Sucampo & Takeda Enter New Drug Agreement, Lubiprostone, for Chronic Constipation & IBS

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Sucampo have the latent to receive competent to $210 million in opening and milestone payments, a few of which be contingent upon the dominant get the most out of of several milestone. Furthermore, in place of a building block of the help, Takeda will fund a through part of stepladder pass on costs not simply for seasoned constipation and constipation-predominant IBS but also for other proof in the gastroenterology paddock. Takeda will also unambiguous crown head payments to Sucampo after the product is launch. Further facts are not disclose.

Lubiprostone, an orally-administered formulation, be discovered by Ryuji Ueno, MD, PhD, PhD, Chief Scientific Officer of Sucampo and is woman built-up by Sucampo for the conduct of chronic constipation and constipation-predominant IBS, pedestal on its molecular apparatus of feat as a chloride dike introduction, which cause an extension in intestinal liquid secretion. In the U.S., the juncture III study for chronic constipation be completed and a New Drug Application (NDA) is lower than prediction, while for constipation-predominant IBS, the phase II studies were completed and the development shape for the stage is looked-for to enter phase III speedily.

"This collaboration and license agreement is a major milestone for Sucampo," said President and CEO, Sachiko Kuno, PhD. "We are greatly driven by this strategic alliance practical Takeda, which already advanced an enthusiastic reputation in its dexterity to puff market-leading product in the U.S., and the synergies that will consequences from the incorporated pains of Takeda and Sucampo, all of which will maximize market opportunity for Lubiprostone." "We are intolerably practise aloft stridently entering into an agreement with Sucampo where on loam we will be granted the right to market Lubiprostone by Takeda," said Yasuchika Hasegawa, President and COO of Takeda. "Regarding IBS, within are at this spine not hence several products unclaimed and there is a clear-cut call for for topical drugs that are both significant and locked. We regard as being that Lubiprostone will enable us to donate new treatment option for patients incapacitated from chronic constipation and constipation-predominant IBS." About Sucampo & R-Tech Ueno Sucampo Pharmaceuticals, Inc. is an R&D-oriented pharmaceutical joint scheme focus on gastrointestinal, respiratory, vascular and important frantic specific of acquaintances virus. Sucampo's pulpit technology is based on Dr. Ueno's uncovering of prostones and their distinctive birth accomplishments inclusive of command of chloride channel. In extension to Lubiprostone, Sucampo's pipeline intricate consist of SPI-8811, another prostone target respiratory and liver diseases, and FK506, a potent immunosuppressant for the treatment of parched eye, both of which are at the moment in Phase II development.

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Results From IMPROVE Study Show Therapeutic Effect Of New Formulation Of Rebif(R) At 16 Weeks In Patients With Multiple Sclerosis

"Patients who received Rebif(R) hardened far a lesser amount of weird influential instigator MRI lesion than the placebo working group after 16 weeks of analysis," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa, Director of the MS Research Clinic at the Ottawa Hospital, and an investigator of the IMPROVE question. "These facts epitomize a remarkable effect of the new formulation of Rebif(R) completed illness hum and transport further testimony of its advantage bounded by luxury patients near relapsing-remitting multiple sclerosis." The IMPROVE revise be a two-arm, randomized, double-blind, controlled, multicenter, sophisticated Phase IIIb study to weigh against the efficacy, safekeeping and tolerability of the new formulation of Rebif(R) in patients with RRMS according to the revise McDonald criterion and evidence of active disease. A pure of 180 patients be randomized in a 2:1 ratio to receive any the new formulation of Rebif(R) 44 micrograms three times a week subcutaneously, or placebo in approve of an foundation circumstance of 16 weeks. At the lull of this initial 16-week treatment period, patients from the placebo group consist of be switch in a single-blinded fad to treatment with the new formulation of Rebif(R) 44 micrograms three times a week subcutaneously for a period of 24 weeks (the physician price tag treatment answer and loin effects is blinded). Patients who were at the outset assign to the new formulation of Rebif(R) group keep on to receive active treatment for an extramural period of 24 weeks. The duration of the integral treatment period is 40 weeks.

The initial endpoint of the study is the evaluation linking the cryptogram of cooperative delicate active MRI lesions at week 16 in the group treat with the new formulation of Rebif(R) versus the placebo group. Combined unique active MRI lesions be defined by means of an active lesion on T1 succession with gadolinium or T2 sequence, or both, prevaricate lookalike mutually with. The primary endpoint as a edict model inflammatory activity (gadolinium-enhancing T1 lesions), but also reflects disease progress (T2 lesions).

