Antisoma Starts Phase II Trial Of AS1402 In Breast Cancer

 Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) announced that it has started a phase II trial evaluating the addition of AS1402 to the endocrine (hormonal) therapy letrozole in post-menopausal women receiving first-line treatment for advanced breast cancer.


Approximately 110 patients will be randomly assigned to receive either letrozole plus AS1402 or standard treatment with letrozole alone. The safety of the AS1402-letrozole combination will be evaluated and its efficacy compared with that of letrozole alone. Measures of efficacy will include response rates, time to tumour progression, progression-free survival and clinical benefit rate. Final results are expected in 2010.


The phase II trial builds on a phase I study in patients with heavily pre-treated breast cancer, which showed that AS1402 monotherapy was well-tolerated and was associated with prolonged stable disease in a number of patients.


AS1402 targets a cancer-associated form of the cell-surface protein MUC1. This form is found in approximately 90% of breast cancers and in a wide range of other tumours. Tissue culture studies have shown that AS1402 binds to MUC1 on cancer cells and leads to their destruction by antibody-dependent cellular cytotoxicity (ADCC), a process involving recruitment of the immune system. Recent studies have shown that MUC1 up-regulates the oestrogen signalling pathway targeted by endocrine therapies. This provides a particular rationale for combining AS1402 with letrozole in Antisoma's phase II trial.


Hospitals in the US, Russia, Ukraine, Poland and France are taking part in the phase II study. The trial's Principal Investigator, Professor Nuhad Ibrahim, of the MD Anderson Cancer Center, University of Texas, said: "There is a clear rationale for testing AS1402 in this group of breast cancer patients, and we are pleased to be participating in this well-designed study."


Antisoma's Chief Operating Officer, Dr Ursula Ney, added: "Worldwide, over 90,000 women each year receive endocrine treatment for advanced breast cancer, so many patients could benefit from any add-on therapy that improved outcomes in this setting. Our phase II study rigorously tests the value of adding AS1402 to endocrine treatment and, if positive, will provide a firm basis for progress to a pivotal phase III trial in breast cancer."

Background on the AS1402 phase II trial


Additional details of the phase II trial of AS1402 will be available shortly at http://www.clinicaltrials.gov. In this study, the anti-MUC1 antibody AS1402 is being tested in combination with a widely used endocrine (hormonal) therapy, letrozole, which belongs to the class of aromatase inhibitors. This is the first study to evaluate AS1402 as part of a combination regimen, phase I trials having tested AS1402 as a single agent. It is believed to be the first trial to combine a MUC1-targeting antibody with endocrine treatment for cancer. Endpoints in the phase II trial include response rates, time to tumour progression, progression-free survival and clinical benefit rate (sum of patients showing a response or disease stabilisation by 'RECIST' (Response Evaluation Criteria In Solid Tumours)).

Background on AS1402


AS1402 (huHMFG1, previously known also as R1550 and Therex) is a humanised antibody against a form of MUC1 found on the surface of various cancers. The drug has successfully completed phase I studies in breast cancer. It was licensed by Antisoma from the Imperial Cancer Research Technologies, the technology transfer arm of the Imperial Cancer Research Fund (now Cancer Research UK).


AS1402 is a humanised antibody that attacks cancer cells by recruiting the patient's immune system, particularly natural killer cells. This is the process of antibody-dependent cellular cytotoxicity (ADCC), which has been demonstrated during experiments in vitro with the AS1402 antibody. A growing body of evidence links the MUC1 protein targeted by AS1402 with cancer progression and metastasis. In particular, MUC1 has been implicated in changes in intracellular signalling and altered interactions with extracellular matrix components such as ICAM-1. These findings reinforce the relevance of MUC1 as a target for anti-cancer treatments and open up the possibility that, in addition to mediating ADCC, naked anti-MUC1 antibodies such as AS1402 may exert effects on cancer cells by altering the interactions of MUC1 with other proteins.

Background on Antisoma


Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer. The Company has operations in the UK and the US. Please visit http://www.antisoma.com for further information about Antisoma.

Antisoma Plc


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It's Your Doctor Calling: Fibromyalgia Sufferers Sought For Motivational Study

  Researchers at the Indiana University School of Medicine seek 200 people with fibromyalgia to determine if motivational reminder telephone calls can prompt patients to exercise more regularly.


Fibromyalgia is a disease that causes pain in joints and muscles in about 5 percent of the population. Although not life-threatening, fibromyalgia can have a debilitating effect on a person's quality of life by causing body aches, headaches, stiffness and disrupted sleep. One of the common prescriptions for the disease is exercise.


Eligible participants include fibromyalgia patients between the ages of 18 and 65 years who have been diagnosed by a rheumatologist and who have no medical conditions that restricts participation in moderate physical activity.


The ongoing study will evaluate how effectiveness of exercise-based motivational interviewing.


Individuals interested in the study can go to http://www.fibrofit.netto pre-qualify, or call Janna Hilligoss at 317-274-1755 for more information .

http://www.fibrofit.net


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Supplements No Better Than Placebo In Slowing Cartilage Loss In Knees Of Osteoarthritis Patients

 In a two-year multicenter study led by University of Utah doctors, the dietary supplements glucosamine and chondroitin sulfate performed no better than placebo in slowing the rate of cartilage loss in the knees of osteoarthritis patients.



This was an ancillary study concurrently conducted on a subset of the patients who were enrolled in the prospective, randomized GAIT (Glucosamine/chondroitin Arthritis Intervention Trial). The primary objective of this ancillary study was to investigate whether these dietary supplements could diminish the structural damage of osteoarthritis. The results, published in the October issue of Arthritis & Rheumatism, show none of the agents had a clinically significant effect on slowing the rate of joint space width loss - the distance between the ends of joint bones as shown by X-ray.



However, in line with other recent studies, the researchers observed that all the study's participants had a slower rate of joint space width loss than expected, making it more difficult to detect the effects of the dietary supplements and other agents used in the study.



