September 9, 2008,? PharmaLive.com – Shares in German drugs and chemicals group Bayer rose nearly 4 percent on Tuesday on market talk of takeover interest from U.S. rival Pfizer, traders said.

Bayer shares were 3.65 percent higher at 54.62 euros by 1005 GMT, compared with a 0.8 percent rise on the German benchmark DAX < .GDAXI> index.

Bayer, which has a market capitalisation of around 40 billion euros ($57 billion), declined to comment. A Pfizer spokesman said the New York-based group did not comment on market speculation.

Bayer, which boasts a healthy pipeline of new drugs and an attractive over-the-counter medicines business, has been a rumored takeover target in the past.

Any acquisition by a pure pharmaceutical company, however, would be complicated, since it would require the break-up of the chemical-drugs hybrid. Bayer is also a top global player in plastics and in agrochemicals.

For Pfizer, buying Bayer would bring an added complication in that the U.S. group only recently sold off its non-prescription drug business to Johnson & Johnson.

Pfizer has a history of doing mega-deals but investors have been disappointed by past acquisitions that have failed to curtail its reliance on ageing blockbusters, including cholesterol fighter Lipitor, which goes off patent in 2011.

The company makes $13 billion a year from Lipitor and needs new products to offset sales declines of this and other products.

Pfizer became the global industry leader by buying Pharmacia and Warner-Lambert during the past decade, but its stock is trading at 11-year lows because its laboratories have failed to deliver enough new drugs.

Barcelona, September 9, 2008 – Laboratorios Almirall, S.A. and Forest Laboratories, Inc. (NYSE: FRX) today announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD). In both the ACCLAIM/COPD I&II (AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients) studies, once-daily aclidinium bromide showed a statistically significant difference vs. placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in moderate to severe COPD patients.

In both studies aclidinium therapy demonstrated a significant difference vs placebo in trough FEV1 at 12 week (p-value <0.001) and 28 weeks (p-value <0.001). The effect of aclidinium compared to placebo in trough FEV1 was maintained over one year (p-value <0.001). The improvement in the trough FEV1, at week 12 and 28, of aclidinium arms compared to placebo was in the range of 60 to 70 mL in both trials. The change from baseline in peak FEV1 observed after dosing aclidinium compared to placebo at 12 and 28 weeks was between 153? and 177 mL (p-value <0.0001), with a median time to peak of 2 hours.

?The studies confirm the bronchodilatory effect of aclidinium at the dose tested, although the magnitude was lower than seen in previous studies. We are working actively with Forest and members of the ACCLAIM/COPD Steering Committee to fully understand these findings to determine the best way forward including the extent of the benefit possible from dosing alternatives?, commented Per-Olof Andersson, Executive Director R&D of Almirall.

Aclidinium significantly improved the percentage of patients showing a clinically relevant improvement (>4 points) in health-related quality of life compared with placebo in the ACCLAIM/COPD I study (week 52; p-value=0.025) as measured by the St. George?s Respiratory Questionnaire (SGRQ). ACCLAIM/COPD II did not reach statistical significance for SGRQ at week 52 (p-value=0.074), however the study showed statistical significance at all previous time-points (p-value<0.01). Pooled analysis of both studies showed a statistically significantly higher percentage of patients improving ?4 units in the SGRQ at week 52 (p-value=0.004).

Secondary endpoint results demonstrated that aclidinium significantly delayed the time to the first moderate to severe exacerbation in patients with COPD in ACCLAIM/COPD II (p-value=0.01), whereas results were not significant in ACCLAIM/COPD I. In the pooled analysis of both studies, there was a positive trend in delaying the time to first moderate or severe exacerbation (p-value=0.054).

?Almirall remains committed to continue the efforts to provide treatment options for COPD patients with aclidinium bromide?, commented Jorge Gallardo, Chairman and Chief Executive Officer of Almirall.

ACCLAIM/COPD study design and results

Two double-blind, multicentre, parallel-group, placebo-controlled Phase III studies were conducted, one in Europe (ACCLAIM/COPD I) and the other primarily in North America (ACCLAIM/COPD II), to evaluate the efficacy and safety of inhaled aclidinium administered once daily. A total of 1,647 patients, across 23 countries participated in these trials. Patients had a diagnosis of moderate to severe COPD and were a minimum of 40 years of age with at least a 10 pack-year smoking history. The mean FEV1 values at baseline were 1.405 and 1.199L for ACCLAIM/COPD I and ACCLAIM/COPD II, respectively. Patients were randomized to receive aclidinium bromide (200 ?g once daily) or placebo over a one-year treatment period.

