New Database Important Resource In Caring For Dialysis Patients

A nationwide database called the Comprehensive Dialysis Study (CDS) includes detailed information on a wide range of health factors in US dialysis patients and provides a valuable new resource for improving dialysis outcomes, according to a report in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN).

“The primary goal of the CDS is to better understand the interrelations among general health, nutrition, physical function, and health-related quality of life in a representative sample of patients recently starting maintenance hemodialysis,” comments Nancy J. Kutner, PhD, Director of the Rehabilitation/ Quality of Life Special Studies Center of the United States Renal Data System (USRDS) at Emory University in Atlanta, GA. “By linking these data with patient-specific information in USRDS files, researchers will be able to examine the predictive significance of early physical and nutritional status for morbidity and mortality outcomes.”

The CDS includes 1,646 patients from a random sample of 295 dialysis facilities in 48 states and the District of Columbia. The patients range in age from 19 to 94 years, with an average age of 60. At the time they were enrolled in the CDS, the patients had been on dialysis for an average of four months.

In telephone interviews, patients provided detailed information on a broad range of factors that may affect health, functioning, and long-term outcomes on dialysis. “The CDS includes patient employment status and validated measures of health-related quality of life, physical activity level, sleep disturbance, and depression collected from all participants,” says Dr. Kutner. One subgroup of patients gave detailed information on dietary intake; another provided blood samples for assessment of nutrition, inflammation and other key measures.

The CDS provides an unprecedented depth of information on a large group of patients just beginning dialysis. It enables researchers to examine the interrelated factors affecting the health of new dialysis patients. Follow-up of patients enrolled in the CDS will enable researchers to determine which baseline characteristics have the greatest impact on long-term dialysis outcomes.

Because of the relatively low participation rate (less than 20 percent), the CDS falls short of being a nationally representative sample of US dialysis patients. “In addition, while CDS patients were generally similar to the overall population, they were younger on average, had higher educational status, were less likely to have heart failure or stroke, and less likely to be nonambulatory or institutionalized, compared to all incident dialysis patients,” according to Dr. Kutner.

Linking the CDS to the USRDS database will help to identify factors associated with survival, hospitalization, use of medical services, and health care costs. “The CDS therefore provides a unique resource to inform the design of interventions addressing several related conditions affecting longevity and health status in patients on dialysis,” Dr. Kutner concludes.

The researchers reported no financial disclosures.

The article, entitled “The Comprehensive Dialysis Study (CDS): A USRDS Special Study” will appear online at cjasn.asnjournals on Wednesday, March 4, 2009, doi 10.2215/CJN.05721108.

Founded in 1966, the American Society of Nephrology (ASN) is the world’s largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its world-renowned meetings and first-class publications, disseminates information and educational tools that empower physicians.

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1725 I St. NW, Ste. 510
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Meridia Helps Obese Teenagers Lose Weight

Meridia (sibutramine), combined with behavioural therapy, has been shown to be effective in helping obese teenagers lose weight, according to a study carried out by Dr. R Berkowitz and team at Children Hospital of Philadelphia. The researchers found the treatment is effective for obese 12-year-olds as well.

The study involved 498 12-16 year old children at 33 weight-loss clinics – all of the children were obese. The children were divided into two groups, one received Meridia combined with behavioural therapy while the other received a placebo and behavioural therapy. The Meridia group lost an average of 14 pounds over a year, while those on a placebo carried on gaining weight. Those on Meridia also managed to achieve better HDL cholesterol levels and triglycerides (HDL is the good cholesterol).

The study found Meridia is relatively safe and effective for younger teenagers. Meridia is approved in the USA just for people over 16 as a drug for aiding weight loss.

You can read about this study in the Annals of Internal Medicine.

The team said further studies are needed to find out whether this treatment has long-term benefits: Do the teenagers continue to lose weight? Do they keep the weight off after treatment stops? Are there any other health benefits, such as a lower likelihood of developing heart disease or diabetes type 2?

The scientists also stressed that this drug is aimed at patients who are obese. It is not for slightly overweight people who want to shed a few pounds. It is an appetite suppressor that has, in the past, been blamed by some groups for causing fatal heart problems.

In this study, 12.5% of children taking Meridia experienced accelerated heart rates, versus 6.2% of children who were on a placebo. The researchers say it is vital for any patient taking this drug to have his/her blood pressure and heart rate closely monitored.