Rheumatologist Allen D. Sawitzke, M.D., associate professor of internal medicine at the University of Utah School of Medicine, was lead investigator. "At two years, no treatment achieved what was predefined to be a clinically important reduction in joint space width loss," Sawitzke said. "While we found a trend toward improvement among those with moderate osteoarthritis of the knee in those taking glucosamine, we were not able to draw any definitive conclusions."



More than 21 million Americans have osteoarthritis, with many taking glucosamine and chondroitin sulfate, separately or in combination, to relieve pain. The original GAIT, led by University of Utah rheumatologist Daniel O. Clegg, M.D., professor of internal medicine, was a multicenter, randomized, national clinical trial that studied whether these dietary supplements provided significant pain relief to people with osteoarthritis in the knees. GAIT found that the supplements produced no more pain relief than placebo (New England Journal of Medicine, February 2006), although a subset of the original GAIT participants with moderate to severe osteoarthritis knee pain appeared to receive significant pain relief when they took a combination of glucosamine and chondroitin sulfate.



In this ancillary study, GAIT patients were offered the opportunity to continue their original study treatment for an additional 18 months, for a total of two years. Participants remained on their originally assigned GAIT treatment: 500 mg of glucosamine three times a day; or 400 mg of chondroitin sulfate three times a day; or a combination of the two supplements; or 200 mg of celecoxib daily; or a placebo.



X-rays were obtained at study entry and again at one and two years. Joint space width was measured on 581 knees from 357 patients. None of the trial groups showed significant improvement. The group taking glucosamine had the least change in joint space width, followed by the groups taking chondroitin sulfate, celecoxib, placebo and the combination of both dietary supplements.



The total joint space width loss over two years for each group was:
0.013mm (glucosamine)



0.107mm (chondroitin sulfate)



0.111mm (celecoxib)



0.166mm (placebo)



0.194mm (glucosamine and chondroitin sulfate)


The interpretation of the results was problematic because the placebo group's joint space width loss was much less at two years than the 0.4mm the researchers' expected. Based on other large studies published in scientific journals, the researchers hypothesized that a loss of 0.2mm or less at two years would mean a slowed rate of cartilage loss. However, because the reduction in rate of joint space loss for all the groups was under the 0.2mm threshold, the researchers concluded none of the agents significantly slowed the loss of joint space width.



Josephine P. Briggs, M.D., director of the National Center for Complementary and Alternative Medicine, one of the study's funders, said although no definitive conclusions can be drawn about the two dietary supplements yet, "the results of the study provide important insights for future research."



Clegg said the trial shed light on osteoarthritis progression, techniques that can more reliably measure joint space width loss, possible effects of glucosamine and chondroitin sulfate, and on identifying patients who may respond best as further studies are pursued.





The other centers in the study were: The Arthritis Research and Clinical Centers, Wichita, Kan.; University of Arizona, Tucson; Case Western Reserve University, Cleveland; Cedars-Sinai Medical Center; Los Angeles; Indiana University, Indianapolis; University of California, Los Angeles; University of California, San Francisco; University of Pittsburgh.



The National Institute of Arthritis and Musculoskeletal and Skin Diseases also funded the study. Both it and the National Center for Complementary and Alternative Medicine are part of the National Institutes of Health.



Source: Phil Sahm

University of Utah Health Sciences



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Retrospective Analysis Of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene

 A retrospective analysis of Phase 3 two-year data presented at the annual meeting of the North American Menopause Society (NAMS) suggest that postmenopausal women treated with bazedoxifene/conjugated estrogens (BZA/CE) may experience incidence of breast tenderness and abnormal mammograms no greater than those treated with placebo. BZA/CE is an investigational compound being studied by Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flashes and night sweats, and for the prevention of postmenopausal osteoporosis. Wyeth describes this compound as a tissue selective estrogen complex (TSEC).


In a retrospective analysis of data from another phase 3 study, treatment with Wyeth's investigational compound bazedoxifene (BZA) alone did not appear to increase mammographic breast density in postmenopausal women with osteoporosis compared to raloxifene (the active comparator) or placebo over two years. BZA is an investigational selective estrogen receptor modulator (SERM) under development for the treatment and prevention of postmenopausal osteoporosis.

Data Highlights


NAMS Poster Titled: Breast Effects of Bazedoxifene/Conjugated Estrogens in a Randomized, Controlled Trial of Postmenopausal Women



In the phase 3 study involving 3,397 postmenopausal women, primarily designed to evaluate the effects of BZA/CE on the endometrium and bone mineral density, mammograms were taken at baseline, and again at years one and two as part of the safety evaluation. Breast tenderness was reported in daily diaries. A retrospective analysis suggested no significant differences in the incidence of breast tenderness or abnormal mammograms between the BZA/CE groups at any of the doses studied and placebo or raloxifene.



In this study, the incidence of treatment-emergent adverse events, serious adverse events, and withdrawals due to adverse events were similar among the active treatment groups and placebo.


NAMS Poster Titled: Effects of Bazedoxifene on Mammographic Breast Density in Postmenopausal Women with Osteoporosis



A retrospective study examined mammograms in a subset representing 726 postmenopausal women from a primary phase 3 fracture reduction study of BZA, raloxifene, and placebo. The objective was to evaluate the quantitative changes in mammographic breast density after 24 months of treatment. This study indicated treatment with BZA over 24 months did not affect mammographic breast density in postmenopausal women with osteoporosis. Changes in breast density with BZA were similar to those with raloxifene and placebo.



Also presented at the NAMS meeting were data on the effects of BZA/CE on sleep and overall menopausal symptoms.

About TSEC



Wyeth describes the pairing of a selective estrogen receptor modulator (SERM) and one or more estrogens as a TSEC. The TSEC concept is based on the blended tissue-selective activity of the components, which is hypothesized to yield different clinical results than those provided by either the SERM or estrogen(s) alone.