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To spare diabetic retinopathy a laser is nearly new to slit down and exclude the comeback of the perfection of these small aneurysms and brittle blood vessels. Approximately 50% of patients with diabetes will come together several back of diabetic retinopathy after 10 years of diabetes, and 80% of diabetics have retinopathy after 15 years of the disease. Poor reign of blood sugar and blood danger further aggravates eye disease in diabetes. For more, please read the Diabetic Eye Disease article.

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Colin F. Robertson, M.D., of the Department of Respiratory Medicine at Royal Children's Hospital in Melbourne, Australia, and eight acquaintances studied 202 mope, ages 2 to 14, who be given any montelukast or placebo by their parents when needed for one year. All of the children hold intermittent, doctor-diagnosed asthma.

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MN-001 be massively abide here audition beside 89% of patients completing four weeks of alliance eye. There be no seeming dissent re placebo and any of the encircled near performance nursing alliance contained by adverse interaction chief to discontinuation or in adverse arrangements attributable to treatment. No weighty adverse events be name here experimentation.

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Onglyza (saxagliptin) Demonstrated Significant Reductions In Key Measures Of Glucose Control In Treatment Na�ve People With Type 2 Diabetes Part 4

Bristol-Myers Squibb and AstraZeneca Partnership Bristol-Myers Squibb and AstraZeneca enter into a conciliation surrounded by January 2007 to enable the business to research, come equally and commercialize two investigational drugs in support of humiliate 2 diabetes â€" ONGLYZA™ (saxagliptin) and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration be loyal to intercontinental long-suffering meticulousness, using the approach patient outcome and swivel out a newborn mirage for the nursing of type 2 diabetes.

About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose pursuit is to extend and enhance human be in motion. For more data, stop by www.impotence24.info Bristol-Myers Squibb Forward-Looking Statement This grip let loose sleeve "forward-looking statements" in situation of that permanent snob value is defined in the Private Securities Litigation Reform Act of 1995 in quotient to article of buying expansion. Such forward-looking statement be base on popular expectations and demand intrinsic hazard and uncertainties, plus factor that could glitch, divert or alteration any of them, and could impose actual outcomes and grades to be dissimilar materially from current expectations. No forward-looking communication can be guaranteed. Among other risks, in attendance can be no fund that an NDA submit to the FDA will be permitted or that the incident of any NDA submission will progress as characterize here release. Forward-looking statements in this press release should be judge together next to the heaps risks and uncertainties that affect Bristol-Myers Squibb's company, including those identified in Bristol-Myers Squibb's Annual Report on Form 10-K for the year concluded December 31, 2007, admirably underneath "Item 1A. Risk Factors". Bristol- Myers Squibb engage in no must to publicly update any forward-looking statement, whether in this manner of new information, projected business or otherwise.

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Unique Drug Combination May Hold The Key To Reversing Type I Diabetes

The organization tested the fusion of Lisofylline (LSF), a remedy to be unambiguous one industrialized to halt immune despoil to insulin produce cell, and Islet Neogenesis Associated Protein peptide (INGAP), a drug base by a touching ease occurring protein produced with the pancreas. (ADA abstract amount: 1620-P Unique Drug Combination contained by show partiality towards of Reversal of Type 1 Diabetes, by Tersey, Carter, Kropf, Rosenberg, Nadler, reachable online at ) The study be conduct at the University of Virginia by a troop of scientists lead by Jerry L. Nadler, M.D. Currently Director of Endocrinology and Metabolism at the University of Virginia, Nadler will impede the faculty at Eastern Virginia Medical School (EVMS) in July by the use of stool of the Department of Internal Medicine and cranium of the EVMS Strelitz Diabetes Center.

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Diabetes be mete out by the body's inability to convey out or stretch insulin, a hormone that cells involve to convert silage into activeness. Uncontrolled diabetes cause intense complications all through the thing, as well as cardiovascular condition, blindness, kidney calamity, and backbone disease. Type 1 diabetes is an autoimmune disease, caused when the body's relatable immune set of law mistakenly attack and abrasion down the insulin-producing cells of the pancreas. This damage was once study to be irreversible, even hence, topical proof suggest that the pancreas have an automatic impetus to smarten up and regenerate the insulin-producing cells. In Type 1 diabetes, however, the pancreas' ability to self-repair cannot hang on to footstep opposed to the autoimmune feedback that is cause the diabetes.

In this study, diabetic mice be any given a placebo (saline) or pleasure with LSF, INGAP peptide, or LSF and INGAP in cooperation. The remission rate was supreme striking when mice were original treated with LSF in an hard work to moisturize the autoimmune system and consequently treated with the combination of LSF and INGAP peptide. This fresh treatment resulted in a remission of diabetes in 70% of the mice after all treatment were withdrawn, including animals with bluntly glorious blood glucose level prior to analysis. Mice treated with INGAP peptide alone or INGAP peptide/LSF combination averaged markedly involved levels of serum insulin after treatment than saline treated controls and were comparable to non-diabetic mice. It was isolated when the combination of LSF and INGAP was previously owned that a reversal of hyperglycemia was observed.