The primary endpoints for ACCLAIM/COPD I and II were bronchodilation at the end of the dosing interval, assessed as trough FEV1 (measured at 23-24h post-dose). For both trials, the primary endpoint was measured at week 12 and week 28 to fulfill FDA and European requirements, respectively.

Aclidinium bromide and placebo were administered to patients using the Genuair?[i] device, a multi-dose dry powder inhaler which operates by a ?one press and inhale? technique.

Overall, safety and tolerability were comparable between aclidinium and placebo in terms of percentage of patients with Serious Adverse Events (aclidinium: 9.1%, placebo 10.7%), fatal Adverse Events (aclidinium: 1.1%, placebo: 1.7%), or with Adverse Events leading to treatment discontinuation (aclidinium: 4.0%, placebo: 5.7%). The most frequently reported adverse events across both studies were nasopharyngitis (aclidinium: 14.5%, placebo: 12.9%) and headache (aclidinium: 12.7%, placebo:12.6%). Potential anticholinergic adverse events were observed in a similarly low percentage of patients, (e.g. dry mouth – aclidinium: 0.7%, placebo: 1.2%).

Forest is pleased with the results of these studies and remains committed with Almirall to the development of aclidinium bromide in COPD?, said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories.

About COPD?

The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and more than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke.

The most common symptoms of COPD are breathlessness (or a “need for air”), abnormal sputum (a mix of saliva and mucus in the airway), and a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens[ii]. There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function and control exacerbations.

About aclidinium bromide and Genuair

Aclidinium bromide is a novel, long-acting inhaled anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.

Aclidinium bromide is administered to patients using a novel, state-of-the-art multidose dry powder inhaler (MDPI), Genuair?. Genuair? was designed with an intuitive feedback system, which through a coloured control window?, an audible click and a slightly sweet taste indicates that the patient has inhaled correctly. The Genuair? inhaler contains 30 doses with a visible dose level indicator and also incorporates significant safety features such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

About Almirall

Almirall, an international pharmaceutical company based on innovation and committed to health, headquartered in Barcelona, Spain, researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people?s health and wellbeing.

The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology in general.

Almirall is currently present in over 70 countries with direct presence in Europe and Latin America through 11 affiliates.

For further information please visit the website at: www.almirall.com

Forbes.com, September 15, 2008 – Smarter matching of drugs to patients is likely to improve on the lukewarm results seen so far with targeted cancer therapies

When Cameron Mitchell collapsed on the floor of his bathroom with a seizure in January 2004, doctors at the emergency room at first thought it might be a stroke. But then MRI scans spotted a small, fast-growing lesion inside his brain. It was glioblastoma, the deadliest form of brain cancer. This tumor diffuses through the brain so widely that it cannot be excised fully. Most victims die within 18 months.

Desperate for better options, Mitchell, who was in the coin laundry business before he got sick, got his oncologist in Michigan to call Duke University, known for its brain cancer expertise (and, recently, for operating on Senator Edward Kennedy). Mitchell was in luck. His tumor had a gene mutation being targeted by a new cancer vaccine being tested by Duke neurosurgeon John Sampson. The vaccine stimulates the body’s immune system to attack cells with the mutation, leaving normal cells unharmed.

That June, following surgery and six weeks of radiation, Mitchell flew to Duke to get his first vaccine treatment, four shots with a big needle into his upper thigh. Aside from irritation at the injection site, there were few side effects; he has flown back for repeat treatments every month since then. Against all odds, his brain cancer has not come back. That puts him in rare company: Only 3% of glioblastoma patients survive five years after diagnosis. “It’s amazing,” says Mitchell, 52. “It has basically prolonged my life for three years so far.”

Mitchell may be one of the first to benefit from a new brain cancer vaccine, now in midstage testing at Pfizer and Avant Immunotherapeutics. It is one of a new wave of ultratargeted treatments moving through human testing at drug and biotech companies. Instead of aiming at broad tumor categories, such as all patients with lung cancer or colon cancer, the new medicines target specific subsets of patients whose tumors have particular gene mutations. The brain vaccine aims at about 40% of brain glioblastoma patients.

