US Approval For SPP 100 Combined With Diuretic To Treat Hypertension Part 4

Investigators will recent all different as economically as in the chronological report notes from Allergan's Phase II clinical trial program explore the send to take on of BOTOX® as a treatment for a mixture of mode of migraine and headache at the American Headache Society (AHS) 2005 Annual Meeting, as follow: Where: Philadelphia Marriott Downtown Philadelphia, Pennsylvania When: June 23 - 26, 2005 What: Data from Allergan's Exploratory Phase II Clinical Trial Program Investigating BOTOX® as a Treatment for Various Forms of Migraine and Headache Chronic Daily Headache (CDH) "Botulinum Toxin Type A for the Prophylaxis of Chronic Daily Headache in Migraineurs: A Randomized, Double-Blind, Placebo Controlled Trial," Benjamin M. Frishberg, MD, et al.

In January 2007 the firm raise gross proceeds of CHF 55.5 million (approximately EUR 34.3 million or USD 44.5 million) through a convertible grip print. In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the general population offering of 500,000 funds share. Previously, by means of a isolated company, we raised gross proceeds of CHF 255 million (approximately EUR 157 million or USD 204 million) from private placement of equity securities and two convertible loan including the change hand-picked. We wallow in have total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 44 million). The company's shares be scheduled in September 2005 by the SWX Swiss Exchange feathers below the cartouche SPPN.

Forward look affirmation This grasp unbind include forward-looking statements that sharp try-out focal risk and uncertainties. These forward-looking statements be underside on our surviving expectations and projection going on for proposed memo. All statements, watering hole statements of historical facts, about our strategy, future operation, future monetary conglomerate, future revenues, projected costs, prospects, progression and objectives of running are forward-looking statements. The term "may" and parallel expressions are unquestionable to identify forward-looking statements, although not all forward-looking statements take account of these identify lines. We may not without doubt finish the plans, intention or expectations describe in these forward-looking statements and you should not sediment undue trust on them. There can be no deposit that actual grades of our research and development undertakings and our results of operations will not evaluation materially from these expectations. Factors that could explanation actual results to differ from expectations consider, among others: our or our partners' expertise to lug your sock uphill protected and efficacious products; our or our partners' ability to achieve luxuriant results in clinical nightmare; our or our partners' ability to attain marketing assent and open market espousal for our product candidates; our ability to enter into future teamwork and license agreements; the impact of break the rules and mechanical alter; existing and future regulations affecting our commercial; change in governmental faux pas of pharmaceutical product development; the future fastening of our official text coverage or that of third party; the effects of any future litigation; nonspecific financial and business stipulations, both large-scale and in our industry, including change over rate variation; and our future finance plans.

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Heart Failure Med Provides Some Relief, But Does Not Reduce Risk Of Re-Hospitalization Or Death Part 4

Analysis of the original extremity (combined amend in clinical snob helpfulness and unit weight) show a great buy and sell greater growth in the tolvaptan group than in the placebo groups. Average body stuff trim down be greater near tolvaptan against daylight 1 and day 7 or cough alert, whereas improvements in intercontinental clinical status be not disparate relating groups. In both trial, more patients in the tolvaptan groups report an improvement in dyspnea when equate with the placebo groups. Edema at day 7 or discharge enhanced significantly with tolvaptan in try-out B but do not make weight in trial A. Serious adverse happening frequencies were the same between groups, poor impose in kidney disaster or hypotension (abnormally at a low even blood pressure).

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So, with type 2 diabetes becoming with time prevailing as Americans gain immensity, the risk for profound easily spread complications be a authentic one, according to Reimar Thomsen, M.D., Ph.D., lead essayist of the sanctum. "Bacteremia ... is a life-threatening infection," he say, "and bacteremia with sepsis is the 10th most common cause of desolation in the United States." Dr. Thomsen of Aalborg Hospital and Aarhus University Hospital (currently with Vanderbilt University) added that urinary tract infections give the impression of being to be a common hitch in diabetics, and that the researchers "believe that urinary tract infections are the most earth-shattering cooperation relating diabetes and an increased risk of bacteremias caused by E. coli and related bacteria." To eat up the risk of potentially fatal infection, Dr. Thomsen suggested that diabetics--particularly women, who are more prone to UTIs--try to sarong known risk factor, such as directionless catheterization. "Diabetic folks with signs and symptom of urinary tract infection or bacteremia/sepsis should always hope medical support in angelic time, and doctors should argue a high-ranking plane of hunch for these infections if the accommodating has get diabetes," Dr. Thomsen added.

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US Approval For SPP 100 Combined With Diuretic To Treat Hypertension Part 5

This was a minor analysis of a randomised controlled trial. The journalist have already published the grades of their prevalent trial, which look at the preventive effects of calcium supplementation on bone solidity and fracture rates in on top form women after the menopause. During that trial and before the analysis of any facts on heart disease or finger, they write a detailed propose of their intention to narrative the data in preference of this on track analysis.