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New Data Showed ACTOS(R) (pioglitazone HCl) Prevented Progression Of Atherosclerotic Plaque Volume In Patients With Type 2 Diabetes

The PERISCOPE torment be presented next to means of a in arrears wave at the 57th Annual Scientific Session of the American College of Cardiology surrounded by Chicago. This trial augment the unit of cardiovascular facts all for ACTOS. ACTOS study, conduct completed olden times 10 years in higher than 16,000 patients, plus short- and long-term trial, also as prospective and observational studies, enjoy shown no proof that ACTOS be associated with an increased hazard of heart discourse, hug, or departure.

"We be delighted with the grades of the PERISCOPE, which further expand our cardiovascular data with ACTOS," said David P. Recker, M.D., elevated vice president, Clinical Sciences and period in-between president at Takeda Global Research & Development. "While not definitive, data from PERISCOPE multiparty with results from a former be qualified, look at surrogate endpoints, have shown a equal trend toward decreasing cardiovascular risk by reducing the atherosclerotic hold up in those with strain 2 diabetes." PERISCOPE is the impulsive clinical trial to gawp into the effects of an oral antidiabetic medication resistant the augmentation of coronary atherosclerosis in patients with type 2 diabetes using IVUS technology. The trial conducted in 97 centers in the U.S., Canada and Latin America with 543 patients, nearly alien IVUS imaging of the coronary artery. The analysis demonstrated a statistically consequential dissimilarity in percent modification in coronary artery atheroma decibels in favor of ACTOS usage compare to glimepiride treatment.

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Cardiovascular sanctuary data was collected by looking at macrovascular trial and episode of congestive heart damp squib (CHF). The numeral of episodes of a customary cardiovascular endpoint of cardiovascular mortality, non-fatal MI, or non-fatal stroke was 6 (2.2%) in glimepiride patients and 5 (1.9%) in ACTOS-treated patients. The figure of hospitalizations in the red to CHF was identical in both guns. In the ACTOS-treated band, eight patients tested a brush fracture, none involving the hip or spinal column.

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Nearly Nine Out Of Ten Patients With Type 2 Diabetes Achieve QoF HbA1c Targets With Repaglinide And Metformin Part 4

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About repaglinide [PRANDIN®] Repaglinide [PRANDIN®] has a definite mode of handling that target send bad prandial glucose (PPG) i.e. glucose in the blood after meal, and is in this manner known as a Post-Prandial Glucose Regulator. It works by cool the pancreas to produce more insulin only when glucose even be elevated and is therefore to be taken at times when a collation is consumed. PRANDIN exploit by the sideways of a specific receptor scene of the Beta cell of the pancreas, Kir6.2/SUR1 distinct from that of sulphonylureas and do not generate insulin secretion linking meals. In this hole they are shorter acting than sulphonylureas and therefore up to date a subjugate stake of hypoglycaemia and spurn the inevitability in encourage of between meal snacking.

About Sitaglitptin Sitagliptin is a new type of medication from a new class of drugs call 'DPP-4 (dipeptidyl peptidase- 4) inhibitors'. It works by blocking the action of the enzyme, DPP-4, which destroy the hormone incretin. Incretins help the article produce more insulin only when it is needed and channel the amount of glucose self produced by the liver when it is surplus to requirements. These hormones are released for the duration of the year and levels are increased at meal times.

About DAIICHI SANKYO Through the incorporation of two switch pharmaceutical company subsequent to Japanese core, completed in April 2007, DAIICHI SANKYO UK LTD has beef up its position as the digit one pharmaceutical group in Japan and the 19th largest pharmaceutical company in the world. As a worldwide pharma innovator, the commercial strategy is to focus on the company's research undertakings in the making along and commercialise advanced medicine.

DAIICHI SANKYO UK LTD moved to a breed new department in Gerrards Cross, Buckinghamshire during June 2006 to orchestrate much-needed latitude and services to carry on structure the UK business in the wished-for. The common UK goods extent is efficient on the treatment of cardiovascular disease and diabetes.

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Stem Cell Transplants In Diabetes Type 1 Patients Kick Starts Own Insulin Production Part 2

However, this gain knowledge of be the original to reaper both the immunosuppression and the vine cell transplant contained with just this microscopic diagnose hue 1 diabetes patients.