The hope is that by better matching drugs to patients likely to benefit, researchers can improve upon the lukewarm results seen with targeted cancer drugs to date. While many drugs that attack single genes have hit the market recently, they often have been used indiscriminately in all patients with a single tumor type. Better targeting could help improve clinical trial success rates by excluding patients for whom the drugs have little chance of working. “The last millennium approach was ‘let’s treat all the patients and that is the biggest market,'” says Pfizer senior marketing director Alison Ayers. “We just cannot continue with that model,” as it means everyone gets side effects, but only some benefit.

“We are heading toward a day where we don’t even think about the anatomical locale of the tumor,” says University of North Carolina researcher Howard McLeod. Instead, he says, researchers will perform tests to determine which mutations drive a tumor’s growth and then give drugs that hit those specific mutations. The downside for drug companies, he says: “Markets will be smaller than before.”

But with drug approvals down, drug companies are more willing to put money into niches. Roche drug research chief Lee Babiss says that in the past, executives at some firms “didn’t want any part of [personalized medicine]. They were absolutely afraid it would limit sales.”

Roche has two cancer drugs in early human trials that will come paired with gene tests to spot the subset of patients likely to benefit. One of them targets a defective gene on the seventh chromosome, present in roughly 7% of all cancers, including most cases of melanoma. Novartis is in final trials of a drug that may help the one-third of acute myeloid leukemia cases with a gene mutation that turns on cell-growth signals.

The brain cancer vaccine is one of the more intriguing targeted cancer treatments. Pfizer licensed the vaccine from Avant in a deal worth up to $440 million, plus royalties. It takes aim at an unusual mutation discovered in the late 1980s by Albert Wong and Bert Vogelstein at Johns Hopkins University and Darell Bigner at Duke. The mutation freezes a crucial protein called epidermal growth factor receptor in the “on” position. Cells are constantly urged to keep growing. Bigner spent years trying to make monoclonal antibodies against the mutant protein. But he says for years he couldn’t get drug companies interested in pursuing the concept. They “took one look at it and said the market is not big enough,” he recalls.

Wong (now at Stanford University) figured the mutated gene might make an ideal target for a vaccine, as it creates an abnormal protein not seen in healthy cells. He hooked up a fragment of the mutant protein to a larger protein from a giant sea snail (the keyhole limpet) that looks foreign and can rev up the immune system. Then, in the mid-1990s, he injected the vaccine into mice with tumors containing the mutant gene. Within ten days the tumors shriveled away. Wong patented the concept but couldn’t get venture capitalists interested. Eventually he got $1 million in grants from Pennsylvania and formed a company that is now part of Avant.

By then the surgeon Sampson, working with Darell Bigner, had devised a similar vaccine, and he began testing it in several small trials starting in 2002. “Most other cancer vaccines aren’t very specific,” says Sampson. “They take a tumor and grind it up” and inject it back into the patient.

His early results are tantalizing, with patients surviving twice as long as they should have, says Sampson. In one trial, presented at a meeting of oncologists in June, 23 patients who got the vaccine along with the established drug Temodar lived 33 months, compared with the 15-month median life span that would have been expected. Another trial, which included Mitchell, found a 26-month survival. M.D. Anderson Cancer Center helped with the trials.

The vaccine “is keeping the beast at bay,” says patient Frances Joyner, 62, who has been getting the shots at Duke for a year, with no recurrence. She was petrified when doctors found a golf-ball-size tumor near the base of her skull in June 2007. But now, “my horizon is back where it should be. I feel I can make plans.”

Neither trial had a control group, making it impossible to tell whether the good survival numbers are due to the vaccine or to some subtle characteristic of their illnesses. A trial comparing the vaccine with standard treatment in 90 glioblastoma patients could yield results next year. No therapeutic cancer vaccine had ever made it to the market here, despite numerous attempts. Better targeting might make this the first.

By Matthew K Wynia MD, MPH, FACP, Medscape.com – Today, there is legal and ethical consensus that patients’ have a right to obtain, amend, and control their records.[1,2]

Easy access might improve patients’ knowledge. Being able to add information — and control who gets to see what — might increase patients’ sense of responsibility. Easy sharing of records could reduce duplication, streamline care, improve accuracy, and prevent errors.