About Menopause



According to the U.S. Census Bureau, in 2006, there were approximately 20 million women of menopausal age (45-54 years) in the United States. As many as 50 percent to 90 percent of women going through menopause experience vasomotor symptoms, such as hot flashes, which can greatly impact a woman's life. Furthermore, between 10 percent and 40 percent of postmenopausal women experience symptoms of vulvar and vaginal atrophy, which typically do not subside without treatment.

About Wyeth Pharmaceuticals



Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.



Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. For additional information about the company, please visit http://www.wyeth.com.

The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. In addition, there can be no assurance that bazedoxifene/conjugated estrogens or bazedoxifene will ever receive regulatory approval or be successfully developed and commercialized. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.



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Zypadhera(TM) Receives Positive Opinion From The European Committee For Medicinal Products For Human Use (CHMP) For Treatment Of Schizophrenia

 The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection, also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine, Eli Lilly and Company (LLY) announced.


The opinion issued by the CHMP will need to be ratified by the European Commission before the new indication is considered approved. The Commission usually makes a decision within two to three months of a CHMP recommendation.


Olanzapine long-acting injection is an investigational formulation that combines olanzapine, an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks. Long-acting injectables have been associated with improved treatment for patients who struggle with adherence to oral medications.(i)


"Because of the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of depot formulations available, we believe that olanzapine long-acting injection has the potential to become a valuable treatment option for patients," said David McDonnell, M.D., clinical research physician at Lilly.


The CHMP opinion was based on a comprehensive data package comprising eight studies, involving 2,054 patients, including a double-blind, placebo- controlled, fixed-dose study (HGJZ)(ii); a double-blind, oral olanzapine- controlled, fixed-dose study (HGKA)(iii); and six open-label studies(iv). In these trials, olanzapine long-acting injection (LAI) was found to be similar to olanzapine oral in terms of rate of symptom exacerbation and showed a similar safety profile as the oral formulation with the exception of injection-related events, including olanzapine LAI Post-Injection Syndrome. (v) Additionally, the trials showed that olanzapine long-acting injection (LAI) separated from placebo as measured by total PANSS score reduction over 8 weeks of treatment, and a drug effect that was observed as early as one week from the first injection.(vi); olanzapine long-acting injection was studied as a once every-four week and a once every-two week injection, without the need for oral antipsychotic supplementation.


As of August 31, 2008, across all clinical trials, olanzapine LAI Post- Injection Syndrome events, including a range of symptoms of sedation (from mild in severity to unconsciousness) and/or delirium (including confusion, disorientation, agitation, anxiety and other cognitive impairment), have been seen in 0.07 percent of injections and 1.4 percent of patients, all of whom have recovered fully. (vii)


As part of the marketing authorization, Lilly has proposed a comprehensive risk minimization plan for identifying and managing olanzapine LAI Post- Injection Syndrome. The plan includes a requirement for a post-injection observation period described in the product labeling, and an extensive healthcare provider training and educational program.


Earlier this month, Zypadhera was approved for use in New Zealand. Independent regulatory reviews of olanzapine LAI applications for schizophrenia are ongoing in the United States, Canada, Australia and other countries.

About Long-acting Injectable Antipsychotic Medications



The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schizophrenia. Depot formulations should be considered as a treatment option when a patient expresses a preference for such treatment due to convenience or if it is determined that a depot formulation is necessary to help with compliance.(viii)


Long-acting antipsychotic formulations have been associated with improved treatment adherence and reduced treatment failures.(ix) By administering long- acting medications, healthcare professionals know when patients have received their medication and can immediately detect non-adherence when a patient fails to return for a scheduled injection.* Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.(xi)

About Schizophrenia



Schizophrenia is a severe and debilitating illness with such symptoms as delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions), disorganized speech and severe disorganized or catatonic behavior. These signs and symptoms are associated with marked social or occupational dysfunction. Features of schizophrenia consist of characteristic signs and symptoms that have been present for a significant portion of time during a one-month period, with some signs of the disorder persisting for at least six months.(xii) In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.

About Olanzapine



Since olanzapine was introduced in 1996, it has been prescribed to more than 26 million people worldwide. Olanzapine is not recommended for use in patients under 18 years of age.


In Europe, olanzapine is indicated for schizophrenia and in clinical trials, it has shown to be effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. It also is indicated for the treatment of moderate to severe manic episodes and, in those patients whose manic episode has responded to olanzapine treatment, it is indicated for the prevention of recurrence in patients with bipolar disorder.

SAFETY INFORMATION



Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases. In some cases, a prior increase in body weight has been reported, which may be a predisposing factor. Appropriate clinical monitoring is advisable, particularly in diabetic patients and in patients with risk factors for diabetes mellitus for which regular glucose control is recommended.


Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials. Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.


The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time. In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 4-6 months.


As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported rarely with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.


Also, as with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD increases as the duration of treatment. If signs and symptoms of TD are observed a dose reduction or discontinuation should be considered and it should be noted that the symptoms can temporally deteriorate or even rise after discontinuation.


Other potentially serious adverse events include low blood pressure, seizures, elevated prolactin levels, elevated liver enzymes, thromobembolism, neutopenia, sweating, insomnia, tremor, anxiety, nausea, or vomiting.


Olanzapine should not be used in patients who have a hypersensitivity to the drug nor those with narrow angle glaucoma. It should not be used to treat dementia-related psychosis and/or behavioural disturbances because of an observed increase in death and cerebrovascular accident. It should also not be used in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease.


The most frequently (seen in >/= 1% of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels, glucosuria, increased appetite, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic transaminases, rash, asthenia, fatigue and oedema.