Adults who have received Meridia tend to lose weight only while they are receiving the drug. Most of them put the weight back on afterwards. Whether or not the same would happen with younger patients remains to be seen.

The makers of Meridia, Abbott Laboratories, funded the study.

Effects of Sibutramine Treatment in Obese Adolescents – A Randomized Trial
Robert I. Berkowitz, MD; Ken Fujioka, MD; Stephen R. Daniels, MD, PhD; Alison G. Hoppin, MD; Stanford Owen, MD; Arlette C. Perry, PhD; Melinda S. Sothern, PhD; Cheryl L. Renz, MD; Mark A. Pirner, MD, PhD; Julia K. Walch, BS; Olga Jasinsky, MBA; Ann C. Hewkin, MSc; Vicky A. Blakesley, MD, PhD, for the Sibutramine Adolescent Study Group
Annals of Internal Medicine
18 July 2006 | Volume 145 Issue 2 | Pages 81-90
View Abstract Online

View drug information on MERIDIA.

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Questioning The Safety And Effectiveness Of Herbal Dietary Supplements

Millions of people are taking herbs and other plant-based dietary supplements to improve their health, but they have precious little information on the actual effectiveness or potential ill effects of these products. That’s the topic of an article in the current issue of Chemical & Engineering News (C&EN), ACS’ weekly news magazine.

C&EN Senior Editor Celia Henry Arnaud suggests that consumers are taking a gamble when it comes to the safety and effectiveness of hundreds of pills and potions cluttering store shelves. Such products include black cohosh and red clover, used by menopausal women to reduce hot flashes, and kava, which is used to treat anxiety and insomnia. Scientists are concerned that some supplements may contain high levels of toxic metals, such as lead and mercury, or pesticides. There’s also the possibility that the plant itself might be toxic or that a supplement can cause harm by reacting with conventional drugs.

The U.S. Food & Drug Administration, which regulates supplements as foods rather than drugs, recently took a step toward improving the situation by requiring all supplement manufacturers to test their products for contaminants. But scientists still know little about the ingredients in many supplements and what effect they might have on the body. Ongoing research is providing new information that will help address these concerns in the future, including the long-term safety of these products for consumers, the article indicates.

Article:
“Supplementing Knowledge”

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Teva Announces Tentative Approval Of Generic Femara(R) Tablets

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva’s Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

The brand product had annual sales of approximately $556 million in the United States, based on IMS sales data.

Source
Teva Pharmaceutical Industries Ltd.

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Peels of oranges and tangerines may lower cholesterol better than drugs

A compound found in the peels of citrus fruit has the potential to lower cholesterol more effectively than some prescription drugs, and without side effects, according to a study by U.S. and Canadian researchers.

A joint study by the U.S. Department of Agriculture and KGK Synergize, a Canadian nutraceutical company, identified a class of compounds isolated from orange and tangerine peels that shows promise in animal studies as a potent, natural alternative for lowering LDL cholesterol (bad cholesterol), without the possible side effects, such as liver disease and muscle weakness, of conventional cholesterol-lowering drugs.

The findings will be described in the May 12 print issue of the Journal of Agricultural and Food Chemistry, a peer-reviewed publication of the American Chemical Society, the world’s largest scientific society.

The compounds, called polymethoxylated flavones (PMFs), are similar to other plant pigments found in citrus fruits that have been increasingly linked to health benefits, including protection against cancer, heart disease and inflammation. The study is believed to be the first to show that PMFs can lower cholesterol, the researchers say.

“Our study has shown that PMFs have the most potent cholesterol-lowering effect of any other citrus flavonoid,” says Elzbieta Kurowska, Ph.D., lead investigator of the study and vice president of research at KGK Synergize in Ontario, Canada. “We believe that PMFs have the potential to rival and even beat the cholesterol-lowering effect of some prescription drugs, without the risk of side effects.”

PMFs are found in a variety of citrus fruits. The most common citrus PMFs, tangeretin and nobiletin, are found in the peels of tangerines and oranges. They are also found in smaller amounts in the juices of these fruits.

Using hamster models with diet-induced high cholesterol, the researchers showed that feeding them food containing 1 percent PMFs lowered levels of LDL cholesterol by 32 to 40 percent.

Previous animal studies by others have shown that similar flavonoids, particularly hesperidin from oranges and naringin from grapefruit, also may have the ability to lower cholesterol, although not as effectively as PMFs, according to Kurowska.