But when combined with the digital age development of electronic personal health records (PHRs) — like those recently unveiled by Google, Microsoft, and others — it’s no surprise that doctors are concerned about the confidentiality, security, and clinical usefulness of PHRs.

The federal privacy law, HIPAA, is supposed to protect medical records, but HIPAA doesn’t apply to many businesses offering PHRs.[3] Concerns over privacy and security breaches have been a factor in low adoption rates of PHRs.[4]

Doctors are also nervous about patients controlling what clinical records are shared with other doctors. Patients might delete or hide important information in their PHR, perhaps unintentionally leading consulting doctors astray.

Electronic PHRs might become voluminous: Will doctors be responsible for knowing everything in a patient’s PHR, including information added by the patient between visits?

And how will knowing that patients can see every note we write affect the way we document visits and our relationships with patients?[5]

Recently, a number of leading business, physician, and patient groups came together and created a set of voluntary rules for PHR privacy and security.[4] Led by the Markle Foundation, this was a big step forward, and the AMA strongly supported it.[6] It must be safe to transfer medical information to an electronic PHR.

Yet even within a safe, secure, and confidential system, doctors and patients will need to learn how best to use electronic PHRs. Our learning curve should be very steep.

Dr. Matt Wynia is Director of the Institute for Ethics at the American Medical Association.

This analysis showed that Multaq(R) (dronedarone) decreased the risk of stroke by 34% in patient with atrial fibrillation or atrial flutter already adequately treated by antithrombotic therapy

BRIDGEWATER, N.J., September 03, 2008 /PRNewswire-FirstCall/ — The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany. Previous results from the landmark ATHENA study have shown that the investigational medicine Multaq(R) (dronedarone) on top of standard therapy decreased the combined primary endpoint of the risk of cardiovascular hospitalizations or death from any cause by a statistically significant 24% (p=0.00000002) as compared to placebo.

The ATHENA stroke post-hoc analysis on non-pre-specified secondary endpoints showed that Multaq(R) decreased the risk of stroke (ischemic or haemorrhagic) compared to placebo by 34% (46 vs 70 stroke events respectively; p=0.027) in atrial fibrillation / atrial flutter patients adequately treated by standard therapy including antithrombotics.

The significant reduction in stroke risk with Multaq(R) was incremental to background anti-thrombotic therapy like oral anticoagulants and / or anti-platelet agents. Similar to the ATHENA primary endpoint of CV hospitalizations or death, this effect appeared early and was maintained during the study follow-up (12 to 30 months).

“ATHENA is a landmark trial that will lead to a paradigm shift in the management of atrial fibrillation as it is the first time that an anti-arrhythmic drug has shown a significant impact on cardiovascular outcomes. As stroke is one of the leading complications of atrial fibrillation, and a major cause of death and long-term disability, these new results demonstrate the unique profile of Multaq(R) beyond its pure rhythm and rate-controlling effects,” said Professor Stuart Connolly, Mc Master University, Department of Cardiology, Hamilton Canada, co-principal investigator of the ATHENA study.

The most frequently reported adverse events of Multaq(R) vs. placebo in the ATHENA trial as seen in the pre-specified safety analysis, were gastrointestinal effects (26% vs. 22%), skin disorders (10% vs. 8%, mainly rash) and mild increase in blood creatinine (4.7% vs. 1%). The mechanism of blood creatinine increase was well defined in a separate study of healthy volunteers. In the ATHENA trial, compared to placebo, Multaq(R) showed a low risk of pro-arrhythmia and no excess of hospitalisations for congestive heart failure. There was a similar rate of study drug discontinuation between the 2 study groups.

About Atrial Fibrillation / Flutter and Stroke

Atrial Fibrillation (AF) is the most common cardiac arrhythmia in clinical practice and is one of the most important independent risk factors for stroke. Stroke is a major public health problem because this acute event often causes permanent neurological disabilities and death. Atrial fibrillation increases the risk of stroke by up to 5 times. It also is responsible for 15-20% of all strokes, which if caused by AF, are 2.2 times more likely to leave patients bedridden.

Atrial fibrillation is a major cause of hospitalization and mortality and affects about 2.5 million people in the USA and 4.5 million people in the European Union. The Atrial Fibrillation Foundation expects the number of patients with AF to double in the next 20 years. Without appropriate management, atrial fibrillation can lead to serious complications, such as stroke and congestive heart failure.