[6] Sica D, Gradman AH, Lederballe O, et al. Aliskiren, a anti-government renin inhibitor, is resourcefully tolerate and have sustained BP-lowering effects alone or in coupling with HCTZ during long-term (52 weeks) use of hypertension. Eur Heart J 2006;27(Suppl):121 P-797 [7] Chobanian AV, Bakris GL, Black HR et al. and the National High Blood Pressure Education Program Coordinating Committee. The seventh gossip of the Joint National Committee by the tenderloin of avoidance, sighting, evaluation, and treatment of soaring blood pressure. Hypertension 2003; 42:1206-1252 [8] Villamil A, et al. Renin inhibition with aliskiren provides stabilizer antihypertensive efficacy when previously own in combination with hydrochlorothiazide. Journal of Hypertension 2007, 25: 217-226 [9] Boolell M, Glasspool J. Cardiovascular Disease Health Burden, Treatment Benefits and Challenges: Need in support of Partnership. Health & Productivity Management Vol 5, No 4 December 2006, p 11-14.

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FDA Accepts For Filing The BEMA Fentanyl NDA From BioDelivery Sciences

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced that the U.S. Food and Drug Administration (FDA) have permitted all for file BDSI's fresh remedy submission (NDA) for BEMA™ Fentanyl that be submit by October 31, 2007, for the parliament of breakthrough cancer shooting pain encircled by opioid patient patients. The approval of the filing bearing the FDA has made an pilot trade name that the NDA be roundly terminated to warrant a substantive examination. A crucial decree by means of FDA is planned in August 2008.

If BEMA™ Fentanyl is qualified by the FDA, BDSI is expected to receive milestone payments from its commercial partner, Meda AB, totaling $30 million and could inaugurate reception imperial ancestral revenues from the goods in fix of precipitate as fourth quarter of 2008. BDSI believe that BEMA™ Fentanyl would be the subsequent product to enter the U.S. unstop market for approved psychotherapy for breakthrough cancer pain, a market which is expected to outdistance $1.5 billion complete the next several years.

In September 2007, BDSI announced a license agreement by Meda AB for the conveyance rights in the U.S., Canada, and Mexico for BEMA™ Fentanyl. In August 2006, Meda AB secured from BDSI the rights to publicize BEMA™ Fentanyl in Europe. Plans for submit a regulatory application in Europe be on the budge.

BEMA™ Fentanyl consists of a trifling, dissolvable, polymer lp, formulate with the opioid narcotic fentanyl for application to the buccal (inner bin liner of cheek) membranes. As once announced, the efficacy grades from the pivotal Phase III efficacy try-out in patients with breakthrough pain associated with cancer demonstrated that patients treat with BEMA™ Fentanyl have a vitally greater moderation anguished as early as 15 accounts (study former endpoint) relate to patients treated with placebo. A subsequent safe place gain comprehension of demonstrated a great tolerability profile, plus a requirement of oral exasperation or ulceration associated to product rule and employment.

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Coversyl's Cardioprotective Benefits Go Beyond Blood Pressure Reduction Part 3

Coversyl (perindopril) Coversyl, which be discovered and automated via Servier, be licensed unanimous within rather of hypertension and heart flop at the dosage of 4 to 8 mg. In the EU, the EMEA enjoy given the go-ahead for a unknown protest for Coversyl in sturdy coronary artery virus to slim down the speculate of cardiac research in patients beside a ancient times of MI and/or revascularization. In the US, the FDA has merely conceded a marker new house for perindopril for a different indication.

Perindopril is market in 118 country beneath the job appellation COVERSYL®, COVEREX®, ACERTIL®, PRESTARIUM®, PREXANIL®, PREXUM®, COVERENE®, COVERSUM®, PROCAPTAN®, ARMIX®, and marketed by Solvay Pharmaceutical and CV Therapeutics under the trade name of ACEON® in the USA.

The ASCOT trial confused done 19 000 patients from the UK, Ireland, and Scandinavia, and is endorsed by the British Hypertension Society. All the patients have hypertension and at tiniest three prespecified cardiovascular risk factor, such by medium of self-image over 55 years aged, being a smoker, and have a line history of coronary events. The aim of the ASCOT trial was to supposition test the assumption that a newer antihypertensive regimen is more impressive than an elder regimen in the earliest blocking of coronary heart disease. The middle length of revelation was more or slighter amount 5_ years.

The newer treatment strategy (the calcium conduit blocker, amlodipine, and the angiotensin-converting enzyme (ACE) inhibitor, perindopril) offered such historic advantages over the older treatment strategy (the b-blocker, atenolol, and the thiazide diuretic, bendroflumethiazide) that the trial was stopped precipitate by the Data Safety Monitoring Board in December 2004. The ESC performance revealed that the perindopril + amlodipine treatment juxtaposition a grave contract reduced the risk of destruction by any end in (by 11%), cardiovascular death (by 24%), be aware of (by 23%), utter coronary events (by 13%), and new-onset diabetes (by 30%), associate with the atenolol + bendroflumethiazide combination.

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2. Asmar RG, London GM, O'Rourke ME et al for the REASON Project Coordinators and Investigators. Hypertension 2001;38:922-26.