Treatment with PMFs did not appear to have any effect on levels of HDL cholesterol, or good cholesterol, the researcher says. No negative side effects were seen in the animals that were fed the compounds, she adds.

The researchers are currently exploring the compound’s mechanism of action on cholesterol metabolism. They now suspect, based on early results in cell and animal studies, that it works by inhibiting the synthesis of cholesterol and triglycerides inside the liver.

A long-term human study of the effect of PMFs on high LDL cholesterol is now in progress. While drinking citrus fruits is full of health benefits, taking PMF supplements could be an easier way to lower cholesterol, since a person would have to drink 20 or more cups a day of orange or tangerine juice to have a therapeutic effect, Kurowska estimates.

KGK Synergize already has developed a nutrition supplement containing PMFs combined with a form of vitamin E that seems to enhance the compound’s effect, according to Kurowska. Marketed as a cholesterol-lowering agent under the trade name SytrinolTM, the supplement recently became available in the U.S.

USDA’s Citrus and Subtropical Products Laboratory in Winter Haven, Fla., and KGK Synergize Inc. provided funding for this study.

The online version of the research paper cited above was initially published April 21 on the journal’s Web site. Journalists can arrange access to this site by sending an e-mail to newsroomacs or calling the contact person for this release.

Contact: Michael Bernstein
m_bernsteinacs
202-872-6042
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Caregiver Commitment In Federal Budget A Good Start, But More Needs To Be Done, Says Canadian Cancer Society

A new family caregiver tax credit announced in today’s federal government budget is a good start in providing more support for all family caregivers, says the Canadian Cancer Society.

“We welcome the tax credit and other measures in the budget as a step in the right direction,” says Dan Demers, Director, Public Issues, Canadian Cancer Society. “But looking forward, we need to continue to work collectively to ensure more is done so that all family caregivers in Canada get the financial support they need and deserve.”

One in four Canadians has cared for a loved one with a serious illness in the last 12 months. This often results in lost income, as well as the increased financial burden of unforeseen expenses such as transportation, medical equipment and supplies, drugs and more. Demers adds that in a recent Society poll, 88 per cent of Canadians said that providing care or assistance for a family member would have a negative impact on their financial situation.

The Society has been advocating for better financial support for family caregivers through improvements to the Compassionate Care Benefit, which is administered by the federal employment insurance program. These improvements include:

– Timeframe for financial benefits: Increase the benefit period from the current six weeks to 26 weeks, accessible during a 52-week period.

– More flexibility: allow people to claim benefits for partial weeks taken over a longer period, rather than blocks of weeks at a time.

– Revise eligibility criteria: change the terminology for people eligible for benefits from “significant risk of death” to “significant need of caregiving due to a life threatening illness.”

– Amend the Canada Labour Code to protect the jobs of caregivers.

The Society also believes that a non-taxable, monthly Family Caregiver tax benefit should be established to help family caregivers with costs.

“We need to address this issue now because this country’s population is aging and increasingly Canadians will be caring for loved ones who have cancer and other life threatening serious illnesses,” says Demers. “An effective and compassionate society helps families who are caring for sick loved ones.”

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Telmisartan provides superior blood pressure control to valsartan and amlodipine

The recently presented results of the VALUE trial have emphasized the critical importance of tight blood pressure control to provide greater protection against cardiovascular events.1 The results provide further evidence in support of international hypertension guidelines which recommend the use of long acting agents that provide sustained 24 hour blood pressure control to reduce cardiovascular risk.2,3

The VALUE trial was designed to test the hypothesis that, for the same degree of blood pressure control, valsartan would reduce cardiac morbidity and mortality more than amlodipine in hypertensive patients at high cardiovascular risk. Although the main outcome of cardiovascular events did not differ between the two treatment groups, there were more pronounced reductions in blood pressure in the amlodipine group than in the valsartan group, which translated into significant reductions of MI and stroke.1

These findings underline the importance of reliable and sustained blood pressure control and confirm that aggressive treatment to reach target blood pressure goals is critical to reducing cardiac events.