About the ATHENA Study

The landmark ATHENA, study is the only double-blind, anti-arrhythmic, morbidity-mortality study in patients with atrial fibrillation. It was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients.

The patients studied in ATHENA were either 75 years of age or older (with or without cardiovascular risk factor) or above 70 years of age with at least one additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size greater than 50 mm or left ventricular ejection fraction lower than 40%). Patients were randomized to receive Multaq(R) 400 mg BID or placebo, with a maximum follow-up of 30 months.

The ATHENA study objectives were to show a potential benefit of Multaq(R) on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization as compared to placebo. The pre-specified secondary endpoints were death from any cause, cardiovascular death and hospitalization for cardiovascular reasons. The pre-specified safety endpoint was the incidence of treatment emergent adverse events (between first study drug intake and last study drug intake plus 10 days) including: all adverse events, serious adverse events, adverse events leading to study drug discontinuation.

The ATHENA stroke post-hoc analysis on non-pre-specified secondary endpoint was conducted in order to confirm the consistent benefit of Multaq in atrial fibrillation or atrial flutter patients in reducing major cardiovascular complications like stroke, which is a leading cause of cardiovascular hospitalization or death in this patient population.

About Multaq(R) (dronedarone)

Multaq(R) is an investigational treatment and the only anti-arrhythmic drug (AAD) to have shown a significant reduction in morbidity and mortality in atrial fibrillation /atrial flutter patients with a favourable safety profile as evidenced by a low incidence of pro-arrhythmia (including torsades de pointes) and extra-cardiac organ toxicity. Multaq(R), discovered and developed by sanofi-aventis, has been studied in a clinical development program including more than 7,000 patients. Multaq(R) is one of the major therapeutic innovations for atrial fibrillation in the last twenty years.

Multaq(R) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA).

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris and in New York .

By Maggie Fox, Medscape.com – Expensive advertising of prescription drugs directly to consumers may do little to encourage sales, U.S. and Canadian researchers reported on Monday.

They said that even though companies spent an estimated $3 billion in 2005 on such ads in the United States, they did not appear to result in more prescriptions.

Most countries ban direct advertising of prescription medications, with the exceptions of the United States and New Zealand.

“People tend to think that if direct-to-consumer advertising wasn’t effective, pharma wouldn’t be doing it,” Harvard Medical School’s Stephen Soumerai said in a statement. “But as it turns out, decisions to market directly to consumers are based on scant data.”

The team at Harvard and the University of Alberta set up an experiment using French-speaking Quebec residents as their “control” group.

English-dominant Canadians see a great deal of U.S. advertising, but French-speaking Quebecois see far less and thus are less likely to be influenced, the researchers reported in the British Medical Journal.

The researchers looked at three drugs: Enbrel, or etancercept, sold by Wyeth and Amgen to treat rheumatoid arthritis and other conditions; Novartis AG’s now-withdrawn irritable bowel drug Zelnorm; and the Nasonex allergy treatment made by ScheringPlough Corp.

PHARMACY SALES

All three drugs were on the market for at least a year before the ads started and none were advertised via legal “soft” ads in Canada that allow mention of the drug’s name but not what it is for.

They looked at prescription data from 2,700 pharmacies compiled by IMS Health Canada and found no difference in sales for Enbrel or Nasonex after the U.S. ads began.

They did see a 40 percent increase in sales of Zelnorm in English-speaking Canada as soon as the U.S. ad campaign began — a jump mirrored by U.S. sales. But after a few years sales flattened out, and the rise could have been because there were no alternatives for consumers, they said.

Pharmaceuticals are not typical consumer products, Soumerai said.

“A person needs to see an ad, get motivated by that ad, contact their doctor for an appointment, show up at the appointment, communicate both the condition and the drug to the doctor, convince the doctor that this drug is preferable to other alternatives, then actually go out and fill the prescription,” he said.

“This is a chain of events that can break at any point.”

The nonprofit Kaiser Family Foundation has come to similar conclusions in reports on direct-to-consumer ads.

In an April report the foundation found that 91 percent of adults surveyed had seen or heard advertisements for prescription drugs, but just one-third spoke to a doctor about a drug they saw advertised, and 54 percent of them got a prescription for a different drug.