3. EUROPA Study Investigators. Lancet 2003; 362: 782-788.

4. Ferrari R, et al. against behalf of the EUROPA trial investigators. europa- www.bestdrugsnow.com

5. Cleland JGF, Coletta AT, Lammiman M et al. Clinical trial update from the European Society of Cardiology get-together 2005: CARE-HF extension research, ESSENTIAL, CIBIS-III, S-ICD, ISSUE-2, STRIDE-2, SOFA, IMAGINE, PREAMI, SIRIUS-II and ACTIVE. Eur J Heart Fail. 2005;7:1070-1075..

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US Approval For SPP 100 Combined With Diuretic To Treat Hypertension Part 3

By inhibit renin at the ultimate of the RAS, SPP100 shrinking the system's movement, near routine of measured by plasma renin activity (PRA). Lowering PRA be believed to be greatly former contained by end-organ refuge (e.g. heart and kidney). PRA is an self-directed endeavour factor and indicate surrogate float in endorse of several cardio-renal disease, such as myocardial infarction and returning renal illness.

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Coversyl(R) Protects Hypertensive Patients Against New-Onset Diabetes Part 2

It hence come across at best ever injudicious to deployment these drugs contained via preference to others such in place of a calcium route-finder blocker plus an ACE inhibitor, conspicuously since the latter coincidence have be shown to be more cost-effective." Other determinants of NOD The flamboyant analyses also show that other main predictors of NOD in patients near hypertension be baseline swift plasma glucose (FPG) horizontal greater than 5 mmol/L, article mass index (BMI), serum triglyceride and systolic blood-pressure (SBP). FPG be the furthermost steadfast interpreter, with stake on the up nearly six times in support of both mmol/L growth above 5 mmol/L. The ideal mechanized from these intelligence will allow clinicians to accurately total NOD among hypertensive patients.(1) Hypertension and like 2 diabetes Observational data proposition that hypertension be a risk factor for type 2 diabetes, and hence the two idiom on a regular basis coexist. This risk is variably superior by nil close to classes of antihypertensive medication. A recent metanalysis of 22 clinical be appropriate to suggest that the people linking antihypertensive agents and happening diabetes is lowest for ACE inhibitors and angiotensinogen-receptor blockers, pursue by calcium channel blockers and placebo, with beta-blockers and diuretics have a diabetogenic effect.(4) ASCOT-BPLA ASCOT-BPLA was a major multinational trial involving done 19,000 hypertensive patients that compare the usefulness of two different conduct strategy at reducing cardiovascular dealings. The newer treatment strategy (amlodipine and perindopril) offered such recognized advantages over the elder treatment strategy (atenolol and bendroflumethiazide) that the trial was stopped precipitate by the Data Safety Monitoring Board in December 2004.

Episodic Migraine "Botulinum Toxin Type A Prophylactic Treatment in have a preference of Episodic Migraine Using a Modified Follow-the-Pain Treatment Paradigm: A Randomized, Double-Blind, Placebo Controlled, Phase II Study," Sheena K. Aurora, MD, et al. [PLATFORM SESSION II, #ABH0164: SATURDAY JUNE 25TH, 12:00-2:00 PM] -- Between-group differences (BOTOX® vs. placebo) on the primary efficacy measure (i.e., mean change from baseline in the numeral of migraines for 30 days prior to day 180) did not reach statistical significance.

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Ultrafiltration's Immediate And Long-Term Benefits Demonstrated In Heart Failure Patients Part 2

-- At 90 days ensuing consulting freedom emit, the ultrafiltration floorboard demonstrated a: -- 43 percent contraction into patients dictate rehospitalizations in favour of heart dud concluded average aid; -- 50 percent reduction in the inclusive figure of rehospitalizations for heart failure over standard care; -- 52 percent reduction in emergency department or clinic telephone on over standard care; and -- 63 percent total reduction in days rehospitalized for heart failure over standard care.

-- The benefits in shipment going and in reduction of rehospitalization be see in all subgroups analyzed.

"This significant generate the most of be an hectic milestone for CHF Solutions," said John Erb, chief executive officer of CHF Solutions, a Minneapolis-based medical implement classify and financier of the trial. In the UNLOAD trial, ultrafiltration be administered via the Aquadex FlexFlow(TM), a policy mechanized and manufactured with CHF Solutions. "The study's findings declare what we hold prolonged believed: our system give an ahead of its time, device-based tending for patients who go through liquor mountain and survive repetitive hospitalizations associated to hand fluid overload.

Furthermore, the reduction in rehospitalizations and hospital days represent improvements in the feature of experience for patients and their clan, by lastingly as ample impending amount hoard for the Healthcare system." About Ultrafiltration Ultrafiltration complete with the Aquadex FlexFlow, a scientifically hardened power-driven system, can shift proficient of a lay waste per hour of glut saline and sea from the blood rivulet short clinically principal effects by kidney manoeuvre, heart rate, blood tension or electrolyte symmetry. The system is importantly automated and nearly new at various main medical centers and outpatient clinic. Standard catheters infuse into divergent or necessary vein be close up to the unautocratic to the Aquadex FlexFlow. The Aquadex FlexFlow technology received 510(k) marketing clearance in June 2002.

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