Telmisartan (Micardis®), an angiotensin II receptor blocker, provides sustained 24 hour control and is consistently superior to other commonly used anti-hypertensives.4

Data from a large database of telmisartan studies using ambulatory blood pressure monitoring (ABPM) show that telmisartan produces significantly greater reductions in mean ambulatory blood pressure in the last 4-6 hours of the dosing interval than the commonly-used antihypertensives valsartan, losartan and amlodipine.4-8

Furthermore, data from recently completed large international studies due to be published imminently confirm that telmisartan (80mg) provides superior blood pressure control compared with valsartan (160 mg) for up to 48 hours after an active dose.9-10
Telmisartan (Micardis®) is currently being investigated in the most ambitious and far-reaching research programme ever conducted with an ARB, with more than 54,000 patients. The ONTARGETTM Trial Programme, the PRoFESS® trial and the PROTECTIONTM trial programme aim to show reduction in cardiovascular morbidity and mortality, secondary stroke prevention and end organ protection.

Whereas VALUE is an anti-hypertensive trial, the forthcoming ONTARGETTM Trial Programme (Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) will answer significant questions around the prevention of cardiovascular disease in a population of more than 31,500 patients who are normotensive or have controlled blood pressure – exploring the effect of combining an ARB (telmisartan) and an ACE inhibitor (ramipril) independently of blood pressure lowering.

The ONTARGETTM Trial Programme is also designed to compare telmisartan to ramipril directly to evaluate whether they provide the same level of cardiovascular protection.

Professor Peter Sleight, Professor Emeritus of Cardiovascular Medicine at the University of Oxford, UK commented: “VALUE has reinforced that prompt blood pressure lowering is critical to protect against cardiovascular events. It seems likely that the initial dosing regimen of the ARB was, with hindsight, suboptimal.

The different question the ONTARGETTM trial will answer is whether an ARB (telmisartan) and an ACE inhibitor (ramipril), alone or in combination, have cardiovascular protective effects, and whether one class is better than the other, in high risk patients similar to HOPE.

The ONTARGETTM trial will also indicate whether telmisartan may provide additional cardiovascular protection, as in the doses we are using it has shown good blood pressure reduction during the risky early morning period, when the risk of cardiovascular events peaks.”

Results of the ONTARGET TM Trial Programme are expected to be announced in 2007.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in 45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while spending more than one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Telmisartan (Micardis®)

Telmisartan was discovered and developed by Boehringer Ingelheim, Germany. Boehringer Ingelheim markets telmisartan under the trademark Micardis® in 84 countries around the world, including the USA, Japan and major European countries.

Telmisartan is also marketed in some countries by Abbott Laboratories, Bayer AG, GlaxoSmithKline, and Yamanouchi.

Contact:

Boehringer Ingelheim GmbH
Corporate Division Communications
Julia Meyer-Kleinmann
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 82 71
Fax: +49/6132/77 66 01

References:

1 Julius, Stevo et.al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine; the Value randomised trial, The Lancet 2004; 636:2022-2031

2 2003 European Society of Hypertension ? European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003;21:1011-1053

3 Chobanian AV et al. The Seventh Report of the Joint National Committee (JNC) on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure. JAMA 2003; 289(19): 2560-2572.

4 Neutel J et al. Evaluation of ARBs for 24 hour BP control: meta-analysis of a clinical database. J Clin Hypertens 2003;5:58-63

5 Littlejohn T et al. A prospective, randomised, open-label trial comparing telmisartan 80 mg with valsartan 80 mg in patients with mild to moderate hypertension using ambulatory blood pressure monitoring. Can J Cardiol 2000;16:1123-1132

6 Smith D et al. Comparison of telmisartan versus losartan: meta-analysis of titration-to-response studies. Blood Press Monit 2003;8:111-117

7 Neutel J. Use of ambulatory blood pressure monitoring to evaluate the selective angiotensin ll receptor antagonist, telmisartan, and other antihypertensive drugs. Blood Press Monit 2000;5 (suppl 1):S35-S40

8 Lacourci?re Y et al. A comparison of efficacies and duration of action of the angiotensin ll receptor blockers telmisartan and amlodipine. Blood Press Monit 1998;3:295-302

9 Lacourciere Y et al. Sustained antihypertensive activity of telmisartan vs valsartan. Blood Press Monit 2004 In press

10 Lacourciere Y et al. Sustained antihypertensive activity of telmisartan vs valsartan. Poster presented at International Society of Hypertension 2004, Sao Paulo Brazil

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Understanding Atherosclerosis

It’s the leading cause of heart disease and stroke: atherosclerosis–a disease characterized by the thickening of arterial walls, restricting blood flow like a narrow pipe. Preventing and reversing this disease is still largely a puzzle to scientists working to put all the right pieces into place and form a complete picture of health for millions of patients who suffer its devastating effects worldwide.