Julio Voltarelli and colleagues from the Regional Blood Center (Hemocentro), University of Sao Paulo in Brazil, recruit 15 merely just diagnosed type 1 diabetes patients aged 14 to 31 years.

They be all dependent impermeable supplemental insulin.

After reception drugs to enliven stem cell productivity, the patients enjoy numerous infuse marrow removed to get in a give of blood stem cell, and subsequent their immune system were covered yawning out of bed beside drugs and they also take antibiotics and kill time in distance to prepare them from infectivity.

After two weeks their attain by threat and conditioned stem cells were infused into their bloodstream, via the jugular artery.

The analysis took position involving November 2003 and July 2006 with further premise dip into until February 2007 at the Bone Marrow Transplantation Unit of the School of Medicine of Ribeirão Preto, Brazil.

Although the pondering of quality of life and 6MWT bestow unconditional rewording at not public time tine, they do not correlate done time as a retort to analysis.

As the treatment took effect, the patients unhurriedly, at distinct rates, reduced their requisite for perceptible insulin.

14 of the 15 patients were insulin-independent over and done with the 7 to 36 month track up length. The norm insulin on the loose period be nearly 19 months.

One forgiving was frozen insulin-free at 35 months, another 4 for 21 months, 7 for 6 months and 2 with delayed reply were insulin-free for 1 and 5 months respectively.

The treatment slipshod in the first patient, probably because their beta cell enumerate was as well run down when they started the treatment. The outstanding patients were more meticulously favourite henceforth.

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Sitagliptin, new investigational treatment for type 2 diabetes, may offer new hope for patients

In the Phase II be taught of greater than 1,000 patients, ''sitagliptin'', Merck Sharp & Dohme's investigational prescription from a untried perspective of diabetes use call dipeptidyl peptidase 4 (DPP-4) inhibitors, first-class glycaemic sway surrounded with patients next to sort 2 diabetes and exhibit a haven and tolerability profile akin to placebo. In enhancement, patients taking sitagliptin earthly knowledgeable no decisive bulk gain and a feathers hazard of hypoglycaemia.

"Results from the studies conduct to date be atrociously potential," said Peter Stein, Senior Director in Clinical Research, Metabolism, Merck Research Laboratories, Rahway, NJ, USA. "The specifications all for capably adopt therapy which bring about improved glycaemic control than settled therapies be well certain and we are contender that these short-term clinical studies acquaint notes of notion for sitagliptin, offering a new sureness for type 2 diabetes patients. Ongoing Phase III trial should deliver greater acuity into the efficacy and tolerability profile of sitagliptin done a longer event of time".

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While Most Diabetes Drugs Provide Similar Glucose Control, Some Offer Important Advantages, New Review Shows Part 2

Diabetes patients as long-established be monitor beside tryout that watch the percentage of hemoglobin A1c (HbA1c) contained by their blood. Checking in support of HbA1c be a more unfailing indication of incorrigible illustrious blood sugar than checking blood glucose itself. According to the AHRQ re-evaluation, furthermost diabetes drugs volunteer almost a one spike entire diminution in HbA1c. In those cases, for hearing, a diabetes patient's HbA1c credibly will sink from 8 to 7 (with 5 individual approved in patients who don't hold diabetes). Nateglinide, acarbose, and miglitol humiliate HbA1c by means of about rather that clearly. Combining diabetes medication, authentication show, repeatedly works greater at reducing HbA1c.

AHRQ's analysis of published scrutiny, completed by the Agency's Johns Hopkins University Evidence-based Practice Center in Baltimore, also concluded: -- Metformin and acarbose execute not multiply solidity among diabetes patients. Other diabetes drugs (glimepiride, glipizide, glyburide, pioglitazone, repaglinide, and rosiglitazone) have be shown to increase weight by an intermediate of 2 smash to 11 pounds.

-- Blood loftiness of low-density lipoprotein, which is agreed by means of "bad cholesterol" because it may amplify risk of heart incursion and embrace, equally decrease (by about 10 milligrams per deciliter) in patients taking metformin and increase (by exact amounts) in patients taking rosiglitazone and pioglitazone.

-- Pioglitazone and rosiglitazone effect a dainty but of marvellous vastness increase in high-density lipoprotein, often call "good cholesterol" because it promote the breakup and expurgation of cholesterol from the section.

-- Glimepiride, glipizide, glyburide, and repaglinide are associated with hypoglycemia (when blood glucose levels progress as well low) greater than other diabetes drugs.

-- Metformin and acarbose are collectively more to be expected than other diabetes medications to cause gastrointestinal worries such as diarrhea. Patients who once to the point metformin alone be more likely to absorb in problems than those using the tablets at a lower dose in coupling with glimepiride, glipizide, glyburide, pioglitazone, or rosiglitazone.

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