About Lilly



Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.co.uk

P-LLY



This press release contains forward-looking statements about the safety and efficacy of olanzapine long acting injection (LAI) and reflects Lilly's current beliefs. However, as with any investigational pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, regulatory milestones and commercialization. There is no guarantee that olanzapine LAI will be approved for the treatment of schizophrenia or that if approved, it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

References


i. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.


ii. Lauriello J., Lambert T., Andersen S., Lin D., Taylor C.C., McDonnell D. Olanzapine Long-Acting Injection: An 8-Week Double-Blind, Randomized, Placebo-Controlled Study in Acutely-Ill Patients with Schizophrenia. Journal of Clinical Psychiatry. May 2008.


iii. Detke H., McDonnell D., Kane J., Naber D., Sethuraman G., Lin D. Olanzapine Long-Acting Injection for the Maintenance Treatment of


Schizophrenia: A 24-Week, Randomized, Double-Blind Trial. Data presented at Schizophrenia International Research Society Meeting. June 21-25, 2008.


iv. McDonnell D., Andersen S., Detke H., Watson S. 160-week interim results from an open-label extension trial of olanzapine long-acting injection. Data presented at Schizophrenia International Research Society Meeting. June 21-25, 2008.


v. Detke H., McDonnell D., Kane J., Naber D., Sethuraman G., Lin D. Olanzapine Long-Acting Injection for the Maintenance Treatment of Schizophrenia: A 24-Week, Randomized, Double-Blind Trial. Data presented at Schizophrenia International Research Society Meeting. June 21-25, 2008.


vi. Lauriello J., Lambert T., Andersen S., Lin D., Taylor C.C., McDonnell D. Olanzapine Long-Acting Injection: An 8-Week Double-Blind, Randomized, Placebo-Controlled Study in Acutely-Ill Patients with Schizophrenia. Journal of Clinical Psychiatry. May 2008.


vii. McDonnell D., Sorsaburu S., Brunner E., Detke H., Andersen S., Bergstrom R., Mitchell M., Ogle K., Watson S., Corya S. Post-Injection Delirium/Sedation Syndrome Observed with Olanzapine Long-Acting Injection. Data Presented at European College of Neuropsychopharmacolgy Meeting. August 30-September 3, 2008.


viii. Falkai P., Wobrock T., Lieberman J., Glenthoj B.,Gattaz W.F., Moller H.J & WFSBP Task Force On Treatment Guidelines For Schizophrenia. The World Journal of Biological Psychiatry, 2006; 7(1): 5/40


ix. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.


x. Kane J.M et al. Guidelines for depot antipsychotic treatment in schizophrenia. European Neuropsychopharmacology, Volume 8, Number 1, 1 February 1998, pp. 55-66(12). p. 58.


xi. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.


xii. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition, 2000, pp. 298.


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



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VEGF Trap-Eye: New Data Confirm Successes In The Treatment Of Age Related Macular Degeneration

 VEGF Trap-Eye can achieve durable improvements in visual acuity and in biologic measurement parameters in the formation of new blood vessels in the treatment of age-related macular degeneration (AMG). This was shown in the final evaluation of a Phase 2 study presented at the annual meeting of the Retina Society in Scottsdale, Arizona. These parameters include retinal thickness and active choroidal neovascularization lesion size (the damaged part of the retina). Bayer HealthCare and Regeneron Pharmaceuticals, Inc (Nasdaq:REGN) are developing VEGF Trap-Eye together. The treatment successes continued for up to a year.


The study showed that VEGF Trap-Eye was also associated with a reduction in the size of the choroidal neovascular membrane (CNV), the active lesion that is the underlying cause of vision loss in patients with wet AMD. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p

"Progression of the active CNV lesion and resulting vision impairment are an inevitable consequence of untreated wet AMD. The reduction in total active CNV lesion size achieved with VEGF Trap-Eye treatment in this Phase 2 clinical study could potentially translate into clinically meaningful outcomes in the larger, controlled Phase 3 studies that are underway," stated Jason Slakter, M.D., head of the independent reading center for the study and a Clinical Professor of Ophthalmology, New York University School of Medicine, New York.


In this double-masked Phase 2 trial, participants were initially treated with either monthly or quarterly fixed dosing for 12 weeks and then continued to receive treatment for another 40 weeks on a PRN (as needed) dosing schedule. Patients receiving fixed monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks (i.e. 4 fixed doses) followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p

Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for 12 weeks followed by PRN dosing also achieved mean decreases in retinal thickness versus baseline of 143 microns (p

While PRN dosing following a fixed quarterly dosing regimen (with dosing at baseline and week 12) also yielded improvements in visual acuity and retinal thickness versus baseline at week 52, the results generally were not as robust as those obtained with initial monthly treatment.


"Anti-VEGF therapy has dramatically changed the treatment paradigm for wet AMD, and improvement in visual acuity is now feasible in most patients. The biggest challenge we have is that with our current drugs, the majority of patients need frequent injections into their eye to maintain their visual acuity gains," stated David M. Brown, M.D., a study investigator and a retinal specialist at The Methodist Hospital in Houston."These study results reinforce our interest in further exploring whether continued administration of VEGF Trap-Eye on an as-needed basis after an initial period of fixed dosing can maintain a durability of effect over time in controlled Phase 3 clinical studies."


VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of eye inflammation (culture-negative endophthalmitis/uveitis) in the study eye, which was deemed not to be drug-related. The most common adverse events were those typically associated with intravitreal injections.

About the Phase 3 Program in Wet AMD


Regeneron and Bayer HealthCare initiated a Phase 3 global development program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3 trials, VIEW 1 and VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet age related macular degeneration), the companies are evaluating VEGF Trap-Eye dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg every 8 weeks (following three monthly doses) in direct comparison with ranibizumab (Lucentis®, a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks according to its U.S. label during the first year of the studies. PRN dosing will be evaluated during the second year of each study. The VIEW 1 study (http://www.regeneron.com/vegftrap_eye.html) is currently enrolling patients in the United States and Canada and the VIEW 2 study (http://www.view2study.com) is currently enrolling patients in Europe, Asia Pacific, Japan and Latin America. The companies are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

About VEGF Trap-Eye


Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye, which lead to the development of wet AMD. The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related placental growth factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. Blockade of VEGF, which can prevent abnormal blood vessel formation and vascular leak, has proven beneficial in the treatment of wet AMD.

About Wet AMD


Age-related Macular Degeneration (AMD) is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry (nonexudative) or wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.

About Bayer HealthCare


The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.


Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Forward looking statements


This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


View drug information on Lucentis.



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Monthly Replacement Contact Lens Wearers Report A Decrease In Wearing Comfort Over The Course Of A Month, Research Shows

 Monthly replacement contact lens wearers notice a decline in lens performance in weeks three and four of wear, a survey reveals. Findings from the research among monthly lens wearers in France, in which 20 different brands of lenses were represented, show a decrease in wearing comfort over the course of a month, with no significant differences between wearers of hydrogel and silicone hydrogel monthly replacement lenses.


About seven in ten monthly silicone hydrogel (71 percent) and hydrogel (68 percent) wearers reported a decrease in wearing comfort as the month progressed. Asked which week of the month, in general, they start to notice that their lenses become more uncomfortable, 95 percent said they become aware of discomfort in weeks three and four. Monthly silicone hydrogel wearers who experienced discomfort tended to notice it earlier in the lens cycle than hydrogel wearers.


"Discomfort and, in particular, dryness-related discomfort is a prime reason that many contact lens wearers either reduce or discontinue wearing their contacts," says Sheila Hickson-Curran, Director, Medical Affairs, VISTAKON®, Division of Johnson & Johnson Vision Care, Inc. "This study suggests that contact lens wearers should talk to their eye care professional if they are noticing a decline in lens performance over time."


Discomfort and other eye related problems could also occur for lens wearers who exceed the recommended wear and replacement schedule of a lens, according to Dr. Hickson-Curran.


Even though doctors and manufacturers provide instructions about caring for and wearing contact lenses, less than half of wearers (46 percent) always replace their contact lenses in accordance with their doctor's recommended schedule, with younger wearers less likely to be compliant according to Americans' Attitudes & Perceptions About Vision Care, a 2006 survey of 3,700 Americans conducted by Harris Interactive® on behalf of The Vision Care Institute™, LLC, a Johnson & Johnson Company.


"It is quite simple," Hickson-Curran notes. "If you wear a daily disposable contact lens, put in a fresh new lens every day; a bi-weekly, once every two weeks, and a monthly, once a month. By not following instructions on proper wear and care, contact lens wearers are more likely to experience discomfort and may put themselves at greater risk for infection or other serious complications."


To help contact lens wearers be compliant, VISTAKON® offers a complimentary online reminder service called ACUMINDER™. Available at http://www.acuminder.com, visitors can elect to receive an automatic reminder about changing or ordering new contact lenses via e-mail, cell phone text message, and/or a computer desktop prompt. A newly launched application for Facebook users (http://www.acuminder.com/facebook) expands its functionality into a multipurpose lifestyle tool that can also send out reminders for just about anything, such as taking daily medications, doctors' visits, work deadlines, important social events and more.


ACUMINDER™ users self report that they are becoming more compliant thanks to the reminder service, which is open to all contact lens wearers. In its first year, more than 11,000 contact lens wearers signed up for ACUMINDER™. In a January 2008 survey, bi-weekly contact lens wearers reported a marked improvement in their contact lens behavior -- the average number of days between lens changes decreased from 19 days to a near-perfect compliance of 15 days.

About the Research


An independent market research company conducted an online survey among consumers in France during October and November 2007. Johnson & Johnson Vision Care, Inc., sponsored the survey although subjects were unaware of the sponsor's identity. The sample was randomly selected from a consumer database of contact lens wearers designed to be representative of all existing brands in the French market. In total, 20 different brands of lenses were represented. The monthly replacement lens SUREVUE® Brand Contact lenses (not available in the United States) was the only Johnson & Johnson Vision Care product represented, since the company's ACUVUE® Brand Contact lenses are recommended for daily, weekly, or bi-weekly replacement.


Data was analyzed for a total of 434 existing contact lens wearers who completed the survey. Of these, 271 were wearing monthly replacement hydrogel lenses and 163 wore monthly silicone hydrogel lenses. All wearers were aged from 18-40 years and were frequent contact lens users, wearing their lenses at least three days a week and either all day long or during the day. Lens wearing history (i.e., number of years' wear) and care regime were not investigated in this survey.


ACUVUE® Brand Contact Lenses are available by prescription only for vision correction. An eye care professional will determine whether contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. To help avoid these problems, follow the wear and replacement schedule and the lens care instructions provided by your eye doctor. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, contact your eye doctor immediately.

ACUVUE® , SUREVUE® ,ACUMINDER™, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.


Johnson and Johnson
http://www.jnj.com



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EVAR Offers Better Results Than Open Repair In High Risk Patients

 Endovascular aneurysm repair (EVAR) yields better results than open surgical repair (OSR) in high risk patients with similar costs, according to a one-year trial study which appears in the October issue of the Journal of Vascular Surgery, published by the Society for Vascular Surgery.


Data was collected from 342 patients who had an abdominal aortic aneurysm (AAA) of more than 5.5 centimeters and required elective AAA repair at London Health Sciences Center (LHSC), London, Ontario, Canada, where EVAR has been used since 1997. Of the 192 patients at a high risk of postoperative complications, 140 received EVAR and 52 had OSR.


In this one-year non-randomized prospective study, demographic, medical, health care resource utilization, cost and quality of life data were collected to determine incremental costs and effects associated with each of these procedures. Sensitivity analyses were conducted to extrapolate the one-year mortality results to a five-year time horizon under various assumptions regarding convergence of mortality rates and re-intervention rates (for EVAR patients only).


"Even with similar baseline characteristics, postoperative complications occurred more frequently in OSR patients at a high-risk of surgical complications," said Dr. Guy De Rose, MD, medical director of surgical care at LHSC and an associate professor of surgery from the division of vascular surgery at the University of Western Ontario in London, Ontario, Canada. "The 30-day mortality rates were 0.7 percent for EVAR and 9.6 percent for OSR and significantly fewer EVAR patients had postoperative complications such as pulmonary edema, pneumonia or sepsis. In addition, the EVAR patients spent less time in the hospital and were less likely to be admitted to the ICU."