So notes a University of Kentucky researcher whose perspective is published in the current issue of Nature. Alan Daugherty, director of the University of Kentucky Cardiovascular Research Center, and Dr. Daniel Rader, an endocrinologist and researcher at the University of Pennsylvania, co-authored the article, which offers insight into the complex process of translating scientific discoveries in the laboratory into new therapies for atherosclerosis.

While advances have been made in understanding how genetics, metabolism of HDL and LDL cholesterol, the inflammatory process, blood clots, and blood pressure regulation all play a part in the atherosclerosis disease process, a solution is likely many years away and will require huge–but worthwhile–investments of time, money and collaboration across fields of study. Decisions remain about which drugs to advance to clinical trials and how to measure the success of those therapies, Daugherty and Rader note.

In striving to become a Top 20 public research institution, the University of Kentucky is a catalyst for a new Commonwealth – a Kentucky that is healthier, better educated, and positioned to compete in a global and changing economy. For more information about UK’s efforts to become a Top 20 university, please go to uky/OPBPA/Top20.html.

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Texas Invests $4.5 Million In Cancer Research At UT Health Science Center At Houston

Texas plans to invest $3 billion in cancer research over the next 10 years and six scientists at The University of Texas Health Science Center at Houston are among the first to receive grants.

The researchers, whose grants total $4.5 million, are working to protect girls from cervical cancer, to interrupt tumor growth at the molecular level and to develop a new approach for the treatment of colon cancer, among other cutting-edge projects.

Texas voters approved a constitutional amendment in 2007 establishing the Cancer Prevention and Research Institute of Texas (CPRIT) and authorizing the state to issue $3 billion in bonds to fund groundbreaking cancer research and prevention programs and services in Texas. Cancer is the second leading cause of death in Texas and claimed an estimated 37,000 lives in 2009, the Texas Cancer Registry reports.

UT Health Science Center at Houston researchers, along with their colleagues at other University of Texas System institutions, received more than half of the $61 million awarded during the initial round of funding through CPRIT.

“We are delighted that our Health Science Center investigators have participated with their colleagues from around the state in this new program to address the prevention and cure of cancer in Texas,” said Peter Davies, M.D., Ph.D., executive vice president for research and interim executive vice president for academic affairs at the Health Science Center.

“We are particularly pleased with the success of several of these investigators in obtaining substantial research awards from CPRIT. We look forward to having these awards serve as a foundation for additional Heath Science Center research programs that will expand our research in the area of cancer cure and cancer prevention,” Davies said.

Sixty-six research projects were selected from nearly 900 research proposals submitted to the institute. Proposals were reviewed by a team of more than 100 scientific experts. CPRIT-funded research will be conducted in state by Texas-based scientists.

John Hancock, Ph.D., chairman of the Department of Integrative Biology and Pharmacology at The University of Texas Medical School at Houston, received a $1,401,529 award for his research into how the growth signals received by cells are scrambled in cancer cells leading to uncontrolled growth. Hancock is a holder of the Fondren Chair in Cellular Signaling at the UT Medical School at Houston.

“One major cause of this problem relates to a protein called Ras, which normally functions as a reversible switch that is toggled on and off. In many cancers, including colon, pancreas and lung, the Ras switch becomes stuck in the on position, which drives the cancer cell to replicate itself indefinitely,” Hancock said. His CPRIT project is focused on developing drugs that will address this.

Mar?­a E. Fern??ndez, Ph.D., associate professor of health promotion and behavioral sciences at The University of Texas School of Public Health, was presented a $1,378,244 grant to test new strategies to reduce the incidence of cervical cancer among Hispanic women. Cervical cancer incidence and mortality rates among Hispanic women are almost twice that of non Hispanic white women, and Hispanic women in Texas experience among the highest rates of cervical cancer mortality in the country, she said.

Fern??ndez will develop and test two educational interventions for the parents of Hispanic girls in the hope that parents will get their daughters a vaccine that prevents the major types of Human Papillomavirus (HPV) that cause cervical cancer. The educational materials include a photonovella (graphic novel) and an interactive video.

“Our study is the first ever to develop and test tailored interactive cancer communication approaches to increase HPV vaccination among Hispanic girls. Because the effectiveness of the interventions will be evaluated in a ‘real world setting,’ the findings of the study will be easily translatable to current clinical and community practice. If effective, the intervention could substantially reduce the cervical cancer-related disease burden among Hispanics in Texas,” she said.