Among doctors, 76 percent said they sometimes recommend a different prescription drug to a patient who mentions a drug ad and 5 percent said they frequently gave patients the drug.

Patients Taking BYETTA Also Reduced Food Intake

ROME, September 09, 2008 /PRNewswire-FirstCall/ — Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a randomized, double-blind, cross-over, four-week head-to-head study demonstrating that BYETTA(R) (exenatide) injection, a GLP-1 receptor agonist, provided significantly lower glucose levels in the post-meal setting when compared to Januvia(TM) (sitagliptin), a DPP-4 inhibitor. Additionally, patients treated with BYETTA reduced post-meal glucagon, showed more efficient use of their body’s own insulin and decreased their food intake when compared to Januvia. This is the first reported head-to-head study directly comparing the therapeutic mechanisms of action (MOA) of BYETTA and Januvia. The findings were presented at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome, Italy. The study will also be published in the peer-reviewed journal, Current Medical Research and Opinion.

“There has been some confusion in the marketplace about the therapeutic differences between BYETTA and Januvia, and data from this first head-to-head study showed a clear difference in the MOAs and resultant short-term clinical effects between these two agents. BYETTA works directly on the GLP-1 receptor, whereas Januvia indirectly affects GLP-1 levels,” said Ralph DeFronzo, M.D., professor of medicine and chief of the Diabetes Division at the Health Science Center in San Antonio and a clinical trial investigator on this study. “Patients on BYETTA experienced significantly lower post-meal glucose levels, improved measures of beta cell function and decreased food intake.”

The primary endpoint of this four-week study compared the effect of BYETTA and Januvia on 2-hour post-meal glucose. Secondary endpoints included post-meal glucagon, insulin secretion rate, gastric emptying, and food intake. Patients were randomly assigned to treatment with either BYETTA (5 mcg twice daily for the first week followed by 10 mcg twice daily for the second week) or Januvia (100 mg once daily) for two weeks; patients were then switched to the alternate therapy for the remaining two weeks. At baseline and at the end of each two week treatment period, patients underwent a standard meal test and other evaluations to assess each drug’s effects on various measures of post-meal glucose control, indicators of beta cell function and other parameters.

Study Findings

In response to a standard meal, patients (evaluable population, N=61) treated with BYETTA had significantly improved post-meal glucose levels two hours after the standard meal when compared to Januvia (133 mg/dL vs. 208 mg/dL at 2 hours respectively, baseline: 245 mg/dL; P<0.0001). Differences in post-meal glucose levels for the intent-to-treat (ITT) population (N=95) also showed significantly lower post-meal glucose levels with BYETTA compared to Januvia (166 mg/dL vs. 210 mg/dL respectively; P<0.0001). As patients were switched from Januvia to BYETTA after two weeks, the post-meal glucose was further improved (-76 mg/dL), while patients who switched from BYETTA to Januvia partially lost the post-meal glucose (+73 mg/dL) control achieved with BYETTA.

The study also showed that after two weeks of treatment both BYETTA and Januvia improved fasting plasma glucose (FPG) (-15 mg/dL and -19 mg/dL respectively, baseline: 178 mg/dL). BYETTA significantly improved an indicator of beta cell function, the insulinogenic index of insulin secretion compared to Januvia (ratio: 1.50 +/- 0.26, P=0.0239). BYETTA also reduced elevated post-meal glucagon (ratio AUC: 0.88 +/- 0.03, P=0.0011) to a greater extent than Januvia and slowed gastric emptying (ratio AUC: 0.56 +/- 0.05, P<0.0001). BYETTA reduced food intake compared to Januvia during buffet-style meals (-134 kcal vs. +130 kcal, P=0.0227), and patients treated with BYETTA experienced a greater reduction in post-meal triglyceride concentrations compared to Januvia (ratio AUC: 0.90 +/- 0.04, P=0.0118).

The most common adverse events for both BYETTA and Januvia were mild to moderate nausea (BYETTA: 34 percent vs. Januvia: 12 percent) and vomiting (BYETTA: 24 percent vs. Januvia: 3 percent). There were no major hypoglycemic events; a single event of minor hypoglycemia (moderate intensity) was reported in a patient treated with BYETTA.