Dr. De Rose noted that, despite the cost of the endograft (approximately $10,000), the total average initial costs of hospitalization for high risk EVAR and OSR patients were similar ($28,139 vs. $31,181 respectively). He added that total one-year medical and indirect costs also were similar at $34,146 vs. $34,170 respectively. At one-year, all cause mortality was statistically lower in EVAR patients (7.1% vs. 17.3%). Five-year extrapolations indicated that EVAR may be cost-effective compared to OSR in high-risk patients over the long-term.


"Our study found that EVAR was a cost-effective strategy compared to OSR in high risk patients and had lower postoperative complications and lower mortality rates," said Dr. De Rose. He added that the quality of life experienced by the participating patients was similar between the two groups during the year following surgery.


"We are continuing to collect data on these patients and the longer-term results will provide more information regarding the cost-effectiveness of EVAR compared to OSR in high risk patients," explained Dr. De Rose.


The LHSC collaborated with the Programs for Assessment of Technology in Health (PATH) Research Institute, St Joseph's Healthcare Hamilton/McMaster University in Hamilton, Ontario, Canada on the current study. This study was conducted at the request of the Ontario Ministry of Health and Long-Term Care to provide evidence to the Ontario Health Technology Advisory Committee to support policy recommendations regarding the use of EVAR in Ontario.

About Journal of Vascular Surgery

Journal of Vascular Surgery provides vascular, cardiothoracic and general surgeons with the most recent information in vascular surgery. Original, peer-reviewed articles cover clinical and experimental studies, noninvasive diagnostic techniques, processes and vascular substitutes, microvascular surgical techniques, angiography and endovascular management. Special issues publish papers presented at the annual meeting of the Journal's sponsoring society, the Society for Vascular Surgery. Visit the Journal web site at http://www.jvascsurg.org.

About the Society for Vascular Surgery


The Society for Vascular Surgery (SVS) is a not-for-profit society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,600 vascular surgeons dedicated to the prevention and cure of vascular disease. Visit the web site at http://www.VascularWeb.org.


Society for Vascular Surgery

633 N St. Clair, 24th Fl.

Chicago, IL 60611

United States
http://www.vascularweb.org



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Baxter's Antimicrobial IV Technology Now Shown To Kill Six Common Pathogens, Including MRSA And VRE

 Baxter Healthcare
Corporation announced that it received 510(k) clearance for expanded
labeling for the first antimicrobial needleless intravenous (IV) connector,
V-Link Luer-activated device (LAD) with VitalShield protective coating.
With a new federal policy restricting reimbursement for
healthcare-associated infections (HAIs) taking effect on October 1,
healthcare professionals are seeking effective techniques and technologies
to reduce the risk of contamination from a broad array of pathogens
(infection-causing agents) within their hospitals.



Launched earlier this year, V-Link with VitalShield has now been shown
to kill at least 99.99 percent of six common pathogens known to cause
catheter-related bloodstream infections. The U.S. Food and Drug
Administration (FDA) cleared expanded labeling for V-Link with VitalShield
based on V-Link's ability to combat three additional pathogens:
vancomycin-resistant Enterococcus faecalis (VRE), Escherichia coli (E.
coli) and Staphylococcus epidermidis (coagulase negative). These three
pathogens improve upon the previously cleared labeling, which included
methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa
and Enterobacter cloacae.



Testing has demonstrated V-Link with VitalShield is effective against
this broad spectrum of microorganisms and retains antimicrobial efficacy
for up to a 96-hour period. In vitro testing for V-Link with VitalShield
was conducted using six strains of six common pathogens known to cause
bloodstream infections. V-Link with VitalShield is already available in the
United States, Canada, Puerto Rico, Australia and New Zealand, and Baxter
plans to launch the product in Europe later this year.



V-Link with VitalShield's expanded indications for use include VRE, a
multi-drug resistant organism, which over the past 20 years has been
increasingly reported as a source of healthcare-associated infections.(1,2)
Pathogens such as VRE and MRSA can contaminate medical devices used to
deliver IV fluids and medication to patients. The V-Link device is uniquely
coated on both inner and outer surfaces with a proprietary silver-based
antimicrobial technology, VitalShield, which helps to prevent contamination
and growth of these pathogens within the device.



"The revised labeling and expanded indications for use further validate
the broad spectrum antimicrobial coverage and effectiveness of V-Link with
VitalShield in lowering the risk of pathogen contamination," said Francois
Lebel, MD, vice president of Clinical and Medical Affairs for Baxter's
Medication Delivery business. "This additional microbial coverage and
long-lasting effect give healthcare professionals added confidence that
they are taking extra precaution to address patient safety."



"Bacteria can contaminate needleless IV connectors, particularly if
healthcare workers do not adhere to proper infection prevention measures.
In my practice, we have begun to evaluate this device and hope to see if
its use leads to lower bloodstream infection rates," said James Steinberg,
MD, associate professor of medicine in the Division of Infectious Diseases
at Emory University School of Medicine.



Starting this October, the Centers for Medicare and Medicaid Services
(CMS) will no longer reimburse U.S. hospitals for costs required to treat
healthcare-associated infections, including catheter-related bloodstream
infections. As the new CMS policy takes effect, healthcare facilities will
look to adopt infection control strategies to improve patient care and
avoid financial penalties.

V-Link with VitalShield Data Results to be Shared at ICAAC/IDSA



Baxter announced today that study results for V-Link with VitalShield
will be presented on October 27 during the first-ever joint meeting of the
American Society for Microbiology and the Infectious Diseases Society of
America (48th Annual ICAAC/IDSA 46th Annual Meeting) in Washington, DC. The
study reviews the effectiveness of V-Link with VitalShield in an in vivo
model of MRSA-generated catheter-related bloodstream infection and will be
presented by Mark Rupp, MD, medical director and professor of infectious
disease at the University of Nebraska Medical Center.



"Catheter-related bloodstream infections are clinically significant
infections with broad implications for both patients and our healthcare
system," said Dr. Rupp. "The data I am presenting at the ICAAC/IDSA meeting
indicate that this silver-coated catheter connector valve may provide a
protective effect against MRSA."