Qingyun “Jim” Liu, Ph.D., a professor at The Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases (IMM), a part of the Health Science Center, received a $1,280,107 grant for research into a novel approach for the treatment of colon cancer.

“A major problem in cancer therapy is that tumors often became resistant to treatment after initial response. Such resistance is believed to be due to the existence of cancer initiating cells, also called cancer stem cells that can regenerate the tumor. Our plan is to find drug targets on these cells that drive their growth so we can discover therapeutics that will block the target and consequently suppress the growth of these cells,” Liu said.

Other Health Science Center researchers getting CPRIT grants include: Eric Wagner, Ph.D., assistant professor of biochemistry and molecular biology at the UT Medical School at Houston, “Understanding the connection between alternative mRNA 3′ end formation and microRNA function during tumorigenesis”; Mikhail Kolonin, Ph.D., assistant professor at the IMM, “Adipose progenitor cells as a new clinical cancer target”; and Perry Bickel, M.D., associate professor at the IMM and the UT Medical School, “Cancer in the Era of Obesity.”

Other UT System institutions receiving grants included: UT Southwestern Medical Center at Dallas ($16,463,118); UT M.D. Anderson Cancer Center at Houston ($12,717,138); UT Health Science Center-San Antonio ($1,772,908); UT Austin ($3,319,732); and UT Dallas ($886,693).

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Trends In The Diabetes Drug Pipeline 2008

The Business Intelligence firm La Merie S.L. conducted an analysis of the
diabetes drug product portfolios and R&D pipelines of more than 160
companies. The study revealed a successful substitution of rhu insulin by
insulin analogs with a combined 2007 market of US$ 10.2 bln and a strong
focus in research on orally available insulin preparations following
traditional long-acting drug delivery approaches. A similar trend was
observed for GLP-1 analogs, one of the two incretin mimetic approaches apart
from DPP-IV inhibitors. The two approved drugs in the incretin mimetic group
achieved 2007 sales of US$ 1.4 bln with strong growth in 2008. Both
approaches have a rather filled clinical pipeline with fierce competition.
PPAR agonists posted 2007 sales of US$ 6.6 bln representing a maturing
market with next generation dual agonists in clinical development, but a
rather empty research pipeline. The next class of novel oral antidiabetics
are SGLT inhibitors with representatives in phase III clinical development.
However, a high clinical stage drop out rate reflects the difficulties with
this approach. First generation cannabinoid 1 (CB1) antagonists are loosing
attractiveness due to psychiatric side effects. This opens the opportunity
for next generation CB 1 antagonists which only act peripherally. Major
approaches among novel oral antidiabetics are glucokinase activators,
11-beta HSD inhibitors and AMPK activators. The preservation of pancreatic
beta cell mass and function is gaining importance and momentum in diabetes
drug R&D. These results and more were found in the search conducted by La
Merie Business Intelligence. The evaluation can be acquired at La Merie’s
online store (pipelinereview/store ).

Diabetes is one of the most challenging health problems of the 21st century.
It is estimated that today around 194 million people suffer from diabetes
(more than 85 % have type 2 diabetes). Forecasts predict that the prevalence
of diabetes will rise to almost 333 million by the year 2025. The 2007
market of major branded diabetes drugs was more than US$ 18 bln with a
variety product categories (proteins, peptides, small molecules). The
pipeline exists of more than 50 different approaches. Stakeholders in
diabetes R&D are established pharmaceutical companies as well as specialty
companies for drug delivery approaches, genetic engineering, cell therapy
and immune therapy by vaccines or antibodies. The Competitive Intelligence
Report Diabetes Drug Pipeline as of November 2008 provides a competitor
analysis in the development pipeline of novel antidiabetic treatment
modalities for type 1 and 2 diabetes. The report includes an overview of the
major marketed diabetes drugs and the respective markets sizes and describes
the corporate diabetes drug product portfolios and R&D pipelines of more
than 160 companies worldwide.

About La Merie

La Merie S.L. is a Business Intelligence enterprise fully dedicated to
provide high quality R&D information to the biopharmaceutical industry. La
Merie offers individual consultancy services and publishes reports and
periodicals. For more information visit lamerie.

About PipelineReview

PipelineReview is the News Center and Online Store of La Merie Business
Intelligence focused on Research and Development in the Biopharmaceutical
Industry.

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