Study Design and Population

The four-week study evaluated patients with type 2 diabetes who were on a stable regimen of metformin and had the following additional criteria: ages between 18 – 70 years; HbA1c: 7.0-11.0 percent, FPG<280 mg/dL; and body mass index (BMI) 25-45 kg/m-squared. Primary analyses were performed on the evaluable population (N=61) which was defined as ITT patients (N=95) who completed pre-defined requirements, including standard meal procedures in both treatment periods and all other required evaluations.

About BYETTA(R) (exenatide) injection

BYETTA is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. 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 stomach, liver, pancreas and brain. BYETTA is approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels. BYETTA is an add-on therapy for people currently using metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained A1C control, low incidence of hypoglycemia when used with metformin or a thiazolidinedione, and progressive weight loss. BYETTA was approved in April 2005 and has been used by approximately one million patients since its introduction. For full prescribing information, visit www.BYETTA.com.

About Diabetes

Diabetes affects more than 23 million in the United States and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. 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.(iii)

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 their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data support that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi,vii)

Important Safety Information for BYETTA

BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.

When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a 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 the most common side effect when first starting BYETTA, but decreases over time in most patients.

If patients experience the following severe and persistent symptoms (alone or in combination): abdominal pain, nausea, vomiting, or diarrhea, they should talk to their healthcare provider because these symptoms could be signs of serious medical conditions. BYETTA may reduce appetite, the amount of food eaten, and body weight. No changes in dose are needed for these side effects. These are not all of the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For full prescribing information, visit 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(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin’s research and development activities leverage the company’s expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California with over 2,000 employees nationwide. Further information about Amylin Pharmaceuticals 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 healthcare 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, Indiana, 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 and the revenues generated from BYETTA may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin’s and Lilly’s most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.

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(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed June 2, 2008.

(ii) “All About Diabetes.” American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed June 8, 2008.

(iii) “Direct and Indirect Costs of Diabetes in the United States.” American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed June 8, 2008.

By Kim Krisberg, September 2008, Medscape.com – Thanks to recent changes to the Medicare program, access to preventive and mental health services will soon be getting easier for millions of older Americans.

In early July, Congress overrode President Bush’s veto of the Medicare Improvements for Patients and Providers Act of 2008, securing new procedures for prevention services, creating parity for mental health co-payments, blocking cuts in physician payments and strengthening protections for low-income beneficiaries. The new measures garnered praise from a number of public health advocacy organizations, including APHA, which had strongly advocated for an improvement in how preventive services are added as well as equal access to mental health services for Medicare’s 44 million beneficiaries.

“This bill is a victory for our nation’s seniors and individuals with disabilities,” said APHA Executive Director Georges Benjamin, MD, FACP, FACEP (E). “It provides those enrolled in the Medicare program with improved and affordable preventive and mental health benefits and also ensures they have access to the providers they need.”

According to the new law, the U.S. health and human services secretary now has the authority to add preventive and early detection services to Medicare that receive grades of an “A” or “B” from the U.S. Preventive Services Task Force. Previously, such measures had to go before Congress before they could be incorporated into the national health care program. In addition, the eligibility period for beneficiaries to take advantage of a “Welcome to Medicare” visit ? a preventive physical examination ? was extended from six months to one year, and the deductible for the visit was eliminated. Mental health also received a boost, with the new law bringing Medicare co-payments for outpatient mental health services into agreement with other medical services. Over the next six years, the current 50 percent coinsurance rate for mental health services under Medicare will phase out to 20 percent ? the same rate for other medical outpatient services. The law also blocked a more than 10 percent cut in Medicare physician payments as well as pending payment cuts through Dec. 31, 2009. Limits on cost-sharing for low-income Medicare beneficiaries also made it into the final bill.

John Clymer, president of Partnership for Prevention, called Medicare’s new preventive services procedure a “huge milestone,” adding that it is a “major step toward putting prevention on a level playing field with diagnostic and therapeutic procedures under Medicare.” While the Centers for Medicare and Medicaid Services has an orderly process for making Medicare coverage decisions, adding preventive services to the program previously required an act of Congress ? a step that is often time-consuming and results in Medicare’s preventive services lagging far behind other health sectors, Clymer said. For example, he told The Nation’s Health, Medicare did not cover routine mammography until 20 years after the American Cancer Society began recommending it. Similarly, Medicare only began covering cholesterol screenings in 2004, with the congressional passage of the Medicare prescription drug benefit, Clymer said.

