euros annually, with most of the costs due to reduced productivity in school or at work.

The audience of the “special event” on Friday 31 March will learn about progress made in the second year of GA2LEN existence. Research issues are examined in relation to their influences within the various age groups. Special attention is given to the fact that allergic diseases and asthma often start early in life and especially in the development of immunoglobulin E antibody (IgE) mediated allergic diseases, like hay fever and asthma, it is important not only to understand genetics but also pre-natal factors that could have an importance.

GA2LEN Annual Conference, Friday, 31 March 2006
Conference programme

10:00-11:00 Press Conference

Speakers:

– Prof. Dr. med. Torsten Zuberbier, Head of Allergy Centre Charitй (Dept. of Dermatology and Allergy), Head of the European Centre for Allergy Research Foundation (ECARF); Secretary General of GA2LEN

– Prof. Dr. med Paul van Cauwenberge, Rector of University of Gent, Belgium, Coordinator of GA2LEN

– Prof. Dr. med. Peter Burney, Professor of Respiratory Epidemiology and Public Health, Vice Chairman for Research of GA2LEN, Imperial College, London, UK

– Dr. Christian Patermann, Director for biotechnology, agriculture and food research at the European Commission, Brussels, BE

11:00- 13:30 Session ‘Allergy throughout life – GALEN in action’ Chair: Paul van Cauwenberge, GALEN Coordinator
Co-Chairs: Jean Bousquet, GALEN Vice Chairperson – Ana Nieto, EC Scientific Officer

11: 00 Welcome, Paul van Cauwenberge, GALEN Coordinator

11:05 Pre-Natal influences, John Warner, United Kingdom

11:30 Childhood environments, Erika von Mutius, Germany

11:50 Triggers for symptoms, Marianne van Hage, Sweden

12:10 The future of the allergy epidemic and its consequences, Peter Burney, United Kingdom

12:30 Improving care for allergic patients, Inger Kull, Sweden

12:50 What patients want from a network of excellence, Marianella Salapatas, EFA (European Federation of Asthma and Airways Diseases Patients’ Associations)

13:10 EU future programmes in Allergy and Asthma, Christian Patermann, Director, European Commission

Questions and answers – Lunch

Michael H. Wappelhorst,
Press and information officer, Research DG, European Commission
E-mail: Michael.Wappelhorst@cec.eu.int.

Spokesperson for Science and Research
Antonia Mochan,
Press and Communication DG, European Commission
E-mail Antonia.Mochan@cec.eu.int

europa.eu.int/comm/research/press/press.cfm