About V-Link Luer-activated device with VitalShield protective coating



Many hospitalized patients need a steady supply of medications or
fluids delivered into their bloodstream. Typically, an IV catheter is
placed in a patient's vein to allow direct access to the bloodstream. In
the process of injecting medications or fluids into a sterile line, surface
or other environmental contaminants may be introduced.



V-Link with VitalShield, a needleless IV connector used with the
catheter or IV tubing, helps to prevent contamination and growth of
specific pathogens within the device at the point of entry to the patient's
bloodstream. Reduction in colonization or microbial growth on the device
has not yet been studied to substantiate a reduction in bloodstream
infections. Silver is a well-known antimicrobial agent, and the V-Link
device is coated on both inner and outer surfaces with a specially designed
formulation, VitalShield, which has been shown to be effective against a
broad spectrum of microorganisms. The silver antimicrobial agent helps
prevent the contamination and growth of these pathogens within the V-Link
device. The antimicrobial agent is not intended to be used as a treatment
for existing infections.



V-Link with VitalShield is the first introduction of Baxter's newly
developed Vital Infusion Systems product line -- an integrated portfolio of
products developed to promote safety and reliability, and decrease risks
associated with IV therapy.

About Healthcare Associated Bloodstream Infections



Researchers have estimated that more than 400,000 vascular
catheter-related bloodstream infections occur each year in the United
States alone.(3) The Centers for Disease Control and Prevention (CDC)
reported in 2007 that MRSA infections cause an estimated 18,650 deaths per
year in the U.S., which are more per year than is caused in the U.S. by
HIV/AIDS.(4,5) In 2004, VRE caused approximately one out of every three
infections in hospital intensive-care units, according to the CDC.(6) There
are several types of healthcare-associated infections -- of these,
bloodstream infections are the most costly and life-threatening, resulting
in an average increase in mortality rate of 18 percent when compared to
patients without a bloodstream infection.(7,8,9) According to U.S.
estimates, healthcare-associated bloodstream infections cost an average of
$34,000 in increased direct hospital costs and can increase patient
length-of-stays by 23 days.(10,11)



Many hospitals and other healthcare facilities have developed extensive
control programs to prevent the occurrence of infections. Even when
clinicians in hospitals do their best to practice good hygiene techniques,
the risk of potential device contamination by pathogens may still persist.

About Baxter



Baxter Healthcare Corporation is the principal U.S. operating
subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International
Inc. develops, manufactures and markets products that save and sustain the
lives of people with hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma, and other chronic and acute medical
conditions. As a global, diversified healthcare company, Baxter applies a
unique combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.



This release includes forward-looking statements concerning the
potential of V-Link with VitalShield to impact catheter-related infections
and Baxter's intention to launch V-Link with VitalShield in Europe later
this year. These statements are based on assumptions about many important
factors, including the following, which could cause actual results to
differ materially from those in the forward-looking statements: the effect
of V-Link with VitalShield on catheter-related infections; our ability to
make V-Link with VitalShield and other new products, including those
associated with the Vital Infusion Systems product line, available for sale
in accordance with our plans; customer and market acceptance of V-Link with
VitalShield, products associated with the Vital Infusion Systems product
line and other new products; clinician practices and procedures; future
actions by the FDA and other regulatory bodies and government authorities
with respect to the company's infusion pumps and other products; and other
risks identified in Baxter International Inc.'s most recent filing on Form
10-Q and other SEC filings, all of which are available on the company's
website. The company does not undertake to update its forward-looking
statements.

References



1. Broadhead J, Parra D, Skelton P. Emerging Multiresistant Organisms
in the ICU: Epidemiology, Risk Factors, Surveillance, and Prevention. Crit
Care Nurse Q 2001; 24(2): 20-29.



2. Lee P, Ferguson D, Laffan J. Vancomycin-Resistant Enterococcus Avium
Infections. Infectious Diseases in Clinical Practice, 2004; 12(4): 239-244.



3. Raad I. Intravascular-Catheter-Related Infections. Lancet, 1998;
351: 893-98



4. Klevens, et al. Invasive Methicillin-Resistant Staphylococcus aureus
Infections in the United States. JAMA, 2007; 298(15): 1763-1771.



5. Centers for Disease Control and Prevention. HIV/AIDS Surveillance
Report: Cases of HIV Infection and AIDS in the United States and Dependent
Areas. 2005: 16-17.



6. National Institute of Allergy and Infectious Diseases. Antimicrobial
(Drug) Resistance -- Vancomycin-Resistant Enterococci (VRE) Overview.
Retrieved June 10, 2008.



7. Stone W, Braccia D, Larson E. Systematic Review of Economic Analyses
of Health care-associated Infections. Am J Infect Control, 2005; 33:
501-509.



8. Infection Control in the Intensive Care Unit -- Second Edition.
Springer Milan; 2005.



9. Berenholtz S, et al. Eliminating Catheter-related Bloodstream
Infections in the Intensive Care Unit. Crit Care Med, 2004; 32(10):
2014-2020.



10. DiGiovine B, et al. The Attributable Mortality and Costs of Primary
Nosocomial Bloodstream Infections in the Intensive Care Unit. Am J Respir
Crit Care Med, 1999; 160: 976-981.



11. Pennsylvania Health Care Cost Containment Council.
Hospital-acquired Infections in Pennsylvania. November 2006.


Baxter Healthcare Corporation
http://www.baxter.com



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Cepheid Receives FDA Clearance For First Rapid On Demand Molecular Diagnostic Test For MRSA And S. Aureus

 Cepheid (Nasdaq:
CPHD) announced it has received clearance from the U.S. Food & Drug
Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue
Infection (SSTI) test, which runs on the GeneXpert(R) System, for the rapid
detection of Methicillin-resistant Staphylococcus aureus (MRSA) and
Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and
soft tissue infections.