“This comes at a good time, because there’s an increasing realization among lawmakers, the public and with the health policy community that we need to push our health care investment upstream,” Clymer said. “In addition to maintaining our leadership in treating disease, we need to become leaders in keeping people healthy and this is a significant milestone toward realizing that vision.”

For more than a decade, Partnership for Prevention has been advocating that lawmakers change the way preventive services are added to Medicare, first testifying before Congress on the subject in 1997. For a long time, Clymer said, “we were a lone voice in the wilderness…it wasn’t long ago that no one in Congress would sponsor this, but the tide began to turn in the middle of this decade.” With the help of a growing number of advocates, such as APHA and AARP, the balance was tipped in favor of “common sense policy,” he noted. Clymer said Partnership for Prevention will continue its Medicare prevention advocacy and will quickly begin pushing to expand tobacco prevention and cessation services. Three years ago, Medicare coverage expanded to include smoking cessation counseling for people with a smoking-related disease, but now Medicare will be able to add smoking cessation as a preventive service, Clymer said.

“This is about value, this is about getting more bang for the buck,” he said. “Prevention is a great value…and helping people stay healthy is the best health care investment we can make.”

Clymer noted that Medicare can be a “bellwether” program, as coverage decisions made elsewhere in the health system often follow Medicare’s lead. The same Medicare trickle-down effect will, with hope, lend support to ending discrimination in mental health coverage, said Ralph Ibsen, vice president for government affairs at the advocacy group Mental Health America. Bringing outpatient mental health co-payments on par with medical services breaks down a significant barrier for those seeking help with mental illness, Ibsen said. Ideally, he said, the new Medicare law would have simply repealed the higher co-payment ? instead of phasing it out over six years ? but “given the fiscal environment we’re in, the pressure at play in terms of finding offsets and the competing provisions, we understood the dynamics and nonetheless celebrate this achievement,” Ibsen told The Nation’s Health. He noted that “there is every expectation” that Congress will pass additional legislation this year requiring such mental health parity in employer-provided coverage.

“Given the fact that Medicare law has stigmatized mental illness since its founding…and the 50 percent co-payment requirement has been a formidable barrier to care for many decades, it’s a tremendous step and one that our organization and many others have been working to change for many years,” he said.

Among older Americans, data suggest that about 20 percent have or will experience a mental disorder, Ibsen noted, and among the population that receives Medicare benefits due to a disability, there are estimates that more than half suffer from a mental illness. Stigmatizing such illnesses and blocking access to treatment not only results in greater suffering, but can complicate and slow down treatment of other health conditions as well, he said.

“The science supports that mental health is fundamental to overall health,” he said. “When federal policies allow for meeting mental health needs, we have every reason to believe that we will get better health outcomes and less costly care.”

Blocking payment cuts for physicians serving Medicare patients was another provision celebrated in the recently passed law. According to American Medical Association President Nancy Nielsen, MD, a scheduled 10.6 percent cut would have been “devastating to seniors and the disabled who rely on Medicare for the health care they need.” The new law gives Medicare physicians a 1.1 percent payment raise, which keeps Medicare physician payments at about the same rate as they were in 2001. During the forthcoming 18-month moratorium on Medicare physician payment cuts, Vicki Gottlich, senior policy attorney at the Center for Medicare Advocacy, said she is looking forward to a bipartisan discussion on how to revise and sustain Medicare’s payment system. Advocates need to make sure that doctors are paid “adequately and fairly for their services,” Gottlich told The Nation’s Health, and that payment structures do not discriminate against providers who serve rural communities, under-served populations and people living on low incomes.

In related Medicare news, the U.S. House of Representatives in late July passed a resolution, known as H. Res. 1368, that would delay action on a White House proposal to cut Medicare spending. The proposal was submitted earlier this year after Medicare trustees pulled what is known as a “trigger,” under which Congress could expedite legislation to cut Medicare services or shift more costs to beneficiaries. Created in 2003, the trigger is sounded when more than 45 percent of Medicare expenditures are financed via general fund revenue. However, many advocates define the 45 percent cap as arbitrary, including APHA, which passed policy in 2007 opposing the trigger. As of early August, the resolution had not passed the Senate.