In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processes
specimens from suspected skin and soft tissue infection swabs to determine
if a patient is infected with MRSA or SA, giving physicians and surgeons a
powerful new tool to aid in selecting the most effective antibiotic therapy
to improve patient management.



"The ability to detect MRSA or SA in less than one hour, versus two to
three days with current culture methods, will enable clinicians to make
real- time decisions as to the best course of treatment or management. The
ability to accurately identify MRSA and SA on a more timely basis is
important in managing both hospital-acquired and community-acquired
infections. According to data from the Centers for Disease Control (CDC),
there are approximately 12 million patient visits in the U.S. each year for
skin infections," said John Bishop, Cepheid's Chief Executive Officer. "We
are very pleased to announce the first molecular SSTI diagnostic test for
MRSA and SA, building on our established position as the leader in the HAI
(Healthcare Acquired Infections) testing market. With our expanding test
menu, we expect Cepheid's GeneXpert System to continue to be the molecular
platform of choice for the management of HAIs."



MRSA is a bacterium that has become resistant to multiple antibiotics
including penicillin and cephalosporins. Current culture-based lab testing
methods require 48-72 hours to determine if a skin or soft tissue infection
is caused by MRSA or SA. As a result, physicians and surgeons often
prescribe broad-spectrum antimicrobial therapies while awaiting culture
results.



"Millions of patients visit emergency departments and urgent care
clinics each year for treatment of 'staph' infections in skin and
underlying tissue, many caused by MRSA. Because culture-based antibiotic
test results are not available to physicians for several days, physicians
have been forced to make decisions about wound drainage and antibiotic
therapy without having the benefit of supportive laboratory data," said Dr.
Donna Wolk, Division Chief of Clinical Microbiology, College of Medicine;
and Research Associate, BIO5 Institute at The University of Arizona. "Our
clinical trial data show that this new laboratory test makes it possible to
accurately detect a staph infection before a patient is released, and it
provides information to support treatment choices. In addition, the
GeneXpert System supports informed antibiotic choices whereby prescribing
antibiotics of last resort can be reserved for those patients truly
infected with MRSA, therefore, reducing the chances of microbes further
developing antibiotic resistance."

Community Acquired Infections in the ER & Healthcare Acquired Surgical
Site Infections



MRSA and SA infections are national medical concerns that place
millions of lives at risk and add millions of dollars to healthcare costs
each year - both in outpatient, or community-acquired infections, and
in-patient, or surgical site infections acquired within the healthcare
environment.



The Centers for Disease Control recently reported that an estimated 12
million people in the United States seek outpatient medical attention each
year for skin and soft tissue infections, of which MRSA plays a major role.
Significant incremental healthcare costs associated with these infections
are a result of additional follow-up visits, changes in antimicrobial
therapy, and transmission of infections to family members and the
community.



The Institute of Healthcare Improvement reports that about 800,000
surgeries are complicated by infections annually. Cost to the health care
system to treat these infections is estimated at $9.5 billion, largely due
to extended hospital stays following surgery. According to a study
published in Clinical Infectious Diseases, increased length of stay is 18
days following a MRSA infection and 9 days for a SA infection.



Xpert MRSA/SA SSTI delivers actionable test results to assist
physicians and surgeons in selecting accurate treatment plans for improved
patient outcomes, better antimicrobial stewardship, and a reduction in both
community- acquired and healthcare-acquired infections.

About the GeneXpert(R) System Molecular Diagnostic Platform



The GeneXpert(R) System is a closed, self-contained, fully-integrated
and automated platform that represents a paradigm shift in the automation
of molecular analysis, producing accurate results in a timely manner with
minimal risk of contamination. The GeneXpert System is the only system to
combine on- board sample preparation with real-time PCR (polymerase chain
reaction) amplification and detection functions for fully integrated and
automated nucleic acid analysis. The system is designed to purify,
concentrate, detect and identify targeted nucleic acid sequences thereby
delivering answers directly from unprocessed samples. Modular in design,
the GeneXpert System has a variety of configurations to meet the broad
range of testing demands of any clinical environment.

About Cepheid



Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand
molecular diagnostics company that develops, manufactures, and markets
fully- integrated systems for genetic analysis in the clinical, industrial
and biothreat markets. The company's systems enable rapid, sophisticated
genetic testing for organisms and genetic-based diseases by automating
otherwise complex manual laboratory procedures. The company's easy-to-use
systems integrate a number of complicated and time-intensive steps,
including sample preparation, DNA amplification and detection, which enable
the analysis of complex biological samples in its proprietary test
cartridges. Through its strong molecular biology capabilities, the company
is focusing on those applications where rapid molecular testing is
particularly important, such as identifying infectious disease and cancer
in the clinical market; food, agricultural, and environmental testing in
the industrial market; and identifying bio-terrorism agents in the
biothreat market. See http://www.cepheid.com for more information.



This press release contains forward-looking statements that are not
purely historical regarding Cepheid's or its management's intentions,
beliefs, expectations and strategies for the future, including those
relating to product performance and future market opportunities and market
size. Because such statements deal with future events, they are subject to
various risks and uncertainties, and actual results could differ materially
from the company's current expectations. Factors that could cause actual
results to differ materially include risks and uncertainties such as those
relating to: unforeseen manufacturing problems; regulatory developments and
practices regarding testing levels; customer and market acceptance of the
product; the failure of products to perform as expected, whether due to
manufacturing errors, defects or otherwise; the impact of competitive
products and pricing; potentially lengthy sales cycles in some markets;
reimbursement rates for the products; and underlying market conditions
worldwide. Readers should also refer to the section entitled "Risk Factors"
in Cepheid's Annual Report on Form 10-K for 2007 and in its most recent
quarterly report on Form 10-Q, each filed with the Securities and Exchange
Commission.



All forward-looking statements and reasons why results might differ
included in this release are made as of the date of this press release,
based on information currently available to Cepheid, and Cepheid assumes no
obligation to update any such forward-looking statement or reasons why
results might differ.


Cepheid
http://www.cepheid.com



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